chronic pain health needs assessment report version 0 3

Chronic pain health needs assessment 1

Health Needs Assessment for Chronic

Pain Jammi Rao, Editor

with support and contribution of Sadia Janjua, Janine Dretzke, Daniel Eayres, Chris

Chiswell,

Version History

Document Title

Version 0.3

Author West Midlands Commissioning Support Unit

Publication Date 12 November 2012

Review Date

Supersedes/New Version 0.2

Comments

This version incorporates changes agreed at meetings between EA, DE, AFS, CC

and SJ. Major review and rewrite of the evidence review section; evidence

tables recast and moved to the appendix with a commentary on each SR in the

main text; DE’s sestion on epidemiology and prevalence of the major subtypes

of chronic pain, CC’s new section on cli nical pathway for chronic pain and

specialised services definitions for chronic pain treatments delivered as part of

the specialised services commissioning process

Previous versions

Version Date Changes

0.1 21.08.2012 First draft sent to EA for comments re style , layout and outline content

0.2 14.09.2012 Planned changes including a) exec summary; b) Corporate needs

assessment chapter out in, c) some editorial and technical tidying up of

content including Table and chart references, bibliographic references, and

spellings and typographic errors. This version was sent to the Black Country

Clinical Senate in time for 36.09 meeting agenda.

There was not the time before his deadline to address the comments made

by EA to version 0.1

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Contents

Executive summary................................................................................................5

1 Introduction ........................................................................................................ 8

2 Background ......................................................................................................... 9

Health needs assessment ............................................................................................ 9

The national context .................................................................................................. 10

The Nature of Chronic Pain ........................................................................................ 12

3 Epidemiology of chronic pain ............................................................................. 14

Definitions .................................................................................................................. 14

Sub-classification of chronic pain .............................................................................. 15

Most common sites of chronic pain .......................................................................... 19

Incidence and prevalence of chronic pain conditions ............................................... 19

The natural history of chronic pain ........................................................................... 37

4 The economic costs of chronic pain ................................................................... 38

NHS Expenditure on chronic pain .............................................................................. 38

NHS chronic pain expenditure in the West Midlands ............................................... 43

Notes on Programme Budget data quality and limitations ....................................... 47

5 Health service utilisation - outpatient activity .................................................... 52

Commissioner perspective ........................................................................................ 52

out-patient activity – provider perspective ............................................................... 58

6 Health service utilisation – inpatient and day case procedures ........................... 61

Data sources and methods ........................................................................................ 61

Results ........................................................................................................................ 62

Trends in Specific Procedures in pain management ................................................. 69

Analysis by provider Trusts ........................................................................................ 72

7 Stakeholder and Corporate needs Assessment ................................................... 74

Chronic Pain – Stakeholders ...................................................................................... 74

Chronic Pain – Service Delivery ................................................................................. 79

Commissioning chronic pain services ........................................................................ 82

Measuring Outcomes ................................................................................................ 84

Recommended Core Outcome Measures in Research .............................................. 85

4 Chronic Pain Health Needs Assessment

Taxonomy of Chronic Pain Services ........................................................................... 86

Pathways for Chronic Pain Patients ........................................................................... 90

8 Rapid evidence review of the effectiveness of interventions for chronic pain. .... 96

Objective .................................................................................................................... 96

Methods ..................................................................................................................... 96

Search methods for identification of studies ............................................................ 96

Data collection and analysis ...................................................................................... 97

Results ........................................................................................................................ 98

Manual therapy ......................................................................................................... 98

Pharmacological procedures ..................................................................................... 98

Patient education. ................................................................................................... 100

Physical treatments ................................................................................................. 100

Behavioural (BT) and cognitive behavioural therapy (CBT) .................................... 102

Invasive procedures ................................................................................................. 103

Multi-disciplinary interventions (MDI) .................................................................... 108

Appendix I – Admitted Patient Commissioning Data Set (CDS) data request

specifications ........................................................................................................... 111

Appendix II – Pain management procedure codes .................................................. 114

Appendix nn ............................................................................................................. 118

Appendix nn ............................................................................................................. 120

Chronic Pain Health Needs Assessment 5

EXECUTIVE SUMMARY

Chronic pain is widely prevalent, affecting an estimated 7.8 million people in England. It is

not one specific disease entity, rather it is a syndrome that usually involves more than self

reported pain in a particular anatomic location.

Estimates of the prevalence of chronic pain vary between surveys, depending on the

definition used, whether disability and interference with normal function is taken into

account, the country location of the study and the method of epidemiological enquiry. In

the UK the prevalence is probably between 11 and 13% of the adult population.

Referrals to pain management clinics are growing across the West Midlands. Total out-

patient attendances rose from 44,700 5 years ago to 51,587 in 2011/12. Just under a third of

these attendances are first appointments. The crude rate of pain clinic attendances as 11.7

per 1000 population, suggesting that a substantial proportion of the estimated cases that

are prevalent in the population are either self-managed or managed in the primary care

setting. There is wide variation between PCTs and between PCT clusters.

In keeping with the rise in out-patient attendances, clinical interventions and procedures in

hospital for the management of chronic pain also show a rise in recent years – from 27,694 5

years ago to 32,444 in 2011/12. Joint injections (43%), spinal operations (19%) and epidural

injections (17%) make up almost 80% of all procedures. The majority of interventions (86%)

are carried out as day cases.

There is a paucity of high quality research evidence to support the use of the many

treatments and interventions that are commonly deployed in the management of chronic

pain. Many of the published clinical trials suffer from methodological problems such as

small sample size, inadequate description of the intervention, short duration of follow up,

failure to achieve blinded assessment of outcomes, high rates of losses to follow-up and

failure to use validated measures of outcome. Systematic reviews of the available clinical

trials are available but they are necessarily limited by the lack of quality in the underlying

clinical trials.

In the case of chronic low back pain,

the evidence does not support the routine use of MRI as a diagnostic aid.

Surgical treatment based exclusively on MRI findings is not supported by the evidence.

Facet joint injections are of little proven value in chronic low back pain.

Spinal cord stimulation in cases of failed back surgery syndrome may confer pain relief more

effectively than either conventional medical management or re-operation, but the risk of

complications needs carefully to be considered.

Surgical operations on the spine when performed in carefully selected patients with lumbar

intervertebral disc prolapse may provide faster pain relief than conservative management

but the effect on longer term outcomes is uncertain. The risk of complications needs


carefully to be considered and set against the risk of progression when neurological

symptoms are present.

There are several interventional procedure guidance documents produced by NICEThese

include laser decompression, mechanical decompression, coblation, endoscopic laser

discectomy and endoscopic laser foraminoplasty. In all these instances the data on safety

and efficacy are not robust enough to allow them to be done without special arrangements

for consent for audit and research.

Cognitive behavioural therapy and other psychological therapies may offer short term

benefit but the quality of research evidence on longer term outcomes is much weaker.

Multi-disciplinary pain management programmes show promise of effectiveness with

moderately strong evidence from systematic reviews; but the underlying clinical trials are of

variable quality, with weak evidence for long term outcomes. There is support for such

programmes in the various guidelines that are available.

In the case of chronic pain other than chronic low back pain:

The available evidence does not support the use of electrotherapy, auriculotherapy and

acupuncture, low level laser therapy for neck pain and for carpal tunnel syndrome. The

generally poor quality of the trials makes it difficult reliably to draw conclusions without the

risk of bias.

Injections of Botulinum toxin-A may show some short term benefits in some cases, but the

quality of the trials lead to a conclusion of insufficient evidence for long term benefit in neck

pain, shoulder pain, myofascial pain, chronic musculoskeletal pain, or the pain of lateral

epicondylitis (tennis elbow)

Interlaminar epidural injections may confer some short term benefit in chronic neck and

upper limb pain but the trials were small and the quality of evidence was poor.

Intra-articular steroid injection in osteoarthritis was shown to confer significant clinical

benefit in but the effect disappears in 3-4 weeks.

Repeated injections of hyaluronic acid in knee osteo-arthritis was shown to confer short

term symptom relief but the evidence of disease modification in the long term is at best

speculative.

Manipulation or mobilisation in subacute or chronic neck pain produces short term benefit

but long term data are lacking.

Mechanical tyraction for chronic neck pain with or without radiculopathy is not statistically

significantly different from placebo.

Manual therapy and exercise in neck pain significanlt reduces pain and improves quality of

life, though the effect on radiculopathy is uncertain.

Gabapentin and pregabalin are effective in reducing pain in neuropathic pain and

fibromyalgia. Some studies suggest that the effect may extend to other outcomes such as a

return to work. Carbamazepine is also effective in reducing pain in chronic neuropathic pain

but side effects may limit its use.

Lamotrigine is not effective in treating chronic pain. Valproic acid is probably not effective in

neuropathic pain and fibromyalgia.


The evidence base for opioids is mixed. Patients able to continue long term opioids

experience significant clinical benefit, even though the evidence for quality of life and

functional improvement is inconclusive.

Cannabinoids are safe and effective in neuropathioc pain and probably also in fibrimyalgia

and rheumatoid arthritis.

Antidepressants are effective in improving pain scores in the treatment of neuropathic pain.

Surgical interventions such as sympathectomy (whether done surgically, chemically or by

radiofrequency ablation) may achieve significant reduction in pain score but the trials were

small and did not include a placebo arm.

Intrathecal delivery of drugs using implantable devices is supported only by low quality

evidence; they are associated with high rates on reversal and infrequent but serious

complications.

Multi-disciplinary interventions in chronic pain offer a safe and effective option for many

chronic pain syndromes. It remains unclear which of the components are critical for patient

benefit. Patient education programmes have not been shown to be effective. Behavioural

and psychological therapies in isolation have weak effects in improving pain.


1 INTRODUCTION

1.1 Chronic pain is a common and universal condition that has a major impact on the lives

of the many millions of people affected by it. Widely quoted estimates of its prevalence

suggest that as many as 7.8 million people in the UK may be affected by chronic pain of

at least moderate severity.

1.2 Chronic pain may be both a symptom of an underlying disease and, more commonly, an

illness or syndrome in its own right. In the latter situation, it can have a substantial

adverse effect on quality of life and well-being due to unemployment, sleeplessness and

depression. However it is relatively recently that chronic pain has come to be

recognised as a public health problem that calls for a different approach to the

traditional one based on regarding pain as a symptom for which there must be a

pathological cause that is amenable to diagnosis and treatment. Concepts are evolving

for the assessment of chronic pain in people without an underlying cause based on an

understanding of chronic pain as a distinct condition that merits a different approach to

management.

1.3 While the majority of cases of chronic pain in population based epidemiologic studies

are accounted for by three categories – pain following trauma, low back pain, and

arthritis and osteoarthritis – there are some disease entities that present major

diagnostic and management challenges. Fibromyalgia or chronic widespread pain is an

example of such a condition where the experience of pain and the consequent effects on

daily life itself leads to further pain and disability. Because of their chronicity and the

lack of effective curative treatments such cases tend to take up a disproportionate

amount of time from both primary care and specialist services.

1.4 There is a close inter-relationship between work, the experience of pain and the

availability of welfare payments for those deemed unfit for work. The initial experience

of pain leads to a prescription of rest and abstention from work and activity; this in turn

leads to deterioration of the original problem which, coupled with welfare payments,

acts as a disincentive to an early return to work. Acute pain is often the trigger for a

prescription of time off work, leading to chronicity, welfare dependency and continuing

chronic pain.

1.5 It is timely therefore to carry out a health needs assessment for chronic pain. In the

following pages this report will consider

The nature and patho-physiology of chronic pain Estimates of the prevalence of chronic pain The use of specialist hospital services for the treatment and management of patients with chronic pain; and the trends in the use of selected surgical procedures Trends in the use of pharmacological agents The effectiveness of treatment and management options available for the management of chronic pain.


2 BACKGROUND

HEALTH NEEDS ASSESSMENT

2.1 Health needs assessment (HNA) is a formal and structured method to understand the

need for health care and related services and support in a defined population, usually in

respect of a specified health or disease based topic. While individuals can also go

through a process of assessment as to their health and/or healthcare needs, HNA is

usually applied to whole populations or large subgroups thereof. HNA makes clear the

distinctions between need, demand and supply.

2.2 Need is defined as the capacity to benefit. It therefore follows that need can exist only

when there is an effective intervention to ameliorate the condition and resources are

available with which to procure the intervention.

2.3 Demand is what patients ask for, based on their lived experiences, what they know and

understand of their condition, and their knowledge and experience of the services and

treatments they expect to be available. It can be more or less than normative need, and

is often influenced by many factors including the media, advertising by suppliers and

anecdotal accounts of their peers. In health care, supply of services often generates its

own demand.

2.4 Supply refers to the health care that is provided; it is determined by the interests and

priorities of professionals, the political process and the resources that are made

available. Newer treatments are often supplied with the expectation that it will generate

its own demand and before the need for them has been fully and unarguably established

by high quality research.

2.5 HNA has the potential to tease out these conflicting and overlapping concepts and make

explicit the choices available to commissioners together with a clearer understanding of

likely impacts of their decisions. Seen in this light, HNA is not an isolated activity but an

integral part of the process of commissioning health care.

2.6 The traditional model of HNA is a composite of 3 separate but interlinked exercises:

Epidemiological needs assessment consists of the use of available data and information from whatever sources may be available to draw a picture of the scale of the condition or disease in question; its distribution among segments of the population defined by age, gender, ethnicity, social class, deprivation, and geographic location. Comparative needs assessment sets the local findings in the context of the region and the country. Comparisons are also possible with other areas of the country that share the same or similar socio-demographic, economic and cultural characteristics. Corporate needs assessment takes account of the views of key stakeholders involved in the provision of current services.

2.7 A distinction is also often drawn between healthcare needs and health needs

assessment. In practice the term HNA is often loosely used to include both; it is helpful

however to be clear of the distinction. Healthcare needs assessment confines itself to

the clinical and other curative and/or professionally delivered support and services that


can be delivered. Health needs assessment takes a broader, more holistic approach and

considers also the wider determinants of health that can often make a big difference to

the outcomes that people and communities experience and value. This report will

confine itself to healthcare needs of people with chronic pain.

THE NATIONAL CONTEXT

2.8 Chronic pain is not formally identified in any national service framework or policy

document as a priority for the health service. It is implicitly included in policy statements

and guidance documents that relate to the underlying diseases that give rise to chronic

pain.

2.9 In March 2000 the Clinical Standards Advisory Group (CSAG) produced a report (1),

‘Services for Patients with Pain’, at the request of Ministers ‘to advise on standards of

clinical care for patients with acute and chronic pain and on access to and availability of

services.’ A part of their report was based on a study carried out by a team from

Manchester and Leicester Universities in 1997 in 12 acute hospital trusts. The report

found that there was wide variation in the provision of services, with acute pain better

catered for than chronic pain. Some hospital services were poorly organised with lack of

dedicated time from consultants and an agreed role for specialist nurses. Among other

findings:

An estimated 7% of the population suffers chronic pain at any one time. A quarter of the population suffers from bouts of musculoskeletal pain, especially in the back. Most people treat themselves or seek help from their general practice. In most areas, pain services were ‘part of the package’. There were few explicit contracts for pain relief and not much by way of needs assessment. Local guidelines where they existed were of poor quality. Chronic pain services were poorly resourced and were unable to cope with the demands placed on them. Shortages of staff trained in psychology, occupational therapy, physiotherapy and of dedicated pharmacist support prevented a multi-disciplinary approach to management. Routine data and information systems did not record activity and outcomes in a systematic and meaningful way to allow evaluation of the services that were offered. Professionals thought that chronic pain as an issue had less of a profile than palliative care and it was difficult to attract investment in services. There was little by way of integration between different parts of the service either between general practice and specialist pain clinics or between pain specialists and other medical specialties. Specialist pain services often discharged fewer patients than they took on, building up a backlog of referrals and leaving patents feeling that their condition was not taken seriously.

2.10 In 2008 the Chief Medical Officer, Sir Liam Donaldson highlighted the problem of chronic

pain in his Annual Report (2). He stated that ‘...millions of people experience chronic

pain... imposing a heavy burden on them, their families and the economy at large.

Although we now have effective means of tackling both pain and the consequences of

pain, services have not kept up with demand and too many people struggle to cope with

their symptoms.’ The report concluded:


Pain is the most common symptoms and affects 7.8 million people in England. Chronic pain is more prevalent now than it was 40 years ago. All age groups are affected: a quarter of school age children reported pain lasting on average more than 3 years; most elderly residents of nursing homes experienced frequent moderate to severe pain. Pain and its effects are costly. Back pain alone is estimated to cost the economy £12.3 billion each year. Not enough is being done to implement programmes to treat pain early and effectively and thus stop pain becoming persistent. Specialist services are inadequate and unable to cope with the demand. Only 14% of people with pain have seen a pain specialist.

2.11 In Nov 2004 a research project by Dr Foster(3) reported on a survey of adult chronic pain

management in primary care. This survey was carried out in association with the Long

Term Medical Conditions Alliance, a charity representing the voice of patients, carers

and service users, and was funded by an educational grant from NAPP Pharmaceuticals,

a company that makes and sells drugs used in pain management. Among the important

conclusions of this survey are:

Chronic pain management is not a healthcare priority in the UK. 64% of primary care organisations (PCOs) failed to allocate specific funding for services in a primary care setting. Only 20% reported having a formal or structured chronic pain management service delivered in primary care. Only 4% of PCOs reported having a practice based register of people with chronic pain. 69% of PCOs reported that they did not have specific guidelines or recommendations for the management of non-cancer chronic pain. Only 8% of PCOs allocate part of their education and training budget to GP training for in the management of chronic pain. The provision and organisation of primary care chronic pain management services varies across the country. There is acknowledgement that there is insufficient money allocated to chronic pain services; that staff is poorly equipped to manage chronic pain; and that prescribing and management guidelines are needed.

2.12 In 2011 the Healthcare Quality Improvement Partnership, Dr Foster Intelligence and the

British Pain Society reported on the first phase of the National Pain Audit(4) – a three

year study set up in October 2009 that aims to establish a national data collection

system to monitor performance of pain services. The audit covers all specialist pain

services in England and Wales and reports organisational performance against a wide

range of standards set by the faculty of Pain medicine, British Pain Society and the

International Association for the Study of Pain. The results of this first phase of the audit

showed:

A total of 214 services were identified in England and Wales. Most PCTs reported between 1 and 3 specialist services for their populations. The poorest returns were for the Midlands and the South East. Most services reported meeting the NHS waiting time targets. The extent to which this also met the needs of patients is not known


64% of Services in England assessed themselves as ‘multi-disciplinary’. But using stricter criteria to define the label in terms of the presence of key personnel, only 40% would meet this standard. Services claiming to offer specialist treatments and interventions often lacked the appropriate staff (as assessed by their own data returns). Training for staff was not available for the majority of services.

THE NATURE OF CHRONIC PAIN

2.13 Pain is the oldest affliction known to man. In traditional medical practice pain is

traditionally seen as an important and useful symptom of an underlying disease. Its

severity, nature, fluctuation and how it responds to or is exacerbated by physical stimuli

are all useful pointers to an underlying pathology or disease process and therefore to a

therapeutically useful clinical diagnosis. When successful and effective treatment of the

underlying condition relieves the pain it provides comfort to the patient and satisfaction

to the doctor that the diagnosis was correct.

2.14 While this concept is helpful in acute short lived pain, it is less so when the pain

continues for more than a few days or weeks, or when the presumed underlying

diagnosis and its treatment fail to relieve the pain. Should pain therefore be regarded as

a disease or syndrome in its own right, quite independent from any presumed causative

disease process?

2.15 Croft (5) presents a compelling argument that chronic pain fits the criteria for a

condition independent of any underlying disease and one that merits definition by

reference to the subjective experience of pain, its severity, and duration. Clinical

experience amply demonstrates individual variation in the experience of pain following

equivalent tissue injury. At population level, variations of the prevalence of chronic pain

with social class, income levels and gender suggest the existence of risk factors that

would allow a public health approach to chronic pain. Physiological evidence from

neuro-imaging studies (PET, functional MRI, EEG and magnetoencephalography) points

to distinct and identifiable structural and functional changes in the brains of patients

with chronic pain (6,7). There remains uncertainty whether these changes lead to or

result from the chronic pain.

2.16 These ideas have led to the emergence of the concept of chronic pain as a condition or

disease or syndrome in its own right. The trigger for the initial experience of pain may

be an external injury or disease but other factors such as an underlying propensity to

chronicity, the availability or lack of fast effective treatment, the presence or lack of a

supportive environment for recovery, and a range of social and economic factors that

determine the level of motivation of the individual come together to determine whether

the end-result is chronic pain.

2.17 The distinction between the traditional biomedical view of pain-as-symptom-of-disease

and the emerging view of pain as a biopsychosocial condition (i.e. with a biological basis

at origin but with psycholigical and sociological determinants that justify viewing chronic

pain as a distinct disease entity) has practical implications . By viewing pain as a

symptom it is tempting for the patient to seek, and for the doctor to provide, extensive


diagnostic work-up and repeated trials of therapeutic interventions in the search for a

cure that may not in reality be possible. Indeed the pursuit of such diagnostic and

therapeutic interventions perpetuates in the mind of the patient the notion that the

pain is a symptom and acts as a barrier to consideration of the alternative model. In

contrast, the model of chronic pain as a specific disease allows alternative and

potentially more effective interventions to be considered and found acceptable.


3 EPIDEMIOLOGY OF CHRONIC PAIN

DEFINITIONS

3.1 From a clinical perspective, chronic pain exists when the patient feels that the pain is not

improving with readily available routine treatments. Pain itself is a subjective symptom

that the patient relates and therefore any distinction between acute and chronic pain must

also be led by the patient. However, for the purpose of epidemiological study of the

prevalence of chronic pain in the population, we need a clear definition even if its use in

questionnaires is dependent upon the subjective experience of patients.

3.2 The International Association for the Study of Pain (IASP) has defined pain as:

"An unpleasant sensory and emotional experience associated with actual or

potential tissue damage, or described in terms of such damage" (8)

3.3 Pain is classified by its chronicity (acute / chronic) and by whether the original underlying

tissue damage occurred within the nervous system or elsewhere (neuropathic /

nociceptive).

3.4 Acute pain is pain that is caused by occurrences such as traumatic injury, surgical

procedures, or medical disorders and which is short-lived, resolving during an appropriate

healing period.

3.5 Chronic pain is used to describe pain that is continuous, long-term or enduring beyond the

expected healing time. Pain itself is a subjective symptom that the patient relates and

therefore any distinction between acute and chronic pain must also be led by the patient.

However, for the purpose of epidemiological study of the prevalence of chronic pain in the

population, we need a clear definition even if its use in questionnaires is dependent upon

the subjective experience of patients. The IASP defines chronic pain as:

“Pain without apparent biological value that has persisted beyond the normal

tissue healing time (usually taken to be 3 months)” [Citation needed]

3.6 With chronic pain the patient’s presentation becomes more complex. There may be

psychological features, including complaints of poor or non-refreshing sleep, tiredness,

depression and poor concentration. Please note that this definition does not exclude the

presence of an underlying pathology.

3.7 The stated duration of 3 months is somewhat arbitrary but has come to be regarded as the

standard by most pain experts. In clinical practice some patients may approach doctors for

help sooner or later than the 3-month cut off period; some clinicians too may be inclined

to refer patients for help at an earlier stage; however, the IASP definition serves as a

useful, simple and practical definition to use in studying the population prevalence of

chronic pain.

3.8 For many underlying diseases and for many patients, pain is not constantly present; and

when it is constant the intensity often fluctuates. This variability in the experience of pain

is captured by the World Health Organisation (WHO) definition of chronic pain as [Citation

needed]:


“Current and persistent pain that has been present most of the time for 6 months or

more”

3.9 Other definitions that have been used in studies include: [IASR 2003]

“Recurrent or continuous pain for more than 3 months”

“Pain on most days for more than 3 months”

“Pain every day for more than 6 months”

“Pain or discomfort, continuous or intermittent, for more than 3 months”

3.10 There are other pain syndromes where there is enough known about the natural history of

the underlying disease process to allow a definition that is not so dependent on duration

alone. For example, post herpetic pain and the pain of trigeminal neuralgia follow very

different courses in the ‘average’ case. An exceptional situation is that of fibromyalgia, an

ill-defined condition that has become prominent in recent years and differs from other

pain syndromes in its lack of definition in terms of the site of the pain and in many cases by

its widespread nature. The term fibromyalgia is seen as unhelpfully suggesting the tissues

involved with little or no evidence in support. Pain experts prefer the term Chronic

Widespread Pain (CWP). The American College of Rheumatology (9) defined CWP as pain

that has lasted for more than 3 months in at least two contra-lateral quadrants of the

body together with pain in the axial skeleton. This leads to some loss of specificity for the

most severe cases and a group from Manchester proposed what is known as modification

that has come to be known as the Manchester definition (10): pain that has persisted for

more than 3 months in at least two sections of two contra-lateral limbs together with

pain in the axial skeleton.

3.11 Pain can be classified clinically as either nociceptive or neuropathic, although in practice

these can co-exist (mixed).

3.12 Nociceptive pain (tissue damage pain) arises from mechanical, chemical or thermal

stimulation of nociceptors (e.g. after surgery, trauma or associated with degenerative

processes such as osteoarthritis). It is important to realise that pain may persist long after

the nociceptive process has ended and that other factors, e.g. psychosocial features, may

need to be considered.

3.13 Neuropathic pain (nerve damage pain) is initiated or caused by a primary lesion,

dysfunction, disease or pathological change in the central or peripheral nervous system

(e.g. in conditions such as diabetic neuropathy or spinal cord injury). It has quite different

clinical features from nociceptive pain. It is less well localised and often is described as

burning or shooting. It can occur in areas that are numb and where there is no tissue

damage. It commonly presents in primary care and can be difficult to diagnose.

SUB-CLASSIFICATION OF CHRONIC PAIN


3.14 For the purpose of health needs assessment pain needs to be described in terms of sub-

categories of need. McQuay et al describe such a categorisation based on an audit of

demand at a pain clinic over a one month period. (11) The categorisation does not use the

mechanism of pain, apart from the generic grouping of neuropathic pain, giving the

following categories:

Musculoskeletal

Cancer

MUPS (medically unexplainable painful syndromes)

Face/head

Neuropathic

Vascular

Chronic postoperative pain.

Examples of conditions under each of these categories is given in Table 1.

3.15 The rationale given for including cancer as a category was that pain clinics commonly

provide invasive options for cancer pain at the behest of the palliative care team. [Text

here on whether/why we are excluding/ including cancer in the remit of this report]

Table 1 :Sub-classification of chronic pain

Musculoskeletal Back degenerative disc disease osteoporotic collapse stenosis facet joint post-trauma/surgery ankylosing spondylitis no clear pathology

Neck degenerative disc disease whiplash

Fibromyalgia/myofascial polymyalgia rheumatica Arthritis osteoarthritis, rheumatoid

Cancer Breakthrough cancer pain neuropathic, movement related, poor control

with oral morphine

MUPS (medically unexplained painful syndromes)

non-cardiac chest pain abdominal pelvic chest pain

Face/head pain Migraine Headache Trigeminal neuralgia Dental atypical facial

Neuropathic diabetic neuropathy postherpetic neuralgia multiple sclerosis


post stroke repetitive strain injury reflex sympathetic dystrophy (CRPS1) traumatic

Vascular Peripheral claudication/Raynaud’s Central angina

Chronic postoperative pain

pain after amputation (phantom and stump) chronic postoperative breast pain chronic postoperative thoracotomy pain chronic postoperative cholecystectomy pain

Source: McQuay et al, 2007(11)

Musculoskeletal pain

3.16 Musculoskeletal pain is pain that arises in or affects the muscles, bones, joints, ligaments

and/or tendons. It may be caused by degenerative diseases such as arthritis or

degenerative disc disease, by a specific trauma or injury, by overuse, underuse

(immobilisation), repetitive actions, poor body alignment, or may have no clear pathology.

3.17 Approximately half of this category is due to back pain. Back pain itself can be classified

into neck pain (cervical), upper back pain (thoracic) and lower back pain (lumbo-sacral).

Lower back pain is the commonest back problem.

Medically unexplained pain syndromes (MUPS)

3.18 These are conditions where the patient has symptoms for which no medical cause can be

found. That is not to say that there is no physical cause, only that such a cause is uncertain,

not determined or in dispute.

3.19 Conditions included in this category include chronic fatigue syndrome (CFS), myalgic

encephalomyelitis (ME), and unexplained chest, abdominal, and pelvic pain. Symptoms of

CFS and ME often include widespread muscle and joint pain and headaches. [Query

overlap between CFS/ME and fibromyalgia/CWP in musculo-skeletal pain]

Face/head pain

3.20 This category included any chronic pain conditions occurring in the face or head. Examples

are migraine, headache, trigeminal neuralgia, atypical facial pain and dental pain.

Neuropathic pain

3.21 As described above neuropathic pain is caused by a lesion, disease or pathological change

in the central or peripheral nervous system. It may be caused by several, often

overlapping, disease processes and represents a varying set of conditions rather than a

single diagnosis. There is no universally accepted sub-classification but four broad classes

of disease based on aetiology and anatomy are recognised: (12)

focal and multifocal lesions of the peripheral nervous system

generalised polyneuropathies of the peripheral nervous system


lesions in the central nervous system

complex neuropathic disorders

Examples of conditions in each of these classes are given in Table 2.(13)

3.22 Neuropathic pain commonly presents in primary care, can be difficult to diagnose and is

often unrecognised. Diagnosis is based on characteristic symptoms, altered sensation, and

a clinical history that matches a neuroanatomical or dermatomal pattern.

Table 2: Neuropathic pain syndromes

Sub-category Conditions

Peripheral nervous system focal and multifocal lesions

Post-herpetic neuralgia Diabetic mononeuropathy Nerve entrapment syndromes Plexopathy from malignancy or radiation Phantom limb pain Post-traumatic neuralgia (such as nerve root compression, post-thoracotomy) Ischaemic neuropathy

Peripheral nervous system generalised polyneuropathies

Metabolic/nutritional conditions: diabetes mellitus amyloid pellagra, beriberi multiple nutritional deficiency, hypothyroidism

Toxic conditions: alcohol platinum or taxane based chemotherapy isoniazid antiretroviral drugs

Infective/autoimmune conditions: HIV acute inflammatory polyneuropathy (Guillain-Barré syndrome) neuroborreliosis (Bannwarth’s syndrome)

Heriditary conditions: Fabry’s disease

Malignant conditions: Carcinomatosis

Other: idiopathic small fibre neuropathy

Central nervous system lesions Spinal cord injury Prolapsed disc Stroke (brain infarction, spinal infarction) Multiple sclerosis Parkinson’s disease Surgical lesions (such as rhizotomy, cordotomy)

Complex neuropathic disorders Complex regional pain syndrome types I and II


Sub-category Conditions

Source: Freynhagen et al, 2009. (13)

Vascular pain

3.23 Vascular pain is the pain resulting from central and /or peripheral vascular conditions such

as coronary artery disease and atherosclerosis. Constriction or blockages of blood vessels

restrict blood flow and starve the muscles of oxygen resulting in cramps and/or pain. This

usually occurs under exertion or stress and is relieved by rest. Examples include

claudication, ischaemic rest pain, Raynaud’s phenomenon and angina.


3.24 Chronic postoperative pain is pain that persists after the expected healing time for surgery.

It is usually focussed around the wound but may also radiate out to other parts of the

body. Specific causes include damage to peripheral nerves or body tissue during surgery,

scarring, and infection or inflammation at the site of the wound. Examples include pain

following amputation (phantom limb pain, stump pain) , mastectomy, thoracotomy, and

cholecystectomy, other postoperative abdominal and spinal pain; and failed back surgery

syndrome.

MOST COMMON SITES OF CHRONIC PAIN

3.25 A WHO survey of chronic care in primary care across 15 centres in Europe, Asia, Africa and

the Americas reported a prevalence of 22% of patients reporting ‘persistent’ pain.(14) The

most common anatomical sites where the pain occurred are given in table C. Back pain

was the most frequent affecting just under half of all those reporting pain. More than two-

thirds of patients reported pain in two or more sites.

Table 3: Anatomical site of pain

Anatomical site Subjects reporting pain (%)

Backpain 47.8

Headache 45.2

Joint Pain 41.7

Arm or leg pain 34.3

Chest Pain 28.9

Abdominal Pain 24.9

Pain Elsewhere 11.7

Number of anatomical sites

1 32.1

2 27.5

3 22.8

4+ 17.5

Source: Gureje et al, 1998. (14)

INCIDENCE AND PREVALENCE OF CHRONIC PAIN CONDITIONS


3.26 A large number of studies have been carried out in many countries over many years to

estimate the population prevalence of chronic pain conditions. The results are influenced

greatly by a variety of factors, of which the most important are the definition of chronic

pain used, the type of study undertaken (population survey or analysis of health records),

method of interview (whether by telephone or face to face), the non-response rate,

specific demographic characteristics of the population studied, the method by which the

sample was drawn, and the specification of the sampling frame.

3.27 Given the intermittent, recurrent, episodic nature of chronic pain, careful consideration

must also be given to the choice of measure of the disease frequency, particularly for the

purposes of health needs assessment. The most commonly reported measures of

incidence of new patients or the point prevalence of patients with chronic pain conditions

provide limited information of the need faced by services. Ideally what is required is a

measure of the frequency over a given period of time. A common measure reported by

population surveys is the lifetime prevalence of a condition, i.e. what proportion of the

population have ever experienced the condition at any point in their life thus far. This too

is difficult to use for needs assessment. In most cases the best measure is period

prevalence, i.e. the proportion of people who have experienced an episode of the

condition during a defined time period, usually one year.

3.28 It is not the purpose of this report to review this vast literature in detail, rather it is to

present reasonable estimates of the incidence and/or prevalence of the various chronic

pain conditions to help quantify the burden of disease.

Chronic pain overall

3.29 The Chief Medical Officer’s report 2008 estimated that 7.8 million people in the UK live

with chronic pain defined as ‘moderate to severe pain that has lasted over 6 months’,

approximately 13% of the population.(2)

3.30 A European-wide pain survey in 2004 reported a similar prevalence figure of 18% in

Scotland with only 3% of people accessing specialist pain clinics.(15) However in a 2007

health needs assessment for chronic pain McQuay et al reviewed a number of European

and Canadian studies which mostly reported much a higher prevalence of up to 50% of the

population.(11)These are summarised in


3.31 Table 4.

3.32 These studies suggest that chronic pain increases in frequency with age and is more

prevalent amongst women than men. Chronic pain may be particularly common in older

people in nursing homes or long-term care institutions. (16) Musculoskeletal pain is the

predominant sub-category. Two of the studies reported that for approximately half of

those with chronic pain the pain was severe.

3.33 McQuay et al estimated a typical Primary Care Trust population to have a prevalence rate

of patients with severe chronic pain of 5-10%.(11)


Table 4: Studies of chronic pain prevalence

Study Location Definition of chronic pain Age group

Prevalence findings

Andersson 1993 (17)

Sweden Duration > 3 months 25-74 Men: 50% Women: 50% Musculoskeletal pain most common. Prevalence increased with age.

Brattberg et al 1989 (18)

Sweden Obvious pain Duration > 6 months

18-84 Men: 38% Women: 42% Musculoskeletal pain most common. Peak prevalence in 45-64 years olds.

Birse & Lander 1998 (19)

Canada Recurrent or persistent pain Duration > 6 months

18+ Men: 35% Women: 66% Musculoskeletal pain most common. Peak prevalence in older age group and young women.

Bowsher et al 1991 (20)

GB Chronic pain lasting on or off Duration > 3months

15+ Persons: 11.5% Prevalence increased with age. Higher prevalence in women than men (1.5:1).

Chrubasik et al 1998

Germany Prolonged pain in the previous 6 months

18-80 Persons: 47% Of which: 87% > 1 year duration; 50% had severe pain; 29% severe and > 1year duration. Musculoskeletal pain most common.

Elliott et al 1999 (21)

Scotland Continuous or persistent pain Duration > 3 months

25+ Persons: 47% Of which half had severe pain or disability. Musculoskeletal pain most common. Prevalence increased with age.

Arnow 2006 USA Currently troubled by pain all the time or on an d off Duration > 6 months

21-75 Persons: 45% 33% reported non-disabling chronic pain. 13% reported disabling chronic pain. Persons with chronic pain were 5 times more likely to be suffering a major depressive disorder.


Study Location Definition of chronic pain Age group

Prevalence findings

Croft 2010 Various Various Adults Crude estimates based on a review of studies: Persons: 40% 25% prevalence for chronic pain interfering with life 10% prevalence for chronic disabling pain.

SjØgren 2009 Denmark Chronic/long-lasting pain Duration > 6 months

Persons: 20% Higher in females and increasing age. Higher prevalence associated with divorce, separation or widowed, <10 years of education and high BMI. 66.6% of chronic pain due to musculoskeletal diseases.

Musculoskeletal pain

3.34 Musculoskeletal disorders are the most common cause of chronic pain. Parsons et al

undertook a review of the literature for the incidence and prevalence of musculoskeletal

conditions for the period 1999-2010.(22) They identified two studies providing population

prevalence estimates for musculoskeletal pain overall: The Tameside Musculoskeletal

Project reported a prevalence of self-reported musculoskeletal pain of 11% in adult men

and 14% in women (13% for persons); the General Household survey 2006 reported similar

figures for long-standing musculoskeletal conditions of 12.6% for adult men and 18.3% for

women (15.6% for persons).(23,24)

Back Pain

3.35 Back pain is one of the commonest causes of disability and absence from work, particularly

during the productive middle years of adult life.(25) Low back pain probably affects around

one-third of the UK adult population each year. Of these, around 20% will consult their GP

about their back pain.(26) From this we can estimate 2.9 million people in England (1 in 15

of the population) will seek advice about back pain from their GP each year.

3.36 The data for quantifying how much of this is chronic pain is less reliable. One of the reasons

for this is the lack of agreement about definitions of chronic back pain, the different time

periods used and its intermittent nature.

3.37 A 1997 low back pain health needs assessment by Croft et al identified two UK surveys

reporting low back pain prevalence.(27) For both studies the one- year period prevalence

for low back pain lasting more than one day was 38% of adults.(28,29) Rates did not vary

much with age or gender. The OPCS study provided a breakdown by the number of days

of pain experience during the year. It reported that 10% of adults had pain for more than

12 weeks and 6% for more than a year.


3.38 A UK-based survey carried out by Webb et al in 1996, using a very broad case definition of

self-reported ‘back pain lasting more than one day in the past 12 months’, found an annual

period prevalence rate of 40% in adults. Using a more clinically relevant definition of pain

reported as ‘lasting for the whole year’, adult prevalence was estimated as 15%.(30)

3.39 Hillman et al, in a two-phase survey carried out in Bradford, reported a one-year

prevalence of low back pain of 39% in adults aged 25-64 years. A quarter of these were

classed as chronic, lasting over 3 months (10%). For 62% of those with chronic low back

pain, the condition was a long-standing problem with a history of five or more years.(31)

3.40 The COST European guidelines for the management of chronic nonspecific low back pain

identified a number of reviews and studies of back pain prevalence.(32) One systematic

review of 30 population prevalence studies of low back pain reported point prevalence of

low back pain ranging from 12-33%, 1-year prevalence from 22-65% and lifetime

prevalence from 11-84%.(33) A further study carried out in Sweden reported a prevalence

of chronic low back pain lasting longer than 3months of 23%.(17)

3.41 The one year period prevalence of low back pain which radiates to the legs below the

knees was 11% and is consistent with other studies reporting figures of 12 to 15% of all

adults.(34,35)

3.42 The prevalence of true sciatica has been estimated at 5%.(36)

3.43 The OPCs study reported 10% of adults reported at least one day of moderate or severe

disability, for 8% this was of more than 12 weeks duration. For 5% of adults disability was

both severe and longer than 12 weeks duration. Scandinavian and Canadian studies have

reported 10-12% of the adult population having low back problems that result in

impairment of daily activities or high disability.(36,37,38)

3.44 The 2007 General Household Survey found 3.7% of men and 3.4% of women reported

longstanding illness as a result of back pain.(24)

Table 5: One year period prevalence of low back pain by category and duration

Category By total days in pain in past year Total

<12 weeks 12 weeks – 1 year

All Year

Prevalence of low back pain (%) 28% 4% 6% 38%

Prevalence of low back pain with leg pain (%)

5% 2% 4% 11%

Prevalence of severe sciatica (%) 0.2% 0.3% 1.5% 2%

Prevalence of moderate and severe disability (%)

2% 3% 5% 10%

Prevalence of severe disability (%) 1% 2% 3% 6%

The category ‘low back pain with leg pain’ includes severe sciatica. Source: Croft et al, 1997.(27)


3.45 Hillman et al reported an overall annual incidence rate for the onset of new back problems

during the year, based on self-report from a questionnaire, of 4.7 per 100 (4.1 per 100

among men and 5.4 per 100 among women).(31)

3.46 The South Manchester Back Pain Study estimated a one year cumulative incidence for new

‘consulting’ episodes of 3.1 per 100 for men and 4.7 per 100 for women, and for new non-

consulting’episodes of 30.7 per 100 for men and 32.1 per 100 for women.(39)

3.47 In a German study of patients with chronic lower back pain, Freynhagen et al found 37% to

have predominantly neuropathic pain. These patients showed higher ratings of pain

intensity, with more numerous and more severe co-morbidities such as depression,

panic/anxiety and sleep disorders. The study estimated that 14.5% of all female and 11.4%

of all male Germans suffer from LBP with a predominant neuropathic pain component.(40)

Ankylosing spondylitis

3.48 Ankylosing spondylitis is a form of arthritis that mainly affects the lower back but may also

include other joints or parts of the body. The ligaments of lower spine become inflamed

and may stimulate bone growth resulting in vertebrae in the spine fusing together.

3.49 Studies have reported annual incidence rates for primary and secondary AS of 7.3 per

100,000 in the USA (41) and 8.7 per 100,000 in Norway.(42)

3.50 The Norway study reported point and period prevalence figures of 0.26% and 0.31%

respectively. This compares to another Norwegian study that reported a point prevalence

of 1,100-1,400 per 100,000.(43) A German study reported a point prevalence of 900 per

100,000 among blood donors in Berlin.(44) All studies report incidence/prevalence rates 3

to 6 times higher in men than in women.

3.51 The point prevalence of AS in the UK has been estimated at 1-2% of the population.(45)

Although dated, this figure is consistent with the second Norwegian and the Berlin studies.

The 4th RCGP survey (1991–92) reported an annual period prevalence for primary care

consultations for AS in the UK of 40 per 100,000 (60 per 100,000 among men and 10 per

100,000 among women).(46)

3.52 McQuay et al’s Chronic Pain HNA reviewed pain prevalence in patients with AS and

estimated 25-50% of AS sufferers experience chronic pain.(11) We estimate a point

prevalence of 250 to 1000 AS patients with chronic pain per 100,000 population.

Neck pain

3.53 McQuay et al’s chronic pain health needs assessment identified seven studies reporting the

prevalence of neck pain. Figures ranged from 5,000 to 20,000 per 100,000 population with

most estimates a round 10,000. They concluded that in a PCT population of 100 000

people there would be about 5000 cases.(11)

Whiplash

3.54 Whiplash describes a type of neck injury caused by sudden acceleration then deceleration

of the head resulting in spraining of the neck ligaments. It most commonly occurs as a

result of a road traffic accident, usually a collision from behind.


3.55 The Association of British Insurers states that 570,000 claims are made a year for whiplash

injuries in the UK, an incidence rate of approximately 900 per 100,000 population.(47) This

figure will be exaggerated by the inclusion of fraudulent claims. In a 2002 paper Galasko

estimates the number of new cases per year in the UK at 250,000 or 400 per 100,000

population.(48)

3.56 A study of whiplash attendances to an emergency department in Southampton found that

1 in 125 new patients had a whiplash associated disorder (WAD) following a road traffic

accident (RTA), and that two thirds of these are likely to have some degree of disability

four to six weeks after injury. Just over half of all the RTA attendances met the inclusion

criteria for WAD.(49)

3.57 In a previous study Galasko et al reported 46% patients attending an emergency

department following injuries sustained in an RTA, were diagnosed with neck sprain.(50)

Osteoarthritis

3.58 Osteoarthritis is an inflammatory disease of the joints that results from the degeneration

of cartilage. It is the most common form of arthritis and commonly affects the hands, feet,

spine, hips and/or knees. Primary osteoarthritis is mostly the result of aging. Secondary

osteoarthritis may also occur as a consequence of other disease or conditions such as

obesity, congenital abnormalities, gout and diabetes.

3.59 It is difficult to determine the exact incidence and prevalence of OA as the structural

changes, usually identified by radiography, do not always correspond with the clinical

syndrome of joint pain and stiffness. The clinical syndrome is more common than

radiographically confirmed osteoarthritis and much radiographic osteoarthritis occurs in

the absence of symptoms. For the purposes of a chronic pain health needs assessment it is

the clinical syndrome that is of relevance.

3.60 Parsons et al have undertaken a review of studies on incidence and prevalence for a

number of musculoskeletal conditions including osteoarthritis.(22) They found incidence

figures reported by the Royal College of General Practitioners Research Surveillance Centre

and the General Practice Research Database. The RCGP RSC reported incidence rates of

patients consulting for the first time with GP diagnosed OA. In 2001, the rate was 700 per

100,000 men and 1,200 per 100,000 women. Incidence increased with age, peaking in the

75+ age group (2,900 per 100,000 men and 3,600 per 100,000 women). Incidence was

higher among women than men in all age groups over 25 years. The GPRD found the

annual incidence of OA to be 1,290 per 100,000 in men and 1,860 per 100,000 among

women aged 40 or over. The same source data sets also provided estimates of period

prevalence. The RCGP RSC reported an annual consulting prevalence in 2001 of 1,800 per

100,000 men and 3,200 per 100,000 women. The GPRD data was used to calculate age-

standardised prevalence rates of 1,200 per 100,000 men and 2,000 per 100,000 women.

3.61 The GP-based prevalence figures from the RCGP RSC and the GPRD are much lower than

those reported in population-based surveys. This suggests that many people with OA do

not consult their GPs.


3.62 In a 2012 review Suri et al report symptomatic prevalence figures for osteoarthritis from

two studies set in the US. The prevalence in the over 45s for osteoarthritis of the knee

ranged rom 7 to 17%; in the hip 10%; and in the hand 11%.(51)

3.63 A Canadian study using routine administrative health data for British Columbia found a

point all-age prevalence of OA of 10.8% (8.9% for men and 12.6% for women). Prevalence

increased with age from around 10% in 45-49 year olds to over a third in those age d 70-74

years. The overall incidence rate of new cases was reported as 1,170 per 100,000 (1,000 in

men and 1340 in women).(52)

Rheumatoid Arthritis

3.64 Early figures for rheumatoid arthritis prevalence were published in 1961 for a study in

Leigh and Wenslydale. It reported a population prevalence of 1.1%.(53) More recent

figures have been published by the Norfolk Arthritis Register based on primary care

consultations. In 1990 this register reported an annual incidence of new cases of RA of 27

per 100,000 men, and 56 per 100,000 women.(54) The same register has also been used to

produce adult prevalence estimates extrapolated to the UK of 0.8% (0.4% among men and

1.1% among women). The prevalence was higher among women than men for all

groups.(55)

3.65 Similar figures were produced by the RCGP RSC for the year 2001 with one year period

prevalence for primary care consultation for RA of 0.2% among men and 0.6% among

women.(22)

Psoriatic arthritis

3.66 Psoratic arthritis is a type of inflammatory arthritis that occurs in patients with psoriasis. It

causes pain and swelling in the joints and may also affect tendons and ligaments.

3.67 The Norfolk Arthritis Register provides an estimate of psoriatic arthritis incidence for the

UK. In 1990-93 it reported an age adjusted incidence of 3.5 per 100,000 in adult males and

3.4 per 100,000 in adult females. Cases were defined as co-occurring psoriasis and

peripheral inflammatory polyarthritis.(56)

3.68 A study in Minnesota estimated the age and sex adjusted annual incidence of psoriatic

arthritis among adults to be 7.2 per 100,000 (9.1 per 100,000 in men and 5.4 per 100,000

in women).(57) A 2007 review by Cimmino reported incidence from four of studies in the

USA and Europe with rates ranging from 3 to 23 per 100,000.(58)

3.69 In the Minnesota study, the point prevalence of PsA in adults in 2000 was reported as 158

per 100,000 (193 per 100,000 men and 127 per 100,000 women).(59) Cimmino’s review

also included prevalence figures and reported point prevalence figures from six studies in

Europe and the USA ranging from 0.06% to 0.42%.(58)

Polymyalgia rheumatic

3.70 Polymyalgia rheumatic is an inflammatory condition that causes pain and stiffness in the

shoulders, neck and pelvis. Other systemic symptoms include lethargy, weight loss and

depression.


3.71 A 2008 review of the disease in the BMJ characterised its epidemiology as follows:(60)

The incidence of the disease in patients aged over 50 is about 100 per 100,000.

The average age of onset is just over 70 years of age. It is seldom diagnosed in

people younger than 50 years of age.

Polymyalgia rheumatica (PMR) is seen mainly in people of north European ancestry,

although it can occur in any ethnic group.

Women are more frequently affected than men with a female:male ratio of

approximately 3:1.

3.72 Defining a prevalent case of PMR is difficult, as the disease may be completely suppressed

by successful treatment with steroids. This may help to explain McQuay et al’s finding that

prevalence figures found in their review varied greatly, ranging from 30 per 100,000 to

2,000 per 100,000.(11)

3.73 Parson et al’s review reported prevalence figures from a UK community based study of

1,090 per 100,000 persons aged over 50 years; and annual period consultation prevalence

rates from the RCGP RSC of 140 per 100,000 men and 311 per 100,000 women.(22)

3.74 For their health needs assessment McQuay et al estimated an incidence rate of 50 per

100,000 person years and a point prevalence of 500 per 100,000 persons in a typical PCT

population. (11)

Chronic Widespread Pain (CWP) and Fibromyalgia

3.75 Chronic widespread pain (CWP) is a musculoskeletal disorder characterised by fatigue and

widespread chronic pain in the muscles and fibrous tissues of the body which can be

described as burning, throbbing, shooting, or stabbing. The cause is uncertain and there is

currently no generally accepted cure. The term fibromyalgia is often used as a pseudonym

but which in strict definition terms is a sub-set of CWP. The American College of

Rheumatology (ACR) diagnosis criteria used for fibromyalgia requires the presence on

examination of at least 11 of 18 specific tender points. Only about 20% of patients with

chronic widespread pain will meet these criteria, the remaining 80% are likely to have pain

that is similarly ‘central’ in nature, i.e. pain that is not due to inflammation or trauma.(61)

3.76 Parsons et al reviewed three UK studies looking at the prevalence of CWP in adults. The

point prevalence figures ranged from 7.9 to 9.4% in men and 10.5 to 15.6% in women.

They found no recent UK figures for the prevalence of fibromyalgia but did report two

North American studies with figures of 0.5% and 1.6% for men and 3.4% and 4.9% in

women.(22)

3.77 A single study was reported that investigated the incidence of GP-diagnosed fibromyalgia

based on data from the GPRD. The consulting incidence of fibromyalgia in 2001 was

estimated to be 35 per 100,000 person years. The incidence was reported to be 4 times

higher in women than in men.(62) CWP and fibromyalgia can occur at any age but peak

incidence and prevalence occurs around 50-64 years.(22,63)


3.78 McQuay et al estimate that in a primary care trust population of 100 000 people there

would be about 10,000 cases of chronic widespread pain, with about 200 to1000 of those

being defined as fibromyalgia.(11)

Knee pain

3.79 In older age groups osteoarthritis is responsible for most cases of knee pain but as

discussed above the epidemiology of joint pain and radiologically confirmed OA is not the

same. Parsons et al identified four studies of the prevalence of knee pain using GP

populations as the sampling frame. Figures reported include a point prevalence of 28.7%

of 40-79 year olds in Nottingham, and 19% of over 18s in the south east; a one month

prevalence of 19% of over 16s in Tameside; and one year period prevalence of 51% of over

50s in Staffordshire.(22,64)

3.80 A review by Peat et al identified five studies in England measuring the prevalence of knee

pain in older adults (various definitions but minimum age was 40 years) with figures

ranging from 13% to 28%.(65)

Shoulder pain

3.81 The prevalence of shoulder pain in the adult population is high. The Parson et al review

reports figures of 7–20% from population based surveys. Surveys in Tameside, Manchester

and South East England all reported prevalence rates of 14% in men and 17% in

women.(22)

3.82 A UK study using the IMS primary care consultation database, reported an incidence rate of

1.47% for adults aged over 18 for all shoulder conditions (1.45% for men, 1.49% for

women). The same study recorded a prevalence of 2.36% (2.28% for men, 2.43% for

women). Only 17% of these shoulder conditions were coded as ‘shoulder joint pain’ or

‘arthralgia – shoulder’, corresponding to a prevalence of 0.24%. Comparison to the

population survey based figures suggests that many people suffering shoulder pain do not

consult their GPs.

Medically unexplained pain syndromes (MUPS) [Query Overlap with musculo-skeletal symptoms

particularly CWP / fibromyalgia]

3.83 There is very little literature on the incidence and prevalence of medically unexplained pain

as a distinct condition. Two Dutch have attempted to quantify the presentation of such

symptoms in general practice. Verhaak et al looked at the consultations for medically

unexplained physical conditions, including a ‘cluster’ of pain conditions. Between 25 to

50% of all the GP consultations were medically unexplained but they included as cases only

those that had a persistent condition, defined by presenting at least 4 times during the

year of the study. Of all patients over 18 years of age who consulted with a GP during the

year, 2.45% had persistent medically unexplained physical symptoms, nearly half of these

(1.2%) had symptoms in the pain cluster.(66)

3.84 The aim of the second study by Kerssens et al was to estimate the prevalence of

unexplained severe chronic pain (USCP) in general practice. Patients were included if they

were aged between 18 and 75 years; and had pain which had lasted at least 6 months, was


the most prominent aspect in the clinical presentation, was serious enough to justify

clinical attention, and had led to obvious discomfort and disability in their daily life for at

least for 1 month. The overall prevalence was 7.91 per 1000 enlisted patients, ranging

from 1.87 in the youngest to 13.50 in the oldest patients.(67)

Face/head

Migraine

3.85 The reported prevalence rates for migraine vary greatly and depend largely on the case

definition used and age and sex structure of the study population. McQuay et al report

prevalence figures of 5 to 8% of men and 14 to 22% of women in a review of 10

studies.(11)

3.86 Rates were highest for both men and women in the 30-45 age group. The findings are

consistent with those reported in a meta-analysis of 18 studies of all ages and from all

countries.(68) Only about one in five or six people who suffer from migraine will seek

medical care.(69)

3.87 McQuay et al estimate that a primary care trust of 100 000 people will have about 10 000

women and 2000 men who suffer from migraine.(11)

Headache

3.88 Tension type headaches are the most common form of headache. McQuay et al identified

5 studies of chronic tension type headache –i.e. where a tension type headache occurs on

15 or more days per month. All of the studies used validated methods such as clinical

examination, telephone interview or self-assessed questionnaires. Four of these studies

reported one-year prevalence figures of between 1 and 3%, with higher rates in women

than in men.(11)

3.89 Cluster headaches are rare, extremely painful and debilitating headaches that occur in

groups or clusters. A review of the limited epidemiological studies by Torelli et al identified

5 studies with prevalence rates ranging from 56 to 326 per 100,000. There own study in

Parma reported a rate of 279 per 100,000 population aged over 14 years (338 per 100,000

men and 227 per 100,000 women).(70)

Trigeminal neuralgia

3.90 Trigeminal neuralgia is rare and there are very few epidemiological studies reporting its

incidence or prevalence. A Minnesota study reported an annual incidence rate of a first

episode of trigeminal neuralgia of 4.7 per 100,000 (3.4 per 100,000men and 5.9 per

100,000 women). The incidence rate rose with age with a peak in the 50-70 years age

group. The authors estimated a prevalence rate for current or recent attack in the 50-70

year age group of 400 per 100,000.(71)

3.91 A large study in Carlisle in the 1950s reported an incidence rate of 2.1 per 100,000 but the

authors noted that this was likely to be an underestimate as data from local ENT hospitals

were not included.(72)


Neuropathic pain

3.92 The overall prevalence of neuropathic pain in the general population is difficult to quantify,

due to the large number of underlying causes and the lack of standardised measurement

methods. However, two surveys suggest a prevalence rate of 6-8% of the general

population report chronic neuropathic pain.(73,74)

3.93 It has been estimated that half of such patients will require medication and regular support

to manage their pain.(75)

3.94 A study of primary care records from the Netherlands estimated the annual incidence of

neuropathic pain in the general population to be almost 1%.(76)

Diabetic neuropathy

3.95 In a community-based study from northwest England of 15,692 patients with diabetes, the

prevalence of clinical neuropathy was 49%, the prevalence of painful neuropathic

symptoms was 34% and the prevalence of painful neuropathy symptoms accompanied by

clinical neuropathy was 21%. The risk of painful neuropathy was increased in patients with

type 2 diabetes, women, and those of South Asian ethnicity.(77) studies have estimated

the prevalence of painful diabetic neuropathy in persons with diabetes to be between 16%

and 26%.(78,79,80)

3.96 The prevalence of diabetes in England in 2011 was 5.5%.(81) From these figures we

estimates that in a typical PCT population of 100,000 there are in the region of 5,500

people with diabetes, of whom approximately 1,850 have painful neuropathic symptoms

and of those 1,100 have clinical diabetic neuropathy.

3.97 Hall and colleagues have undertaken two studies of the incidence of painful diabetic

neuropathy using similar methods but two different UK primary care databases. They

reported incidence rates of 15.3 and 26.7 per 100 000 person years.(82,83)

Postherpetic neuralgia

3.98 Studies identified by McQuay et al estimate that Herpes zoster occurs in the general

population at a rate of about 340 per 100,000 person years. Postherpetic neuralgia (PHN)

is a common complication of herpes zoster, occurring in about 13–26% of cases. In the

studies reviewed, painful neuropathy in over 40% of people with herpes zoster aged over

50 was a common finding.(11)

3.99 A review of neuropathic pain epidemiology studies by Smith et al (84) found incidence

figures of 3, 27.3 and 40.2 per 100,000 person years. (85,86,87) A further study reported

an incidence rate for primary care consultation for postherpetic neuralgia of 34 per

100,000 person years.(88)

Multiple sclerosis (MS)

3.100 The crude incidence rate of MS in the UK has been estimated at 3.4 per 100,000 person

years for men and 7.4 for women.(89)


3.101 Based on a review of prevalence studies Richards et al estimated the prevalence rate of MS

in England & Wales for 2000 to be between 107 and 117 per 100,000 population.(90)

3.102 McQuay et al reviewed a number of studies examining the prevalence of chronic pain in

patients with MS. The definitions of chronic pain differed and but in all studies pain was

common, prevalence figures ranged from 29% to 65%.(11)

3.103 Based on the above figures we estimate a typical PCT population of 100,000 people in

England or Wales could expect to have about 55 patients with multiple sclerosis and

chronic pain and 3 new cases with pain each year.

Chronic post-stroke pain

3.104 Estimates of the incidence of stroke from two studies in England varied from 116 to 152

per 100,000 person years for men and from 135 to 171 for women.(91,92) A third study

reported a lower incidence of 104 per 100,000 person years for both genders

combined.(93)

3.105 Estimates for the prevalence of stroke in England vary depending on the source. Estimates

based on GP records suggest an all age prevalence of about 0.7%. (92),(93) Population

survey-based and modelled estimates suggest a prevalence figure around 3 times higher at

around 2 to 2.5%.(94,95)

3.106 In two studies identified by McQuay et al the prevalence of chronic pain in patients who

had had a stroke varied from 2% to 8.4%.(11)

3.107 In a primary care trust of 100 000 people we estimate there could be as many as 40 to 200

people living with chronic post-stroke pain.

Complex Regional Pain Syndrome (CRPS)

3.108 Complex regional pain syndrome (CRPS) is a type of chronic limb pain with clinical features

that include sensory, sudo- and vasomotor disturbances, trophic changes and impaired

motor function. The major characteristics are the presence of pain that is severe, diffuse,

non-dermatomal, and associated with allodynia (pain response to a non-painful stimulus).

The disease course varies from relatively mild and self-limiting to chronic disease with a

high impact on daily functioning and quality of life. CRPS most commonly affects a single

limb but involvement of other limbs by a spread of the process from the original affected

limb is known to occur.

3.109 The International Association for the Study of Pain divides CRPS into two types based on

the presence of nerve lesion following the original injury.

Type I, also known as Sudeck's atrophy, reflex sympathetic dystrophy (RSD), reflex

neurovascular dystrophy (RND), or algoneurodystrophy, does not have

demonstrable nerve lesions.

Type II, also known as causalgia, has evidence of obvious nerve damage.

3.110 Two population based studies have attempted to measure the incidence and prevalence of

CRPS in the general population. The first, set in Rochester, Minnesota over the period

1989-99 reported an incidence rate for CRPS I of 5.46 per 100,000 person years.(96)


Women were much more likely to be affected than men with incidence rates of 8.57 and

2.16 per 100,000 respectively. One-year period prevalence was also reported with a figure

of 20.57 per 100,000 population overall and 35.33 and 5.06 for males and females

respectively. Onset could occur at any age but the incidence increased to a peak in the 50-

69 age groups and decreased again thereafter. Incidence and one-year period prevalence

rates for CRPS II were found of 0.82 per 100,000 person years and 4.2 per 100,000 persons

respectively with no significant difference observed between genders. The study also

found that 74% of the CRPS cases underwent resolution, often spontaneously.

3.111 The second, more recent study was undertaken in the Netherlands over the period 1996-

2005 using a primary care research database. (97) The estimated overall incidence rate of

CRPS was over four times higher than the American study at 26.2 per 100,000 person

years. Females were affected at least three times more often than males (ratio: 3.4). The

highest incidence occurred in the 61-70 years age group. The study did not report

prevalence.

Vascular pain

3.112 There is substantial information on the incidence and prevalence of cardiovascular disease

due to its high mortality and morbidity. There is limited information about the incidence

and prevalence of painful symptoms associated with these conditions.

Intermittent claudication

3.113 Population studies have found that about 20% of people aged over 60 years have some

degree of PAD, and the most common initial symptom is pain in the leg on walking known

as intermittent claudication.(98)

3.114 A Dutch study of the prevalence of intermittent claudication reported a point prevalence in

an over 55 years population of 1.6% (2.2% of men and 1.2% of women). The same study

undertook a review of a further 13 population based surveys for similar age groups with

figures of the order of 1 to 2%.(99) A further Dutch study estimated the incidence rate of

IC as 640 per 100,000 person years in the over 55s.(100) The Framingham Heart Study in

Massachusetts reported a lower incidence of 225 per 100,000 person years in those aged

over 40 during the 1990s.(101)

3.115 A typical primary care trust of 100 000 people might expect to have 529 400–800 people

with intermittent claudication, and see 100-180 new cases a year.

Raynaud’s phenomenon

3.116 McQuay et als health needs assessment identified four population studies measuring the

prevalence of Raynaud’s phenomenon. The figures ranged from 2% to 15% but depended

to a large extent on the disease definition used.(11)

3.117 An additional 7-year study of Raynaud’s phenomenon based on the Framington Heart

Study in Massachusetts showed baseline prevalence rates of 11% in women and 8% in

men.(102)


3.118 We estimate a typical PCT population of 100,00 might expect to have of the order of 1,800

to 13,000 people with Raynaud’s phenomenon but cannot quantify how many of these will

be suffering from chronic pain.

Angina

3.119 The British Heart Foundation (BHF) report lifetime prevalence (having ever been diagnosed

with) angina in England 2009 based on data from the GPRD.(94) Male prevalence increases

from 0.1% in 0-44 year olds to 16.7% in the over 75s with an all age prevalence of 2.0%.

Female prevalence increases from 0.1% in 0-44 year olds to 11.5% in the over 75s with an

all age prevalence of 21.2%. These GP-based prevalence figures are lower than those

reported by population surveys. The Health Survey for England 2006 reports lifetime

prevalence rates in males from 0.1% in 16-24 year olds to 22.7% in the over 75s with an all

age proportion of 4.8%. For females, proportions increase from 0.1% in the 16-24 year olds

to 15.9% in the over 75s, with an all age figure of 3.3%.(103)

3.120 McQuay et al identified 4 population survey based studies which provide reliable

prevalence estimates for angina in the UK and estimated a figure of 5% in all adults.(11)

3.121 The BHF also report incidence rates for angina in England 2009 based on the same GPRD

source. Male rates increase from 54 per 100,000 person years in the 45-54 age group to

194 in the 65-74 year olds. Female rates are lower and increase from 30 per 100,000

person years in the 45-54 age group to 128 in the 65-74 year olds. All age incidence rates

are 45 per 100,000 person years for men and 25 for women. These incidence rates appear

low compared to the prevalence levels reported.

3.122 Neither of the above measures reported above lifetime prevalence or incidence of angina

provide information that readily quantifies the expected need for chronic pain services

related to angina.

3.123 A primary care trust with a population of 100 000 might expect to have about 4000 people

who have or have had angina.


3.124 The lack of an accepted definition for chronic postoperative pain is a major barrier for

quantifying its incidence and/or prevalence from the literature. Poor study design and

variations in the definitions of time after surgery, severity of pain, and its effect on quality

of life and function are largely responsible for the wide range in the published incidence

figures for given procedures. However it is clear from the scale of the estimates that

chronic postoperative pain is a significant problem. The best estimates for chronic pain

following major surgery are of the order of 10 to 50% of which between 2 to 10% are likely

to be severe.(104)

3.125 In most affected patients, postoperative chronic pain closely resembles neuropathic pain.

Major nerves trespass the surgical field of most of the surgical procedures associated with

chronic pain, and damage to these nerves is probably a prerequisite for the development

of postoperative chronic pain. In a subset of patients, a continuous inflammatory


response, such as after inguinal mesh hernia repair, can contribute to a maintained

inflammatory pain. Differentiation of neuropathic from non-neuropathic causes of

postsurgical pain is essential for the design of effective strategies to prevent and treat the

conditions.

3.126 Table 6 summarises the incidence estimates for selected surgical procedures from a

number of reviews and studies. In his review Macrae estimated a total incidence of new

cases of postoperative chronic pain for his included procedures to be between 41,000 and

103,000 in the UK, based on the number of procedures being undertaken.(105)This is

equivalent to 65 to 165 new cases per 100,000 population.

Pain after amputation (phantom limb pain)

3.127 The reviews suggest anywhere from 10% to 85% of patients undergoing an amputation will

suffer from chronic postoperative pain.

3.128 McQuay et al’s health needs assessment differentiates estimates for phantom limb pain

and stump pain. They reported phantom limb pain occurring in half to three-quarters of

amputees and that the pain can continue to persist long after the surgery (7 years). In one

study 7.5% experienced constant pain in the phantom limb. Studies on stump pain

reported rates of chronic pain from 49% to 62%.(11)

3.129 From data from a Dutch and a Finnish study McQuay et al estimates a prevalence of 25

amputees in a typical PCT population of 100,000 most of whom will have phantom limb

and/or stump pain.

3.130 A UK primary care based study has reported an incidence rate of 0.8 per 100,000 person

years for phantom limb pain.(106)

Chronic postoperative breast pain

3.131 McQuay et al reviewed 8 studies reporting the occurrence of chronic pain after breast

surgery. There was some variation because of time after surgery and whether the

definition included lumpectomy or only full mastectomy, but typically 20 to 50% of

patients reported chronic pain. Between 5 and 10% reported severe disabling pain.(11) A

wider range for chronic pain prevalence of 13 to 69% was reported by a second

review.(107)

3.132 Despite changes in surgical practice that have reduced the number of radical mastectomies

and replaced them with less invasive techniques the rate of chronic postoperative pain

remains high. A 2007 study of sentinel lymph node biopsy or axillary lymph node

dissection reported a prevalence of 22% and 55% respectively for numbness at 5 years

after surgery. (108)

Chronic postoperative thoracotomy pain

3.133 Chronic pain after thoracotomy was common occurring in 5 to 65% of patients. Estimates

for the occurrence of severe pain ranged from 10% to 15% to 25%.(11,109) It is difficult to

quantify the number of thoracotomy procedures performed in England as the routine HES


statistics report on the main procedure in an episode. Thoracotomy is unlikely to be

recorded as the main procedure.

Chronic postoperative cholecystectomy pain

3.134 McQuay et al reported two prospective studies investigating the occurrence of chronic scar

pain following open cholecystectomy. At 12 months occurrence of chronic pain at the

incision site was 27%, and at 24 months 21%. Two further studies attempted to compare

the occurrence of chronic pain after between open and laparoscopic cholecystectomy. Stiff

et al. reported a occurrence of 3.4% after laparoscopic compared with 9.7% after open

procedure. Wilson and Macintyre found a similar occurrence of 7% in both

groups.(110,111)

Other postoperative pain

3.135 Poobalan et al’s review of pain following inguinal hernia repair concluded that 30% of

patients report chronic pain of which a third (10%) are moderate to severe. The reported

pain was predominantly neuropathic in character.(112) A second inguinal hernia review by

Aasvang and Kehlet estimated 12% of patients will suffer from chronic postoperative

pain.(113)

3.136 Studies investigating postoperative pain following orthopaedic surgery have reported an

incidence of chronic pain between 8 and 28% for hip replacement with pain limiting daily

activities to a moderate, severe or very severe degree in 12.1%.(114,115) An incidence of

35% has been reported for knee replacement.(116)

3.137 There have been very few studies of chronic pain following minor orthopaedic surgery. One

study in France has reported chronic postoperative pain incidence of 22% in patients

undergoing surgery for Carpal Tunnel Syndrome, a rate similar to those reported above for

major surgeries.(117)

Table 6: Estimated incidence of chronic postoperative pain and disability after selected surgical procedures

Procedure Kehlet 2006 (118) NHS QI

Scotland

2006

(119)

Macrae

2008

(120)

McQuay

2007 (11)

Selected

Other

(121,122,

123)

Main

procedure

episodes

England

2011/12

(124,125)

Chronic

pain

Severe

(dis-

abling)

pain

Amputation 30-50% 5-10% 30-85% 50–85% 51-85% 15,000

Breast surgery

(lumpectomy and

mastectomy)

20-30% 5-10% 11-57% 20–50% 25-50% 58,000

Thoracotomy 30-40% 10% 5-67% 5–65% 14-67%

Cholecystectomy 3-56% 5–50% 3-27% 69,000

Inguinal hernia repair 10% 2-4% 0-63% 5–35% 30% 81,000


Caesarean section 10% 4% 6% 166,000

Cardiac surgery 30–55% 41,000

Coronary artery

bypass surgery

30-50% 5-10% 20,000

Hip replacement 12% 8-22% 83,000

Knee replacement 35% 79,000

THE NATURAL HISTORY OF CHRONIC PAIN

3.138 Chronic pain is not yet formally recognised as a separate disease entity and therefore not

recorded as such. Clinical data systems record the underlying disease and therefore there

is not much readily available information on the course of chronic pain over time. There is

therefore a paucity of good data on which to base robust conclusions about the natural

history of chronic pain. Research studies too are scarce since chronic pain is a field that has

only recently been opened up to epidemiological investigations.

3.139 One of the few good follow-up studies is that by Elliott(126), who reported a 4 year follow-

up study based on the original cohort that was assembled in 1996 for their prevalence

study reported earlier(127). They achieved a response rate of 83% of the original

respondents. 79% of those with chronic pain at baseline still had it at follow-up with an

average annual recovery rate of 5.4%. Older people (aged 45-74) with chronic pain were

less likely to recover than those aged 25-34.

3.140 The course of chronic widespread pain (CWP) has been reported in a follow-up study from

Manchester(128). A postal survey was carried out of 2334 adults registered with 2 general

practices and repeated again 7 years later with those of the initial responders who were

still registered with the same practices. While CWP prevalence was broadly similar on both

occasions (11% and 10% respectively), the interesting finding was of the persistence of

CWP. Of those with CWP initially, a third recorded CWP on the follow-up survey, while only

2% of subjects with no initial pain recorded CWP on the subsequent survey. Age was an

important factor in the persistence of CWP. Among subjects with CWP in the initial survey

who were aged over 50, 77% reported CWP 7 years later. Pain once established is likely to

persist or recur and older age appears to be a risk factor.

3.141 In a one year follow-up study of subjects with CWP identified in a survey of people

sampled from a population-based register, researchers from the same unit in Manchester

found that CWP persisted in 56% of patients at 1 year. This is a useful finding since the

impression gained from clinic based cohorts is that the persistence of pain is much more

frequent. Persistence of pain symptoms was also found to be associated with a pattern of

illness behaviour characterised by frequent visits to the doctor and high baseline test

scores for psychological distress and fatigue.


4 THE ECONOMIC COSTS OF CHRONIC PAIN

4.1 The CMO report of 2008(2) reported a figure of £12.3 billion as the total cost of back pain

alone. This figure included not only the direct costs of investigating and treating the

underlying disease and the pain itself but also the indirect costs incurred due to lost

productivity arising from sickness absence, compensation payments, and welfare benefits.

Of the direct costs of chronic pain, prescriptions of pain relieving drugs account for an

expenditure of £584 million each year.

4.2 Phillips(129) provides a concise summary of the available research from different countries

into the economic impacts of pain. For the UK, the indirect (lost productivity) cost of back

pain was estimated to be between £5 billion and £10.7 billion in 1998 depending on the

assumptions made.

4.3 The link between a health related problem and employment was explored exhaustively in

the report by Dame Carol Black(130). Back pain is the fourth most common cause of short

duration sickness absence (up to one week), after colds, flu and diarrhoea and sickness.

Back pain and other pain related ‘problems with joints or muscles’ each accounted for 10%

of absences of between 1 and 4 weeks.

4.4 A clear distinction is necessary between painful conditions (injury, joint and muscle pain,

low back pain) and chronic pain. Specialist pain services see the most severe cases of

chronic pain; these are difficult to treat and rehabilitate and so they may have the

impression that a return to work is not the norm. However, more systematic studies show

that 85% of those off work due to musculoskeletal injuries and 83% of those with back

pain actually return to work after and absence of 4 weeks or more.

4.5 Of the 4 leading causes of long term sickness absence, two (musculo-skeletal conditions,

and back pain) are related to chronic pain. The other two are stress/anxiety/depression,

and cancer-related illnesses, where too there may be an overlay of pain as a leading cause

of loss of functional ability.

NHS EXPENDITURE ON CHRONIC PAIN

4.6 The Department of Health’s Programme Budget project provides a source of information

on where the NHS is spending its budget. Since 2003/4 annual data have been supplied by

Primary Care Trusts detailing their expenditure by specific healthcare conditions or

categories. The programme budgeting collection for 2010/11 comprised 23 categories,

most of which are based on the World Health Organization’s International Classification of

Disease version 10 chapter headings. Examples include: Cancers & Tumours, Mental Health

Disorders, and Problems of Circulation. Each of the categories is further divided down into

more specific sub-categories. Budgets spent on chronic pain are assigned to the category

7-Neurological Problems and the sub-category 7A-Chronic Pain.

4.7 In addition the data set for 2010/11 also saw the introduction, for the first time, of a

breakdown of the programme budget category data by 12 care settings.(131) These

settings are described in Table 7.


Table 7: Programme Budget care settings

Care setting name Description

Prevention & health promotion

Primary & secondary prevention, health promotion, family planning, school health services, national screening programmes, public health programmes for communicable and non-communicable disease, epidemiological surveillance and public health administration.

Primary care Primary care costs relating to services provided by GPs, primary dental services and primary ophthalmic services excluding those which relate to prevention/health promotion.

Primary prescribing Primary care activity relating to prescribing or pharmaceutical services, excluding those which relate to prevention/health promotion.

Inpatient: Elective & Daycase

Admitted patient care activity which takes place in a hospital setting where the admission was elective or as a day-case.

Inpatient: Non-elective

Admitted patient care activity which takes place in a hospital setting where the admission was as an emergency/non-elective.

Outpatient Outpatient attendances or procedures.

Other secondary care Activity included with this setting will include direct access services, unbundled services (excluding critical care) and secondary care services which cannot be allocated to more specific settings. Mental Health secondary care services should also be included within this care setting.

Ambulance Urgent and emergency transport, i.e. Ambulance activity and 111 expenditure.

A&E All activity which takes place within A&E departments and minor injury units.

Community care Care delivered outside of a hospital and within local communities. Inpatient and outpatient activity carried out within community hospitals should be classified as secondary care activity. All other activity carried out in community hospitals should be classified as community care.

Care provided in other setting

All other health and social care services which are not included within the other health settings. Includes prison healthcare, nursing homes, hospice care. Continuing care, intermediate care, respite care, free nursing care should be included within this setting. Social care and learning disability services should be included within this setting unless otherwise specified by the mappings.

Non health / social care Expenditure which is not related to the commissioning or provision of health/social care services (e.g. costs relating to facilities & estates).

4.8 Mapping activity and budget data to programme budget categories and care settings is a

detailed process. Guidance documentation is provided to PCTs by the Department of

Health (131) and PCTs are encouraged to adhere to the outlined mappings even where

local knowledge may enable more accurate allocations. If uniform allocation is achieved

then variation of expenditure between PCTs is less likely to reflect coding and calculation

differences.

4.9 Spend and activity mapping to sub-category 7A-Chronic Pain for the main care settings of

primary prescribing, outpatient and inpatient settings data are outlined below:

Primary prescribing


4.10 The mapping of the spend on drugs prescribed in primary care to Programme Budget sub-

category is not undertaken at the patient or script level, i.e. it is not possible to assign

individual scripts to a sub-category based on the indication for which it was written.

Instead, British National Formulary classifications are used to map the total PCT spend on

each type of drug to the sub-categories. Where drugs have indications from across more

than one sub-category, the expenditure is allocated to those categories on a defined split

basis.

4.11 Table 8 lists those drugs from BNF classification section 4.7 – Central Nervous system:

Analgesics that are allocated to 7A–Chronic pain, together with their splits.

Table 8: Primary care prescribing – drugs mapped to Programme Budgeting sub-category 7A-

Chronic Pain

BNF Section Sub-section Chemical substance Programme Budget Sub-

category (% split)

4 Central nervous system

4.7: Analgesics

4.7.1 Non-opioid analgesics 7A/15X/16X (5:75:20)

4.7.2 Opioid analgesics

Buprenorphine 7A/2X (50:50)

Codeine phosphate 7A/13B/15X/16X (50:5:35:10)

Dihydrocodeine tartrate 7A/15X/16X (50:40:10)

Tramadol hydrochloride 7A/15X/16X (50:40:10)

4.7.3 Neuropathic pain 7A

Source: Programme Budgeting mappings and definitions, Department of Health.(132)

4.12 The spend on primary care prescribed drugs for chronic pain includes 5% of all non-opioid

analgesics; 50% of the opioid analgesics buprenorphine, codeine phosphate,

dihydrocodeine tartrate and tramadol hydrochloride; and all neuropathic pain drugs

(though many of these preparations share additional indications).

Outpatients - attendances 4.13 Outpatient activity is mapped to Programme Budgeting sub-category at the level of

individual attendance based on its treatment function code (clinic or specialty code). Two

treatment function codes are mapped to 7A Chronic Pain and these are 191 Pain

Management and 241 Paediatric Pain Management.

4.14 Mandatory national tariffs apply for Pain Management attendances as outlined in Table 9.

The actual local tariff will include a local market forces factor. Paediatric Pain Management


attendances are excluded from the national tariffs and prices are agreed locally.

Table 9: Pain Management outpatient attendance tariffs

Attendance type 2010/11 £

2011/12 £

First Attendance - Single Professional 160 156

First Attendance - Multi Professional 231 220

Follow Up Attendance - Single Professional 84 83

Follow Up Attendance - Multi Professional 95 98

Source: NHS Payment by Results 2010-11 National Tariff Information, Department of Health.(133)

Outpatients - Procedures 4.15 Spends associated with certain procedures performed in outpatients are also mapped to

Programme Budget sub-categories. These are assigned at the individual activity level based

on the Health Resource Group (HRG) code to which the procedure is mapped. There are 2

HRG codes mapped to 7A-Chronic Pain:

4.16 AB05Z - Intermediate Pain Procedures

4.17 AB06Z - Minor Pain Procedures

4.18 The procedures that are mapped to these two HRG codes are listed in appendix I.

4.19 Both of these HRG codes are allocated a cost of £202 (FY 2010/11) and £229 (FY2011/12)

within the national tariff. (133)

Inpatient spells 4.20 Inpatient activity is mapped to Programme Budgeting sub-category at the level of

individual spell based on the spell’s primary diagnosis code. There are 90 ICD10 diagnosis

codes identified by the guidance that are mapped to 07A Chronic Pain (Table 10).(132)

Unlike for outpatient activity, it is not possible to provide a simple list of costs associated

with the inpatient spells that are assigned to Chronic Pain. The cost of each spell is

assigned according to the spell’s HRG code and whether the activity was undertaken as an

elective or emergency admission. HRG codes are assigned primarily on the basis of the

procedure(s) undertaken, and not on the diagnosis. Consequently there is no direct

mapping of HRG and associated cost to programme budgeting categories.

4.21 There are a number of HRG codes that relate specifically to the care of pain and the tariffs

for these give an idea of the cost involved in individual treatments. Not all of the activity

assigned with these HRG codes will be assigned to Chronic Pain Programme Budget sub-

category (e.g. some might be assigned to 15-Problems of the musculoskeletal system or

04A Diabetes) but a significant proportion of the Chronic Pain sub-category is likely to

consist of these HRG codes. The codes and their associated costs are given in Table 11.

[Are these HRGs likely to be used in the management of Acute Pain?]. For example, in

2011/12, a complex major pain procedure carries a tariff of £708 for a daycase/elective

admission and £5,025 for a non-elective admission. For both elective and non-elective


admissions for this HRG, a trim point of 5 days is assigned after which a further £227 per

day is costed. (133)

Table 10: Inpatient primary diagnosis codes mapped to Programme Budget sub-category 07A Chronic Pain

ICD10 ICD Text ICD10 ICD Text

B330 Epidemic myalgia G636 Polyneuropathy in other musculoskeletal disorders

G440 Cluster headache syndrome G638 Polyneuropathy in other diseases classified elsewhere

G441 Vascular headache G64X Other disorders of peripheral nervous system

G442 Tension-type headache H571 Ocular pain

G443 Chronic post-traumatic headache H920 Otalgia

G444 Drug-induced headache K146 Glossodynia

G448 Other specified headache syndromes M255 Pain in joint-Site unspec

G500 Trigeminal neuralgia M315 Giant cell arteritis with polymyalgia rheumatica

G501 Atypical facial pain M353 Polymyalgia rheumatica

G521 Disorders of glossopharyngeal nerve M541 Radiculopathy-Site unspe

G546 Phantom limb syndrome with pain M542 Cervicalgia-Site unspe

G564 Causalgia M543 Sciatica-Site unspe

G570 Lesion of sciatic nerve M544 Lumbago with sciatica-Site unspe

G571 Meralgia paraesthetica M545 Low back pain-Site unspe

G572 Lesion of femoral nerve M546 Pain in thoracic spine-Site unspe

G573 Lesion of lateral popliteal nerve M548 Other dorsalgia-Site unspe

G574 Lesion of medial popliteal nerve M549 Dorsalgia

G575 Tarsal tunnel syndrome M774 Metatarsalgia-Site unspec

G576 Lesion of plantar nerve M791 Myalgia-Site unspec

G578 Other mononeuropathies of lower limb M792 Neuralgia and neuritis

G579 Mononeuropathy of lower limb M796 Pain in limb-Site unspec

G580 Intercostal neuropathy M913 Pseudocoxalgia-Site unspec

G587 Mononeuritis multiplex N644 Mastodynia

G588 Other specified mononeuropathies N940 Mittelschmerz

G589 Mononeuropathy R070 Pain in throat

G600 Hereditary motor and sensory neuropathy R071 Chest pain on breathing

G601 Refsum's disease R072 Precordial pain

G602 Neuropathy in association with hereditary ataxia R073 Other chest pain

G603 Idiopathic progressive neuropathy R074 Chest pain

G608 Other hereditary and idiopathic neuropathies R101 Pain localized to upper abdomen

G609 Hereditary and idiopathic neuropathy R102 Pelvic and perineal pain

G610 Guillain-Barr‰ syndrome R103 Pain localized to other parts of lower abdomen

G611 Serum neuropathy R104 Other and unspecified abdominal pain

G618 Other inflammatory polyneuropathies R200 Anaesthesia of skin

G619 Inflammatory polyneuropathy R201 Hypoaesthesia of skin

G620 Drug-induced polyneuropathy R202 Paraesthesia of skin

G621 Alcoholic polyneuropathy R203 Hyperaesthesia

G622 Polyneuropathy due to other toxic agents R208 Other and unspecified disturbances of skin sensation

G628 Other specified polyneuropathies R300 Dysuria

G629 Polyneuropathy R309 Painful micturition

G630 Polyneuropathy in infectious and parasitic diseases EC

R51X Headache

G632 Diabetic polyneuropathy R520 Acute pain

G633 Polyneuropathy in other endocrine and metabolic diseases

R521 Chronic intractable pain

G634 Polyneuropathy in nutritional deficiency R522 Other chronic pain

G635 Polyneuropathy in systemic connective tissue disorders

R529 Pain

Source: Programme Budgeting mappings and definitions, Department of Health.(132)


4.22 One clear characteristic of the tariffs is the difference between elective and non-elective

costs. For the 2011/12 financial year the non-elective costs are between 2 and 7 times

higher than the equivalent daycase/elective.

Table 11: Pain related HRG codes and national tariffs, FYs 2010/11 and 2011/12

HRG code

HRG name Combined Daycase / Elective tariff (£)

Elective long stay trim point

(days)

Non-elective

spell tariff (£)

Non-elective

long stay trim point

(days)

Per day long stay payment (for days

exceeding trim

point) (£)

Eligible for

Specialist Top-up

National Tariff 2010/11

AB01Z Complex Neurosurgical Pain Procedures

1,980 3 5,940 3 307 Yes

AB02Z Complex Major Pain Procedures

743 1 4,355 1 231 Yes

AB03Z Complex Pain Procedures

668 1 3,661 41 227 Yes

AB04Z Major Pain Procedures 643 1 2,475 21 222 Yes

AB05Z Intermediate Pain Procedures

544 1 2,079 39 202 Yes

AB06Z Minor Pain Procedures 463 1 1,449 14 239 Yes

National Tariff 2011/12

AB01Z Complex Neurosurgical Pain Procedures

2,503 9 5,574 9 209 Yes

AB02Z Complex Major Pain Procedures

708 5 5,025 5 209 Yes

AB03Z Complex Pain Procedures

636 5 4,225 29 209 Yes

AB04Z Major Pain Procedures 612 5 2,856 26 209 Yes

AB05Z Intermediate Pain Procedures

518 5 2,400 41 209 Yes

AB06Z Minor Pain Procedures 229 5 1,672 14 209 Yes

Source: NHS Payment by Results 2010-11 National Tariff Information, Department of Health.(133)

4.23 A full list of the individual procedures allocated to each of the pain management HRG

codes is given in Appendix I.

NHS CHRONIC PAIN EXPENDITURE IN THE WEST MIDLANDS

4.24 Data from the 2010/11 Programme Budgeting PCT benchmarking tool (134) reported a

total expenditure by PCTs in England of £92 billion, of which £1.2 billion were spent on the

7A-Chronic Pain sub-category. The equivalent figures for the PCTs in the West Midlands

were a total spend of £9.7 billion of which £119 million (1.2%) were spent on chronic pain.


4.25 Table 12 provides the breakdown of the West Midlands spend on chronic pain in 2010/11

by PCT and care setting. Within the West Midlands as a whole the care setting with the

largest spend was the inpatient non-elective setting with £55.8 million (47%), followed by

inpatient elective and daycase with £29.5 million (25%), primary care prescribing £8.2

million (7%) and outpatients £7.3 million (6%). There was also significant expenditure in

community care, ambulance, non-health and social care settings and health and social care

provided in other settings. Prevention and health promotion, GP, dental and ophthalmic,

and accident and emergency settings recorded no or miniscule expenditure.

4.26 The population of the West Midlands is approximately one-tenth of that of England. In

order to compare in expenditure in the West Midlands to that across the country as a

whole the figures need to be presented on a per capita basis. Table 13 presents the

expenditure per 100,000 unified weighted population, which takes into account the

population’s need for hospital and community health services, prescribing and primary

medical services. The total expenditure on chronic pain for West Midlands was £2.1 million

per 100,000 compared to the national average of £2.4 million. The West Midlands

expenditure was lower than national in all care settings other than ambulance, community

care, and health and social care. West Midlands expenditure was particularly low in the

prevention and health promotion, GP, dental and ophthalmic, outpatient, and other

secondary care settings.

4.27 There are marked variations in the expenditure on chronic pain between the West

Midlands PCTs, both in terms of the total amounts and the splits between the care

settings. Total expenditure varied from £2.6 million in Herefordshire PCT to £14.8 million

in South Staffordshire PCT (Figure 1). The variation persists even after expressing the

expenditure per 100,000 population weighted for need for hospital and community

services. Herefordshire PCT’s spend was the lowest in the region at £1.5 million per

100,000 unified weighted population. Stoke on Trent PCT had the highest spend of £2.7

million per 100,000 - nearly twice that of Herefordshire. The regional average is £2.1

million per 100,000 (Figure 2).

4.28 All of the 17 West Midlands PCTs allocated expenditure for chronic pain to the key care

settings, i.e. primary care prescribing, elective and non-elective inpatients, outpatients and

ambulance settings. Only 10 PCTs allocated spend to other secondary care, 12 to

community care and 6 to health and social care provided in another setting. The

percentage splits for each PCT are illustrated in Figure 3.


Figure 1: Total expenditure on Programme Budget sub-category 7A-Chronic Pain, West Midlands PCTs, FY 2010/11

Figure 2: Total expenditure per 100,000 unified weighted population on Programme Budget sub-

category 7A-Chronic Pain, West Midlands PCTs, FY 2010/11

0 2,000 4,000 6,000 8,000 10,000 12,000 14,000 16,000

Herefordshire PCT

Telford and Wrekin PCT

Walsall Teaching PCT

North Staffordshire PCT

Solihull Care Trust

Heart of Birmingham Teaching PCT

Wolverhampton City PCT

Dudley PCT

South Birmingham PCT

Shropshire County PCT

Sandwell PCT

Coventry Teaching PCT

Stoke On Trent Teaching PCT

Birmingham East and North PCT

Worcestershire PCT

Warwickshire PCT

South Staffordshire PCT

Expenditure (£ thousands)

PC

T

Source: Programme Budgeting benchmarking tool 2010/11, Department of Health

0 500,000 1,000,000 1,500,000 2,000,000 2,500,000 3,000,000

Herefordshire PCT





Sandwell PCT

Worcestershire PCT

Dudley PCT





Warwickshire PCT

Solihull Care Trust




West Midlands

England

Expenditure (£s) per 100,000 unifed weighted population

PC

T

Source: Programme Budgeting benchmarking tool 2010/11, Department of Health.


4.29 Notable variations in the proportional split between the care settings include:

Telford and Wrekin PCT spent a negligible proportion of its chronic pain expenditure

on non-elective inpatient care (1% vs. a regional average of 47%) but a very large

proportion on inpatient elective care (77% vs. a regional average of 25%).

Solihull PCT spent 16% of its expenditure on health and social care provided in other

setting (compared to a regional average of 3%).

Shropshire County PCT allocated 25% of its expenditure to community service

compared to a regional average of 4%.

Stoke on Trent Teaching PCT allocated 14% and 26% of its expenditure to community

care and health and social care in other settings respectively, compared to regional

averages of 4% and 3%.

Sandwell spent virtually nothing in the community and other settings compared to a

regional average of 10%.

Figure 3: Proportion of expenditure on Programme Budget sub-category 7A Chronic Pain by care setting, West Midlands PCTs, FY 2010/11

4.30 Table 13 shows how the total expenditure and the proportional split by care setting for

each PCT translate into actual spend in each setting per weighted population. Additional

variations highlighted by this table include:

Low primary care prescribing expenditure in Heart of Birmingham Teaching PCT.

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Herefordshire PCT




Solihull Care Trust



Dudley PCT



Sandwell PCT




Worcestershire PCT

Warwickshire PCT


Total West Midlands PCTs

PC

T

Prevention & Health Promotion GP, dental & ophthalmic Primary prescribing & pharma services

Inpatient: Elective and Daycase Inpatient: Non-elective Outpatient

Other secondary care Ambulance A&E (inc. MIU & WIC)

Community Care Health & social care provided in other setting Non-health / social care

Source: Programme Budgeting benchmarking tool 2010/11, Department of Health.


High primary care prescribing expenditure in Stoke on Trent Teaching PCT.

High elective inpatient expenditure in South Staffordshire PCT.

Low elective inpatient expenditure in Birmingham East and North, Heart of

Birmingham, South Birmingham, Stoke on Trent and Walsall PCTs.

Low outpatient expenditure in North Staffordshire, South Staffordshire, Walsall and

Wolverhampton PCTs.

An expenditure on ambulances three times the regional average in South

Staffordshire PCT.

NOTES ON PROGRAMME BUDGET DATA QUALITY AND LIMITATIONS

4.31 There are concerns as to how well the data collected and published by the Programme

Budget project accurately reflect the true allocation of expenditure. It is unclear how much

of the variation described above reflects real differences in activity or service models and

how much is an artefact of differential coding or erroneous reporting. The Audit

Commission has identified and described issues with NHS data definitions and how they

are implemented by local providers and commissioners. (135). These issues affect the

collection of data for Payment by Results (PbR) but are also a concern for secondary uses

of data such as for the Programme Budget project. Two key problems are:

Defining short stay activity as a daycase admission or an outpatient attendance

Defining a short period of observation as a non-elective admission or a ward

attendance (which is treated as an outpatient attendance).

4.32 The existing commissioning data sets do not allow the recording of information in the same

manner in different settings and do not necessarily reflect the current delivery of care.

When activity takes place in inpatients the data recorded is exhaustive. If this activity

moves to outpatients much of this detail disappears, including that on diagnosis. If this

activity then moves to a community or primary care setting it can vanish completely, and

without detailed local knowledge it would appear this activity no longer takes place. The

difference in tariff between elective, non-elective and outpatient settings for what may be

the same activity can also act as a disincentive to record activity accurately and to properly

align costs with activity.

4.33 The majority of activity carried out by Pain Management specialists is delivered in

outpatients. However, the focus for clinical coding in the NHS has been concentrated on

admitted patients, because there are both time and resource implications in coding

significant amounts of outpatient activity. Pain Management services need to understand

if and how their data is coded and ensure that their activity is correctly recorded on their

patient administration system (PAS).(136) The NHS Information Centre (NHSIC) report that

their Expert Working Group for Pain Management have reviewed national patient activity

and found that some Pain Management services are unaware that their activity could and

should be captured in a more appropriate way. This could be due to a lack of awareness of


the coding systems and the reasons why coding is important. This inaccuracy can lead to

underreporting of the actual total costs submitted for calculating the PbR tariffs as well

underreporting and misclassification of expenditure for the Programme Budget project.


Table 12: Expenditure (£ thousands) on Programme Budget sub-category 7A-Chronic Pain by care setting, West Midlands PCTs, FY 2010/11

PCT PCT Name Care setting Total expenditure

Prevention & health

Promotion

Primary care Secondary care Urgent / emergency care Community care

Health & social care provided in

other setting

Non-health / social

care GP, dental &

ophthalmic

Primary prescribing & pharma services

Inpatient: elective

and daycase

Inpatient: non-

elective

Outpatient Other secondary

care

Ambulance A&E (inc. MIU & WIC)

5PG Birmingham East and North PCT

- - 547 1,287 5,403 808 - 255 - 3 253 124 8,680

5MD Coventry Teaching PCT - - 513 2,184 4,057 349 - 207 - - - 214 7,524

5PE Dudley PCT - - 473 1,409 3,568 460 23 160 - - - 205 6,298

5MX Heart of Birmingham Teaching PCT

- - 287 674 3,261 471 78 243 - - 29 207 5,250

5CN Herefordshire PCT - - 189 523 1,343 178 9 115 - 148

- 80 2,585

5PH North Staffordshire PCT - - 370 1,399 2,134 104 124 - 45 - 224 4,400

5PF Sandwell PCT - - 587 1,721 3,510 645 449 198 - - - 1 7,111

5M2 Shropshire County PCT - - 407 1,029 2,722 246 378 182 - 1,706 15 129 6,814

TAM Solihull Care Trust - - 249 732 2,182 411 - 117 - 720 132 4,543

5M1 South Birmingham PCT - - 477 1,071 4,040 762 - 219 - 37 - 184 6,790

5PK South Staffordshire PCT - - 961 5,884 6,027 244 - 952 - 230 - 530 14,828

5PJ Stoke On Trent Teaching PCT

- - 615 652 2,892 568 - 174 - 1,194 2,263 255 8,613

5MK Telford and Wrekin PCT 2 8 247 2,793 20 278 4 101 - 72 - 91 3,616

5M3 Walsall Teaching PCT - - 477 832 2,476 176 20 164 - 2 2 114 4,263

5PM Warwickshire PCT - - 734 3,271 4,729 520 524 302 - 610 - 550 11,240

5MV Wolverhampton City PCT - - 387 806 3,363 195 232 166 - 416 - 231 5,796

5PL Worcestershire PCT - - 675 3,227 4,076 850 85 334 - 716 - 375 10,338

Q34 West Midlands 2 8 8,195 29,494 55,803 7,265 1,802 4,013 - 5,179 3,282 3,646 118,689

Eng England 187 475 78,647 296,341 610,377 103,453 53,350 29,585 - 35,957 11,449 44,081 1,263,902

Source: 2010-11 Programme budgeting PCT benchmarking tool, Department of Health. (134)


Table 13: Expenditure (£) per 100,000 unified weighted population on Programme Budget sub-category 7A-Chronic Pain by care setting, West Midlands PCTs, FY 2010/11

PCT PCT Name Care setting Total expenditure

Prevention & health

Promotion

Primary care Secondary care Urgent / emergency care Community care

Health & social care provided in

other setting

Non-health / social

care GP, dental &

ophthalmic

Primary prescribing & pharma services

Inpatient: elective

and daycase

Inpatient: non-

elective

Outpatient Other secondary

care

Ambulance A&E (inc. MIU & WIC)

5PG Birmingham East and North PCT

- - 120,929 284,526 1,194,479 178,630 - 56,375 - 663 55,933 27,414 1,918,949

5MD Coventry Teaching PCT - - 147,589 628,331 1,167,188 100,406 - 59,553 - - - 61,567 2,164,634

5PE Dudley PCT - - 150,516 448,367 1,135,395 146,379 7,319 50,915 - - - 65,234 2,004,125


- - 92,500 217,229 1,051,016 151,803 25,139 78,319 - - 9,347 66,716 1,692,068

5CN Herefordshire PCT - - 109,334 302,549 776,909 102,971 5,206 66,526 - 85,616 - 46,279 1,495,390

5PH North Staffordshire PCT - - 172,968 654,005 997,603 48,618 - 57,968 - 21,037 - 104,716 2,056,914

5PF Sandwell PCT - - 162,210 475,577 969,944 178,238 124,076 54,715 - - - 276 1,965,035

5M2 Shropshire County PCT - - 144,331 364,906 965,282 87,237 134,047 64,541 - 604,986 5,319 45,746 2,416,397

TAM Solihull Care Trust - - 129,921 381,935 1,138,501 214,447 - 61,047 - - 375,674 68,874 2,370,399

5M1 South Birmingham PCT - - 124,393 279,297 1,053,557 198,715 - 57,111 - 9,649 - 47,984 1,770,705

5PK South Staffordshire PCT - - 166,525 1,019,597 1,044,376 42,281 - 164,965 - 39,855 - 91,840 2,569,439

5PJ Stoke On Trent Teaching PCT

- - 195,923 207,710 921,317 180,950 - 55,432 - 380,378 720,934 81,236 2,743,881

5MK Telford and Wrekin PCT 1,213 4,852 149,811 1,694,015 12,130 168,613 2,426 61,259 - 43,670 - 55,193 2,193,182

5M3 Walsall Teaching PCT - - 167,741 292,579 870,705 61,892 7,033 57,672 - 703 703 40,089 1,499,118

5PM Warwickshire PCT - - 148,637 662,385 957,633 105,301 106,111 61,156 - 123,526 - 111,376 2,276,124

5MV Wolverhampton City PCT - - 141,127 293,923 1,226,382 71,110 84,603 60,535 - 151,702 - 84,239 2,113,621

5PL Worcestershire PCT - - 129,968 621,344 784,815 163,664 16,366 64,310 - 137,863 - 72,205 1,990,535

Q34 West Midlands 35 141 144,843 521,295 986,296 128,406 31,850 70,928 - 91,537 58,008 64,442 2,097,781

Eng England 357 907 150,177 565,865 1,165,519 197,544 101,872 56,493 - 68,660 21,862 84,173 2,413,430

Source: 2010-11 Programme budgeting PCT benchmarking tool, Department of Health. (134)


5 HEALTH SERVICE UTILISATION - OUTPATIENT ACTIVITY

COMMISSIONER PERSPECTIVE

5.1 This section describes the growth in out-patient activity in pain services provided by

secondary care facilities. Outpatient commissioning data sets (CDS) for the financial

years 2007/8 to 2011/12, accessed via Healthcare Commissioning Services, Dudley. The

Outpatient CDS carries the data for an outpatient attendance or a cancelled/missed

appointment. It covers all NHS and private outpatient activity taking place under the

care of a consultant, midwife or nurse in any:

Acute, community or mental health NHS Trust Primary Care Trust Other NHS hospital Non-NHS hospitals or institutions where the care delivered is NHS-funded.

5.2 Providers of NHS commissioned care must submit and make available the CDSs to

commissioners. Within the West Midlands the data sets are submitted to, stored and

accessed via a data warehouse managed by Healthcare Commissioning Services (HCS),

based in Dudley. Two outpatient data requests were submitted to HCS for counts of

attendances of adults aged 16 years and over to pain management clinics where the

patient attended and was seen for the financial years 2007/8 to 2011/12.

5.3 For patients resident in West Midlands PCTS: counts were broken down by financial

year, gender, first attendance status and PCT. For patients attending the West Midlands

providers: counts broken down by financial year, gender, first attendance status and

Provider Trust. The resulting outputs included counts where the first attendance status

was for first or follow-up tele-consultations. These counts were excluded from the

further analysis – only first and follow-up face to face consultations were included.

5.4 There were a total of 245,331 attendances at outpatient pain management clinics for

adults resident in the West Midlands and treated by any provider during the 5-year

period 2007/8 to 2011/12 (Table 14 ). Of these 76,830 (31%) were first attendances and

168,501 (69%) were follow-up attendances. The total number of attendances increased

from 44,700 in 2007/8 to 51,587 in 2011/12, a rise of 15%. The rate of increase over the

period was greater for first attendances (35%) compared to follow-up attendances (8%)

(figure 2). Consequently the proportion of first attendances also increased over the 5

years, from 29% in 2007/8 to 33% in 2011/12.


Table 14. Pain management outpatient clinic attendances for residents in West Midlands aged 16+ years by gender by attendance type, FYs 2007/08 to 2011/12.

Gender Attendance type

Financial year Total

all years 2007/08 2008/09 2009/10 2010/11 2011/12

Male First attendance face to face 4,563 5,090 5,548 5,956 5,977 27,134

Male Follow-up attendance face to face 10,467 10,608 11,115 11,332 11,085 54,607

Male Total 15,030 15,698 16,663 17,288 17,062 81,741

Female First attendance face to face 8,228 8,986 10,266 10,949 11,267 49,696

Female Follow-up attendance face to face 21,442 21,628 23,633 23,933 23,258 113,894

Female Total 29,670 30,614 33,899 34,882 34,525 163,590

Persons First attendance face to face 12,791 14,076 15,814 16,905 17,244 76,830

Persons Follow-up attendance face to face 31,909 32,236 34,748 35,265 34,343 168,501

Persons Total 44,700 46,312 50,562 52,170 51,587 245,331

Persons Percentage of first attendances 28.6% 30.4% 31.3% 32.4% 33.4% 31.3%

Persons 95% confidence interval lower limit [1] 28.2% 30.0% 30.9% 32.0% 33.0% 31.1%

Persons 95% confidence interval upper limit [1] 29.0% 30.8% 31.7% 32.8% 33.8% 31.5%

Source: Outpatient Commissioning Data Set, Healthcare Commissioning Services Notes: [1] based on the Wilson score method.

Figure 4. Pain management outpatient clinic attendances for residents in West Midlands aged 16+ by attendance type, FYs 2007/8 to 2011/12. The blue line shows first attendances, the red line shows follow-up attendances and the green line shows the total attendances. The black dotted line shows the % of the total that are first attendances (right hand axis)

0.0%

5.0%

10.0%

15.0%

20.0%

25.0%

30.0%

35.0%

40.0%

0

10

20

30

40

50

60

2007/08 2008/09 2009/10 2010/11 2011/12

Co

un

t o

f at

ten

dan

ces

(th

ou

san

ds)

Financial year Source: Outpatient Commissioning Data Set,


Table 15: Pain management outpatient clinic attendances for West Midlands residents aged 16+ by Primary Care Trust and attendance type, FYs 2007/8 to 20011/12.

Primary Care Trust / Cluster Population years at risk [1]

First attendance face to face

Follow-up attendance face to face

Total Percentage of first attendances Crude first attendance rate [2] Crude total attendance rate [2]

Percent 95% CI limits [3] Rate 95% CI limits [4] Rate 95% CI limits [4]

Lower Upper Lower Upper Lower Upper

5PG Birmingham East and North PCT 1,565,426 7,732 19,545 27,277 28.3% 27.8% 28.9% 4.9 4.8 5.1 17.4 17.2 17.6

5MD Coventry Teaching PCT 1,256,540 5,084 7,795 12,879 39.5% 38.6% 40.3% 4.0 3.9 4.2 10.2 10.1 10.4

5PE Dudley PCT 1,244,319 4,729 11,654 16,383 28.9% 28.2% 29.6% 3.8 3.7 3.9 13.2 13.0 13.4


1,051,302 5,299 13,821 19,120 27.7% 27.1% 28.4% 5.0 4.9 5.2 18.2 17.9 18.4

5CN Herefordshire PCT 739,725 1,695 3,225 4,920 34.5% 33.1% 35.8% 2.3 2.2 2.4 6.7 6.5 6.8

5PH North Staffordshire PCT 878,079 1,218 1,965 3,183 38.3% 36.6% 40.0% 1.4 1.3 1.5 3.6 3.5 3.8

5PF Sandwell PCT 1,146,991 7,784 19,675 27,459 28.3% 27.8% 28.9% 6.8 6.6 6.9 23.9 23.7 24.2

5M2 Shropshire County PCT 1,197,926 3,596 6,897 10,493 34.3% 33.4% 35.2% 3.0 2.9 3.1 8.8 8.6 8.9

5QW Solihull PCT 827,616 4,746 11,275 16,021 29.6% 28.9% 30.3% 5.7 5.6 5.9 19.4 19.1 19.7

5M1 South Birmingham PCT 1,381,884 6,551 23,290 29,841 22.0% 21.5% 22.4% 4.7 4.6 4.9 21.6 21.4 21.8

5PK South Staffordshire PCT 2,486,734 2,716 4,993 7,709 35.2% 34.2% 36.3% 1.1 1.1 1.1 3.1 3.0 3.2

5PJ Stoke On Trent PCT 1,000,465 2,351 3,212 5,563 42.3% 41.0% 43.6% 2.3 2.3 2.4 5.6 5.4 5.7

5MK Telford and Wrekin PCT 643,451 2,543 4,781 7,324 34.7% 33.6% 35.8% 4.0 3.8 4.1 11.4 11.1 11.6

5M3 Walsall Teaching PCT 1,011,340 921 1,965 2,886 31.9% 30.2% 33.6% 0.9 0.9 1.0 2.9 2.8 3.0

5PM Warwickshire PCT 2,180,531 6,483 11,767 18,250 35.5% 34.8% 36.2% 3.0 2.9 3.0 8.4 8.2 8.5

5MV Wolverhampton City PCT 959,676 2,767 4,204 6,971 39.7% 38.6% 40.8% 2.9 2.8 3.0 7.3 7.1 7.4

5PL Worcestershire PCT 2,273,231 10,615 18,437 29,052 36.5% 36.0% 37.1% 4.7 4.6 4.8 12.8 12.6 12.9

Arden 3,437,071 11,567 19,562 31,129 37.2% 36.6% 37.7% 3.4 3.3 3.4 9.1 9.0 9.2

Birmingham and Solihull 4,826,227 24,328 67,931 92,259 26.4% 26.1% 26.7% 5.0 5.0 5.1 19.1 19.0 19.2

Black Country 4,362,326 16,201 37,498 53,699 30.2% 29.8% 30.6% 3.7 3.7 3.8 12.3 12.2 12.4

Staffordshire 4,365,277 6,285 10,170 16,455 38.2% 37.5% 38.9% 1.4 1.4 1.5 3.8 3.7 3.8

West Mercia 4,854,333 18,449 33,340 51,789 35.6% 35.2% 36.0% 3.8 3.7 3.9 10.7 10.6 10.8

Total All West Midlands PCOs 21,845,235 76,830 168,501 245,331 31.3% 31.1% 31.5% 3.5 3.5 3.5 11.2 11.2 11.3

Source: Outpatient Commissioning Data Set, Healthcare Commissioning Services; Mid-year population estimates, Office for National Statistics.

[1] Based on ONS mid-year population estimates for the years 2007 to 2010, current as of September 2011. Estimates for 2010 are also used as proxies for 2011 as data for this year are yet to be published.

[2] Rates are expressed per 1,000 population years at risk.

[3] Based on the Wilson score method(137).

[4] Based on Byar's approximation to the Poisson distribution(138)


5.5 Table 15 shows the detailed data on first and follow-up outpatient attendances and the

crude attendance rate (per 1000 person- years) for each of the Primary Care Trusts in

the West Midlands. Since we used 5 years of data to calculate the crude attendance

rate, we used person-years at risk as the denominator. In effect this can be regarded as

the rate per 1000 residents who are have sufficiently severe and disabling chronic pain

to be seen in a secondary care pain clinic. There is considerable variation between PCTs.

For first attendances it varies more than 7-fold from 0.9 per 1000 in Walsall to 6.8 per

1000 in Sandwell. We did not investigate the reasons for this variation but almost

certainly it results from a combination of availability of services, ability of general

practices to manage chronic pain, referral threshold and traditional referral practices. It

appears unlikely that true variation in the incidence or prevalence of chronic pain

accounts for more than a small part of this variation.

5.6 The trend in outpatient attendances by PCT Cluster, and crude attendance rate are

shown in Table 16. Once again there is considerable variation between clusters, and this

is shown in Figure 5; Birmingham and Black Country cluster have the highest rate, about

4 times the rate of Staffordshire.

Table 16. Crude rate of all attendances to pain management outpatient clinics for West Midlands residents aged 16+ years by PCT Cluster, FYs 2007/08 to 2011/12.

PCT Cluster Financial year Total all years 2007/08 2008/09 2009/10 2010/11 2011/12

Total attendances Arden 5,407 5,999 6,766 6,519 6,438 31,129 Birmingham and Solihull 17,638 17,565 19,341 19,537 18,178 92,259 Black Country 11,109 10,046 11,352 10,740 10,452 53,699 Staffordshire 2,451 2,936 3,479 3,877 3,712 16,455 West Mercia 8,095 9,766 9,624 11,497 12,807 51,789 Total West Midlands

residents 44,700 46,312 50,562 52,170 51,587 245,331

Crude attendance rate Arden 8.0 8.8 9.8 9.4 9.3 9.1 Birmingham and Solihull 18.5 18.3 20.0 20.1 18.7 19.1 Black Country 12.8 11.5 13.0 12.3 11.9 12.3 Staffordshire 2.8 3.4 4.0 4.4 4.2 3.8 West Mercia 8.4 10.1 9.9 11.8 13.1 10.7 Total West Midlands

residents 10.3 10.6 11.6 11.9 11.7 11.2

Source: Outpatient Commissioning Data Set, Healthcare Commissioning Services; Mid-year population estimates, Office for National Statistics.


Source: Outpatient Commissioning Data Set, Healthcare Commissioning Services. Figure 5. Crude rates of attendance at pain management clinics by residents in West Midlands aged 16+ by PCT Cluster, FYs 2007-8 to 2011-12.

5.7 The variation in rates of outpatient attendance between PCTs and Clusters is shown in

the funnel plots (Figure 6, Figure 7 and Figure 8). These charts show the dispersion of

PCT and cluster rates around the average rate for the West Midlands with the +/- 2 SD

and +/- 3 SD control limits denoting the expected common cause variation due to

statistical chance alone.

0

5

10

15

20

25

2007/08 2008/09 2009/10 2010/11 2011/12

Cru

de

rate

p

er 1

,00

0 p

op

ula

tio

n y

ears

at

risk

Financial year

Arden Birmingham and Solihull Black Country

Staffordshire West Mercia West Midlands average


Figure 6. Funnel plot of crude rate of all attendances to pain management outpatient clinics , West Midlands residents aged 16+ by PCT and Cluster, FYs 2007/8 to 2011/12.

Figure 7. Funnel plot of crude rte of first attendances to pain management outpatient clinics West Midlands residents aged 16+ by PCT and Cluster, FYs 2007/8 to 2011/12.

0

5

10

15

20

25

0 1,000,000 2,000,000 3,000,000 4,000,000 5,000,000

Cru

de

rate

p

er 1

,00

0 p

op

ula

tio

n y

ears

at

risk

Population years at risk

West Midlands average

2SD limits

3SD Limits

PCTs

PCT Clusters

Source: Outpatient Commissioning Data Set, Healthcare Commissioning Services; Mid-year population

0

1

2

3

4

5

6

7

8

0 1,000,000 2,000,000 3,000,000 4,000,000 5,000,000

Cru

de

rate

p

er 1

,00

0 p

op

ula

tio

n y

ears

at

risk


West Midlands average 2SD limits 3SD Limits PCTs PCT Clusters

Source: Outpatient Commissioning Data Set, Healthcare Commissioning Services; Mid-year population


Figure 8. Funnel plot of First attendances as a percentage of all attendances to Pain management out-patient clinics, West Midlands residents aged 16+ by PCT and PCT cluster, FYs 2007/8 to 2011/12.

OUT-PATIENT ACTIVITY – PROVIDER PERSPECTIVE

5.8 Table 17 shows the attendances to outpatient pain management clinics for each of the

West Midlands Provider Trusts. It includes all patients treated at the Trusts, including

those residents outside of the West Midlands region. There were a total of 229,736

attendances to the West Midlands providers. This is over 15,000 fewer attendances than

reported for the West Midlands residents. This suggests a net flow of patients being

treated by providers outside the region. Three Trusts undertook significantly larger

volumes of activity: The Royal Orthopaedic Hospital NHS Trust in south Birmingham

(47,514), Sandwell and West Birmingham Hospitals NHS Trust (39,889) and the Heart of

England NHS Foundation Trust in east Birmingham and Solihull (32,245).

5.9 The average percentage of first attendances across the regional providers was 31.1%,

which matches that seen for the West Midlands resident patients. Percentages varied

from a low of 17.3% at the Royal Orthopaedic Hospital NHS Trust to 45.1% at the

Worcestershire Acute Hospitals NHS Trust. The distribution of the percentage of first

attendances by provider trust displays over-dispersion when compared to the control

limits around the regional average (Figure 9).

0

5

10

15

20

25

30

35

40

45

0 20,000 40,000 60,000 80,000 100,000

Pe

rcen

tage

of

firs

t at

ten

dan

ces

Number of attendances


Source: Outpatient Commissioning Data Set, Healthcare Commissioning Services.


Table 17. Pain management outpatient clinic attendances for West Midlands provider patients aged 16+ years by Provider Trust by attendance type, FYs 2007/08 to 2011/12

Provider Trust First attendance face to face

Follow-up attendance face to face

Total Percentage of first attendances

Percent 95% CI limits [1]

Lower Upper

RJC SOUTH WARWICKSHIRE NHS FOUNDATION TRUST

2,410 3,339 5,749 41.9% 40.7% 43.2%

RJE UNIVERSITY HOSPITAL OF NORTH STAFFORDSHIRE NHS TRUST

3,687 5,203 8,890 41.5% 40.5% 42.5%

RKB UNIVERSITY HOSPITALS COVENTRY AND WARWICKSHIRE NHS TRUST

6,158 8,075 14,233 43.3% 42.5% 44.1%

RL1 THE ROBERT JONES AND AGNES HUNT ORTHOPAEDIC HOSPITAL NHS FOUNDATION TRUST

1,048 4,258 5,306 19.8% 18.7% 20.8%

RL4 THE ROYAL WOLVERHAMPTON HOSPITALS NHS TRUST

3,301 4,669 7,970 41.4% 40.3% 42.5%

RLT GEORGE ELIOT HOSPITAL NHS TRUST 1,996 6,000 7,996 25.0% 24.0% 25.9%

RNA THE DUDLEY GROUP NHS FOUNDATION TRUST 5,700 13,289 18,989 30.0% 29.4% 30.7%

RR1 HEART OF ENGLAND NHS FOUNDATION TRUST 10,998 21,247 32,245 34.1% 33.6% 34.6%

RRJ THE ROYAL ORTHOPAEDIC HOSPITAL NHS FOUNDATION TRUST

8,230 39,284 47,514 17.3% 17.0% 17.7%

RRK UNIVERSITY HOSPITALS BIRMINGHAM NHS FOUNDATION TRUST

5,281 7,829 13,110 40.3% 39.4% 41.1%

RWP WORCESTERSHIRE ACUTE HOSPITALS NHS TRUST 6,836 8,334 15,170 45.1% 44.3% 45.9%

RXK SANDWELL AND WEST BIRMINGHAM HOSPITALS NHS TRUST

10,740 29,149 39,889 26.9% 26.5% 27.4%

RXW SHREWSBURY AND TELFORD HOSPITAL NHS TRUST

5,033 7,642 12,675 39.7% 38.9% 40.6%

Total All West Midlands Providers 71,418 158,318 229,736 31.1% 30.9% 31.3%

Source: Outpatient Commissioning Data Set, Healthcare Commissioning Services. Notes: [1] Based on the Wilson score method(137).


Figure 9. Funnel plot of first attendances as a percentage of all attendances to pain management outpatient clinics West Midlands provider patients aged 16+ by provider Trust, FYs 2007/8 to 2011/12.

5.10

5.11 A note on over- dispersion. We have used funnel plots to show the extent of variation

between PCTs and between provider units in this and the following sections. Funnel

plots present control limits that display ‘common-cause’ or process variation. This is the

variation that can be expected to occur in a process that is stable or ‘under control’. The

limits are calculated under the assumption that the only source of common-cause

variation in the process is that of random variation. Variation outside these limits is

often called special-cause or extra-process variation and is the result of systematic or

unusual deviations in the process. In the funnel plots above, the distributions show

much greater variation than that of the expected ‘common-cause’. This is known as

over-dispersion and often occurs when there are large numbers of events, and

confounding factors that influence the process are not accounted for. Whether these

factors are considered legitimate and should be included as source of common-cause

variation or remain as special causes is a matter of judgement and will depend on the

purpose of the monitoring. For example, in performance management the purpose is to

identify differences in organisational performance and consequently it is usual to adjust

the control limits or the data to eliminate potential sources of variation, such as case-

mix and demography. In public health the purpose is often to highlight the sources of

such variation for their own sake so the control limits are left unaltered. The APHO

monograph(139) on statistical process control charts gives more detail on the

methodology and interpretation.

0

5

10

15

20

25

30

35

40

45

50

0 10,000 20,000 30,000 40,000 50,000

Pe

rcen

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Number of attendances


Source: Outpatient Commissioning Data Set, Healthcare Commissioning Services.


6 HEALTH SERVICE UTILISATION – INPATIENT AND DAY CASE PROCEDURES

6.1 This chapter describes the growth in hospital-based clinical activity for chronic pain.

Surgical and other interventional procedures are carried out either as day cases or as

inpatient episodes of care. The analysis presented here relates to clinical work

undertaken on West Midlands residents (regardless of where it was done); and,

separately, work done by West Midlands provider Trusts (regardless of the geographic

residence of patients.

DATA SOURCES AND METHODS

6.2 The source of data was the Admitted Patient commissioning data sets (CDS) for the

financial years 2007/8 to 2011/12, accessed via Healthcare Commissioning Services,

Dudley. This data set records clinical details for every finished consultant episode. ). It

covers all NHS and private inpatient activity taking place under the care of a consultant,

midwife or nurse in any:

Acute, community or mental health NHS Trust Primary Care Trust Other NHS hospital Non-NHS hospitals or institutions where the care delivered is NHS-funded.

6.3 Providers of NHS commissioned care must submit and make available the CDSs to

commissioners. Within the West Midlands the data sets are submitted to, stored and

accessed via a data warehouse managed by Healthcare Commissioning Services (HCS),

based in Dudley. Four inpatient data requests were submitted to HCS for counts of FCEs

of adults aged 16 years and over where the primary procedure recorded for the episode

was a pain management procedure and the episode was completed during the financial

years 2007/8 to 2011/12.

Patients treated by the West Midlands providers: counts broken down by financial year, gender, admission method, patient classification and Provider Trust. Patients treated by the West Midlands providers: counts broken down by financial year, gender, primary procedure and Provider Trust. Patients resident in West Midlands PCTS: counts broken down by financial year, gender, admission method, patient classification and PCT. Patients resident in West Midlands PCTS: counts broken down by financial year, gender, primary procedure and PCT.

6.4 Full details of the specifications are given in Appendix I. The list of pain management

procedures is given in Appendix II, specified by OPCS4 procedure codes at the 4-digit

level.

6.5 Obvious data errors were found by inspection of the output counts. These related to the

fields on patient classification and method of admission, where the codes clearly

showed that the relevant FCE were maternity or delivery episodes. For the provider

patients based output (output 1) this represented a total count of 206 out of 154,097

FCEs. For the resident based output (output 3) this represented a total count of 212 out


of 161,782 FCEs. These categories were excluded from all further analyses of these

outputs. Ideally the episodes with these methods of admission and/or patient

classification would also be excluded from the corresponding outputs of counts broken

down by procedure (outputs 2 and 4). This was not possible as these outputs do not

contain the method of admission and patient classification breakdown needed to

identify them. However, given the very small number of episodes involved the inclusion

of these episodes in the procedure based analyses is negligible.

RESULTS

6.6 Pain management inpatient procedure episodes.

There were a total of 161,570 inpatient episodes for pain management procedures for

adults resident in the West Midlands and treated by any provider during the 5-year

period 2007/8 to 2011/12 (Table 18). Of these, 86% were elective day cases, 8% were

elective ordinary admissions, 2% elective regular attenders and 4% were emergency

admissions (Figure 10). Women accounted for 62% of episodes compared to 38% for

men.

Elective episodes.

The main interest of this report is elective activity. Over the five years a total of 154,478

(96%) of the episodes were for elective procedures. The episode count increased from

26, 523 in the year 2007/8 to 33, 583 in 2009/10 but since then has fallen again to

30,863 in 2011/12 (Table 18, Figure 11). Over the 5-year period, day cases accounted for

89.7% of the elective activity. This proportion slowly increased from 87.4% in 2007/8 to

92.0% in 2011/12. The trend in the number of day cases follows that described for all

elective activity (Figure 11)

6.7 Table 18 also presents the volume of elective pain management procedure episodes as

a rate against the denominator resident population. Overall there were 7.1 elective

episodes for every 1,000 population years at risk. Over the five years the adult

population of the West Midlands increased only marginally (by less than 2%).

Consequently the annual trend in the rate over the five years mirrors that of the simple

counts described in figure 3. The rate increased from 6.1 in 2007/8 to 7.7 in 20089/10

and has since fallen to 7.0 in 2011/12 (Figure 12).


Table 18. Pain management inpatient procedure episodes for West Midlands residents aged 16+ years by gender, method of admission and patient classification, FYs 2007/08 to 2011/12

Gender Method of Admission

Patient Classification

Financial year Total all years

2007/08 2008/09 2009/10 2010/11 2011/12

Male Emergency Total 499 588 767 777 790 3,421

Male Elective Total 9,666 11,373 12,454 11,933 11,470 56,896

Male Elective Day case 8,291 9,722 11,112 10,722 10,382 50,229

Male Elective Ordinary admission

1,144 1,197 982 988 1,029 5,340

Male Elective Regular attender 231 454 360 223 59 1,327

Other and unspecified 70 57 81 82 86 376

Male Total 10,235 12,018 13,302 12,792 12,346 60,693

Female Emergency Total 531 580 594 606 642 2,953

Female Elective Total 16,856 19,991 21,102 20,204 19,390 97,543

Female Elective Day case 14,877 17,551 19,172 18,671 18,007 88,278

Female Elective Ordinary admission

1,544 1,593 1,293 1,156 1,286 6,872

Female Elective Regular attender 435 847 637 377 97 2,393


Female Total 17,458 20,640 21,768 20,877 20,095 100,838

Persons Emergency Total 1,030 1,168 1,361 1,383 1,432 6,374

Persons Elective Total 26,523 31,366 33,583 32,143 30,863 154,478

Persons Elective Day case 23,169 27,275 30,311 29,399 28,392 138,546

Persons Elective Ordinary admission

2,688 2,790 2,275 2,144 2,315 12,212

Persons Elective Regular attender 666 1,301 997 600 156 3,720


Persons Total 27,694 32,660 35,097 33,675 32,444 161,570

Persons Population

4,325,911

4,353,750

4,374,393

4,395,591

4,395,591

21,845,235

Persons Crude elective episode rate [1] 6.1 7.2 7.7 7.3 7.0 7.1

Persons 95% confidence interval lower limit [2]

6.1 7.1 7.6 7.2 6.9 7.0

Persons 95% confidence interval upper limit [2]

6.2 7.3 7.8 7.4 7.1 7.1

Persons Day case as a % of all elective episodes

87.4% 87.0% 90.3% 91.5% 92.0% 89.7%

Persons 95% confidence interval lower limit [3]

86.9% 86.6% 89.9% 91.2% 91.7% 89.5%

Persons 95% confidence interval upper limit [3]

87.7% 87.3% 90.6% 91.8% 92.3% 89.8%

Source: Admitted Patient Commissioning Data Set, Healthcare Commissioning Services.

Notes:

[1] Rates are expressed per 1,000 population years at risk.

[2] Based on Byar's approximation to the Poisson distribution. (138)

[3] Based on the Wilson score method(137)


Figure 10. Pain management in-patient procedure episodes f0or West Midlands residents aged 16+ by method of admission and pat8ient classification, FY’s 2007/8 to 2011/12.

Figure 11. Elective pain management in-patient procedure episodes for West Midlands residents aged 16+ by method of admission and patient classification, FYs 2007/8 to 2011/12.

Emergency 6,374

4% Other and

unspecified 718 0%

Day case 138,546

86%

Ordinary admission

12,212 8%

Regular attender 3,720

2%

Source: Admitted Patient Commissioning Data Set, Healthcare

0

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35

40

2007/08 2008/09 2009/10 2010/11 2011/12

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Financial year

Elective - Total Elective - day case Elective - ordinary admission



Figure 12. Crude episode rates for elective pain management in-patient procedures for West Midlands residents aged 16+ by FYs 2007/8 to 2011/12.

6.8 Table 19. Provides a breakdown of the episode count and crude population episode rate

for the 5-year period by Primary Care Trust (PCT) and PCT Cluster. At PCT level, there is

a large variation in the total number of elective episodes ranging from 2,712 in Telford &

Wrekin PCT to 18,673 in Dudley PCT. This variation in the counts is not simply due to the

different population sizes of the PCTs. When expressed as a crude rate per 1,000

population years at risk the crude elective admission rates for PCTs exhibit almost

four-fold variation (from 4.1 in Heart of Birmingham PCT to 15.0 in Dudley PCT).

6.9 Figure 13. Displays these rates against a funnel plot of the control limits based on West

Midlands average rate of 7.1 and the expected ‘common-cause’ variation due to chance

alone. The observed distribution shows clear over-dispersion beyond the control limits.

Similar over-dispersion is seen at PCT Cluster level with rates ranging from 6.0 in

Birmingham and Solihull cluster to 9.4 in the Black Country.

6.10 The proportion of elective episodes that are treated as day cases may highlight

differences in practice for the care commissioned by the PCTs. For the West Midlands

region as a whole, day cases comprised 89.7% of elective episodes. At PCT level this

ranged from a low of 81.4% in Shropshire PCT to 95.0% in Warwickshire PCT. Cluster

level values ranged from 86.5% in West Mercia to 94.4% in Arden. The PCT and Cluster

distributions display over-dispersion when compared to the control limits around the

West Midlands regional average (Figure 14)

0

1

2

3

4

5

6

7

8

9

2007/08 2008/09 2009/10 2010/11 2011/12

Cru

de

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per

1,0

00

po

pu

lati

on

Financial year


I = 95% confidence interval


Table 19. Pain management inpatient procedure episodes for West Midlands residents aged 16+ years by Primary Care Trust by admission method and patient classification, FYs 2007/08 to 2011/12

Primary Care Trust \ Cluster Population years at risk [1]

Emergency episodes

Elective episodes Other and unspecif’d episodes

Total episodes

Day case as % of elective Crude elective rate [2]

Day cases

Ordinary Regular Total Percent 95% CI [3] Rate 95% CI [4]

LL UL LL UL

5PG Birmingham East and North PCT 1,565,426 310 7,339 436 504 8,279 31 8,620 88.6% 87.9% 89.3% 5.3 5.2 5.4

5MD Coventry Teaching PCT 1,256,540 424 11,012 728 20 11,760 38 12,222 93.6% 93.2% 94.1% 9.4 9.2 9.5

5PE Dudley PCT 1,244,319 547 16,854 1,767 52 18,673 28 19,248 90.3% 89.8% 90.7% 15.0 14.8 15.2

5MX Heart of Birmingham Teaching PCT 1,051,302 340 3,834 216 234 4,284 16 4,640 89.5% 88.5% 90.4% 4.1 4.0 4.2

5CN Herefordshire PCT 739,725 341 2,998 384 7 3,389 45 3,775 88.5% 87.3% 89.5% 4.6 4.4 4.7

5PH North Staffordshire PCT 878,079 190 3,874 493 6 4,373 14 4,577 88.6% 87.6% 89.5% 5.0 4.8 5.1

5PF Sandwell PCT 1,146,991 343 9,107 589 242 9,938 37 10,318 91.6% 91.1% 92.2% 8.7 8.5 8.8

5M2 Shropshire County PCT 1,197,926 369 4,297 970 12 5,279 86 5,734 81.4% 80.3% 82.4% 4.4 4.3 4.5

5QW Solihull PCT 827,616 147 3,404 166 136 3,706 8 3,861 91.9% 90.9% 92.7% 4.5 4.3 4.6

5M1 South Birmingham PCT 1,381,884 401 10,722 648 1,137 12,507 50 12,958 85.7% 85.1% 86.3% 9.1 8.9 9.2

5PK South Staffordshire PCT 2,486,734 709 15,987 1,694 209 17,890 102 18,701 89.4% 88.9% 89.8% 7.2 7.1 7.3

5PJ Stoke On Trent PCT 1,000,465 262 4,893 634 4 5,531 25 5,818 88.5% 87.6% 89.3% 5.5 5.4 5.7

5MK Telford and Wrekin PCT 643,451 146 2,314 392 6 2,712 20 2,878 85.3% 83.9% 86.6% 4.2 4.1 4.4

5M3 Walsall Teaching PCT 1,011,340 470 6,009 681 64 6,754 68 7,292 89.0% 88.2% 89.7% 6.7 6.5 6.8

5PM Warwickshire PCT 2,180,531 456 14,533 730 30 15,293 49 15,798 95.0% 94.7% 95.4% 7.0 6.9 7.1

5MV Wolverhampton City PCT 959,676 270 5,199 478 4 5,681 47 5,998 91.5% 90.8% 92.2% 5.9 5.8 6.1

5PL Worcestershire PCT 2,273,231 649 16,170 1,206 1,053 18,429 54 19,132 87.7% 87.3% 88.2% 8.1 8.0 8.2

Arden 3,437,071 880 25,545 1,458 50 27,053 87 28,020 94.4% 94.1% 94.7% 7.9 7.8 8.0

Birmingham and Solihull 4,826,227 1,198 25,299 1,466 2,011 28,776 105 30,079 87.9% 87.5% 88.3% 6.0 5.9 6.0

Black Country 4,362,326 1,630 37,169 3,515 362 41,046 180 42,856 90.6% 90.3% 90.8% 9.4 9.3 9.5

Staffordshire 4,365,277 1,161 24,754 2,821 219 27,794 141 29,096 89.1% 88.7% 89.4% 6.4 6.3 6.4

West Mercia 4,854,333 1,505 25,779 2,952 1,078 29,809 205 31,519 86.5% 86.1% 86.9% 6.1 6.1 6.2

Total All West Midlands PCOs 21,845,235 6,374 138,546 12,212 3,720 154,478 718 161,570 89.7% 89.5% 89.8% 7.1 7.0 7.1

Source: Admitted Patient Commissioning Data Set, Healthcare Commissioning Services; Mid-year population estimates, Office for National Statistics. Notes:

[1] Based on ONS mid-year population estimates for the years 2007 to 2010, current as of September 2011. Estimates for 2010 are also used as proxies for 2011 as data for this year are yet to be published.

[2] Rates are expressed per 1,000 population years at risk. [3] Based on the Wilson score method.(137)

[4] Based on Byar's approximation to the Poisson distribution(138)


Figure 13. Funnel plot of crude episode rate for elective pain management in-patient procedures for West Midlands residents aged 16+ by PCT and PCT Cluster, FYs 2007/8 to 2011/12.

Figure 14. Funnel plot of day cases as percentage of all episodes for elective pain management in-patient procedures, West Midlands residents aged 16+ by PCT and PCT Cluster, FYs 2007/8 to 2011/12.

0

2

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0 1,000,000 2,000,000 3,000,000 4,000,000 5,000,000

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West Midlands average

2SD limits

3SD Limits

PCTs

Source: Admitted Patient Commissioning Data Set, Healthcare Commissioning Services; Mid-year population estimates, Office for National Statistics.

75

80

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95

100

0 5,000 10,000 15,000 20,000 25,000 30,000 35,000 40,000 45,000

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Number of elective episodes

West Midlands average 2SD limits 3SD Limits PCTs



6.11 Trends by PCT Cluster.

Table 20 shows how the PCT Cluster level elective activity volumes and crude rates have

changed over the five years. Arden, Birmingham and Solihull and Black Country Clusters

have similar trends to that described above for the West Midlands as a whole, i.e. their

episode counts and rates peaked in 2009/10 and have decreased since. This decrease

has been most marked in Arden where the crude elective episode rate has dropped by a

third over two years. Birmingham and Solihull’s rate has remained consistently above

the regional average over the five years. Both Staffordshire and West Mercia have seen

significant increase in their elective activity in the year 2011/12 (Figure 15).

Table 20. Crude episode rate for elective pain management inpatient procedures for West Midlands residents aged 16+ years by PCT Cluster, FYs 2007/08 to 2011/12

PCT Cluster Financial year Total all

years 2007/08 2008/09 2009/10 2010/11 2011/12

Total elective episodes

Arden 4,925 5,865 6,294 5,753 4,216 27,053

Birmingham and Solihull 5,059 5,950 6,445 6,120 5,202 28,776

Black Country 7,032 8,009 8,813 8,733 8,459 41,046

Staffordshire 4,744 5,518 5,487 5,474 6,571 27,794

West Mercia 4,763 6,024 6,544 6,063 6,415 29,809

Total West Midlands residents

26,523 31,366 33,583 32,143 30,863 154,478

Crude elective episode rate

Arden 7.3 8.6 9.1 8.3 6.1 7.9

Birmingham and Solihull 5.3 6.2 6.7 6.3 5.3 6.0

Black Country 8.1 9.2 10.1 10.0 9.7 9.4

Staffordshire 5.5 6.3 6.3 6.2 7.5 6.4

West Mercia 4.9 6.2 6.7 6.2 6.6 6.1

Total West Midlands residents

6.1 7.2 7.7 7.3 7.0 7.1



Figure 15. Crude episode rate for elective pain management in-patient procedures, West Midlands residents aged 16+ by PCT Cluster, FYs 2007/8 to 2011/12.

TRENDS IN SPECIFIC PROCEDURES IN PAIN MANAGEMENT

6.12 There are a large number of specific procedures used in pain management. Using the 3-

digit OPCS4 codes there are 17 broad categories of operation. Data on the number of

each of these procedures is shown in Table 21. The figures include all activity, i.e. for all

methods of admission and all patient classifications. The vast majority of these episodes

are elective activity (over 95%). The three most common procedures alone account for

80% of the activity undertaken (Figure 16). The most common procedure was a puncture

of a joint with over 70,000 episodes or 43% of the activity. This includes aspiration and

injection of a therapeutic substance into the joint. The second most frequent procedure

was other operations on spine – specifically these are all injections around spinal facet of

spine – with over 31,000 episodes (19%). Over 28,000 (17%) of episodes had a

therapeutic epidural injection performed. The next most frequent procedures were

operations on spinal nerve root (5.6%), neurostimulation of peripheral nerve (4.9%) and

therapeutic spinal puncture (3.0%).

6.13 The trend in the 6 most common procedures over the 5 years is shown in Figure 17. The

most notable feature is the steady increase in the frequency of puncture of the joint.

Not only is it the most frequent procedure but it has increased from just under 12,000

episodes in 2007/8 to in excess of 15,000 in 2011/12, a rise of 29%.

0

2

4

6

8

10

12

2007/08 2008/09 2009/10 2010/11 2011/12

Cru

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,00

0 p

op

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ears

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Financial year

Arden Birmingham and Solihull Black Country

Staffordshire West Mercia West Midlands average



Table 21. Pain management inpatient procedure episodes for West Midlands residents aged 16+ years by 3-digit OPCS4 procedure code and year, FYs 2007/08 to 2011/12

OPCS4 Procedure code (3-digit) [1]

Financial year Total all years

2007-08

2008-09

2009-10

2010-11

2011-12

Count %

W90

Puncture of joint 11,946 13,499 15,088 14,327 15,391 70,251 43.4%

V54 Other operations on spine 5,086 6,333 7,433 6,820 5,456 31,128 19.2%

A52 Therapeutic epidural injection 5,470 6,056 6,235 5,472 4,848 28,081 17.4%

A57 Operations on spinal nerve root 1,348 1,942 1,422 1,638 2,758 9,108 5.6%

A70 Neurostimulation of peripheral nerve

1,142 1,690 2,194 2,328 531 7,885 4.9%

A54 Therapeutic spinal puncture 847 900 1,027 1,045 1,017 4,836 3.0%

V48 Denervation of spinal facet joint of vertebra

494 649 536 643 823 3,145 1.9%

V25 Primary decompression operations on lumbar spine

504 710 470 576 674 2,934 1.8%

V33 Primary excision of lumbar intervertebral disc

462 472 335 360 465 2,094 1.3%

V52 Other operations on intervertebral disc

80 80 99 115 91 465 0.3%

A48 Other operations on spinal cord 78 93 101 96 97 465 0.3%

V29 Primary excision of cervical intervertebral disc

98 70 55 84 121 428 0.3%

V38 Primary fusion of other joint of spine 71 94 47 92 87 391 0.2%

V26 Revisional decompression operations on lumbar spine

45 57 45 43 65 255 0.2%

V34 Revisional excision of lumbar intervertebral disc

41 39 27 38 56 201 0.1%

A09 Neurostimulation of brain 20 17 24 19 9 89 0.1%

V35 Excision of unspecified intervertebral disc

6 5 3 9 3 26 0.0%

Total all procedures 27,738 32,706 35,141 33,705 32,492 161,782 100.0%


Notes:

[1] Recorded as the primary procedure within the episode.


Figure 16. Most widely used pain management procedures (using 3-digit OPCS4 procedure code), West Midlands residents aged 16+, FYs 2007/8 to 2011/12.

Figure 17. Trends in the most frequently used procedures, West Midlands residents aged 16+, FYs 2007/8 to 2011/12.

Puncture of joint (W90) 70251 43%

Other operations on spine (V54)

31128 19%

Therapeutic epidural injection

(A52) 28081 17%

Operations on spinal nerve root

(A57) 9108 6% Neurostimulation

of peripheral nerve (A70)

7885 5%

Therapeutic spinal puncture (A54)

4836 3%

Other pain management procedures

10,493 7%

Source: Admitted Patient Commissioning Data Set, Healthcare Commissioning

0

2

4

6

8

10

12

14

16

18

2007/08 2008/09 2009/10 2010/11 2011/12

Co

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Financial year

W90 Puncture of joint

V54 Other operations on spine

A52 Therapeutic epidural injection

A57 Operations on spinal nerve root

A70 Neurostimulation of peripheral nerve



ANALYSIS BY PROVIDER TRUSTS

6.14 Table 22 shows the pain management inpatient procedure episodes for each of the

West Midlands Provider Trusts. It includes all patients treated at the Trusts, including

those resident outside of the West Midlands region and excludes episodes classified as

maternity and delivery episodes (as described in Methods above). There was a total of

153,891episodes to West Midlands providers of which 145,542 were elective episodes.

This is nearly 9,000 fewer elective episodes than reported for West Midlands residents.

This suggests a net flow of patients being treated as elective cases by providers outside

the region.

6.15 Three Trusts undertook significantly larger volumes of elective activity: The Dudley

Group NHS Foundation Trust (21,684), The Royal Orthopaedic Hospital NHS Trust in

south Birmingham (21,921), University Hospitals Coventry and Warwickshire NHS Trust

(20,811). 85.8% of elective activity across the region was done as day cases; this is

slightly lower than the day case percentage for the West Midlands resident patients

(89.7%). Day case percentage varied from a low of 41.5% at the University Hospitals

Birmingham NHS Trust to 99.0% at South Warwickshire NHS Foundation Trust.

Birmingham Women’s NHS Foundation Trust had a rate of 5.3% but this was based on

just 18 cases over 5 years. The distribution of the percentage of first attendances by

provider trust displays over-dispersion when compared to the control limits around the

regional average (Figure 14).

Figure 18. Funnel plot of day cases as a percentage of all elective episodes for West Midlands provider trust patients aged 16+, FYs 2007/8 to 2011/12.

0

10

20

30

40

50

60

70

80

90

100

0 5,000 10,000 15,000 20,000 25,000

Pe

rcen

tage

of

day

cas

es

Number of elective episodes

West Midlands average 2SD limits 3SD Limits Provider Trusts



Table 22: Pain management inpatient procedure episodes for West Midlands Provider patients aged 16+ years by Provider Trust by admission method and patient classification, FYs 2007/08 to 2011/12

Provider Trust Emergency episodes

Elective episodes Other and unspecif’d episodes

Total episodes

Day case as % of elective

Day cases Ordinary admissions

Regular attenders

Total Percent 95% CI limits [1]

Lower Upper

RNA THE DUDLEY GROUP NHS FOUNDATION TRUST 659 19,574 2,110 0 21,684 25 22,368 90.3% 89.9% 90.7%

RRJ THE ROYAL ORTHOPAEDIC HOSPITAL NHS FOUNDATION TRUST 175 19,839 2,082 0 21,921 69 22,165 90.5% 90.1% 90.9%

RKB UNIVERSITY HOSPITALS COVENTRY AND WARWICKSHIRE NHS TRUST 1,027 16,953 3,845 13 20,811 153 21,991 81.5% 80.9% 82.0%

RRK UNIVERSITY HOSPITALS BIRMINGHAM NHS FOUNDATION TRUST 731 4,559 3,813 2,626 10,998 555 12,284 41.5% 40.5% 42.4%

RXK SANDWELL AND WEST BIRMINGHAM HOSPITALS NHS TRUST 574 8,574 281 179 9,034 37 9,645 94.9% 94.4% 95.3%

RWP WORCESTERSHIRE ACUTE HOSPITALS NHS TRUST 519 8,175 175 13 8,363 18 8,900 97.8% 97.4% 98.0%

RJE UNIVERSITY HOSPITAL OF NORTH STAFFORDSHIRE NHS TRUST 553 6,102 1,593 2 7,697 48 8,298 79.3% 78.4% 80.2%

RL4 THE ROYAL WOLVERHAMPTON HOSPITALS NHS TRUST 311 6,390 597 0 6,987 56 7,354 91.5% 90.8% 92.1%

RJD MID STAFFORDSHIRE NHS FOUNDATION TRUST 291 6,393 349 102 6,844 26 7,161 93.4% 92.8% 94.0%

RR1 HEART OF ENGLAND NHS FOUNDATION TRUST 431 5,923 210 0 6,133 16 6,580 96.6% 96.1% 97.0%

RJC SOUTH WARWICKSHIRE NHS FOUNDATION TRUST 193 5,948 63 0 6,011 11 6,215 99.0% 98.7% 99.2%

RBK WALSALL HEALTHCARE NHS TRUST 487 4,724 618 0 5,342 57 5,886 88.4% 87.5% 89.3%

RXW SHREWSBURY AND TELFORD HOSPITAL NHS TRUST 507 3,680 306 1 3,987 40 4,534 92.3% 91.4% 93.1%

RL1 THE ROBERT JONES AND AGNES HUNT ORTHOPAEDIC HOSPITAL NHS FOUNDATION TRUST

49 2,730 1,264 8 4,002 87 4,138 68.2% 66.8% 69.6%

RLT GEORGE ELIOT HOSPITAL NHS TRUST 79 2,877 79 0 2,956 7 3,042 97.3% 96.7% 97.9%

RLQ WYE VALLEY NHS TRUST 359 2,129 206 0 2,335 43 2,737 91.2% 90.0% 92.3%

RJF BURTON HOSPITALS NHS FOUNDATION TRUST 146 207 66 0 273 7 426 75.8% 70.4% 80.5%

RQ3 BIRMINGHAM CHILDREN'S HOSPITAL NHS FOUNDATION TRUST 2 140 5 0 145 0 147 96.6% 92.2% 98.5%

RLU BIRMINGHAM WOMEN'S NHS FOUNDATION TRUST 0 1 18 0 19 1 20 5.3% 0.9% 24.6%

Total All West Midlands PCOs 7,093 124,918 17,680 2,944 145,542 1,256 153,891 85.8% 85.6% 86.0%

Source: Admitted Patient Commissioning Data Set, Healthcare Commissioning Services. Notes:

[1] Based on the Wilson score method(137).


7 STAKEHOLDER AND CORPORATE NEEDS ASSESSMENT

CHRONIC PAIN – STAKEHOLDERS

The development of services for people affected by Chronic Pain is advocated by several

professional, third sector and patient representative groups.

7.1 Chronic Pain Policy Coalition.

Policy Connect host the Chronic Pain Policy Coalition (CPPC), a collaboration

formed in 2006 with an aim to ‘unite patients, professionals and

parliamentarians in a mission to develop an improved strategy for the

prevention, treatment and management of chronic pain and its associated

conditions’. The coalition currently lists the following organisations as its

collaborators;

7.2 Medical & Nursing Colleges, and Other Societies

The Royal College of Anaesthetists

The Royal College of General Practitioners

The Royal College of Nursing

Royal College of Obstetricians and Gynaecologists

The Royal College of Physicians

British Society for Rheumatology

The Faculty of Occupational Medicine

The British Pain Society

The British Medical Acupuncture Society

7.3 Patient Support and Representative Groups.

These organisations have variable membership and scale. To assist in reviewing

the likely impact of these groups, where a charitable income could be identified

for 2010/11 or 2011/12, this has been indicated. (Note that this will not include

income for any associated non-charitable companies).

Action for ME - £689,333

Action on Pain - £26,929

BackCare (National Back Pain Association) - £496,521

The British Polio Fellowship - £874,232

Derbyshire Chronic Pain Support Group (COPING) – Not identified

Empower – Not identified

Endometriosis SHE Trust - £7,953

FibroAction - £30,512

Fibromyalgia Association UK - £45,697

The Migraine Trust - £497,752

National Lichen Sclerosus Support Group – Not identified

Pain Association Scotland - £241,580 (Scottish Charitable Commission)

Pain Concern - £34,917 (Scottish Charitable Commission)

Pain Relief Foundation - £318,458


Pelvic Pain Support Network - £12,966

Poole Endometriosis Support Group – Not identified

Scleroderma Society - £194,337

Shingles Support Society - £100,941

Spinal Injuries Association - £2,164,274

Vulval Pain Society - £5,003

The coalition is funded from a variety of sources, including sponsorship from

medical corporate sponsors, named as Astellas, Grunenthal, Lilly, Medtronic,

Napp, Pfizer and Sanofi Pasteur MSD.

The coalition campaigns against a five point manifesto which it established in

2007. It suggests that the effective approach to the management of chronic

pain requires;

1. Education – integrating management of chronic pain in all professional training 2. Empowerment – to support people making decisions about their condition 3. Collaboration – to bring stakeholders together to deliver joined up patient strategy 4. Early Access – to prevent acute pain becoming chronic pain 5. Measurement – to see pain measured as a basic vital sign in patient management

CPPC hosted the first English ‘Pain Summit’ in November 2011, and published

recommendations for future development of chronic pain services in July

2012(140). It made four overarching recommendations;

A. Clear standards and criteria must be agreed and implemented nationally for the identification, assessment and initial management of problematic pain.

B. An awareness campaign should be run to explain the nature, extent, impact, prevention and treatment of chronic pain to the wider general and NHS community.

C. Nationally-agreed commissioning guidance must be developed and agreed, describing best value care in chronic pain to reduce unwarranted variation

D. A data strategy for chronic pain should be agreed through creation of an epidemiology of chronic pain working group.

The coalition identifies that, despite progress on information gathering, through

the Health Survey for England and the National Pain Audit, commissioning

practice varied widely, and suggested that although examples of best practice in

areas from needs assessment to service delivery could be identified, there was

a lack of consistency across England in the delivery of chronic pain services.

7.4 Other Organisations


Many of the organisations within the CPPC also advocate independently for

developments in services for patients with chronic pain;

7.5 British Pain Society

The British Pain Society (BPS), a charitable professional organisation, represents

a multidisciplinary body of doctors, nurses, physiotherapists, psychologists,

occupational therapists and other healthcare and related research professionals

involved in the treatment and management of pain. It delivers its charitable

purposes through education and training, professional publications including

treatment guidance, patient literature and participation and membership of

chronic pain stakeholder groups, including those hosted by the National

Institute for Health and Clinical Excellence.

The BPS has undertaken significant work on the development of pain

management pathways, and has recently had two pathways published on the

Map of Medicine

Initial assessment and early management of pain(141)

Spinal Pain(142) The society has also independently published draft pathways covering several

other areas, and has a stated intention to progress these towards publication

through Map of Medicine*. These cover neuropathic pain, chronic widespread

pain and low back pain. The BPS publishes its own Pain Rating Scale, available in

17 languages, which assesses pain against intensity and distress at time of

assessment and during the previous week on an 11 point scale, alongside the

interference with normal everyday activities caused by pain (subjective single

point assessment).

7.6 Royal College of Anaesthetists

Many pain management services are led or supported by anaesthetists, and the

professional college delivers the majority of its professional function to chronic

pain services through the Faculty of Pain Medicine, which covers both the care

of patients with acute pain and chronic pain. The Faculty publishes guidance on

professional competencies for the Pain Management Specialist(143), and is

supported by the college in publishing recommendations on the provision of

services for Chronic Pain Management(144). The college guidance recommends

that a good pain management service will offer;

Ready access for patients to a local, first class chronic pain service

A seamless service between primary and secondary care

A specialised chronic pain management services in each region for adult patients with complex pain problems

* When accessed on 25

th October 2012, it was noted that the project deadline for this had elapsed. No

information was identified on the future timeline for final publication of these additional pathways.


Specialised chronic pain management services in each region for children and young people with complex pain problems with a requirement to work with children and their families

Established links between acute and chronic pain management services within each hospital to enable patients with pain who present acutely and whose symptoms do not resolve to be managed appropriately as an outpatient

Co-operation between chronic pain management and palliative care services within hospitals and the community

Provision of appropriate time for direct clinical care for consultants in pain medicine, allied health professionals, managers and support staff

Appropriate accommodation, facilities and equipment in accordance with best practice recommendations

Formal links between hospitals on a regional basis so that a comprehensive range of treatments can be offered to all patients who need them

Provision of pain management programmes (PMP) that promote restoration of physical and psychological function, encourage self care and decrease use of healthcare resources

A robust 24/7 on-call system with support from other disciplines (e.g. spinal/ neurosurgery, radiology, microbiology) if neuro-modulation techniques are used

Sufficient funding to enable the service to achieve required targets and quality standards

Continuing professional development of all staff

Equity of access and service provision for all patients

The Royal College of Anaesthetists also includes Chronic Pain services within its

audit criteria(145). These offer specific and substantial audit criteria against

which Chronic Pain Services can be assessed. Standards include;

Management of patients with repeat admissions for chronic pain

Availability and resourcing of core chronic pain services

Long term use of opioid analgesia in chronic non-malignant pain

Each standard is accompanied by specific audit criteria and suggested data

collection sources. For example, in the assessment of management of patients

with repeat admissions, the college propose five standards;

Reduce re-admission rates for non surgical pain.

Develop resources to manage non acute pain effectively.

Reduce length of stay related to acute exacerbations of chronic pain.

Development of shared care amongst specialties.

Reduction of medication-related adverse events.

Standards and targets for best practice are also proposed.


The priority focus of the college is in delivering training for anaesthetists in the

techniques of managing chronic pain, including best practice guidance on

specific procedures. Outside of its participation on policy and steering groups,

and the above references, no further documents were identified on specific

advocacy for future developments in chronic pain services.

7.7 Spinal Injuries Association

The Spinal Injuries Association is, by charitable income, a major stakeholder.

However, review of the online document archive did not demonstrate any

relevant, contemporary publications outside of the association's contribution to

the Chronic Pain Policy Coalition.

7.8 International Association for the Study of Pain (IASP)

The IASP is one of the international bodies connected with chronic pain, that

significantly contributes to UK practice and treatment. Three outputs are

particularly relevant in the commissioning and delivery of chronic pain services;

1. The 'Desirable Characteristics of National Pain Strategies'(146). These are recommendations by the IASP to assist in the construction of overarching strategy documents linked to Chronic Pain. The critical recommendations are;

Access to pain education for health professionals and the general population Coordination of the care system to ensure timely access to the right support A quality improvement program to address access and standards of care A reasonable proportion of direct and dedicated funding for pain research.

The same guidance also identifies critical success factors around effective epidemiology, clear and available service descriptions, cross-stakeholder working, and strong timescales for delivery.

2. IASP also make 'Recommendations on Pain Treatment Services(147) ', which superseded specific guidance for pain treatment facilities(148) in 2009. This guidance provides broad behaviours for chronic pain services, including the need for interdisciplinary communication, co-ordinated and programmed care delivery, and a commitment to advancing and improving services.

3. Finally, IASP produces a detailed taxonomy(149) for the classification of pain by type and location. This taxonomy is not currently linked to the ICD-10 or NHS classification systems.

7.9 Patient Support Groups

No standardised networks or central co-ordination of support groups for

chronic pain services were identified. Specific subgroups of patients, such as

those with Arthritis, Back pain or Fibromyalgia are served by established disease

specific support networks, but chronic pain per se has no similar national

coverage.


Organisations such as Action for Pain, Action on Pain and Pain Concern maintain

websites and discussion groups, but do not identify with a specific local

footprint. There is no evidence of systematic professional support on these

websites, with the dominant focus being on peer advice and information

sharing. Pain Concern are identified as PPE representatives on the development

of several national guidelines and strategies connected with pain services, but

do not have clear advocacy aims listed within their charitable objectives.

Neil Betteridge, an independent policy analyst and consultant, and previous

chief executive of Arthritis Care, provides the patient and public representative

on the CPPC executive committee. The CPPC does not include a clear single

patient representative body within its membership.

The West Midlands NHS Local website does not list any support groups

provided outside the context of direct NHS care, and the West Midlands

Commissioning Support Unit was not made aware of any local groups during

the conduct on the needs assessment.

Website and document review of the other organisations within the CPPC did

not identify further relevant substantiated policy documents relevant to the

advocacy and development of Chronic Pain services.

The Patient Association, not directly connected with the CPPC, has also

contributed to the chronic pain policy debate through the 2010 ‘Public

Attitudes to Pain’ report(150). This patient focussed survey concluded with the

Patient Association calling on the Government and healthcare professionals to

take action to -

Establish a clear care pathway for pain services in the NHS and recognise pain as a disease in its own right

Ensure that patients have access to all the information they require to make informed and complete decisions about the care pathway

Provide further education for healthcare professionals on pain services

Ensure that NICE guidelines on Medicines Adherence are followed by healthcare professionals

CHRONIC PAIN – SERVICE DELIVERY

7.10 A survey of NHS provider units in the West Midlands region was conducted by

the West Midlands Commissioning Support Unit as part of the healthcare needs

assessment. This included a standardised set of questions (shown in the

Appendix), and was followed by an electronic reminder where no response was

received. Nine sufficient responses were received, and these results can be seen

summarised in Table 23. An original copy of the questionnaire is included within

the appendices.


7.11 All providers that responded offered a formal chronic pain management service,

led by the department of Anaesthetics, and delivering a multi-disciplinary clinic.

Some services have dedicated staff working full time for the chronic pain service,

whilst others shared team members with the in-hospital acute pain service, or

with wider multidisciplinary teams, particularly physiotherapy, psychology and

occupational health. Some services used referral to other departments to

complete the multi-disciplinary team

The number of clinical sessions varied widely, as did the number of doctors and

senior specialist nurses supporting the service. Where patient numbers were

stated, these again showed substantial variation, and were not directly

correlated with the number of clinical sessions held.

An array of interventions were offered. Commonly offered interventions

reported through the survey included;

TENS

Anticonvulsants (Gabapentin, Carbamazepine)

Antidepressants

Analgesic, Steroid and Anaesthetic Injections

Back Injections

Intra-articular injections

Nerve Ablation

Psychotherapy

Cognitive Behavioural Therapy

Interventions mentioned infrequently included;

Ultrasound

Low Level Laser Therapy

Facet Denervations

Trigger Injections

Percutaneous chordotomy

Visco-supplementations

Acupuncture

Pain Management Programmes

Spinal Cord Stimulation

Sacral Nerve Stimulation

Capsaicin Patch Therapy

Intrathecal Drug Delivery and Injections

Botulinum A Injections

Note that these were free text responses, and organisations may only have

reported certain therapies, such as those seen as advanced, controversial, or

essential to the delivery of a service. Individual Funding Requests were reported

by four of the nine responders, and included applications for funding to out of

region complex pain services.


7.12 Summary of Service Design & Delivery by Trust

Table 23: Summary of Questionnaire responses by trust

Trust HoE ROH SWBH S Warks UHCW DGOH RJAH Burton UHNS

Formalised Service Yes Yes Yes Yes Yes Yes Yes Yes Yes

Service Specification Yes Some Yes No Yes Yes No Yes Some

Clinical Sessions

(approximate number) 10 9 20 4.5 12 22 9 9 9

Consultants 2 1 4 2 3 5 2 1 3

Other Doctors 0 1 0 0 0 2 0 0 0

Nurses 2 2-3 5* 1 1 2 1 Unknown Unknown

Psychology Support Dedicated Dedicated Dedicated By Referral None Stated Dedicated None Stated Dedicated None Stated

Physiotherapy Support Dedicated Cross Cover Cross Cover Through

Main Dept None Stated Dedicated None Stated Dedicated Dedicated*

Referrals (Approximate) 3500 2075 2500 Unknown 1500 Unknown 600 Unknown Unknown

NPA Contributor Yes Yes Yes Yes Yes Yes No No No

Notes

Nurses also

cover acute

pain service

Supra-

Regional 3o

IFRs

New Service *0.1 WTE

only


COMMISSIONING CHRONIC PAIN SERVICES

7.13 Chronic pain services have previously been commissioned through Primary Care

Trusts, with some particular services commissioned through the West Midlands

Specialised Commissioning Team. The implementation of the Health and Social

Care Bill means that the majority of commissioning responsibility for these

services is being transferred to Clinical Commissioning Groups, with specialist

services now becoming the responsibility of the National Commissioning Board.

The West Midlands Commissioning Support Unit has encountered difficulties in

identifying leads in either sender or receiver organisations, at both local and

regional level, who have operational knowledge of the commissioning of these

services, or with sufficient resource to support the unit in identifying the scope

of the existing commissioned service.

It is therefore only possible to present ‘cameos’ of the current chronic pain

commissioning structure;

Service specifications, with varying degrees of detail, do exist for the majority of services. However, these largely focus on necessary targets, such as waiting times and routes of access, and do not provide precise descriptions of the scope of a chronic pain service.

Chronic pain services are largely accessed through General Practice services, although where community pain teams exist, there may be routes of direct referral to an acute provider service

Few commissioners or providers were aware of specific commissioned pathways. Where these were referenced, they were direct transcriptions or copies of national Map of Medicine pathways. No alternative pathways covering other chronic pain conditions were identified.

As well as routinely commissioned services, commissioners made reference to Individual Funding Requests, particularly around complex therapeutic interventions such as neurostimulators.

There was evidence that many commissioners currently included certain procedures used for the relief of pain within lists of procedures of limited clinical value, or for which specific eligibility criteria had to be met. This was most consistently applied in relation to certain joint injection procedures.

An example was identified within a public health pharmacy team of clear guidance on prescribing for chronic pain relief. However, work to connect this to referral pathways, and non-pharmacological interventions had been suspended whilst the new commissioning responsibilities were established.

Worcestershire was the only West Midlands area identified to have a localised pathway listed on Map of Medicine. This addressed both musculoskeletal and neuropathic pain, focussing on management prior to referral to the specialist pain clinic.

Providers reported varying qualifying criteria for access to their chronic pain service. Some reported pre-screening by primary care trusts, some used timeframe criteria (for example, at least three months of pain), and others triaged referrals on a case by case basis, either undertaken by medical or senior nursing staff.

Two Clinical Commissioning Groups (CCGs) stated that they were developing more community focussed pathways, particularly around low back pain, but


this work was at draft stage, and further detail was not yet available. Four other CCGs contacted were as yet unable to provide a contact for commissioning of these services and referred back to their respective Primary Care Trusts.

7.14 The West Midlands Primary Care Trusts have also previously commissioned

some complex services through the West Midlands Specialised Commissioning

Team. These were defined by the Specialised Services National Definitions Set

(SSNDS), specifically SSNDS 31(151) which established the scope of specialised

services for Chronic Pain. These specifically relate to the commissioning of

certain denervation and chordotomy procedures, both surgical and

radiofrequency, and implantable neuro-stimulation techniques.

7.15 From April 1st, 2013, the responsibility for commissioning of these procedures

will become the responsibility of the National Commissioning Board. Clinical

Reference Groups (CRGs) have been established to construct and assure service

specifications for identified services, including some chronic pain services.

However, these service specifications have not yet been released into the public

domain. The full list of CRGs can be viewed at

http://specialisedcommissioning.com/clinical-reference-groups/

Key CRGs for the development of chronic pain services include;

Specialised Pain CRG

Complex Spinal Surgery CRG

Adult Neurosurgery CRG

Final outputs from these CRGs are expected by April 2013, and will inform the

commissioning pathways for more specialised interventions for patients with

chronic pain. Draft consultation versions of the central service specifications,

which will be used both within the National Commissioning Board and the NHS

standard contract, are expected by December 2012.

7.16 The Specialised Pain CRG is still at an early stage of development, but the clinical

panel has been established. It is chaired by Dr Andrew Baranowski, a pain

specialist working at University College London Hospitals, with commissioning

support led by Joan Ward from NHS South Central and public health input from

John Harris, a public health practitioner in London. The group also has Regional

Representatives from the four England 'old-SHA' sectors, and PPE Members

from Pain Concern and the Chronic Pain Policy Coalition. Invited Members also

attend the group, representing Psychology, Physiotherapy, Cancer Services,

Academic Interests, British Pain Society, Faculty of Pain Medicine, the RCGP and

the Chronic Pain Coalition.


No information was available on the scope or timeline of potential products of

this CRG(152).

The WMCSU has however been able to review an early draft of the chronic pain

service specification. This proposes the following commissioning model for

chronic pain services. No detailed pathways have yet been proposed.

The proposed pathway identifies that referrals will only be made from

secondary or tertiary care services into very specialised interventions and

conditions, of which the service specification identifies between six and ten that

may already meet criteria to be considered very specialised. It was noted that

the draft service specification did not yet provide detail on how tertiary

activities would be identified in data streams from non-specialised activity

delivered in a concurrent setting.

The early draft specification proposes that minimum standards will be defined

by the British Pain Society, Faculty of Pain Medicine, Royal College of

Anaesthetists and International Association for the Study of Pain, with

pathways parallel to those proposed by British Pain Society, and already

discussed above.

MEASURING OUTCOMES

7.17 Prior discussions with local providers identified an array of assessment tools in

use, including Visual Analogue Scores (Usually 0-10 range), Hospital Anxiety and

Depression Scores, McGill questionnaire, 5th Vital Sign, and the Rowland Morris

Scoring Systems. The draft service specification highlights a series of proposed

GPCommunity

CareSecondary Tertiary

Contracted by CCGs

Non-SpecialisedActivity referred

into the tertiary

setting but not

specifically specialised

Specialised ActivityIdentified by using:

•Specific clinic ID

•OPD diagnostic code

•Patient Register

•Inpatients using OPCS/ICD

10. If not sensitive enough

see following model

Contracted by CCGs Contracted by NHS


metric for monitoring clinical progress and assessing clinical outcomes; again,

these are unconfirmed and subject to further substantial consultation;

Brief Pain Inventory (short form)

SF-12 Quality of Life Score

PHQ-9 Depression Assessment

Monitoring of employment/education/training status

Patient Global Impression of Change

Service monitoring metrics proposed include;

Percentage of patients assessed within 3 months from referral

Percentage of patients entering multi-disciplinary treatment pathways within 6 weeks following assessment

Percentage of patients discharge to primary care within 12 months from referral.

It should be noted that these proposed measures are not representative of

those used in research methodologies. In particular, the Cochrane Collaboration

Pain, Palliative and Supportive Care (PaPaS) review group have considered

potential outcome measures for use in the evaluation of evidence for

systematic review(153,154,155) and support the adoption of the IMMPACT

assessments in this context.

The Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials

(IMMPACT) provide a set of outcomes which it deems meaningful in research,

and to patients. They also recommend certain scales for use in the assessment

of pain.

RECOMMENDED CORE OUTCOME MEASURES IN RESEARCH

Pain o 11 point (0-10) numerical rating scale of pain intensity o Usage of rescue analgesics o Categorical rating of pain intensity (none/mild/moderate/severe) where

numerical ratings may be problematic

Physical Functioning o Multidimensional Pain Inventory Interference Scale o Brief Pain Inventory interference items

Emotional Functioning o Beck Depression Inventory o Profile of Mood States

Participant ratings of global improvement and satisfaction with treatment o Patient Global Impression of Change

Symptoms and adverse events - passive capture of spontaneously reported adverse events and symptoms and use of open-ended prompts

Participant Disposition (in line with CONSORT guidance)


The IMMPACT group identify that the following responses to pain interventions are

significant within trial groups for Pain;

At least 50% pain reduction* or At least 30% pain reduction

Absolute score of 30/100 or less (no worse than mild pain)

Patient Global Impression of very much improved

*In the latest update to IMMPACT it is suggested growing evidence favours an

outcome of a 50% reduction in pain.

No minimum level for improvements in function are set by the IMMPACT group.

TAXONOMY OF CHRONIC PAIN SERVICES

7.18 Based on the information that was received, and through the treatments

identified in the epidemiological and literature reviews, taxonomy for the

delivery of Chronic Pain services has been constructed.

This hierarchy demonstrates that the majority of care is delivered through self

care, and primary care services, but with increasingly complex investigations and

interventions deployed through secondary care, and ultimately highly

specialised tertiary or quarternary care, limited to a few specialist centres.


7.19 Prior to the current NHS reconfiguration, the SSNDS defined the specialist pain

interventions using the following ICD-10 and OPCS-4 codes;

OPCS OPCS-4.5 Category OPCS-4.5 Sub-category Yes Maybe Comments

A365 Other operation on

cranial nerve

Denervation of trigeminal nerve (v) x

A472 Other destruction of

spinal cord

Radiofrequency controlled thermal

destruction of spinothalamic tract

x only in conjunction with a

pain ICD code

A473 Other destruction of

spinal cord

Percutaneous chordotomy of spinal

cord


pain ICD code

A483 Other operations on

spinal cord

Insertion of neurostimulator adjacent

to spinal cord

x for tertiary treatment of

neuropathic pain

A484 Other operations on

spinal cord

Attention to neurostimulator adjacent

to spinal cord NEC


neuropathic pain

A543 Therapeutic spinal

puncture

Implantation of intrathecal drug

delivery device adjacent to spinal cord


pain ICD code


puncture

Attention to intrathecal drug delivery

device adjacent to spinal cord


pain ICD code


puncture

Removal of intrathecal drug delivery

device adjacent to spinal cord


pain ICD code

A701 Neurostimulation of

peripheral nerve

Implantation of neurostimulator into

peripheral nerve


pain ICD code


peripheral nerve

Maintenance of neurostimulator in

peripheral nerve


pain ICD code


peripheral nerve

Removal of neurostimulator from

peripheral nerve


pain ICD code


peripheral nerve

Other specified neurostimulation of

peripheral nerve


pain ICD code

V481 Denervation of

spinal facet joint of

vertebra

Radiofrequency controlled thermal

denervation of spinal facet joint of

cervical vertebra


spinal pain


V482 Denervation of

spinal facet joint of

vertebra

Denervation of spinal facet joint of

cervical vertebra NEC


spinal pain

X662 Cognitive

behavioural therapy

Cognitive behavioural therapy by

multidisciplinary team

x requires ICD 10 code : where

CBT given as part of an

intensive in-patient

rehabilitation programme

ICD ICD Category ICD Sub Category Yes Maybe

G441 Other headache syndromes Vascular headache NOC x

G521 Disorders of other cranial nerves Disorders of glossopharyngeal nerve x

G564 Mononeuropathies of upper limb Causalgia x

G570 Mononeuropathies of lower limb Lesion of sciatic nerve x

G572 Mononeuropathies of lower limb Lesion of femoral nerve x

G574 Mononeuropathies of lower limb Lesion of medial popliteal nerve x

G579 Mononeuropathies of lower limb

Mononeuropathy of lower limb,

unspecified x

G580 Other mononeuropathies Intercostal neuropathy x

G601 Hereditary and idiopathic neuropathy Refsum's disease x

G602 Hereditary and idiopathic neuropathy

Neuropathy in association with

hereditary ataxia x

G603 Hereditary and idiopathic neuropathy Idiopathic progressive neuropathy x


Other hereditary and idiopathic

neuropathies x


Hereditary and idiopathic

neuropathy, unspecified x

G611 Inflammatory polyneuropathy Serum neuropathy x

G619 Inflammatory polyneuropathy

Inflammatory polyneuropathy,

unspecified x


G620 Other polyneuropathies Drug-induced polyneuropathy x

G622 Other polyneuropathies

Polyneuropathy due to other toxic

agents x

G64X

Other disorders of peripheral nervous

system

Other disorders of peripheral

nervous system x

R201 Disturbances of skin sensation Hypoaesthesia of skin x

R203 Disturbances of skin sensation Hyperaesthesia x

It should be noted that this classification system is known to have flaws. Specialised Services

specifically note that;

“As with other specialised services there are difficulties with the current ICD-10

classification system because it does not identify severity or extent of disability and

hence cannot distinguish between complex cases of pain treated by specialist pain

management centres services and those treated by local hospitals.

The OPCS codes for pain management were extensively reviewed during 2003- 2005

and have continued to be refined since then. The use of flags and co-morbidity data

has produced more refined HRGs which better distinguish between local non-

specialised and specialised services for ostensibly similar procedures. If new

treatments for pain arise then new OPCS codes are sought.”

PATHWAYS FOR CHRONIC PAIN PATIENTS

7.20 This taxonomy, alongside the service information that could be derived locally,

and from the evidence reviews, was then used to construct patient pathways to

describe the potential patient journeys for those with chronic pain. Note that it

is possible to travel through the pathway several times, taking different routes

at different times, and also that not all services may be available or

commissioned in all areas.

The following pages show the pathways of care;

1. All potential pathways 2. Those managed through primary care 3. Those managed through a community chronic pain service 4. Those managed through a hospital chronic pain service 5. Those managed through a disease specific pathway


8 RAPID EVIDENCE REVIEW OF THE EFFECTIVENESS OF INTERVENTIONS FOR

CHRONIC PAIN.

OBJECTIVE

8.1 To conduct a rapid review of the evidence for the effects and effectiveness of

interventions for chronic pain, including chronic low back pain.

8.2 Two key clinical practice guidelines on the diagnostic assessment and management of

low back pain have been published, one by NICE(156) the other jointly by the American

College of Physicians and American Pain Society(157). Both guidelines are supported by

systematic reviews of the evidence. Where relevant, some of the findings of the

guidelines have been appraised and included in this rapid evidence review. A more

comprehensive overview of their main recommendations are presented in Appendix ??

METHODS

8.3 Criteria for considering studies.

Types of studies

Systematic reviews and evidence based guidelines published in English from 2007 onwards.

Types of participants.

Adults from ages 18 to 70 years with chronic pain persisting for three months or longer, including chronic low back pain. Papers which included participants with cancer pain, post-operative pain or pain associated with acute trauma were excluded.

Types of interventions

Any intervention.

Types of outcomes

Primary outcome: Pain, with at least 50% pain reduction on the visual analogue scale and better management of pain.

Secondary outcome: Adverse events.

SEARCH METHODS FOR IDENTIFICATION OF STUDIES

Bibliographic database searches: a systematic literature search were undertaken in the Cochrane Library (all databases) 2011 Issue 4 (chronic pain); 2012 Issue 2 (back pain), MEDLINE (OVID) 1948 – Nov week 3 2011 (chronic pain); 1948 – May 2012 (back pain), EMBASE (OVID) 1980 – 2011 week 48 (chronic pain); 1980 – May 2012 (back pain), TRIP Database and the ARIF Database of Systematic Reviews. Where appropriate a filter for systematic reviews was applied to the searches.

PROSPERO was searched to identify ongoing systematic reviews.


The searches were limited to papers written in English and those published from 2007 onwards. Retrieved publications were entered into a Reference Manager database. Full details of the search strategies can be found in Appendix ??

DATA COLLECTION AND ANALYSIS

8.4 Selection of studies.

Titles and abstracts of references were screened by one reviewer. Any uncertainties

were resolved with a second reviewer. The full text of the articles was retrieved where

it was unclear whether or not the review was to be included.

8.5 Data extraction and management.

A data extraction table was devised jointly by two reviewers which included author of

the paper, year of publication, type of study, population, intervention, comparator,

outcome, follow-up and results. Data were extracted by one reviewer and put into

Summary of Findings tables. Uncertainties were resolved with the second reviewer.

8.6 Methodological quality assessment.

The methodological quality of the included references for systematic reviews was

independently assessed by two reviewers, using the PRISMA checklist for reporting bias

and AMSTAR for critical appraisal. The quality of guidelines was assessed using GRADE

and completeness of reporting using the AGREE checklist.

The Oxford Centre for Evidence Based Medicine grading system was used to rate the

level of evidence for each included systematic review:

```


RESULTS

MANUAL THERAPY

8.7 This category of interventions comprises manipulation and mobilisation in chronic neck

pain, and patellar taping and bracing for chronic knee pain.

Two good quality systematic reviews were identified(158,159) and the findings are

summarised in Appendix 1

The first review is a Cochrane Review and as such is an authoritative summary of the

present state of the evidence. The review evaluated manipulation or mobilisation

techniques in acute, sub-acute or chronic neck pain.

The second review evaluated manual therapy combined with exercise in neck pain with

or without radicular symptoms or cervicogenic headache.

8.7.1 Conclusions.

While the estimated effects of manipulation or mobilisation techniques in neck pain

look impressive the quality of evidence is poor.

Moderate quality evidence supports this treatment combination for pain reduction

and improved quality of life over manual therapy alone for chronic neck pain; and

suggests greater short-term pain reduction when compared to traditional care for

acute whiplash. Evidence regarding radiculopathy was sparse.

8.7.2 Implications for practice.

Manipulation or mobilisation techniques in neck pain should be available for those

patients who chose to have it.

Manual therapy combined with exercise in neck pain could be made available to

patients.

PHARMACOLOGICAL PROCEDURES

8.8 Pharmacological procedures include antipsychotics, antidepressants, NSAIDs, opioids,

anti-epileptic drugs, capsicum pain plasters, anaesthetics, and cannabinoids.

Fifteen systematic reviews were identified which looked at a range of pharmacological

interventions(160,161,162,163,164,165,166,167,168,169,170,171,172,173,174) and the

findings are summarised in Appendix 2

Antipsychotics.

One medium to good quality review (160) evaluated antipsychotics for chronic pain. The

authors concluded that data was limited, most trials only studied small patient samples

and further research was required.

Anti-depressants.


Three recent good quality reviews evaluated anti-depressants (161,162,163). Overall,

the reviews showed that there is strong evidence for the use of antidepressants in

chronic pain management.

Topical treatments.

A Cochrane Review (164) looked at topical rubefacients containing salicylates or

nicotinamides and found that the evidence was limited by the quality and size of the

available studies.

Opioids.

The effectiveness of opioids was investigated in three reviews which were assessed as

either medium or good quality (165,166,167). The evidence for the use of opioids for

short-term treatment was reasonable for older patients without comorbidity, with

frequent surveillance for adverse effects (165). Overall, however, the results of all three

reviews indicated that the evidence base was poor and results were based on weak,

positive evidence.

Cannabinoids

One good quality review looked at cannabinoids for non-cancer chronic pain (168).

Results showed there is evidence that cannabinoids are safe and modestly effective in

neuropathic pain with preliminary evidence of efficacy in fibromyalgia and rheumatoid

arthritis. However, further large studies of longer duration examining specific

cannabinoids in homogeneous populations are needed before firm conclusions can be

drawn.

Anticonvulsives

Six good quality reviews investigated anticonvulsive/ antiepileptic drugs

(169,170,171,172,173,174). Three were Cochrane Reviews (169,170,174) . One Cochrane

Review (174) concluded that Gabapentin is effective for neuropathic pain however pain

relief may vary between pain conditions and dose. Another (170) found Carbamazepine

effective but the quality of included studies was poor. A third found that Lamotrigine

was not effective(169).

8.8.1 Conclusions.

Evidence for the use of antipsychotics was weak.

There is strong evidence for the effectiveness of anti-depressants in chronic pain

management.

The evidence for the use of topical treatments (rubefacients) is limited.

The evidence base for opioids was poor and results were based on weak, positive

evidence.

Cannabinoids are modestly effective in neuropathic pain with preliminary evidence of

efficacy in fibromyalgia and rheumatoid arthritis. However, further large studies of

longer duration examining specific cannabinoids in homogeneous populations are

needed before firm conclusions can be drawn.

Antiepeliptic drugs have either indeterminate or limited effect.


Results from three Cochrane reviews suggest varying effectiveness of anticonvlusives.

One (174) concluded that Gabapentin is effective for neuropathic pain however pain

relief may vary between pain conditions and dose. Another (170) found

Carbamazepine effective but the quality of included studies was poor. A third found

that Lamotrigine was not effective.


Lamotrigine does not have a significant place in therapy and should not be

commissioned as treatment for any type of chronic pain.

Carbamazepine treatment should be commissioned but only for selected patients

with neuropathic pain.

Gabapentin should be commissioned for selected patients.

The use of antidepressant ( tricyclic antidepressants –TCAs, and serotonin re-uptake

inhibitors - SSRIs) should be included as part of the pain service.

PATIENT EDUCATION.

8.9 Therapeutic patient education was investigated in one recent, good quality Cochrane

review(175). Patients included those with neck pain associated with whiplash or non-

specific and specific mechanical neck pain with or without radiculopathy or cervicogenic

headache. Summaries of findings are presented in Appendix ??

8.9.1 Conclusion.

Effectiveness for educational interventions for neck pain, including advice to activate,

advice on stress-coping skills, workplace ergonomics and self-care strategies has not

been shown.


The evidence available does not support the commissioning of education based

interventions for neck pain.

PHYSICAL TREATMENTS

8.10 This includes laser therapy, therapeutic ultrasound, traction, and transcutaneous

electrical nerve stimulation (TENS). Summaries of findings are in Appendix ??

Seven systematic reviews investigated physical treatments

(176,177,178,179,180,181,182). With two exceptions (177,181), all were of either

medium or good quality. Findings are summarised in Appendix ??

Two reviews investigated low level laser therapy (LLLT) (177,183); one (183) for chronic

neck pain, the other (177) for neck pain and carpal tunnel syndrome. Although the

reviews showed moderate statistical significance for efficacy of LLLT for chronic pain,

treatment should be regarded as experimental due to poor methodological quality and

variability of results and small sample size.

Ultrasound for shoulder pain was investigated in one medium to good quality review


(Alexander 2010). It showed that ultrasound had an indeterminate effect.

One good quality Cochrane review looked at traction for neck pain (Graham 2008). It

found no evidence from RCTs supported or rejected use of either continuous or

intermittent traction for neck pain.

Patellar taping and bracing was investigated in one good quality review(180) . It found

evidence for medially-directed force on the patella and limited evidence to demonstrate

efficacy of patellar bracing. However, outcomes were limited by the presence of high

heterogeneity between study outcomes and significant publication bias.

H wave electrical stimulation for neuropathic pain and soft tissue inflammation was

reviewed by (181). The review was of poor quality and based on uncontrolled studies

therefore little reliance can be based on the reported beneficial effect of H-wave device.

One good quality review(182) investigated physical rehabilitation interventions for non-

specific low back pain (LBP). Overall evidence from RCTs showed effectiveness of

treatments was low. The clinical effect of back school, LLLT, patient education, massage,

traction, superficial heat/cold, and lumbar supports is not clear due to insufficient data.

Only MDT, exercise and BT have some effect on pain intensity and disability, thus only

these three interventions should be provided as conservative treatments in daily

practice in the treatment of chronic LBP.

The NICE guideline (156) makes the following recommendations for low back pain:

consider offering a course of manual therapy, including spinal manipulation, comprising up to a maximum of nine sessions over a period of up to 12 weeks; consider offering a structured exercise programme tailored to the person which should comprise up to a maximum of eight sessions over a period of up to 12 weeks; offer a group supervised exercise programme in a group of up to ten people; a one-to-one supervised exercise programme may be offered if a group programme is not suitable for a particular person.

8.10.1 Conclusions

Low level laser treatment for chronic pain should be regarded as experimental due to

poor methodological quality and variability of results and small sample size.

Ultrasound had an indeterminate effect, however, it would be premature to conclude

that this treatment is ineffective. More research is required.

Further well conducted RCTs to determine efficacy of traction for neck pain are

required. Recommendations cannot be made with the available evidence.

Evidence was found for medially-directed force on the patella and limited evidence to

demonstrate efficacy of patellar bracing. However, outcomes were limited by the

presence of high heterogeneity between study outcomes and significant publication

bias.


Only MDT, exercise and behavioural therapy have some effect on pain intensity and

disability in chronic low back pain, thus only these three interventions should be

provided as conservative treatments in daily practice in the treatment of chronic LBP.


Only MDT, exercise and behavioural therapy have some effect on pain intensity and

disability in chronic low back pain, thus only these three interventions should be

provided as conservative treatments in daily practice in the treatment of chronic LBP.

Consideration should be given for commissioning manual therapy (including spinal

manipulation) and structured exercise programmes, either in a group or on a one-to-

one basis for low back pain.

BEHAVIOURAL (BT) AND COGNITIVE BEHAVIOURAL THERAPY (CBT)

8.11 Four good quality systematic reviews(184,185,186,187) and a good quality NICE

guideline(156) (ref to guidance and supporting review) were identified and their findings

are presented in Appendix ??

The review by Eccleston(188) is a Cochrane review which evaluated the effectiveness of

psychological therapies on pain, disability and mood. It found that overall there is lack of

evidence for BT, except for pain immediately following treatment, when compared with

‘treatment as usual’. CBT has some small positive effects for pain, disability and mood.

There is insufficient data on quality or content of treatment to investigate their influence

on outcomes. Overall, CBT and BT may have a positive effect on altering mood outcomes

but the results were not statistically significant.

Another Cochrane review (187) investigated behavioural therapy (respondent, operant

and cognitive, behavioural therapy) plus physiotherapy, behavioural therapy plus

inpatient rehabilitation for chronic back pain. For patients with back pain, there is

moderate quality evidence that in the short-term, operant therapy is more effective

than waiting list and behavioural therapy is more effective than usual care for pain relief,

but no specific type of behavioural therapy is more effective than another. In the

intermediate to long-term, there is little or no difference between behavioural therapy

and group exercises for pain or depressive symptoms.

Macea (185) investigated the effectiveness of web-based behavioural interventions on

chronic pain. Results of this meta-analysis suggest that web-based interventions for

chronic pain effect are associated with small reductions in pain in the intervention group

compared with waiting-list control groups however the effect is weak and uncertain.

The review by Hoffman (186) which looked at psychological therapies for chronic low

back pain found there was a significant reduction in pain intensity and depression in


favour of CBT. However there were concerns about the poor quality of the included

RCTs.

The NICE guideline (156) focused on CBT compared with self care (information package

or a book on back pain) for low back pain. The evidence for effectiveness was provided

by two RCTS. One found no significant difference between groups in terms of pain or

fear. The other found: a greater reduction in average pain intensity for the self-care

group, but difference was significant only at 6 months; significantly lower fear-

avoidance scale scores in the self-care group at all follow-up times; significantly less

disability in the self-care group at 3 months but not at 6 or 12 months and no more

favourable mental health outcomes in self-care group.

8.11.1 Conclusions.

The Cochrane review (189) found that CBT and BT have weak effects in improving

pain.

Both CBT and BT interventions may be effective in altering mood outcomes and the

effect may be maintained at 6 months.


The evidence for behavioural therapies in isolation is weak and is not sufficient to

commission these services as individual interventions, however, there is a role for

CBT as part of a comprehensive multi-disciplinary programme.

In view of the small effect and the likely bias, web-based behavioural therapy should

not be commissioned.

CBT may be considered for chronic low back pain but the quality of RCTs examining

its effectiveness should be borne in mind.

INVASIVE PROCEDURES

8.12 Twenty three systematic reviews were identified which looked at a range of invasive

procedures

(176,190,191,192,193,194,195,196,197,198,199,200,201,202,203,204,205,206,207,208,

209,210,211). Also two NICE Interventional Procedures Guidelines, IPG 300 (212) and

IPG 357(213) and one NICE clinical guideline (156) were identified. The findings are

summarised in Appendix ??

Radiofrequency thermal ablation.

A good quality Cochrane review (206) looked at radiofrequency ablation

sympathectomy for neuropathic pain and complex regional pain syndrome. It concluded

that there is little evidence on sympathectomy (one small RCT met the inclusion criteria

of the review).

Intrathecal drug therapy.

Two medium/good quality reviews investigated intrathecal drug therapy for chronic pain


(195,201). Hayek (195) found modest improvements in patient reported pain scores

however included studies were poorly reported. The results of the review by Patel (201)

were based on four observational studies of which two showed positive results for short

and long-term pain relief. However, the results should be treated with caution given the

low quality of the studies and the lack of RCTs.

Nerve blocks.

Nerve blocks and local anaesthesia for chronic pain was investigated in a good quality

review by Vlassakov 2011. All reviewed articles were single case reports or case series so

no reliable conclusion could be drawn concerning the effectiveness of nerve blocks with

local anaesthetics in neuralgia.

Cervical epidural injections.

A medium/good quality review by Benyamin 2009 (211) reviewed the evidence for

cervical epidural injections for whiplash related neck pain. A significant effect was

observed in relieving chronic intractable pain of cervical origin and providing long-term

relief.

Local analgesia.

A medium/ good quality review looked at local analgesia for chronic stump pain and PLP

(critical ischaemia of peripheral vascular disease) (209). It would appear that there is no

robust evidence to support the use of pre-emptive analgesia to minimise risk of chronic

pain after amputation for critical ischaemia of peripheral vascular disease.

Facet joint injections.

Two reviews looked at facet joint injections for chronic low back pain. One, a good

quality Cochrane review (205) found insufficient evidence to support use of injection

therapy in subacute and chronic low back pain, but it may be beneficial to a subgroup of

patients who may respond to a specific type of injection therapy. The other review

(192), of medium/good quality, concluded that lumbar facet joint and radiofrequency

neurotomy are effective but lumbar intra-articular injections are likely to be ineffective.

The NICE guideline (156) included patients with chronic back pain. The findings, based

on the one RCT which met the inclusion criteria of the review were that injections are of

little value in treating chronic low back pain.

Botulinum Toxin (BoNT)

Five good quality reviews (196,198,199,204,210) investigated this intervention for

shoulder and neck pain; lateral epicondylitis; and myofascial pain.

One Cochrane review (199) found that the evidence failed to confirm either a clinically

important or a statistically significant benefit of BoNT-A injection for chronic neck pain

associated with or without associated cervicogenic headache. Likewise, there was no

benefit seen for disability and quality of life at four week and six months.


Another Cochrane review (204) concluded that BoNT -A injections seem to reduce pain

severity and improve shoulder function and range of motion when compared with

placebo in patients with shoulder pain due to spastic hemiplegia or arthritis however the

high risk of bias in the included RCTS demands caution in interpreting these results.

Although Zhang (210) found that BoNT-A had a small to moderate analgesic effect in

chronic musculoskeletal pain conditions, especially in plantar fasciitis, tennis elbow and

back pain (but not in whiplash or shoulder pain), further evidence is required before

definitive conclusions can be drawn.

Kalichman (198) found that the evidence provided moderate support for use of BoNTA -

A injections into fore arm extensor muscles (60 units) for treatment of chronic

treatment-resistant lateral epicondylitis.

Finally, the review (196) which investigated BoNT-A for myofascial pain reported that

current evidence does not support the use of BTA injection in trigger points for

myofascial pain.

Trigger point injections

This intervention for musculoskeletal pain was reviewed in one review (202). In general,

regardless of the drug, injected trigger point injection was no more effective than other

less invasive treatments such as laser and ultrasound.

Opiods.

A recent and good quality Cochrane review (214) examined the effectiveness of any

opioid taken by any route in any dose for at least six months in pain of any cause except

cancer. Its findings suggested that opioids could be useful for those patients who have

no previous history of addiction or abuse, however, the evidence supporting this

conclusion is weak. More, longer term studies are required to identify those patients

who would be likely to benefit from such treatment.

Pulsed radiofrequency(PRF).

Pulsed radiofrequency for Zygapophyseal joint pain, cervical radicular pain, lumbosacral

pain, trigeminal neuralgia, chronic shoulder pain was investigated in one review [Chua

2011]. The review was of medium quality and found that PRF may be of benefit in

treatment of cervical radicular pain and chronic shoulder pain, but less effective for

lumbar zygapophyseal joint pain and trigeminal neuralgia but that further research is

required to warrant its use.

Spinal cord stimulation (SCS).

Two reviews were identified which investigated SCS (193,203). Both were of medium to

good quality.

The most recent review found that SCS for Failed Back Surgery Syndrom and Complex


Regional Pain Syndrome was effective when compared with conventional treatment.

The other (203) had the same findings. However, for ischaemic pain, there may need to

be selection criteria developed for Critical Limb Ischaemia, and SCS may have clinical

benefit for refractory angina in the short term.

Auriculotherapy.

One good review (190) investigated auriculotherapy for all types of chronic pain.

Although, overall it was found to be an effective intervention, the review concluded that

further large, well-designed trials are required.

Surgery.

Five systematic reviews (176,197,200,207,215) and two NICE Interventional Procedures

Guidelines (212,213) were identified. Summary of findings are presented in Appendix ??.

A Cochrane review of medium /good quality (216) investigated discectomy, micro-

discectomy, chemonucleolysis, automated percutaneous discectomy, nucleoplasty, and

laser discectomy in patients with lumbar prolapsed disc who had indications for surgical

intervention. It concluded that the evidence was weak and there was insufficient data to

draw any conclusions about effectiveness of any of the surgical treatments investigated.

Another good quality Cochrane review (197) looked at the effectiveness of spinal fusion

for chronic low back pain. The results, which were based on three good quality RCTs

showed that surgical fusion may improve pain related disability compared to non-

surgical intervention, but the effect was not statistically significant.

A medium quality review, (176) looked at the effectiveness of surgery for low back pain.

The included studies were assessed as low and high quality, but there were potential

biases in some studies including performance bias, and detection bias. There were high

drop-out rates in one trial and data were missing. Trials for decompressive surgery were

assessed as high quality but a high proportion of patients did not adhere to the

treatment. Overall, there was a lack of long-term studies, so the benefits were not

known.

A medium /good quality review which looked at total disc replacement surgery for back

pain (207) found that there are no long-term studies to test the longevity of the

prostheses which was evaluated. Therefore, current evidence does not support routine

use of surgery for the treatment of chronic low back pain.

Lumbar fusion for chronic back pain was investigated in one medium quality review

(200). It appeared that the intervention may be more effective than non-operative care

for chronic back pain but may not be more effective than structured rehabilitation,

including CBT. However, methodological limitations of RCTs prevent firm conclusions

about lumbar fusion.

Lumbar fusion for chronic back pain was investigated in one medium quality review


(200). It appeared that the intervention may be more effective than non-operative care

for chronic back pain but may not be more effective than structured rehabilitation,

including CBT. However, methodological limitations of RCTs prevent firm conclusions

about lumbar fusion.

Both of the Interventional Procedures Guidelines were based on good quality reviews of

the research literature.

IPG 300 addressed percutaneous endoscopic laser lumbar discectomy. The evidence

consisted of case series. The guideline states: “ Current evidence on the safety and

efficacy of percutaneous endoscopic laser lumbar discectomy is inadequate in quantity

and quality. Therefore this procedure should only be used with special arrangements for

clinical governance, consent, and audit or research”.

IPG 357 addressed percutaneous intradiscal laser ablation in the lumbar spine. The

evidence consisted of case series and non-randomised comparative studies. The

guideline states: “Current evidence on the safety and efficacy of percutaneous

intradiscal laser ablation in the lumbar spine is adequate to support the use of this

procedure provided that normal arrangements are in place for clinical governance,

consent and audit. Patients selected for the procedure should be limited to those with

severe pain refractory to conservative treatment, in whom imaging studies have shown

bulging of an intact disc, and who do not have neurological deficit requiring surgical

decompression.”

8.12.1 Conclusions.

There is little good evidence of effectiveness of sympathectomy, intrathecal drug

therapy, nerve blocks, local analgesia, opioids, or auriculotherapy for chronic pain.

A significant effect was observed for cervical epidural injections in relieving cervical

neck pain.

Facet joint injections are of little value in treating chronic low back pain.

There is low to moderate support for the use of botulinum toxin injections for

shoulder pain, neck pain, lateral epicondylitis and myofascial pain.

Trigger point injections appear to be no more effective than other less invasive

treatments.

Further research is needed to warrant the use of pulsed radiofreqency for chronic

pain.

Spinal fusion may improve pain related disability but the effect was not significantly

significant.


Current evidence does not support the use of routine surgery for chronic back pain.

There was insufficient good quality data to draw any conclusion about the

effectiveness of many surgical interventions for low back pain. This included

decompressive surgery, discectomy, micro-discectomy, chemonucleolysis, automated

percutaneous discectomy, nucleoplasty and percutaneous endoscopic laser

lumbardiscectomy.

Percutaneous endoscopic laser lumbar discectomy should only be used with special

arrangements for clinical governance, consent, and audit or research.

Current evidence on the safety and efficacy of percutaneous laser ablation in the

lumbar spine is adequate to support the use of this procedure provided normal

arrangements are in place for clinical governance, consent and audit.


SCS should be commissioned for use for those patients who fail to respond to other

treatments.

Spinal fusion can only be recommended cautiously to patients with chronic low back

pain.

Botulinum toxin should not be commissioned for chronic pain.

Surgery should only be commissioned for treatment in highly selected patients who

fail all other treatments and with caution. Patients should be made aware of

implications of surgery.

Surgical discectomy should not be commissioned for routine use, but only in carefully

selected patients with sciatica due to lumbar disc prolapsed.

Current evidence on the safety and efficacy of percutaneous laser ablation in the

lumbar spine is adequate to support the use of this procedure provided normal

arrangements are in place for clinical governance, consent and audit.

MULTI-DISCIPLINARY INTERVENTIONS (MDI)

8.13 Two good quality systematic reviews (217,218) a NICE guideline and guideline from the

American Pain Society / American College of Physicians (157) investigated MDI

programmes.

The reviews identified used different definitions of MDI, therefore, they are not directly

comparable.


The results of one Cochrane review(218) found that one high quality study showed

effectiveness for low intensive multidisciplinary treatment compared to control, but not

for intensive multidisciplinary treatment for chronic low back pain. The other (low

quality) studies found no effectiveness compared to controls. Three high quality RCTs

found effectiveness for some outcome measures (but not all) for intensive compared to

non-intensive programmes. It concluded that multidisciplinary back training has a

positive impact on work participation of people with chronic low back pain. The

evidence for a positive effect on quality of life is limited. Intensity of treatment is not

associated with treatment effectiveness. It concluded that further research should be

carried out with clearer definitions of chronic low back pain, intensity of treatment and

multidisciplinary back training.

The second review investigated multi-disciplinary pain interventions for adults with

chronic non-specific musculoskeletal pain for example low back pain or back pain and

fibromyalgia. Results showed that evidence was strong for MDI being more effective

than control group treatment in 15 studies, five studies showed no difference. Three

studies that compared in-patient versus out-patient treatment found moderate

evidence for better long term outcomes with intensive in-patient MDI.

All interventions considered in the NICE guideline (156), which was under-pinned by a

good quality systematic review, had to have a psychological component such as CBT,

counselling or coping skills training. Studies were included if the content was broadly

similar to that recommended in the British Pain Society guidelines (BPS 2007) as follows:

“education on pain physiology, pain psychology, healthy function and self-management

of pain problems; and of guided practice on setting goals and working towards them,

identifying and changing unhelpful beliefs and ways of thinking, relaxation, and changing

habits which contribute to disability. Participants practise these skills in their home and

other environments to become expert in their application and integration. “PMPs are

delivered in a group format to normalise pain experience, to maximise possibilities of

learning from other group members, and for economy.”

The guideline recommends to consider referral for a combined physical and

psychological treatment programme, comprising around 100 hours over a maximum of

eight weeks, for people who have received at least one less intensive treatment and

have high disability and/or significant psychological distress. Combined physical and

psychological treatment programmes should include a cognitive behavioural approach

and exercise.

The APS/ACP guidelines (157) findings were as follows:

Intensive (>100 hours), daily interdisciplinary rehabilitation was moderately superior to non-

interdisciplinary rehabilitation or usual care for short-and long-term functional status, and

for pain outcomes (at three to four months in two trials). Long-term pain and return to work

outcomes were inconsistent;


Less intensive interdisciplinary rehabilitation was no better than non-interdisciplinary

rehabilitation or usual care;

Functional restoration with a CBT component was more effective than usual care, normal

activities or standard exercise therapy for reducing time lost from work. There was little

evidence that functional restoration without a CBT component is effective;

In conclusion, interdisciplinary rehabilitation was more effective than usual care for sub-

acute back pain.

8.13.1 Conclusions.

There is considerable heterogeneity between reviews and between the included

RCTs. Effectiveness of the intervention is likely to vary depending on the comparator,

in particular whether it is an active comparator (which may incorporate some of the

elements or similar elements of the multidisciplinary intervention), or a wait list

control. Comparisons across studies (and across reviews) are therefore difficult due

to variability in the definition of multidisciplinary treatment (type and number of

elements), the comparators, the outcome measures/instruments used and follow-up

times (e.g. short-term, intermediate or long-term). The ‘treatment as usual’ often

used as the comparator is likely to vary between studies. Due to the heterogeneity,

there are often few studies that make a direct head-to-head comparison between

particular combinations of treatments.

Overall, there seems be some moderately strong evidence, based on RCTs of variable

quality, that multidisciplinary programmes/more intensive programmes are

significantly better than usual care/less intensive programmes for some outcomes

relating to pain and function. This was the case mainly for shorter-term outcomes,

with less evidence for longer-term outcomes. No evidence was identified for

residential programmes specifically. Several reviews highlight that it is not known

which treatment components are most effective and which patients would benefit

most.


Bearing in mind the caveats above, multi-disciplinary pain management programmes

should be commissioned.


APPENDIX I – ADMITTED PATIENT COMMISSIONING DATA SET (CDS) DATA REQUEST SPECIFICATIONS

Request 1: Admitted patient episodes by Provider Trust, admission method, patient classification, gender and financial year

Dataset

Setting: Admitted Patient episodes

Source dataset: Admitted Patient Care - General Episode Commissioning Data Set

Unit: Finished Consultant Episodes (FCEs)

Inclusion criteria:

Coverage: Patients admitted to a West Midlands provider

Ages: 16 years and over

Gender: Persons

Time period: Financial years: 2007/8, 2008/9, 2009/10, 2010/11, 2011/12

Other: Where primary procedure is in the attached OPCS4 Code list (Appendix II)

Output table

Statistic column: Count of FCEs

Row variables: Financial year, Provider Trust, admission method, patient classification, gender

Column variable: n/a

FY Provider Trust Code

Provider Trust Name

Gender Admission Method

Patient Classification

Count of FCEs

Request 2: Admitted patient episodes by Provider Trust, primary procedure, gender and financial year

Dataset




Inclusion criteria:

Coverage: Patients admitted to a West Midlands provider


Gender: Persons




Output table


Row variables: Financial year, Provider Trust, primary procedure, gender


FY Provider

Trust Code

Provider Trust

Name

Gender Primary procedure

OPCS4 Code (4-digit)

Count of

FCEs

Request 3: Admitted patient episodes by Primary Care Trust, admission method, patient classification, gender and financial year

Dataset




Inclusion criteria:

Coverage: Patients resident in West Midlands Primary Care Trusts


Gender: Persons



Output table


Row variables: Financial year, Primary Care Trust, admission method, patient classification, gender


FY ONS

Area

Code

PCT

Code

PCT Name Gender Admission

Method

Patient

Classification

Count of

FCEs


Request 4: Admitted patient episodes by Primary Care Trust, primary procedure, gender and financial year

Dataset




Inclusion criteria:

Coverage: Patients resident in West Midlands Primary Care Trusts


Gender: Persons



Output table


Row variables: Financial year, Primary Care Trust, primary procedure, gender


FY Provider

Trust Code

Provider Trust

Name

Gender Primary procedure

OPCS4 Code (4-digit)

Count of

FCEs


APPENDIX II – PAIN MANAGEMENT PROCEDURE CODES

OPCS4 Code

Procedure

A48.3 Insertion of neurostimulator adjacent to spinal cord

A48.4 Attention to neurostimulator adjacent to spinal cord NEC

A48.5 Reprogramming of neurostimulator adjacent to spinal cord

A48.6 Removal of neurostimulator adjacent to spinal cord

A48.7 Insertion of neurostimulator electrodes into the spinal cord

A48.8 Other specified other operations on spinal cord

A09.1 Implantation of neurostimulator into brain

A09.2 Maintenance of neurostimulator in brain

A09.3 Removal of neurostimulator from brain

A09.4 Operation on neurostimulator in brain NEC

A09.5 Insertion of neurostimulator electrodes into the brain

A09.8 Other specified neurostimulation of brain

A09.9 Unspecified neurostimulation of brain

A70.1 Implantation of neurostimulator into peripheral nerve

A70.2 Maintenance of neurostimulator in peripheral nerve

A70.3 Removal of neurostimulator from peripheral nerve

A70.4 Insertion of neurostimulator electrodes into peripheral nerve

A70.5 Electroacupuncture

A70.6 Acupuncture NEC

A70.7 Application of transcutaneous electrical nerve stimulator

A70.8 Other specified neurostimulation of peripheral nerve

A70.9 Unspecified neurostimulation of peripheral nerve

A48.3 Insertion of neurostimulator adjacent to spinal cord

A48.4 Attention to neurostimulator adjacent to spinal cord NEC

A48.5 Reprogramming of neurostimulator adjacent to spinal cord

A48.6 Removal of neurostimulator adjacent to spinal cord

A48.7 Insertion of neurostimulator electrodes into the spinal cord

A48.8 Other specified other operations on spinal cord

A52.1 Therapeutic lumbar epidural injection

A52.2 Therapeutic sacral epidural injection

A52.3 Epidural blood patch

A52.8 Other specified therapeutic epidural injection

A52.9 Unspecified therapeutic epidural injection

A54.1 Injection of destructive substance into cerebrospinal fluid

A54.2 Injection of therapeutic substance into cerebrospinal fluid

A54.3 Implantation of intrathecal drug delivery device adjacent to spinal cord

A54.4 Attention to intrathecal drug delivery device adjacent to spinal cord

A54.5 Removal of intrathecal drug delivery device adjacent to spinal cord

A54.8 Other specified therapeutic spinal puncture

A54.9 Unspecified therapeutic spinal puncture

A57.1 Extirpation of lesion of spinal nerve root


OPCS4 Code

Procedure

A57.2 Rhizotomy of spinal nerve root

A57.3 Radiofrequency controlled thermal destruction of spinal nerve root

A57.4 Injection of destructive substance into spinal nerve root

A57.5 Destruction of spinal nerve root NEC

A57.6 Reimplantation of spinal nerves into spinal cord

A57.7 Injection of therapeutic substance around spinal nerve root

A57.8 Other specified operations on spinal nerve root

A57.9 Unspecified operations on spinal nerve root

V29.1 Primary laminectomy excision of cervical intervertebral disc

V29.2 Primary hemilaminectomy excision of cervical intervertebral disc

V29.3 Primary fenestration excision of cervical intervertebral disc

V29.4 Primary anterior excision of cervical intervertebral disc and interbody fusion of joint of cervical spine

V29.5 Primary anterior excision of cervical intervertebral disc NEC

V29.6 Primary microdiscectomy of cervical intervertebral disc

V29.8 Other specified primary excision of cervical intervertebral disc

V29.9 Unspecified primary excision of cervical intervertebral disc

V33.1 Primary laminectomy excision of lumbar intervertebral disc

V33.2 Primary fenestration excision of lumbar intervertebral disc

V33.3 Primary anterior excision of lumbar intervertebral disc and interbody fusion of joint of lumbar spine

V33.4 Primary anterior excision of lumbar intervertebral disc NEC

V33.5 Primary anterior excision of lumbar intervertebral disc and posterior graft fusion of joint of lumbar spine

V33.6 Primary anterior excision of lumbar intervertebral disc and posterior instrumentation of lumbar spine

V33.7 Primary microdiscectomy of lumbar intervertebral disc

V33.8 Other specified primary excision of lumbar intervertebral disc

V33.9 Unspecified primary excision of lumbar intervertebral disc

V34.1 Revisional laminectomy excision of lumbar intervertebral disc

V34.2 Revisional fenestration excision of lumbar intervertebral disc

V34.3 Revisional anterior excision of lumbar intervertebral disc and interbody fusion of joint of lumbar spine

V34.4 Revisional anterior excision of lumbar intervertebral disc NEC

V34.5 Revisional anterior excision of lumbar intervertebral disc and posterior graft fusion of joint of lumbar spine

V34.6 Revisional anterior excision of lumbar intervertebral disc and posterior instrumentation of lumbar spine

V34.7 Revisional microdiscectomy of lumbar intervertebral disc

V34.8 Other specified revisional excision of lumbar intervertebral disc

V34.9 Unspecified revisional excision of lumbar intervertebral disc

V35.1 Primary excision of intervertebral disc NEC

V35.2 Revisional excision of intervertebral disc NEC

V35.8 Other specified excision of unspecified intervertebral disc


OPCS4 Code

Procedure

V35.9 Unspecified excision of unspecified intervertebral disc

V25.1 Primary extended decompression of lumbar spinal cord and intertransverse fusion of joint of lumbar spine

V25.2 Primary extended decompression of lumbar spinal cord NEC

V25.3 Primary posterior decompression of lumbar spinal cord and intertransverse fusion of joint of lumbar spine

V25.4 Primary posterior laminectomy decompression of lumbar spinal cord

V25.5 Primary posterior decompression of lumbar spinal cord NEC

V25.6 Primary lateral foraminotomy of lumbar spine

V25.7 Primary anterior corpectomy of lumbar spine and reconstruction HFQ

V25.8 Other specified primary decompression operations on lumbar spine

V25.9 Unspecified primary decompression operations on lumbar spine

V26.1 Revisional extended decompression of lumbar spinal cord and intertransverse fusion of joint of lumbar spine

V26.2 Revisional extended decompression of lumbar spinal cord NEC

V26.3 Revisional posterior decompression of lumbar spinal cord and intertransverse fusion of joint of lumbar spine

V26.4 Revisional posterior laminectomy decompression of lumbar spinal cord

V26.5 Revisional posterior decompression of lumbar spinal cord NEC

V26.6 Revisional lateral foraminotomy of lumbar spine

V26.7 Revisional anterior corpectomy of lumbar spine and reconstruction HFQ

V26.8 Other specified revisional decompression operations on lumbar spine

V26.9 Unspecified revisional decompression operations on lumbar spine

V38.1 Primary fusion of joint of thoracic spine

V38.2 Primary posterior interlaminar fusion of joint of lumbar spine

V38.3 Primary posterior fusion of joint of lumbar spine NEC

V38.4 Primary intertransverse fusion of joint of lumbar spine NEC

V38.5 Primary posterior interbody fusion of joint of lumbar spine

V38.6 Primary transforaminal interbody fusion of joint of lumbar spine

V38.8 Other specified primary fusion of other joint of spine

V38.9 Unspecified primary fusion of other joint of spine

V48.1 Radiofrequency controlled thermal denervation of spinal facet joint of cervical vertebra

V48.2 Denervation of spinal facet joint of cervical vertebra NEC

V48.3 Radiofrequency controlled thermal denervation of spinal facet joint of thoracic vertebra

V48.4 Denervation of spinal facet joint of thoracic vertebra NEC

V48.5 Radiofrequency controlled thermal denervation of spinal facet joint of lumbar vertebra

V48.6 Denervation of spinal facet joint of lumbar vertebra NEC

V48.7 Radiofrequency controlled thermal denervation of spinal facet joint of vertebra NEC

V48.8 Other specified denervation of spinal facet joint of vertebra

V48.9 Unspecified denervation of spinal facet joint of vertebra

V52.1 Enzyme destruction of intervertebral disc

V52.2 Destruction of intervertebral disc NEC

V52.3 Discography of intervertebral disc

V52.4 Biopsy of lesion of intervertebral disc NEC


OPCS4 Code

Procedure

V52.5 Aspiration of intervertebral disc NEC

V52.8 Other specified other operations on intervertebral disc

V52.9 Unspecified other operations on intervertebral disc

V54.4 Injection around spinal facet of spine

W90.1 Aspiration of joint

W90.2 Arthrography

W90.3 Injection of therapeutic substance into joint

W90.4 Injection into joint NEC

W90.8 Other specified puncture of joint

W90.9 Unspecified puncture of joint


APPENDIX NN

Key recommendations of the NICE CG 88 and the American College of Physicians / American Pain

Society Guidelines on low back pain.

National Institute for Health and Clinical Excellence. Low back pain. Early management of

persistent non-specific low back pain. CG 88; 2009.

Key recommendations:

Information, education and patient preferences:

Provide people with advice and information to promote self-management of their low back pain.

Offer one of the following treatment options, taking into account patient preference: an

exercise programme, a course of manual therapy or a course of acupuncture. Consider

offering another of these options if the chosen treatment does not result in satisfactory

improvement

Physical activity and exercise

Consider offering a structured exercise programme tailored to the person: this should

comprise up to a maximum of eight sessions over a period of up to 12 weeks.

Offer a group supervised exercise programme, in a group of up to 10 people.

A one-to-one supervised exercise programme may be offered if a group programme is not

suitable for a particular person.

Manual therapy

Consider offering a course of manual therapy, including spinal manipulation, comprising up

to a maximum of nine sessions over a period of up to 12 weeks

Invasive procedures

Consider offering a course of acupuncture needling comprising up to a maximum of 10

sessions over a period of up to 12 weeks.

Do not offer injections of therapeutic substances into the back for non-specific low back

pain.

Combined physical and psychological treatment programme

Consider referral for a combined physical and psychological treatment programme, comprising

around 100 hours over a maximum of 8 weeks, for people who:

− have received at least one less intensive treatment and

− have high disability and/or significant psychological distress

Assessment and imaging

Do not offer X-ray of the lumbar spine for the management of non-specific low back pain.

Only offer an MRI scan for non-specific low back pain within the context of a referral for an

opinion on spinal fusion.


Referral for surgery

Consider referral for an opinion on spinal fusion for people who:

− have completed an optimal package of care, including a combined physical and psychological

treatment programme (section 1.7) and

− still have severe non-specific low back pain for which they would consider surgery.

Diagnosis and treatment of low back pain: a joint clinical practice guideline from the American

College of Physicians and the American Pain Society. Ann Int Med 2007; 147 (7): 478-91.

Key recommendations:

Recommendation 1: Clinicians should conduct a focused history and physical examination to help place patients with low back pain into 1 of 3 broad categories: nonspecific low back pain, back pain potentially associated with radiculopathy or spinal stenosis, or back pain potentially associated with another specific spinal cause. The history should include assessment of psychosocial risk factors, which predict risk for chronic disabling back pain (strong recommendation, moderate-quality evidence). Recommendation 2: Clinicians should not routinely obtain imaging or other diagnostic tests in patients with nonspecific low back pain (strong recommendation, moderate-quality evidence). Recommendation 3: Clinicians should perform diagnostic imaging and testing for patients with low back pain when severe or progressive neurologic deficits are present or when serious underlying conditions are suspected on the basis of history and physical examination (strong recommendation, moderate-quality evidence). Recommendation 4: Clinicians should evaluate patients with persistent low back pain and signs or symptoms of radiculopathy or spinal stenosis with magnetic resonance imaging (preferred) or computed tomography only if they are potential candidates for surgery or epidural steroid injection (for suspected radiculopathy) (strong recommendation, moderate-quality evidence). Recommendation 5: Clinicians should provide patients with evidence- based information on low back pain with regard to their expected course, advise patients to remain active, and provide information about effective self-care options (strong recommendation, moderate-quality evidence). Recommendation 6: For patients with low back pain, clinicians should consider the use of medications with proven benefits in conjunction with back care information and self-care. Clinicians should assess severity of baseline pain and functional deficits, potential benefits, risks, and relative lack of long-term efficacy and safety data before initiating therapy (strong recommendation, moderate-quality evidence). For most patients, first-line medication options are acetaminophen or non-steroidal anti-inflammatory drugs.

Recommendation 7: For patients who do not improve with self-care options, clinicians should

consider the addition of non-pharmacologic therapy with proven benefits-for acute low back pain,

spinal manipulation; for chronic or sub-acute low back pain, intensive interdisciplinary rehabilitation,

exercise therapy, acupuncture, massage therapy, spinal manipulation, yoga, cognitive-behavioural

therapy, or progressive relaxation (weak recommendation, moderate-quality evidence).


APPENDIX NN

Search strategies for evidence of effectiveness of interventions in chronic pain

Database Search strategy

Cochrane Library 2011 Issue 4 1. “chronic pain” 2. MeSH descriptor Pain explode all trees 3. MeSH descriptor Chronic Disease explode all

trees 4. (2 AND 3) 5. (1 OR 4)

ARIF (Aggressive Research Intelligence Facility)

Chronic pain (selected abstracts)

MEDLINE (OVID MEDLINE (R) 1948 to November week 3 2011

1. Chronic pain.ab, ti. 2. Pain.sh. 3. Chronic disease.sh. 4. 2 AND 3 5. 1 OR 4 6. Limit 5 to “reviews (maximises specificity)”

EMBASE 1974 to 2011 week 48 1. Chronic pain. ti, ab. 2. Exp pain/ 3. Exp chronic disease/ 4. 2 AND 3 5. 1 OR 4 6. Limit 5 to “reviews (maximises specificity)”

TRIP database 1. “Chronic pain”

PROSPERO (International prospective register of systematic reviews that are ongoing)

Chronic pain Pain


Search strategies to identify evidence of effectiveness for chronic back pain

Database Search strategy

Cochrane library 2012 Issue 2

#1 ("low back pain") OR ("back pain") #2 "chronic" #3 (#1 AND #2) #4 ("cognitive behavioural therapy") OR ("cognitive behaviour therapy") OR ("cognitive therapy") OR ("behaviour therapy") OR ("behavioural therapy") OR ("CBT") #5 (#3 AND #4) #6 ("discectomy") OR ("lumbar discectomy") #7 (#3 AND #6) #8 ("microdiscectomy") OR ("microdecompression") OR ("lumbar microdecompression") #9 (#3 AND #8) #10 ("facet joint injection") #11 (#3 AND #10) #12 ("pain management programme") OR ("pain management programmes") #13 (#3 AND #12)

MEDLINE (OVID MEDLINE (R) 1948 to May 2012)

1. back pain.tw. 2. Back Pain/ 3. low back pain.tw. 4. Low Back Pain/ 5. chronic low back pain.tw. 6. dorsalgia.tw. 7. 1 or 2 or 3 or 4 or 5 or 6 8. microdiscectomy.tw. 9. microdecompression.tw. 10. Decompression, Surgical/ 11. 8 or 9 or 10 12. facet joint injection.tw. 13. pain management program*.tw. 14. Pain Management/ 15. 13 or 14 16. discectomy.tw. 17. Diskectomy/ 18. diskectomy.tw. 19. 16 or 17 or 18 20. cognitive behavioural therapy.tw. 21. Cognitive Therapy/ 22. behaviour therapy.tw.

23. cognitive psychotherap*.tw. 24. cbt.tw. 25. 20 or 21 or 22 or 23 or 24 26. 7 and 11 27. 7 and 12 28. 7 and 15 29. 7 and 19 30. 7 and 25


EMBASE (1974 to May 2012)

1. back pain.tw. 2. backache/ 3. backache.tw. 4. low back pain.tw. 5. low back pain/ 6. chronic low back pain.tw. 7. dorsalgia.tw. 8. 1 or 2 or 3 or 4 or 5 or 6 or 7 9. microdiscectomy.tw. 10. intervertebral diskectomy/ 11. intervertebral diskectomy.tw. 12. microdecompression.tw. 13. decompression surgery/ 14. 9 or 10 or 11 or 12 or 13 15. facet joint injection.tw. 16. methylprednisolone acetate/ or corticosteroid/ or bupivacaine/ or methylprednisolone/ or lidocaine/ or local anesthetic agent/ or betamethasone/ 17. 15 or 16 18. pain management program*.tw. 19. discectomy.tw. 20. 10 or 11 or 19 27. cbt.tw. 28. 21 or 22 or 23 or 24 or 25 or 26 or 27

21. cognitive behavioural therap*.tw. 22. cognitive therapy/ 23. behaviour therapy.tw. 24. behavior therapy/ 25. cognitive psychotherap*.tw. 26. psychological aspect/ 29. 8 and 17 30. 8 and 18 31. 8 and 20 32. 8 and 14 33. 8 and 28


Appendix 1 Link to main document

Summary of findings: Manual therapy (manipulation and mobilisation)

Citation Year Title, Authors

Number and type of primary studies Included Excluded

With or without meta-analysis

Population Intervention Comparator Outcome measures Primary

Outcome measures Secondary

Findings Summary Finding Effective, statistically significant Indeterminate or of limited effect Likely to be ineffective or potentially harmful

Quality ?Cochrane review PRISMA – items not reported Critical Appraisal - bias, heterogeneity, size of effect estimate and precision, generalizability

OCEBM level

Comments

Gross (2010) (219) Manipulation or mobilisation for neck pain

27 RCTs (1522 participants)

With meta-analysis

Neck pain without radicular findings, including neck pain without specific cause, whiplash associated disorder, myofascial pain syndrome, neck disorders associated with degenerative diseases

Manipulation or mobilisation

Placebo (sham/mock mobilisation or other sham treatment), adjunct treatment, wait list or no treatment, another treatment (manipulation or mobilisation versus another treatment, one technique of manipulation or

Pain relief, disability, function, patient satisfaction, global perceived effect, QoL

Cervical manipulation for sub-acute/chronic neck pain: moderate quality evidence suggested manipulation and mobilisation produced similar effects on pain, function and patient satisfaction at intermediate-term-follow-up. Low quality evidence that manipulation alone compared to a control may provide short term relief following one to four sessions (SMD pooled=-0.90; 95%CI:-1.78, -0.02). Thoracic manipulation

Cervical manipulation and mobilisation produced similar changes Either may provide immediate or short-term change; no long-term data are available. Thoracic manipulation may improve pain and function Optimal techniques and

Cochrane review PRISMA:2 items missing AMSTAR: Good

Level 1 As a Cochrane review, this is an authoritative summary of the present state of evidence. While the estimated effects look impressive the quality of evidence is poor. Hence these treatments should be available for those









OCEBM level

Comments

mobilisation versus another, one dose of manipulation or mobilisation versus another dose

for acute/chronic neck pain: Low quality evidence supported thoracic manipulation as an additional therapy for pain reduction (NNT 7; 46.6% treatment advantage) and increased function (NNT 5; 40.6% treatment advantage) in acute pain and favoured single session of thoracic manipulation for immediate pain reduction compared to placebo for chronic neck pain (NNT 5; 29% treatment advantage). Mobilisation for sub-acute/chronic neck pain: in addition to the evidence noted above, low quality evidence for sub-acute and chronic neck pain

dose are unresolved Further research is very likely to have an important impact on the estimate of effect and is likely to change the estimate

patients who choose to have it









OCEBM level

Comments

indicated that 1) Combination of Maitland mobilisation techniques was similar to acupuncture for immediate pain relief and increased function; 2) There was no difference between mobilisation and acupuncture as additional treatments for immediate pain relief and improved function; 3) Neural dynamic mobilisations may produce clinically important reduction of pain immediately post-treatment. Certain mobilisations were superior Side effects: 3 of 8 studies that looked at side effects reported









OCEBM level

Comments

none. The other 5 reported only minor and temporary effects

Miller (2010) (159) Manual therapy and exercise for neck pain: a systematic review

17 RCTs With meta-analysis

Neck pain with or without radicular symptoms or cervicogenic headache

Manual therapy including manipulation or mobilisation techniques, combined with exercise

Placebo, wait list/no treatment group, an adjunct treatment (e.g., mobilisation and exercise plus ultrasound versus ultrasound), or another treatment

Pain function/disability, QOL, global perceived effect, patient satisfaction for short-term ((closest to 4 weeks) to long-term (closest to 12 weeks) follow-up

Of 17 RCTs included, 29% had a low risk of bias. Low quality evidence suggests clinically important long-term improvements in pain (SMD= -0.50 (95%CI:-0.76, -0.24) than exercise alone, but no long-term differences across multiple outcomes for (sub) acute/chronic neck pain with or without cervicogenic headache.

Moderate quality evidence supports this treatment combination for pain reduction and improved quality of life over manual therapy alone for chronic neck pain. Evidence suggests that there is greater short-term pain reduction when compared to traditional care for acute whiplash Evidence regarding radiculopathy was sparse

Not Cochrane review PRISMA:5 items missing AMSTAR: Good

Level 1



Summary of findings: Pharmacological procedures








OCEBM level

Comments

Siedel (2010) (160) Antipsychotics for acute and chronic pain in adults

11 studies, randomised controlled trials (770 participants)

Without meta-analysis

Patients of either gender, with acute or chronic pain

Any form of antipsychotic treatment (at any dose)

No treatment, placebo, or other pain-relieving treatments (e.g., non-steroidal, anti-inflammatory drugs, anti-depressants, anticonvulsants, opioids)

Reduction in pain intensity, as measured by the visual analogue scale, self-reported pain relief

Adverse effects, attrition, measures of satisfaction or patient preference, assessment of quality of life

Of 11 RCTs, 5 studies showed beneficial effects of antipsychotics in treatment of acute and chronic pain Results regarding treatment of neuropathic pain were contradictory; there was no significant effect for post herpetic neuralgia with fluphenazine, but there was significant pain reduction in trigeminal neuralgia

Positive effects on painful conditions in 6 trials, whereas 5 trials failed to report any analgesic effect.

Not Cochrane review PRISMA:8 items missing AMSTAR:Good/medium

Level 1 Data was limited, most trials only studied small patient samples. Further research is required









OCEBM level

Comments

with pimozide treatment Most frequently reported adverse effects were involuntary movements, parkinsonism, akathisia and sedating effects

Hauser (2009) (161) Treatment of fibromyalgia syndrome with antidepressants

18 randomised controlled trials (1427 participants)

With meta-analysis

Fibromyalgia Tricyclic and tetracyclic antidepressants [TCAs], selective serotonin reuptake inhibitors [SSRIs], serotonin and noradrenaline reuptake inhibitors [SNRIs], or monoamine oxidase

Pharmacological placebo

Pain, fatigue, sleep, and depressed mood

Health-related quality of life

Strong evidence for association of antidepressants with pain reduction (SMD -0.43; 95%CI: -0.55, -0.30), fatigue (SMD: -0.13; 95%CI:-0.26, -0.01), depressed mood (SMD: -0.26; 95%CI:-0.39, -0.12), sleep disturbances (SMD: -0.32; 95%CI: -0.46, -0.18) Strong evidence for

Short-term usage of amytriptyline and duloxetine can be considered for treatment of pain and sleep disturbances in fibromyalgia.

Not Cochrane review PRISMA:2 items missing AMSTAR:Good

Level 1 Internal and external validity of RCTs was limited, short duration, long-term treatment evidence is lacking. Lack of information on whether antidepressant reduce fibromyalgia









OCEBM level

Comments

inhibitors [MAOIs]

association of antidepressants with improved health-related QOL (SMD: -0.31; 95%CI: -0.42, -0.20) Effect sizes for pain reduction were large for TCAs (SMD: -1.64; 95%CI: -2.47, -0.71), medium for MAOIs (SMD: -0.54; 95%CI: -1.02, -0.07) and small for SSRIs (SMD: -0.36; 95%CI: -0.77, -0.01) and SNRIs (SMD: -0.36; 95%CI: -0.46, -0.25)

related costs

Saarto (2010) (162) Antidepressants for neuropathic pain

61 randomised controlled trials, included 3293 participants

Adult male and female patients with any neuropathic pain

TCAs, MAOIs, SSRIs, SNRIs, RIMAs, newer antidepressant (nefazodone,mirtazepine, venlafaxine), other

Placebo, active control drug, another antidepressant, any other intervention

Patient reported global improvement or pain relief or both, measured

Quality of life, adverse effects, sleep parameters, depression measures

TCAs are effective and have an NNT of 3.6 (95% CI 3 to 4.5) RR 2.1 (95% CI 1.8 to 2.5) for the achievement of at least moderate pain relief

There is some, limited evidence for the role of SSRIs Both TCAs and venlafaxine have NNTs of


Level 1 The use of antidepressant (TCAs and SSRIs) should be included as part of the pain service









OCEBM level

Comments

(bupropion, etoperidone, flupenthixol, fluphenazine, hypericum (St John’sWort), mirtazepine, nefazodone, reboxetine, tianeptine, and tryptophan

on any scale

Limited evidence for the effectiveness of the newer SSRIs but no studies of SNRIs were found Insufficient data to assess effectiveness for other antidepressants such as St John’s Wort and L-tryptophan. For diabetic neuropathy the NNT for effectiveness was 1.3 (95% CI 1.2 to 1.5) RR 12.4 (95% CI 5.2 to 29.2) (five studies); for post herpetic neuralgia 2.7 (95% CI 2 to 4.1), RR 2.2 (95% CI 1.6 to 3.1) (four studies) evidence that TCAs

approximately 3 for moderate pain relief. There is evidence to suggest that other antidepressants may be effective but numbers of participants are insufficient to calculate robust NNTs. SSRIs are generally better tolerated by patients but more high quality studies are required









OCEBM level

Comments

are not effective in HIV-related neuropathies. The number needed to harm (NNH) for major adverse effects defined as an event leading to withdrawal from a study was 28 (95% CI 17.6 to 68.9) for amitriptyline and 16.2 (95% CI 8 to 436) for venlafaxine The NNH for minor adverse effects was 6 (95% CI 4.2 to 10.7) for amitriptyline and 9.6 (95% CI 3.5 to 13) for venlafaxine

Lunn (2011) (163) Duloxetine for treatming painful

6 randomised or quasi-randomised controlled trials, 2220

With meta-analysis

Any form of painful peripheral neuropathy or chronic

All formulations and doses of duloxetine

Placebo or other controls

Improvement of pain (up to 12 weeks) using

Long-term (more than 12 weeks) improvement of pain,

Duloxetine at 60 mg daily is effective in treating painful diabetic peripheral neuropathy in the

Moderately strong evidence that duloxetine 60 mg and 120 mg daily is

Cochrane review PRISMA: no items missing

Level 1 Duloxetine is effective and should be part of the pain service









OCEBM level

Comments

neuropathy or chronic pain

participants pain validated scales of pain intensity or pain relief

improvement in short-term and long term pain of at least 30%, improvement in any validated QOL score of more than 30%

short-term to 12 weeks with a risk ratio (RR) for 50% pain reduction at 12 weeks of 1.65 (95% confidence interval (CI) 1.34 to 2.03); NNT 6 (95%CI: 5 to 10) Duloxetine at 60 mg daily is also effective in fibromyalgia over 12 weeks (RR for 50% reduction in pain 1.57, 95%CI 1.20 to 2.06; NNT 8, 95%CI: 5 to 17) and 28 weeks (RR 1.58, 95%CI: 1.10 to 2.27) Adverse events were common in both treatment and placebo arms but more common in the treatment arm with a dose

efficacious for treating pain in diabetic peripheral neuropathy and fibromyalgia Minor side effects are common at therapeutic doses but serious side

effects are rare. Direct comparisons needed of duloxetine with other antidepressants and with other drugs already shown to be efficacious in neuropathic pain with

AMSTAR:Good

that is commissioned









OCEBM level

Comments

dependent effect. Most side effects were minor, but 16% of participants stopped the drug due to side effects. Serious adverse events were rare

unbiased economic analyse

Matthews (2009) (164) Topical rubefacients for acute and chronic pain in adults

7 randomised controlled trials included

With meta-analysis

Acute and chronic pain

Topical rubefacients containing salicylates or nicotinamides

Topical placebo

“clinical success”, defined as a 50% reduction in pain, or equivalent measure such as a “very good” or “excellent” global assessment of treatment, or “none” or “slight”

numbers of participants with adverse events: local and systemic, and cough numbers of withdrawals: all cause, lack of efficacy, adverse events

In chronic pain the NNT for effective pain relief was 6.2 (95% CI: 4.0 to 13) when compared to topical placebo). There were insufficient data to draw conclusions against active controls

The evidence was limited by the quality and size of the available studies. The evidence of effectiveness was more robust in chronic pain with rubefacients providing effective relief to 1 in 6 patients who use them over

Cochrane review PRISMA:1 item missing AMSTAR:Good

Level 1









OCEBM level

Comments

pain on rest or movement measured on a categorical scale patient-reported reduction in pain of at least 50% patient-reported global assessment of treatment; pain on movement pain on rest, or spontaneous pain

and above background improvement with a placebo









OCEBM level

Comments

undefined “improvement”

Papaleontiou (2010) (165) Outcomes associated with opioid use in the treatment of chronic non-cancer pain in older adults: a systematic review and meta-analysis

31 RCTs, 8 open-label observational studies, one retrospective cohort study 8690 participants

With meta-analysis

Chronic non-cancer pain in older adults

Tramadol, opioids

Placebo, or add on to existing therapy, or another active treatment

Pain intensity, physical quality of life, mental quality of life, sleep

Weighted mean subject age was 64.1 years (mean age range:60-73) Mean duration of treatment studies was 4 weeks and only 5 studies lasted longer than 12 weeks. In meta-analysis, effect size for pain reduction was -0.557 (P<0.001), -0.432 (P<0.001) for physical disability reduction, and 0.859 (P=0.309) for improved sleep Common adverse

Among older adults with chronic pain, there was no significant comorbidity, and short term use of opioids was associated with reductions in pain intensity, improved physical functioning but decreased mental health functioning

Not Cochrane review PRISMA: 4 items missing AMSTAR:Good/medium

Level 1 (majority of studies were RCTs)

Limitations in the available evidence require further research, however, use of opioids for short-term treatment is reasonable for older patients without comorbidity and either nociceptive or neuropathic pain with frequent surveillance for adverse









OCEBM level

Comments

effects included constipation, nausea, dizziness, and prompted opioid discontinuation in 25% of cases

effects

Riemsma (2011) (166) Systematic review of tapentadol in chronic severe pain

10 RCTs involving severe pain, and 42 for moderate and severe pain

With meta-analysis

Nociceptive or neuropathic, malignant or non-malignant, severe pain, or moderate/severe pain

Tapentadol Oxycodone and placebo

Pain intensity, pain relief (30% and 50%, patient global impression of change, quality of life, quality of sleep, discontinuations, as well as serious adverse events and selected

For moderate to severe pain, 42 relevant trials were identified for comparisons with transdermal buprenorphine,transdermal fentanyl, hydromorphone, morphine, and oxymorphone were made Treatment with tapentadol was statistically significant over oxycodone for pain intensity, 30% and

Benefit to risk ration of tapentadol appears to be improved compared to strong opioids


Level 1









OCEBM level

Comments

adverse events

50% pain relief, patient global impression of change, and quality of life Adverse effects of opioid treatment were significantly less frequent with tapentadol compared to oxycodone. Discontinuation was significantly reduced wit tapentadol treatment Fentanyl and oxymorphone showed trends similar to tapentadol

Manchikanti (2011) (167) A systematic review of

23 RCTs were included

With meta-analysis

Adults aged at least 18 years with pain due to

Any opioid administered either orally or topically, any

Placebo treatment

Minimum of 12 weeks of follow-up,

Fair evidence for the use of tramadol in management of osteoarthritis. For

Evidence for all drugs assessed, including tramadol, for all

Not Cochrane review PRISMA: 7

Level 1 The evidence base for the use of opioid or topical









OCEBM level

Comments

randomised controlled trials of long-term opioid management for chronic non-cancer pain

any cause other than cancer lasting for at least 3 months prior to trial enrolment, and previously failed non-opioid pharmacotherapy treatment

dose for at least 12 weeks

pain relief (average change in pain scores, proportion of patients with at least 50% pain relief, health related QOL and function)

all drugs assessed, including tramadol, for all other conditions, the evidence was poor

other conditions was poor and based on weak positive evidence, indeterminate evidence or negative evidence

items missing AMSTAR:Good

opioids is generally poor. If these agents are used at all in chronic pain then patient reported outcomes and evaluation of benefit must guide the decision whether to continue to use them

Wiffen (2011) (169) Lamotrigine for acute and chronic pain

12 RCTs, 1511 participants

With meta-analysis

Central post stroke pain, chemotherapy induced neuropathic pain, diabetic neuropathy, HIV related neuropathy, mixed neuropathic

Lamotrigine Placebo or active control

Patient reported pain relief of 50% or greater, patient reported global impression of clinical change,

No study evaluated lamotrigine in acute pain There is no convincing evidence that lamotrigine is effective in treating chronic pain at doses of about 200-400 mg daily.

This update confirmed with further evidence from a larger pool of studies and subjects the earlier conclusion that lamotrigine is not effective in

Cochrane review PRISMA:No items missing AMSTAR:Good

Level1 Lamotrigine does not have a significant place in therapy and should not be commissioned as treatment for any type of chronic pain









OCEBM level

Comments

pain, spinal cord injury,related pain, trigeminal neuralgia

pain on movement, pain on light touch , pain on rest, any other pain related measure, adverse effects within a subgroup analysis of the elderly if data were available

Almost 10% of participants taking lamotrigine reported a skin rash

treating chronic pain

Wiffen (2011) (170) Carbamazepine for acute and chronic pain in adults

15 RCTs (12 cross-over and 3 parallel group studies), 629 participants

With meta-analysis

Trigeminal neuralgia, post herpetic neuralgia, diabetic neuropathy, HIV related neuropathy, central post

Carbamazepine Placebo or active control

Patient reported pain relief of 50% or greater, patient reported global impression

Five studies with 298 participants showed carbamazepine to be better than placebo. Using any grade of improvement the response was 70%

Carbamazepine is effective in chronic neuropathic pain but with caveats Quality of trials, duration of


Level 1 Carbamazepine treatment should be commissioned but only for neuropathic pain and then only for selected









OCEBM level

Comments

stroke pain, irritable bowel, and temporomandibular joint dysfunction pain

of clinical change, pain on movement, pain on rest or spontaneous pain, any other pain related outcomes, adverse events

with carbamazepine v. 12% with placebo (event rate ratio or relative benefit 6.1 (95% CI 3.9 to 9.7), NNT 1.7 (95% CI: 1.5 to 2.0). Four studies (188 participants) reporting outcomes equivalent to 50% pain reduction or more over baseline had a similar NNT Side-effects were frequent. 66% of participants on carbamazeoine experienced at least one adverse event, vs 27% with placebo; relative risk 2.4 (95% CI 1.9 to 3.1); NNH 2.6 (95% CI: 2.1 to 3.5). Adverse event

follow up and reporting of outcomes were all poor therefore, caution is needed in interpretation, and meaningful comparison with other interventions is not possible

patients









OCEBM level

Comments

withdrawals occurred in 12 of 323 participants (4%) with carbamazepine and 0 of 310 with placebo. Five deaths occurred in patients on carbamazepine, with no obvious drug association

Lynch (2011) (168) Cannabinoids for treatment of chronic non-cancer pain: a systematic review of randomised controlled trials

18 RCTs Without meta-analysis

Chronic non-cancer pain

Cannabinoids Placebo or active control group

Pain reduction (VAS),Neuropathiy pain scale, McGill pain scale

A significant analgesic effect of cannabinoid as compared with placebo was reported by 15 of the 18 trials, and several reported significant improvements in sleep. There were no serious adverse

There is evidence that cannabinoids are safe and modestly effective in neuropathic pain with preliminary evidence of efficacy in fibromyalgia and rheumatoid arthritis

Not Cochrane review PRISMA:11 items missing AMSTAR: Good

Level 1 Further large studies of longer duration examining specific cannabinoids in homogeneous populations are needed before firm conclusions can be drawn









OCEBM level

Comments

effects. Adverse effects most commonly reported were generally well tolerated, mild to moderate in severity and led to withdrawal from the studies in only a few cases

Plested (2010) (171) Pregabalin, the lidocaine plaster and duloxetine in patients with refractory neuropathic pain: a systematic review

17 trials Without meta-analysis

Refractory neuropathic pain due to any cause, lower back pain with a neuropathic component

Pregabalin, lidocaine plaster, and duloxetine

Pain intensity (VAS)

Sensory and affective scores (McGill pain questionnaire), function interference, sleep interference, pain associated distress

9/17 studies were for pregabalin, 7/17 were for lidocaine plaster, and one study for duloxetine. Only 6 studies included treatments within UK licensed indications and dose ranges Reported efficacy outcomes were

Indeterminate or of limited effect

Not Cochrane review PRISMA: 10 items missing AMSTAR:Good

Level 2? Included studies had heterogeneous patient populations and study designs. Studies were of poor quality, were small, and enrolled a variety of different refractory









OCEBM level

Comments

inconsistent between studies. Significant improvements in total, sensory and affective Short-form McGill pain questionnaire in all studies, and in function interference, sleep interference, and pain associated distress with pregabalin treatment. Only one of three studies for lidocaine plaster reported statistical significance for reduction of pain intensity. One study for

neuropathic conditions Further research required









OCEBM level

Comments

duloxetine showed that pain severity (VAS) was statistically reduced at endpoint compared to baseline Limited or no QOL data available for lidocaine plaster or duloxetine Pregabalin showed efficacy benefits in patients with neuropathic pain inadequately controlled by gabapentin Adverse events were poorly reported 6 studies reported withdrawals for pregabalin and 4









OCEBM level

Comments

studies for lidocaine plaster. No data was available for duloxetine

Tzellos (2010) (172) Gabapentin and pregabalin in the treatment of fibromyalgia: a systematic review and a meta-analysis


With meta-analysis

Adults aged 18 and over with Fibromyalgia

Gabapentin and pregabalin

placebo >30% pain reduction, percentage of dropouts due to lack of efficacy

Pregabalin at a dose of 600, 450 and 300 mg per day is effective in FBM compared to placebo (NNT: 7, upper 95% CI: 12, 450 mg). A number of adverse events (AE), such as dizziness, somnolence, dry mouth, weight gain, peripheral oedema, is consistently associated with treatment at any dose and could lead one out of four patients to quit

Pregabalin at a dose of 450mg per day is effective in treatment of fibromyalgia


Level 1

Although effective, adverse effects are associated with treatment. Further analysis of evidence is required









OCEBM level

Comments

treatment (NNH: 6, lower 95% CI: 4, 600 mg). Indirect comparison meta-analysis suggests that PB at a dose of 450 mg per day could result in more responders than at 300 mg, but this result needs to be interpreted with caution as there were no significant differences between 600 and 300 mg or between 600 and 450 mg. Data on GP is limited

Siler (2011) (173) Systematic review of the comparative effectiveness of

8 studies (7 for pregabalin, 1 for gabapentin)

With meta-analysis

Fibromyalgia Any anti-epileptic drug

Placebo Impact on pain (the proportion of patients with response,

Both drugs reduced mean pain scores more than placebo at a modest rate (pregabalin, 38% to 50%;

Moderate benefit in short-term

Not Cochrane review PRISMA:6 items missing

Level 1 Pregabalin and gabapentin can be used for treatment of









OCEBM level

Comments

antiepileptic drugs for fibromyalgia

change in pain score from baseline, functional status, or sleep quality) and adverse events

gabapentin, 51%). In a 6-month trial of pregabalin responders, 32% continued to have response at 6 months, with a mean time to loss of response of 34 days. Compared to placebo, the drugs had similarly high rates of adverse events and withdrawals

AMSTAR:Good/medium

fibromyalgia in the short-term, but studies are required to assess long term benefits of pregabalin and gabapentin

Moore (2011) (174) Gabapentin for chronic neuropathic pain and fibromyalgia in adults


With meta-analysis

Painful diabetic neuropathy, post herpetic neuralgia, trigeminal neuralgia, phantom limb pain, postoperative or traumatic neuropathic

Gabapentin in any dose, by any route

Placebo, no intervention, or any other active comparator

Patient reported pain intensity reduction of 30% or greater. Patient reported pain intensity

Any pain-related outcome indicating some improvement. Withdrawals due to lack of efficacy. Participants

Twenty-nine studies (3571 participants), studied gabapentin at daily doses of 1200 mg or more in 12 chronic pain conditions; 78% of participants were in studies of post herpetic neuralgia, painful diabetic neuropathy or

Gabapentin is effective treatment for painful neuropathic pain

Cochrane review PRISMA: No items missing AMSTAR: Good

Level 1 Results of pain relief may vary between neuropathic pain conditions, as well as dose of gabapentin Gabapentin should be









OCEBM level

Comments

pain, complex regional pain syndrome, cancer-related neuropathy, HIV-neuropathy, spinal cord injury, fibromyalgia

reduction of 50% or greater. Patient reported global impression of clinical change (PGIC) much or very much improved. Patient reported global impression of clinical change (PGIC) very much improved

experiencing any adverse event. Participants experiencing any serious adverse event. Withdrawals due to adverse events. Specific adverse events, particularly somnolence and dizziness

mixed neuropathic pain. Using the IMMPACT definition of at least moderate benefit, gabapentin was superior to placebo in 14 studies with 2831 participants, 43% improving with gabapentin and 26% with placebo; the NNT was 5.8 (4.8 to 7.2). Using the IMMPACT definition of substantial benefit, gabapentin was superior to placebo in 13 studies with 2627 participants, 31% improving with gabapentin and 17% with placebo; the NNT was 6.8 (5.6 to 8.7) Adverse events

commissioned but for selected patients









OCEBM level

Comments

occurred significantly more often with gabapentin. Persons taking gabapentin can expect to have at least one adverse event (66%), withdraw because of an adverse event (12%), suffer dizziness (21%), somnolence (16%), peripheral oedema (8%), and gait disturbance (9%). Serious adverse events (4%) were no more common than with placebo

Derry (2009) (220)Topical capsaicin for chronic neuropathic


With meta-analysis

Adults with neuropathic pain of at least moderate

Topical capsaicin (low dose formulation <0.1%)

Placebo or other active treatment

Clinical improvement of at least 50% reduction

Numbers of participants with adverse events: local, systemic and

Six studies (389 participants in total) compared regular application of low dose (0.075%)

Effective Cochrane review PRISMA: one item missing

Level 1 Capsaicin seems to be effective in providing clinically









OCEBM level

Comments

pain in adults intensity resulting from any cause, with a duration of at least three months

in pain, patient reported global assessment of treatment, pain on movement, pain on rest or spontaneous pain, undefined improvement

cough Numbers of withdrawals: all cause, lack of efficacy and adverse effects

capsaicin cream with placebo cream; the NNT for any pain relief over six to eight weeks was 6.6 (4.1 to 17). Two studies (709 participants in total) compared a single application of high dose (8%) capsaicin patch with placebo patch; the NNT for _ 30% pain relief over twelve weeks was 12 (6.4 to 70). Local skin reactions were more common with capsaicin, usually tolerable, and attenuated with time; the NNH for repeated low dose application was 2.5 (2.1 to 3.1). There were

AMSTAR: Good

useful relief (but at the expense of local skin irritation) from various neuropathic pain conditions alone or in combination with other treatment in patients who fail to respond to or cannot tolerate other available therapies









OCEBM level

Comments

insufficient data to analyse either data set by condition or outcome definition. All studies satisfied minimum criteria for quality and validity, but maintenance of blinding remains a potential problem.

Noble (2010) (214) Long-term opioid management for chronic non-cancer pain (update of 2008)

One RCT and 26 pre-post case studies (27 treatment groups, 4893 participants)

With meta-analysis

Adults with pain due to any cause other than cancer lasting from at least three months prior to enrolment. Previous non-opioid pharmacotherapy must have failed before beginning

Any opioid taken by any route in any dose for at least six months

No comparator

Adverse effects, discontinuation from study due to adverse effects, discontinuation due to insufficient pain relief, average change in pain score, proportion of patients

Many participants discontinued due to adverse effects (oral: 22.9% [95% confidence interval (CI): 15.3% to 32.8%]; transdermal:12.1% [95% CI: 4.9% to 27.0%]; intrathecal: 8.9% [95% CI: 4.0% to 26.1%]); or insufficient pain relief (oral: 10.3% [95% CI: 7.6% to 13.9%]; intrathecal:

Some long-term benefit

Cochrane review PRISMA: two items missing AMSTAR: Medium

Level 4 Weak evidence suggests that patients able to continue opioids long-term experience clinically significant pain relief Inconclusive evidence for quality of life and /









OCEBM level

Comments

opioids with at least 50% pain relief, health-related QoL

7.6% [95%CI: 3.7% to 14.8%]; transdermal: 5.8%[95% CI: 4.2% to 7.9%]) Signs of opioid addiction were reported in 0.27% of participants in the studies that reported that outcome. All three modes of administration were associated with clinically significant reductions in pain, but the amount of pain relief varied among studies Findings regarding quality of life and functional status were inconclusive due to an insufficient quantity

functional improvement Many minor adverse events (like nausea and headache) occurred, but serious adverse events, including iatrogenic opioid addiction, were rare Long term opioids should be commissioned but their use should be restricted to selected patients in view of the









OCEBM level

Comments

of evidence for oral administration studies and inconclusive statistical findings for transdermal and intrathecal administration studies

lack of conclusive evidence of benefit

Gill (2011) (221) Valproic acid and sodium valproate for neuropathic pain and fibromyalgia in adults

3 RCTs (2 were in diabetic neuropathy (total 84 subjects with 42 on placebo and 42 on valproate; one study was in post-herpetic neuralgia (23 active and 22 placebo)


Adults with one or more of the following chronic neuropathic conditions: painful diabetic neuropathy, post-herpetic neuralgia, trigeminal neuralgia, phantom limb pain, postoperative or traumatic

Valproic acid or sodium valproate in any dose, by any route, administered for the relief of neuropathic pain or fibromyalgia

Placebo, no intervention, or any other active comparator

Patient-reported pain relief of 30% or greater Patient-reported pain relief of 50% or greater Patient-reported PGIC much or very much improved

Any pain-related outcome indicating some improvement Withdrawals due to lack of efficacy. Participants experiencing any adverse event Participants experiencing

The primary outcome – 50% or more pain relief was reported only in 1 study, while all 3 reported group means for pain reduction from baseline to end-point. 1 study in diabetic neuropathy and the study in post-herpetic neuralgia reported significant differences in favour of valproic acid. Pooled analysis not

Likely to be ineffective

Cochrane review PRISMA: three items missing AMSTAR: Medium

Level 1 These results hint at a beneficial effect of valproic acid. The effect may have been overestimated because the studies did not analyse the data on an intention to treat basis. Evidence does not









OCEBM level

Comments

neuropathic pain, complex regional pain syndrome, cancer-related neuropathy, Guillain Barré, HIV-neuropathy spinal cord injury, fibromyalgia

Patient-reported PGIC very much improved

any serious adverse event Withdrawals due to adverse events Specific adverse events, particularly somnolence and dizziness

possible due to insufficient data. Adverse events (nausea, drowsiness and abnormal liver function tests were reported more often in active treatment group

justify the use of valproic acid or sodium valproate in neuropathic pain

Straube (2011) (222) Interference with work in fibromyalgia: effect of treatment with pregabalin and relation to pain response

4 RCTs Meta-analysis

Adults with fibromyalgia

Pregabalin Placebo Pain improvement (0-10 numerical pain rating scale score at beginning of trial and end of trial pain state (VAS 100mm

All patients improved but those on pregabalin saw greater reduction in days lost. Days of work lost in placebo group fell from a mean of 2.2 (SD 2.3) days to 1.9 (SD 2.1) days at trial end (p < 0.01). Patients on 600 mg pregabalin saw a reduction

Effective Not Cochrane review PRISMA: 13 items missing AMSTAR: Low (some questions not applicable)

Level 1 This meta-analysis shows that effective pain relief translates into other benefits – in this case a return to work A reduction









OCEBM level

Comments

pain scale) from 2.1 (SD 2.2) days to 1.6 (SD 2.0) days (p < 0.001) Patients with a good pain response saw the best improvement in days lost from work: from 2.0 (SD 2.2) days to 0.97 (SD 1.6) days (p < 0.0001) for those experiencing >/= 50% pain improvement and from 1.9 (SD 2.2) days to 0.73 (SD 1.4) days (p < 0.0001) for those achieving a low level of pain at trial end (<30 mm on the VAS) Patients achieving both >/= 50% pain improvement and a pain score <30 mm

of more than a day a week in time off work can be achieved in patients with good pain responses









OCEBM level

Comments

on the VAS had the largest improvement, from 2.0 (SD 2.2) days to 0.60 (SD 1.3) days (p < 0.0001)



Summary of findings: Patient education








OCEBM level

Comments

Gross (2012) (175) Patient education for neck pain


Neck pain associated with whiplash or non-specific and specific mechanical neck pain with or without radiculopathy or cervicogenic headache

Therapeutic patient education

Placebo (sham/mock education strategy), other treatment added to both arms of trial, wait list or no treatment, another treatment

Pain intensity, function, disability, knowledge transfer, behaviour change

QOL, global perceived effect, patient satisfaction. Adverse effects, follow-up

Moderate quality evidence (one trial, 348 participants) than an educational video of advice focussing on activation was more beneficial for acute whiplash related pain vs no treatment at intermediate-term (RR=0.79; 95%CI:0.59, 1.06) but not long-term follow-up (0.89; 95%CI: 0.65, 1.21) Low quality evidence (one trial, 102 participants) that whiplash pamphlet on advice focusing on activation is less beneficial for pain

With exception of one trial, this review has not shown effectiveness for educational interventions, including advice to activate, advice on stress-coping skills, workplace ergonomics and self-care strategies

Cochrane review PRISMA: one item missing AMSTAR: Good

Level 1 The evidence available does not support the commissioning of education based interventions for neck pain









OCEBM level

Comments

reduction, or no different in improving function and global perceived improvement from generic information given out in emergency care (control) for acute whiplash at short or intermediate term follow-up

Haines (2009) (223) Patient education for neck pain with or without radiculopathy

10 RCTs with meta-analysis

Adults with neck pain with or without radiculopathy

Patient education

Placebo (sham/mock education strategy) or other treatment (eg sham TENS), other treatment added to both arms of the trial (eg education and ultrasound versus ultrasound), waiting list control or no

Pain relief, function/disability, global perceived effect, QoL, patient satisfaction, follow up

Of the 10 trials, two trials were of high quality, 8 trials focussed on activation compared to no treatment or to various active treatments, including therapeutic exercise, manual therapy, and CBT, showed inferiority or no difference for pain, spanning a full range of follow-up periods and disorder types. Two trials showed no benefit for chronic neck pain and stress

Limited effect Cochrane review PRISMA: one item missing AMSTAR: Medium

Level 1 The review has not shown effectiveness for educational interventions in various disorder types and follow-up periods, including advice to activate, advice on stress coping skills, and 'neck school'. In future research, further









OCEBM level

Comments

treatment, or another treatment (eg education versus another intervention, one technique of education versus another, or one dose of education versus another dose)

coping skills at intermediate/long-term follow-up. One trial compared effects of traditional neck school to no treatment, yielding limited evidence of no benefit for pain at intermediate-term follow-up in mixed acute/subacute/ chronic neck pain

attention to methodological quality is necessary. Studies of multimodal interventions should consider study designs, such as factorial designs, that permit discrimination of the specific educational components



Summary of findings: Physical treatments








OCEBM level

Comments

Chow (2009) (183) Efficacy of low level laser therapy in the management of neck pain: a systematic review and meta-analysis of randomised placebo or active-treatment controlled trials

16 RCTs included

With meta-analysis

Acute neck pain Chronic neck pain

Low level laser therapy

Placebo or active treatment

Reduction in pain intensity (VAS)

Acute neck pain: results of two trials showed RR of 1.69 (95% CI: 1.22-2.33) for pain improvement of LLLT vs placebo Chronic neck pain: 11trials reported changes in VAS and pain intensity reduced by 19.86mm (95% CI:10.04-29.68) 5 trials reported RR for pain improvement of 4.05 (95% CI: 2.74-5.98) of LLLT

Moderate statistical significance for efficacy of LLLT for acute/chronic neck pain in short and medium term For chronic neck pain, average reduction of VAS of 19.86mm

Not Cochrane review PRISMA: 4 missing items AMSTAR: Good

Level 1 These results must be seen as preliminary evidence. Further trials are required









OCEBM level

Comments

across all studies was considered clinically relevant Clinical benefits of LLLT occur both when LLLT is used as monotherapy and in the context of regular exercise and stretching programme

Mark (2010) (177) Low level laser therapy for carpal tunnel syndrome and chronic neck pain

6 randomised controlled trials included 4 studies included


Chronic neck pain, carpal tunnel syndrome

Low level laser therapy

Sham treatment

Pain relief on VAS, McGill pain questionnaire, neck pain and disability score, functionality

Chronic neck pain: studies showed variable results. Two studies showed statistically significant findings for primary outcome of change in VAS score. Two studies showed changes in VAS

Treatment should be regarded as experimental due to poor methodological quality and variability of

Not Cochrane review PRISMA:11 items missing AMSTAR: Low

Level 1 Further larger trials required to confirm clinical benefit, LLLT cannot be recommended









OCEBM level

Comments

but not statistically significant. Two studies showed no difference between treatments

results and small sample size

Alexander (2010) (178) Exposure to low amounts of ultrasound energy does not improve soft tissue shoulder pathology: a systematic review

8 RCTs included


Shoulder pain Ultrasound Control treatment

Pain reduction Quality of life, functionality

Three studies produced significantly better outcomes compared to control groups Two studies reported significantly reduced pain and significant improvements in function

Indeterminate, optimal ultrasound energy not known


Level 1 Optimal parameters for effectiveness of ultrasound is not known, it would be premature to conclude that this treatment is ineffective. More research is required

Graham (2008) (179) Mechanical traction for neck pain with

7 RCTs included

With meta-analysis

Neck pain with or without radiculopathy

Mechanical traction alone or in combination with other

Placebo or another treatment

Pain relief using the VAS score, NRS.

Functional or disability measures including work-related

No evidence from RCTs that supports or rejects use of either continuous or intermittent traction for neck pain

Indeterminate Cochrane review PRISMA:6 items missing

Level 1 Requires further well conducted RCTs to determine









OCEBM level

Comments

or without radiculopathy

treatments disability, return to work, patient satisfaction, global perceived effect and quality of life

AMSTAR:Good

efficacy of traction. Recommendations cannot be made with the available evidence

Warden (2008) (180) Patellar taping and bracing for the treatment of chronic knee pain: a systematic review and meta-analysis

7 RCTS included 9 randomised cross-over studies

With meta-analysis

Chronic knee pain

Patellar taping and/or bracing

No taping or bracing

Pain relief using 100 mm VAS score

On 100mm scale, pain decreased with tape application (95%CI:22.2 to 10;P<0.001) compared to no tape and sham tape by 10.9mm (95%CI:-18.4 to -3.4; P<0.001) Anterior knee pain and OA, pain decreased with medially-directed tape compared with no tape by 14.7mm (95%CI:-22/8 to -6.9; P<0.001) and 20.1 mm (95%CI:-26.0 to 14.3; P<0.001) respectively

Evidence for medially-directed force on patella Limited evidence to demonstrate efficacy of patellar bracing


Level 1 Outcomes limited by presence of high heterogeneity between study outcomes and significant publication bias









OCEBM level

Comments

Blum (2008) The H-wave

5 studies included but not clear what type of studies included 2 studies included disproportionately large populations; one study had 1291 participants and the other had 5132 participants

With meta-analysis

Neuropathic pain and soft tissue inflammation

H-wave electrical stimulation

No treatment Pain reduction and reduction in use of pain medication

For chronic soft tissue inflammation and neuropathic pain: Decreased pain ratings, mean weighted effect size=0.59, estimated effect size=0.00003 (95%CI:0.580, 0.600) Decreased intake of pain medication, mean weighted effect size=0.56, estimated effect size variance=0.000013(95%CI:0.553, 0.567) Improved patient functionality, mean weighted effect size=0.70, estimated effect size variance=0.00002 (95%CI:0.691, 0.709) Chi2 test for homogeneous effect sizes

Strong to moderate effect in providing pain relief, reducing medication requirement and increasing functionality. May facilitate quicker return to work and other related daily activities

Not Cochrane review PRISMA:5 items missing AMSTAR:Low/medium

Not clear Systematic review is of poor quality, based on uncontrolled studies and little reliance can be based on the reported beneficial effect of H-wave device









OCEBM level

Comments

highly significant variability (P<0.00001), indicating a robust significant effect size for increased functionality relative to both pain relief and reductions in pain medication. Little to no evidence of any adverse effects

Van Middelkoop (2011) (182) A systematic review on the effectiveness of physical and rehabilitation interventions for chronic non-specific low back pain


With meta-analysis

Adults older than 18 years with non-specific chronic LBP that persisted for 12 weeks or more

Physical and rehabilitation intervenetions

No treatment, waiting list controls, other interventions

Pain and physical functional status (pain intensity (VAS, McGill pain questionnaire), back specific disability (ODI), perceived recovery, return to work, side effects)

Exercise therapy versus usual care: exercise treatment improved post-treatement pain intensity and disability and long-term function BT versus no treatment/waiting list: BT was more effective in reducing pain intensity at short-term follow-up compared to no

Overall evidence from RCTs, effectiveness of treatments was low. Exercise versus usual care, quality of evidence was low

Not Cochrane review PRISMA:6 items missing AMSTAR: Good to medium

Level 1 The clinical effect of back school, LLLT, patient education, massage, traction, superficial heat/cold, and lumbar supports is not clear due to insufficient









OCEBM level

Comments

treatment/waiting list controls MDT versus no treatment/waiting list controls: MDT reduced pain intensity and disability at short-term follow-up compared to no treatment/ waiting list control

BT versus no treatment/waiting list control, quality of evidence was low MDT versus no treatment/waiting list control, evidence of effectiveness was moderate at short-term at reducing pain in cLBP

data. Only MDT, exercise and BT have some effect on pain intensity and disability, thus only these three interventions should be provided as conservative treatments in daily practice in the treatment of cLBP



Summary of findings: Behavioural and cognitive behavioural therapy

Summary of findings for systematic reviews








OCEBM level

Comments

Eccleston (2009) (224) Psychological therapies for the management of chronic pain (excluding headache) in adults


With meta-analysis

Adults reporting non-cancer pain of at least three months duration in any body site, with neck facial or dental pain

Cognitive behavioural therapy, behavioural therapy

Placebo other active treatment, treatment as usual, or waiting list control

Pain experience, negative mood, disability

Overall lack of evidence for BT, except for pain immediately following treatment, when compared to TAU CBT has some small effects for pain, disability and mood

Insufficient data on quality or content of treatment to investigate their influence on outcomes CBT and BT may have a positive effect on altering mood outcomes but results are not statistically

Cochrane review PRISMA: 2 items missing AMSTAR: good

Level1 CBT and BT have weak effects in improving pain Both interventions may be effective in altering mood outcomes and the effect may be maintained at 6 months The evidence for









OCEBM level

Comments

significant behavioural therapies in isolation is weak and is not sufficient to commission these services as individual interventions There is a role for CBT as part of a comprehensive multi-disciplinary programme

Macea (2010) (185) The efficacy of web-based cognitive behavioural interventions for chronic pain: a systematic review and

11 randomised trial studies, 2953 participants

With meta-analysis

Adults with chronic pain

Internet-based cognitive behavioural programmes, with or without minimal therapist contact for patients in treatment of

Waiting list group

Pain improvement

Results of this meta-analysis suggest that web-based interventions for chronic pain effect are associated with small reductions in pain in the interventions group compared with waiting-list control groups

The effect of web-based psychological interventions is weak and uncertain

Not Cochrane review PRISMA- 6 items missing AMSTAR: Good

Level 2 In view of the small effect and the likely bias, web-based behavioural therapy should not be commissioned









OCEBM level

Comments

meta-analysis chronic pain The 11 studies showed wide variability in the type of assessments that were used, the study population, the aetiology of chronic pain, and time of intervention Drop-out rate from the study was 26%

Hoffman (2007) (186) Meta-analysis of psychological interventions for chronic low back pain

34 RCTs, Meta-analysis

Adults with non-cancerous cLBP

Psychological interventions

Waiting list control or treatment as usual

Pain intensity, QOL, physical and emotional functioning

3 or 4 RCTs (depending on outcome) for CBT versus waiting list controls: There was significant reduction in pain intensity at post-treatment in favour of CBT but not at follow-up (time not specified). No significant differences for HRQOL or depression (post –treatment only stated). 3 or 4 RCTs (depending on outcome) for CBT

Effective for CBT Although the review methodologywas generally good, it was unclear which studies were contributing to the meta-analyses and whether there was

Not Cochrane review PRISMA: 5 items missing AMSTAR: Good

Level 1 Results provide support for efficacy of psychological interventions in reducing self-reported pain, pain-related interference, depression, disability, and increasing HRQOL in









OCEBM level

Comments

versus self-regulatory treatment: there was a significant reduction in pain intensity and depression in favour of CBT at follow-up (time not specified) but not at post-treatment

clinical heterogeneity. RCTs of variable quality; authors comment on lack of reporting on treatment fidelity and concurrent treatments

patients with CLBP. Psychological interventions could be commissioned for the treatment of CLBP

Henschke (2010) (187) Behavioural treatment for chronic low-back pain



Adults with non-specific chronic low back pain that had persisted for 12 weeks or more

Combined behavioural treatment (respondent, operant and cognitive, behavioural therapy) + physiotherapy, behavioural therapy+ inpatient rehabilitation

Waiting list controls, usual care, group exercise, other treatment

Self-reported or observed overall improvement, back-pain specific functional status (Rowland Morris questionnaire or ODI), generic functional status, return

For most comparisons, there was only low or very low quality evidence to support the results. There was moderate quality evidence that:i) operant therapy was more effective than waiting list (SMD -0.43; 95%CI -0.75 to -0.11) for short-term pain relief;ii) little or no difference exists between operant, cognitive, or combined

Only CBT showed significant difference between waiting list control for short-term pain control Other comparisons : likely to be ineffective

Cochrane review PRISMA: 2 items missing AMSTAR: Good

Level 1 For patients with CLBP, there is moderate quality evidence that in the short-term, operant therapy is more effective than waiting list and behavioural therapy is









OCEBM level

Comments

to work, pain intensity (VAS or NRS)

behavioural therapy for short- to intermediate-term pain relief;iii) behavioural treatment was more effective than usual care for short-term pain relief (MD -5.18; 95%CI -9.79 to -0.57), but there were no differences in the intermediate- to long-term, or on functional status;iv) there was little or no difference between behavioural treatment and group exercise for pain relief or depressive symptoms over the intermediate- to long-term;v) adding behavioural therapy to inpatient rehabilitation was no more effective than inpatient rehabilitation alone

more effective than usual care for pain relief, but no specific type of behavioural therapy is more effective than another. In the intermediate- to long-term, there is little or no difference between behavioural therapy and group exercises for pain or depressive symptoms. CBT should









OCEBM level

Comments

be commissioned as part of a multidisciplinary programme


Summary of Findings: Guidelines

Citation

Low back pain. Early management of persistent non-specific low back pain. CG 88; 2009(156)

Guideline: Care pathway domain and topic

Treatment: BT and CBT: CBT

PICOT summary

Pop: People aged 18 or older with symptoms of non-specific low back pain (LBP) which has not resolved within 6weeks of initial onset, consultation or exacerbation up to a period of 12 months. Int: CBT Comp: Usual care in general practice, pamphlet, information package Out: Pain

Guideline evidence: Study design Searching and study selection Validity

Study designs: RCTs Searching: Comprehensive search strategy. Studies were selected which matched the inclusion/exclusion criteria. Validity: Each paper was assessed for quality and critically appraised using the Institute’s criteria for quality assessment.

Guideline evidence: Outcomes: Benefits Harms Cost effectiveness

1 RCT: No significant differences between groups in terms of pain or fear avoidance (follow-up time not stated). 1 RCT: Greater reduction in average pain intensity for the self care group but difference significant only at 6 mths.Significantly lower fear avoidance scale scores in the self care group at all follow-up times. Significantly less disability in self care group at 3 mths but not 6 or 12 mths.No more favourable mental health outcomes in self care group.

GRADE assessment

High

Did evidence justify recommendations

Yes


Appendix 6. Link to main document

Summary of findings: Invasive procedures

Summary of findings: systematic reviews








OCEBM level

Comments

Straube (2010) (206) Cervico-thoracic or lumbar sympathectomy for neuropathic pain

1 study satisfied inclusion criteria, 4 others were excluded

No Adults with peripheral or central neuropathic pain syndromes and complex regional pain syndrome.

Radiofrequency thermal ablation Sympathectomy (Cx-thoracic or lumbar)

Chemical sympathectomy using Phenol injection

Subjective Pain scores, no binary outcomes reported

% patients with <30% or mild pain relief, pain relief of <4 weeks duration, adverse events, occurrence of persistent new or expanded pain

1 RCT included. 20 patients, 10 in each arm, Both groups sign reductions in pain scores (from 8-9/10 to 4/10 and remained at 3-5 out of 10 over 4 months.

Both types of sympathectomy seem equally efficacious but comparisons with sham procedure is lacking. Small sample size. Soreness at injection site lasted 5-7 days. Paresthesia in 2 patients in Rf group and 1 in phenol group. Number with serious adverse events not

Cochrane review PRISMA: 5 items missing AMSTAR:Good

Level 2 Sympathectomy is based on little high quality evidence. Other evidence suggests that it can work at least in some cases. Should be used with caution if at all, outside a research context.









OCEBM level

Comments

reported.

Hayek (2011) (195) Intrathecal therapy for cancer and non-cancer pain

15 studies for non- non cancer pain. Of the manuscript reviewed 5 were cancer pain related and 39 were excluded

No Adults with various forms of chronic non-cancer pain

Intrathecal drug delivery

Does not apply since all 15 studies were observational in nature

Pain relief defined as a 2 point drop in 11 point pain scale, or a decrease of 30% on baseline pain intensity

Function improvement, reduction in oral medication, QoL changes, decrease in side effects from oral drugs

The included non-cancer studies were generally poorly reported. Most reported modest improvements in patient reported pain scores as measured by a visual analogue score Adverse events ranged from no cases in some studies to 23/136 in one study with some studies reporting substantial rates of removal. Rare but serious complications include infection and granuloma

Intrathecal infusion of drugs using in implantable programmable system is supported by level 2c grade of evidence (lowest of 6 possible grades used by Guyatt), and is suggested that other alternative treatments may be equally reasonable


Level 3 The available evidence base does not justify the commissioning of this treatment in any but the most exceptional circumstances.

Vlassakov (2011) (208) Local

12 included studies: single case

Not applicable

Neuralgias, radicular pain syndromes

Nerve blocks with local anaesthetics

No comparator Pain relief There were no controlled studies. Nine reports

All reviewed articles were single case

Not Cochrane review

Level 4 More research efforts are warranted.









OCEBM level

Comments

anaesthetic blockade of peripheral nerves for treatment of neuralgias: systematic analysis

reports or case series

associated with chronic pain or more than a 3-month duration

assessed a single block outcome. All reported pain relief beyond the duration of conduction blockade. The nine studies represented a total of 69 patients, 30 of whom had complete pain relief and 10 had at least 50% relief. Seven reports assessing continuous pain for more than 1 week after single block reported complete or profound pain relief in 11 of 17 patients. All 3 reports assessing series of blocks in a large number of patients (270) reported overall positive results

reports or case series, no reliable conclusion could be drawn concerning the effectiveness of nerve blocks with local anaesthetics in neuralgia. However, two features of the analysed reports-the large magnitude of the effect and the high consistency of the reported outcome

PRISMA:13 items missing AMSTAR:Good/medium

Cannot justify commissioning on the basis of evidence provided in the study

Benyamin 3 RCTs and Without Chronic mechanical Cervical epidural Comparator not Pain relief Psychological Studies were at level A significant Not Cochrane Level 2









OCEBM level

Comments

(2009) (211) Systematic review of the effectiveness of cervical epidurals in the management of chronic neck pain

17 observational studies

meta-analysis

or whiplash-related neck pain with or without radiculopathy for at least 3 months

injections with or without steroids

indicated functionality

improvement, return to work, change in opioid intake

2 (evidence obtained from well designed controlled trials without randomisation) in managing chronic neck and upper extremity pain with 1C (strong recommendation, low quality or very low quality evidence)

effect was observed in relieving chronic intractable pain of cervical origin and providing long-term relief with an indicated evidence level of II-1 on the AHRQ

review PRISMA:7 items missing AMSTAR:good/medium

Ypsilantis (2010) (209) Pre-emptive analgaesia for chronic limb pain after amputation for peripheral vascular disease: a

11 studies (7 RCTs, 2 case-control studies, 2 prospective observational cohort studies)


Chronic stump pain and PLP (critical ischaemia of peripheral vascular disease)

Pre-emptive analgaesia (local) anaesthetics, opiates, N-methyl-D- aspartate receptor agonists, a2-agonists, gamma-aminobutyric acid analogues administered separately or in

Comparator not indicated in review

Pain relief 11 studies, five different types of analgesic drugs evaluated. Beneficial effect of combined bupivacaine, diamorphine, and clonidine in reducing the risk of phantom limb pain was supported by only one study (level 3

There is no robust evidence to support the use of pre-emptive analgesia to minimise risk of chronic pain after amputation for critical ischaemia of peripheral


Level 1 (7/11 studies were RCTs)

Not recommended for commissioning









OCEBM level

Comments

systematic review

combinations, through the oral, invtravenous, epidural, or regional route

evidence), epidural and perineural infusions containing local anaesthetic +/- opiates are effective in treating acute perioperative pain, although not without potentially serious complications Most studies characterised by high dropout rates because of disease-related mortality

vascular disease. The methods used are effective in treating acute post operative pain

Staal (2008) (205) Injection therapy for subacute and chronic low back pain


Meta-analysis not possible

Patients with low back pain with symptoms persisting for at least 1 month, Subacute low back pain lasting for 4 weeks or longer and chronic pain as lasting for 12 weeks or longer

Epidural injections, facet joint injections (intra-articular, peri-articular, and nerve blocks), tender and trigger point injections using drugs consisting of

Placebo Pain relief or improvement

Global measure of improvement, back-specific disability, generic health status or well-being, disability for work, patient satisfaction

Facet joint injections with corticosteroid vs placebo: One RCT (Carette 1991) showed no significant difference at 3 months. Differences at 6 months described as statistically significant (self-rated

Statistical pooling was not possible because of clinical heterogeneity in the trials. Results indicate that there is no strong evidence for or against

Cochrane review PRISMA:4 items missing AMSTAR:Good

Level 1 There is insufficient evidence to support use of injection therapy in subacute and chronic low back pain, but may be beneficial to a









OCEBM level

Comments

corticosteroids, local anaesthetics, and a variety of other drugs

improvement, pain, and functional status in favour of active treatment) One RCT(Lilius 1990) showed no statistical differences between groups for pain, disability or work attendance at 1 hour, 2 weeks, 6 weeks and 3 months (corticosteroid injected intra-articularly, corticosteroids injected peri-capsularly and placebo injections) Facet joint injections with corticosteroids vs other treatments: 4RCTs: Manchikanti (2001) showed no significant

the use of any type of injection therapy Adverse events were either not reported or there were no complications reported. Only 3 RCTs were of high quality

subgroup of patients who may respond to a specific type of injection therapy









OCEBM level

Comments

differences for pain relief, overall health, physical, functional and psychological status and return to work throughout a 2.5 yr follow-up period (facet joint injections with corticosteroids, local anaesthetics, and Sarapin vs similar injections with local anaesthetics and Sarapin) Mayer (2004) showed no significant post-treatment differences for pain or disability (facet joint injections with mixtures of local anaesthetics and corticosteroids) with a home stretching exercise programme vs exercise









OCEBM level

Comments

programme only Marks (1992) showed significant difference in favour of facet joint injections (compared to facte nerve blocks) at 1 month, but not at post-treatment, 2 weeks or 3 months, for pain relief. No difference for disability scores or work attendance Fuchs (2005) Showed no significant difference for pain relief, disability or QOL over a 180-day period (facet joint injections with sodium hyaluronate vs injections with corticosteroids)









OCEBM level

Comments

Facet joint injections with local anaesthetics vs other treatments: 1 RCT, Ravel (1999) showed significantly higher pain relief post treatment with facet joint injections with lidocaine compared to injections with saline. In both groups these injections were followed with an injection of corticosteroids. Other outcomes were not measured

Datta (2009) (192) Systematic assessment of diagnostic

7 studies included, consecutive or non-consecutive allocation and


Chronic low back pain

Lumbar facet joint interventions

Placebo or comparative local anaesthesic block under fluoroscopy

For diagnostic interventions: Pain relief was categorised as at

For diagnostic interventions: measures of improvement in functional status, psychological

Diagnostic lumbar facet joint nerve blocks: Study 1: 500 patients evaluated for facet joint pain, 397 were evaluated for low

Lumbar facet joint and radiofrequency neurotomy are effective Lumbar intra-

Not Cochrane review PRISMA:5 items missing AMSTAR:Mediu

Level 5 Strong recommendations for lumbar facet joint injections and radiofrequency neurotomy









OCEBM level

Comments

accuracy and therapeutic utility of lumbar facet joint interventions

observational studies

least 80% pain relief from baseline pain and ability to perform previously painful movement For therapeutic interventions: short-term pain relief (lasting 6 months or less) and long-term relief (lasting longer than 6 months)

statusm return to work, reduction in opioid intake

back pain (prevalence 31%; 95%CI: 27%, 36%; false positive rate with single blocks with lidocaine: 95%CI: 22%, 32%)) Study 2: 438 patients evaluated of which 303 patients had lumbar pain (prevalence 27%; 95%CI: 22%, 33%) with a false-postive rate of single blocks in the lumbar region of 45% (95%CI: 36%, 53%) Study 3: zygapophysial joint pain in 20 patients (32%; 95%CI: 20% to 44%) obtained ≥50% pain relief after saline treatment.

articular injections likely to be ineffective

m/good Very weak recommendation for lumbar intra-articular injections









OCEBM level

Comments

23/57 patients who completed the study failed to obtain pain relief after saline injection but obtained relief with one or more intra-articular local anaesthetic Study 4: 120 patients with low back pain were evaluated for facet nerve blocks, provocative discography, and sacroiliac joint injections. Facet joint

Zhang (2011) (210) The efficacy of botulinum toxin type A in managing

14 RCTs and 1 crossover study

With meta-analysis

Shoulder pain, whiplash, plantar fasciitis, tennis elbow, myofascial pain

Intra-muscular or subcutaneous botulinum toxin A (single or complementary therapy)

Placebo, non-active injection or other treatments in reducing chronic musculoskeletal pain (e.g. exercise)

Duration of pain severity, disease of interest, dosing regimen, length of

Small to moderate pain reduction among BoNTA patients when compared to control (SMD= -0.27; 95%CI: -0.44, -0.11)

BoNTA had a small to moderate analgesic effect in chronic musculoskeletal pain conditions, especially in


Level 1 (majority of studies were RCTs)

Further evidence is required before definitive conclusions can be drawn The evidence









OCEBM level

Comments

chronic musculoskeletal pain: a systematic review and meta-analysis

follow-up Subgroups, only tennis elbow (SMD= -0.44; 95%CI: 0.86, -0.01) and plantar fasciitis (SMD= -1.04; 95% CI: -1.68, -0.40) demonstrated significant pain relief One back pain study also demonstrated positive results for BoNTA

plantar fasciitis, tennis elbow and back pain, but not in whiplash or shoulder patients Studies were small with follow-up between 4 to 24 weeks

does not support commissioning of this treatment

Langevin (2011) (199) Botulinum toxin for subacute/chronic neck pain

9 randomised and quasi-randomised trials

With meta-analysis

Sub-acute/chronic non-specific neck pain/mechanical neck pain

Botulinum toxin A intra-muscular injections alone or in addition to another treatment (e.g., exercise)

Placebo or another active treatment (ultrasound)

Patient reported pain, function, disability, QOL, global perceived effect and satisfaction

High quality evidence for little or no difference in pain between BoNTA and saline injections at four weeks (five trials; 252 participants; SMD pooled -0.07 (95% confidence intervals (CI) -0.36 to 0.21)) and six months for

Likely to be ineffective at 4 weeks and 6 months for chronic pain

Cochrane review PRISMA: 1 item missing AMSTAR:Good

Level 1 This evidence fails to confirm either a clinically important or a statistically significant benefit of BoNT-A injection for chronic neck pain associated









OCEBM level

Comments

chronic neck pain.

Very low quality evidence of little or no difference in pain between BoNT-A combined with physiotherapeutic exercise and analgesics compared to saline injection with physiotherapeutic exercise and analgesics for patients with chronic neck pain at four weeks (two trials; 95 participants; SMD pooled 0.09 (95% CI -0.55 to 0.73)) and six months (one trial; 24 participants; SMD -0.56 (95% CI -1.39 to 0.27)).

Very low quality evidence from one

with or without associated cervicogenic headache. Likewise, there was no benefit seen for disability and quality of life at four week and six months









OCEBM level

Comments

trial (32 participants) of little or no difference between BoNT-A and placebo at 4 weeks (SMD 0.16 (95% CI -0.53 to 0.86)) and six months (SMD 0.00 (95% CI -0.69 to 0.69)) for chronic cervicogenic headache.

Very low quality evidence from one trial (31 participants), of benefit from BoNT-A in global perceived effect in chronic neck pain at four weeks (SMD -1.12 (95% CI: -1.89 to -0.36)).

Singh (2010)

6 RCTs (164 participant

With meta-

Shoulder pain due to any cause

Botulinum toxin injection by any

Placebo injection or another active

Pain measured

Function or disability, joint

A single injection of BoNT-A (v placebo)

Indeterminate or of limited

Cochrane review

Level 1 High risk of bias demands









OCEBM level

Comments

(204) Botulinum toxin for shoulder pain

s) analysis

route, including, but not limited to intramuscular, subcutaneous, intradermal or intra-articular routes

treatment on a VAS or semi-quantitative scale Adverse effects, total and serious; number of withdrawals due to adverse events, and deaths

range of motion, QOL, patient or physician evaluated success of treatment, radiographic progression for patients with shoulder arthritis, stroke patient disability

significantly reduced pain at three to six months post-injection (MD -1.2 points, 95% CI -2.4 to -0.07; 0 to 10 point scale) but not at one month (MD -1.1 points, 95% CI -2.9 to 0.7) in post stroke shoulder pain. Shoulder external rotation was increased at one month (MD 9.8°, 95% CI 0.2 to 19.4) but not at three to six months. Shoulder abduction, external rotation or spasticity did not differ between groups, nor did the number of adverse events (RR 1.46, 95% CI 0.6 to 24.3). One RCT in arthritis-

effect PRISMA:1 item missing AMSTAR:Good

caution. Botulinum toxin A injections seem to reduce pain severity and improve shoulder function and range of motion when compared with placebo in patients with shoulder pain due to spastic hemiplegia or arthritis It is unclear if the benefit of pain relief in post-stroke shoulder pain at three to six months but not at one month is due to limitations of evidence, which









OCEBM level

Comments

related shoulder pain indicated that botulinum toxin reduced pain severity (MD -2.0, 95% CI -3.7 to -0.3; 10 point scale) and shoulder disability with a reduction in Shoulder Pain and Disability Index score (MD -13.4, 95% CI -24.9 to -1.9; 100 point scale) when compared with placebo. Shoulder abduction was improved (MD 13.8 degrees, 95% CI 3.2 to 44.0). Serious adverse events did not differ between groups (RR 0.35, 95% CI: 0.11, 1.12)

includes small sample sizes with imprecise estimates, or delayed onset of action. More studies with safety data are needed

Kalichman (2011)

4 RCTs With meta-

Lateral epicondylitis

Botulinum toxin injections

Placebo Level of pain

Meta-analysis of 4 RCTs showed a

Indeterminate or of limited

Not Cochrane review

Level 1 Present literature









OCEBM level

Comments

(198) Injection of botulinum toxin for treatment of chronic lateral epicondylitis:Systematic review and meta-analysis

analysis reduction, grip strength

moderate effect for pain favoring botulinum toxin (effect size -0.5, 95% CI: -0.9,-0.1) at 3 months and no effect for grip strength Qualitative analysis of studies that could not be pooled also showed improvement in pain, but was limited by potential bias No data presented on safety.

effect PRISMA: 5 items missing AMSTAR:Good

provides support for use of botulinum toxin A injections into fore arm extensor muscles (60 units) for treatment of chronic treatment-resistant lateral epicondylitis

Ho (2007) (196) Botulinum toxin A for myofascial trigger point injection: a qualitative systematic

5 clinical trials


Chronic myofascial pain


Placebo Pain intensity, pain pressure threshold

One trial with 14 and 12 patients with a saline control arm concluded that BoNTA was effective, while four other trials (sample sizes ranging from 22 to 66 in both arms) concluded

Indeterminate or of limited effect

Not Cochrane review PRISMA: 12 items missing AMSTAR: Medium/good

Level 1 Current evidence does not support the use of BTA injection in trigger points for myofascial pain. The evidence









OCEBM level

Comments

review that Botulinum toxin injection was not better than saline injection in improving the pain.

Of the studies excluded from this review many were open label trials that claimed superior efficacy for botulinum toxin. The included studies were all small in size and methodologically

weak.

does not support commissioning this treatment

Scott (2009) (202) Trigger point injections for chronic non-


Chronic non-malignant musculoskeletal pain


Placebo or no treatment

Pain reduction, pain pressure, subjective function, medication usage

Detailed results from RCTs presented. 10 of 15 studies had very small sample sizes. Internal validity ranged from good to poor.

Likely to be ineffective

Not Cochrane review PRISMA: 4 items missing AMSTAR:Good

Level 1 Efficacy not proven. Only advantage of including local anaesthetic in the injection appears to be to









OCEBM level

Comments

malignant musculoskeletal pain: a systematic review

In general, regardless of the drug injected trigger point injection was no more effective than other less invasive treatments such as laser and ultrasound

reduce the pain of the needling The evidence available does not support commissioning this treatment

Patel (2009) (201) Systematic review of intrathecal infusion systems for long-term management of chronic non-cancer pain

15 observational studies


Chronic non-cancer pain

Intrathecal infusion devices

? At least 50% pain relief

Improvement of function, reduction amount of oral medication, decrease in side effects from systemic drugs, improvement in QOL

Of 4 observational studies, only two studies showed positive results for short- and long-term relief. The studies included were regarded as strongly recommended by authors, but low quality or very low quality evidence Study showed that benefits of intrathecal infusion devices outweighed

Indeterminate or of limited effect.

Not Cochrane review PRISMA:8 items missing AMSTAR:Medium/good

Level 2 Although this study strongly recommended intrathecal devices for management of chronic non-cancer pain, there were limitations to the study, including paucity of literature, lack of quality of evidence and lack of









OCEBM level

Comments

risk and burdens randomised controlled trials

Chua (2011) (191) Pulsed radiofrequency treatment in interventional pain management: mechanisms and potential indications-a review

6 RCTs for PRF


Zygapophyseal joint pain, cervical radicular pain, lumbosacral pain, trigeminal neuralgia, chronic shoulder pain

Pulsed radiofrequency

Corticosteroid injection, sham intervention, conventional radiofrequency thermocoagulation

Global perceived effect (>50%), pain reduction using VAS, disability

Cervical radicular pain: one study showed significant improvement (>50%) of global perceived effect and VAS (NNT=3 in sham group and NNT =1,1 in PRF group). After 6 months, NNT for sham intervention=6, PRF group=1.6 Lumbar zygapophyseal joint pain: One RCT showed PRF against RF denervation to have comparable results at 6 months, reduced pain scores maintained at 1 yeear only for the RF group.

Evidence shows that PRF may be of benefit in treatment of cervical radicular pain and chronic shoulder pain, but less effective for lumbar zygapophyseal joint pain and trigeminal neuralgia

Not Cochrane review PRISMA:13 items missing AMSTAR:Medium

Level 1 Further research is required to warrant use of PRF for the treatment of chronic pain









OCEBM level

Comments

Another RCT showed no significant difference between RF and PRF groups in improvement of pain scores. Over a three month interval, RF showed significant improvement in VAS score (but potential bias due to lack of blinding, lack of numbers of withdrawals, and patients lost to follow-up) Lumbosacral radicular pain: one RCT showed no significant difference in VAS between PRF only group and PRF+RF group, no significant neurological deficits. Loss of analgesic effect between 2 to









OCEBM level

Comments

4 months. By month 8, majority of patients returned to baseline pain intensity Trigeminal neuralgia:one RCT showed significant pain reduction in all patients treated with RF, while only 2/20 patients in the PRF group experienced the same level of pain relief. Chronic shoulder pain: one RCT for intra-articular corticosteroid injection vs suprascapular nerve RF showed significant improvements up to three months in









OCEBM level

Comments

terms of pain scores, range of motion, and QOL. Patients in the intra-articular corticosteroid injections had improved pain scores and shoulder disability scores compared to suprascapular nerve RF. In another study, suprascapular nerve RF has been shown to be effective up to 6 months

Dretzke (2011) (193) The clinical and cost-effectiveness of neurostimulation for relief of chronic/ne

Two RCTs for SCS


FBSS, CRPS

SCS

Conventional medical treatment

Pain reduction by at least 50%

Functional ability, EQ-5D improvement

FBSS: One trial (PROCESS) reported at least 50% pain reduction at 6 months compared to patients receiving conventional medical management and the effect was

SCS for FBSS: Effective, statistically significant SCS for CRPS I: effective, statistically significant

Not Cochrane review

Level 1 FBSS: Evidence suggests that SCS is more effective than conventional medical management or re-operation in terms of pain relief. SCS may be more









OCEBM level

Comments

uropathic pain: an evidence based review

sustained at 12 months follow-up and 24 months follow-up. Functional ability was measured by ODI which improved significantly for the SCS group and was sustained at 24 months compared to patients receiving conventional medical management, and between group differences were significant. There was no difference in the use of opiate, other analgesic, or antidepressant between the SCS group and the CMM group. Another trial (North)

effective at improving function and HRQOL. Two RCTs reported device-related complications, but were minor. Incidence of AEs upon removal of the SCS device was low, and number of device related incidences fall after the first year. Other complications included infections, and cerebrospinal fluid leakage. CRPS I: Evidence from a small but









OCEBM level

Comments

reported significantly higher positive outcomes in the SCS group, with 39% reporting at least 50% improvement in pain scores alone. The mean follow-up for this trial was 2.9 years. Patient-self reported neurological function was generally worse at long-term follow-up in the re-operation group compared to the SCS group, although differences were not statistically significant. An increase in opiate use in 42 % of patients of the the re-operation group compared to 13% in the SCS group was

well-conducted RCT suggests a significant reduction in pain and significant improvement in global perceived effect at 6 months and two years. The effect on quality of life at any time-point is not known. SCS should be commissioned for use for those patients who fail to respond to other treatments









OCEBM level

Comments

also reported. CRPS I: patients implanted with SCS reported a significant reduction in pain as measured by VAS at 6 months and 2 years. Similar changes were also observed for global perceived effect, which diminished at the three year time point, and at 5 years there were no longer any significant differences between standard therapy groups and SCS groups. SCS did not appear to influence HRQOL or functional status. Patient satisfaction was high in those patients who received a









OCEBM level

Comments

permanent implant.

Simpson (2009) (203) Spinal cord stimulation for chronic pain of neuropathic or ischaemic origin: systematic review and economic evaluation


Adults with chronic neuropathic or ischaemic pain who have had inadequate response to medical or surgical treatment other than SCS

Spinal cord stimulator devices

Medical and/or surgical treatment (appropriate to condition) that does not include spinal cord stimulation

Pain, health related QOL, physical and functional abilities, anxiety and depression, medication use, complications and adverse effects (eg, procedural complications and technical failures

Of 11 RCTs (three for neuropathic pain and eight of ischaemic pain), trials were available for FBSS and CRPS type I. SCS was found to be more effective than conventional medical management or re-operation in reducing pain. Evidence failed to show that effectiveness for SCS in critical limb pain relief compared to conventional medical management. SCS was effective in delaying refractory angina pain onsest at short term follow-up but no more than

Evidence suggested that SCS was effective in reducing the chronic neuropathic pain of FBSS and CRPS type I. For ischaemic pain, there may need to be selection criteria developed for CLI, and SCS may have clinical benefit for refractory angina in the short term

Not Cochrane review PRISMA:11 items missing AMSTAR: Medium/good

Level 1 Further studies required for other types of neuropathic pain or subgroups of ischaemic pain









OCEBM level

Comments

coronary artery bypass grafting. Complications varied from study to study, but were usually minor

Ibrahim (2009) (197) Surgical versus non-surgical treatment of chronic low back pain: a meta-analysis of randomised trials


Meta-analysis


Spinal fusion with or without instrumentation

Physical therapy with or without cognitive therapy

Pain-related disability( Owestry disability index), daily life and social participation

Patient satisfaction, return to work

3 RCTs compared surgical vs non-surgical treatment for low back pain short-term. All studies were of good methodological quality. Pooled results showed a trend in favour of surgery (mean ODI difference=4.13; P=0.10; 95%CI: -0.48 to 9.17) Heterogeneity in surgical techniques, analysis had limitations due to paucity of studies. The only outcome

Limited benefit Cochrane review PRISMA: 4 items missing AMSTAR:Good

Level 1 Surgical fusion may improve ODI compared to non-surgical intervention at 2 years follow-up, but effect was not statistically significant. Spinal fusion can only be recommended cautiously to patients with chronic low back pain. Further long term follow up of studies is required.









OCEBM level

Comments

measure examined was ODI, and other outcomes were not addressed which could limit conclusions. Possible publication bias due to small number of studies

Current evidence does not support routine use of surgery for treatment of chronic low back pain

Van den Eerenbeemt (2010) (207) Total disc replacement surgery for symptomatic degenerative lumbar disc disease: a systematic review of the literature

19 studies (16 prospective cohort, 3 prospective controlled studies, 3 RCTs)



Total disc replacement surgery

Lumbar fusion

Pain intensity (VAS), functional status, global improvement, return to work

Physiological outcome, radiological outcome, patient satisfaction

Charite trial (artificial disc) was considered to have a low risk of bias for 2 year follow-up and was non-inferior to the BAK interbody fusion system (57.1 vs 46.5% for 2 year follow-up; 57.8 vs 51.2% for 5 year follow-up). There were no statistically significant differences in mean pain and physical function scores. The prodisc artificial disc was found to be

Not of benefit due to low quality evidence

Not Cochrane review PRISMA: 8 items missing AMSTAR:Medium/good

Level 3 (majority of studies were cohort studies)

There are no long-term studies to test the longevity of the prostheses evaluated in this study. Current evidence does not support routine use of surgery for the treatment of chronic low back pain









OCEBM level

Comments

statistically more effective compared to lumbar circumferential fusion, but risk of bias was high. Flexicore trial: high risk of bias, no clinical relevant There were no statistically significant difference in mean pain and physical function scores.differences on pain and physical function compared to circumferential spinal fusion at 2 year follow-up. No conclusions can be drawn from the study









OCEBM level

Comments

Asher (2010) (190) Auriculotherapy for pain management:a systematic review and meta-analysis of randomised controlled trials

17 studies (8 perioperative, 4 acute, and 5 chronic pain)

With Meta-analysis

All chronic pain and acute pain types

Auriculotherapy Sham, placebo, or standard care control

Pain reduction, medication use

17 studies met inclusion criteria (8 perioperative, 4 acute, and 5 chronic pain). Auriculotherapy was superior to controls for studies evaluating pain intensity (SMD, 1.56 [95% confidence interval (CI): 0.85, 2.26]; 8 studies). For perioperative pain, auriculotherapy reduced analgesic use (SMD, 0.54 [95% CI: 0.30, 0.77]; 5 studies). For acute pain and chronic pain, auriculotherapy reduced pain intensity (SMD for acute pain, 1.35 [95% CI:

Effective, but significant heterogeneity existed for acute and chronic pain groups analysed except for perioperative subgroup.

Not Cochrane review PRISMA: 1 item missing AMSTAR:Good

Level 1 Auriculotherapy may be effective for treatment of various pain types, further large, well-designed trials are required









OCEBM level

Comments

0.08, 2.64], 2 studies; SMD for chronic pain, 1.84 [95% CI: 0.60, 3.07], 5 studies)

Mirza (2007) (200) Systematic review of randomised trials comparing lumbar fusion to non-operative care for treatment of chronic back pain

5 RCTs, 4 of which focused on non-specific chronic back pain

Chronic back pain Lumbar fusion surgery

Non-operative care

Pain reduction VAS), disability

All trials enrolled similar subjects. One study suggested greater improvement in back-specific disability for fusion compared to unstructured nonoperative care at 2 years, but the trial did not report data according to intent-to-treat principles. Three trials suggested no substantial difference in disability scores at 1-year and 2-years when fusion

Moderately effective over non-surgical care

Not Cochrane review PRISMA:9 items missing AMSTAR:Medium

Level 1 Lumbar fusion may be more effective for treatment of chronic back pain than non-operative care Lumbar fusion may not be more effective than structured rehabilitation including CBT Methodological limitations of RCTs prevent firm conclusions about lumbar fusion









OCEBM level

Comments

was compared to a 3-week cognitive behaviour treatment addressing fears about back injury. However, 2 of these trials were underpowered to identify clinically important differences. The third trial had high rates of cross-over (20% for each treatment) and loss to follow-up (20%)

Gibson (2008) (225) Surgical interventions for lumbar disc prolapse

40 RCTs and two Quasi-RCTs (5197 participants)


Patients with lumbar prolapsed disc who have indications for surgical intervention

Discectomy, micro-discectomy, chemonucleolysis, automated percutaneous discectomy, nucleoplasty, and laser discectomy

Conservative treatment

Self-reported pain relief Resolution or improvement in pain Disability/QOL

Measures of objective physical impairement (spinal flexion, improvement in straight leg raise, alteration in muscle power, change in neurological

Of 40 RCTs, only 4 trials directly compared discectomy with conservative management, but was not conclusive. Other trials showed that discectomy produced better outcomes than chemonucleolysis

Some positive effect

Cochrane review PRISMA:6 items missing AMSTAR:Good/medium

Level 1 Further research is required, weak evidence, insufficient data to draw any conclusions about effectiveness of any of the surgical treatments









OCEBM level

Comments

Return to work Rate of subsequent back surgery

signs) Adverse complications(early: damage to spinal cord, cauda equine, dural lining, nerve root or any combination, infection, vascular injury, allergic reaction to chymopapain, medical complications, death. Late: chronic pain, altered spinal biomechanics, instability or both, adhesive arachoiditis, nerve root dysfunction,

(which was better than placebo) Microdiscectomy gave broadly comparable results to standard discectomy Information on many trials was limited, but included recurrence of symptoms, need for additional surgery, and allergic reactions Many of the trials had design weaknesses that could lead to bias

investigated. Surgical discectomy should not be commissioned for routine use, but only in carefully selected patients with sciatica due to lumbar disc prolapse









OCEBM level

Comments

myelocele recurrent disc prolapsed) Cost data

Chou (2009) (176) Surgery for low back pain

84 studies (4 RCTs 2 SRs)

With meta-analysis

Adults 18 years and over with low back pain of any duration, alone or with leg pain

Surgery Non-surgical interventions

Back specific function, generic health status, pain, work disability or patient satisfaction

Fusion versus non-surgical therapy/non-radicular low back pain with common degenerative changes: Swedish lumbar spine study (n=294) statistically significant results in favour of surgery for (i) ‘excellent’ or ‘good’ assessment by independent assessors; (ii) patient ratings (‘better’ or ‘much better’), (iii) pain (VAS score) and (iv) proportion returning

Effective, statistically significant

Not Cochrane review PRISMA: AMSTAR: medium

Level 1 Studies assessed as low and high quality, but potential biases in some studies including performance bias, and detection bias. High drop-out rates in MRC trial, and missing data. Trials for decompressive surgery were assessed as high quality but a high proportion of patients did









OCEBM level

Comments

to work MRC spine stabilisation trial (n=349) statistically significant improvements in ODI after 24 months but difference not considered clinically significant (NB this trial included 11% of patients with spondylolisthesis and 15% had non-fusion surgical treatment) Two smaller trials (n=60, n=64) found no significant differences on any main outcomes after one year (trend towards slightly improved outcomes with surgery in one

not adhere to treatment. Lack of long-term studies, so benefits not known. Fair evidence exists that is in favour of surgery over non-surgical treatment, but should only be commissioned for treatment in highly selected patients who fail all other treatments and with caution. Patients should be made aware of implications of surgery.









OCEBM level

Comments

trial) In the latter three trials, non-surgical treatment consisted of intensive rehabilitation incorporating CBT; in the Swedish study the non-surgical treatment was less intensive and more heterogeneous. There were differences in inclusion criteria between trials One SR (Ibrahim 2008) pooled three of the above trials (one small trial not identified) and found the difference on the ODI to be (just) non-significant (trend towards favouring surgery). Other outcomes









OCEBM level

Comments

were not pooled. Artificial disc replacement versus fusion. Chronic non-radicular back pain with single level degenerative disc disease: 2 RCTs found that artificial disc was not inferior to anterior lumbar inter body fusion on a composite outcome of ‘clinical success’ at 24 months; no statistically significant differences in mean ODI, VAS, or rates of employment at 24 months. Another study found artificial disc to be superior to circumferential fusion on a









OCEBM level

Comments

composite outcome of success after 24 months; no statistically significant differences in mean ODI, pain score or SF-36 scores. NB: trial was designed as a non-inferiority trial, but appears to have been analysed as a superiority trial Discectomy versus non-surgical therapy for radiculopathy with prolapsed lumbar disc: one RCT for open discectomy found that surgery was associated with lower likelihood of poor results (statistically significant) after one year, but not long term. A higher









OCEBM level

Comments

quality trial found no differences between treatments but there was very poor treatment adherence in on treatment analyses adjusted for confounders, surgery was found to be moderately superior (statistically significant at one to two years) NB, technique left at discretion of surgeons (open or microdiscectomy). Microdiscectomy: two trials found surgery to be moderately superior to non-surgical treatment at 6-8 weeks, but not long term (26 weeks). In









OCEBM level

Comments

both trials around 40% of patients in control arms eventually underwent surgery, which could potentially affect results (reduce benefit of surgery) in an intention-to-treat analysis. A further two trials are identified that find surgery to be more effective than more conservative management, at least in the shorter term (up to 18 months in one trial). Decompressive surgery: laminectomy versus non-surgical therapy for symptomatic spinal stenosis (+/-









OCEBM level

Comments

degenerative spondylolisthesis): two trials found moderate benefits (ODI, pain, good result) in favour of surgery, mainly up to one year. Two larger trials found few differences between surgery and non-surgical therapies over two years, but almost half of patients did not adhere to treatment assignment. Decompressive surgery: interspinous spacer device versus non-surgical therapy for symptomatic spinal stenosis: Two trials found that an









OCEBM level

Comments

interspinous spacer device was substantially superior to non-surgical treatment in terms of overall treatment success at two years. One trial found lower rates of subsequent laminectomy with the interspinous spacer device, the other found no difference in rates.



Citation



Treatment: Invasive procedures: Facet joint injections

PICOT summary

Pop: People aged 18 or older with symptoms of non-specific low back pain (LBP) which has not resolved within 6 weeks of initial onset, consultation or exacerbation up to a period of 12 months. Int: Facet joint injections of methylprednisolone acetate (isotonic saline). Comp: Usual care in general practice. Out: Pain scores; disability scores; psychological distress; safety; adverse events


Study designs: Systematic reviews and RCTs Searching: Comprehensive search strategy. Studies were selected which matched the inclusion/exclusion criteria. Validity: Each paper was assessed for quality and critically appraised using the Institute’s criteria for quality assessment.


Based on 1 RCT: After 1 month: none of the outcomes evaluating pain, functional status and back flexion differed statistically between the groups. At 6 months: more improvement, less pain (VAS score) and less physical disability in the treatment group 1-6 months: sustained improvement in 22% (active) v 10% (placebo), not stat. sig (p=0.19) Injections are of little value in treating Chronic LBP.

GRADE assessment

High


Yes

Comments


Citation

Percutaneous endoscopic laser lumbar discectomy. NICE IPG 300;2009 and Overview document(212,226).


Treatment: Invasive procedures: Surgery: Percutaneous endoscopic laser lumbar discectomy

PICOT summary

Pop: Symptomatic lumbar disc prolapse Int: Percutaneous endoscopic laser lumbar discectomy Comps: Usual care Out: Success rates (MacNab score); pain; mobility

Guideline evidence:


Study design Searching and study selection Validity

Study designs: Case series Searching: Comprehensive search strategy Validity: Validity is commented on but no method stated.


Efficacy 3 case series a) (n=300). Return to work and increased mobility in 67%, reduced pain medication in 32% (those with central prolapsed, n=279) b) (n=67). VAS leg pain and score on Oswestry Disability Index improved at 18 months (significantly for ODI); 88% with good or excellent results at final follow-up. c) (n=43). 81% of patients with good or excellent outcome (MacNab criteria) Safety a) Reoperation in 2%, psoas haematoma in <1% and sympathetic medicated pain in 5% b) 3% conversion to open procedure, 1% repeat surgery, 1% recurrent herniations, 3% injured thecal sac, 13% transient dysaesthesia in the leg c) Transient dysaesthesia in 5%, 1 patient with further surgery Comments a) outcome measures not well described b) Loss to follow-up not described, no objective outcome measures c) Consecutive sample, radiologist blinded to study Guideline: Current evidence on the safety and efficacy of percutaneous endoscopic

laser lumbar discectomy is inadequate in quantity and quality. Therefore this procedure should only be used with special arrangements for clinical governance, consent, and audit or research

GRADE assessment

Low


Yes


Citation

Percutaneous intradiscal laser ablation in the lumbar spine. NICE IPG 357; 2010 and Overview document(213,227).


Treatment: Invasive procedures: Surgery

PICOT summary

Pop: Lumbar disc herniation Int: Percutaneous intradiscal laser ablation Comps: Microdiscectomy; automated percutaneous lumbar discectomy Out: Success rates (MacNab criteria); pain score

Guideline evidence: Study design Searching and study

Study designs: Case series; non-randomised comparative study Searching: Comprehensive search strategy Validity: Validity is commented on but no method stated.


selection Validity


Laser disc decompression only:

a) One case series (n=518) reported a success rate (based on McNab criteria) of 75%; absolute figures and follow-up not stated. b) One case series (n=576) reported that 61% of patients were satisfied with the outcome of the procedure; absolute figures and follow-up not stated. c) Case series (n=182), safety outcomes only reported d) Case-series (n=10), found no effect on low back pain or sciatica Safety a) 2 patients with aseptic discitis, 2 with septic discitis and 1 patient with a retro-oesophageal abscess b) 4 patients with aseptic discitis c) 4 patients with subchondral osteonecrosis d) leg sensory disturbance and/or muscle weakness in 3 patients Comments a) Results only for 350/518 patients (68%). Unclear when outcome was assessed. b) 67% at last follow-up c) Unclear completeness of follow-up; retrospective safety study d) Retrospective safety study, 100% follow-up Laser disc decompression versus microdiscectomy: Non-randomised comparative study (n=1000) reported similar rates of ‘excellent or good’ MacNab criteria scores in both groups. Safety Appear to be slightly more neurological symptoms, higher reoperation rates and other adverse events in the microdiscectomy group. Comments 100% follow-up. Unclear if retrospective. Laser disc decompression versus automated percutaneous lumbar discectomy Non-randomised comparative study (n=106). No significant differences between success rates (defined as excellent, good, passable or poor) between the groups. Safety 1 patient with infection of intervertebral disc (automated group). Comments No significant differences in study populations in the two groups. 100% follow-up, but timing unclear. Unclear if retrospective. Laser disc decompression using Nd:Yag laser (case series) Laser disc decompression using KTP laser versus automated percutaneous lumbar discectomy Non-randomised comparative study and case series (n=81).Relatively high failure rates (25% and 26%) in KTP laser and automated group meant that these techniques were abandoned early in the initial study (failure=daily back pain or daily use of analgesics). Safety 2 patients with aseptic discitis requiring hospitalisation in laser disc decompression using Nd:Yag group Comments 100% follow-up in both studies. No description of allocation of patients in comparative study Guideline: Current evidence on the safety and efficacy of percutaneous intradiscal laser

ablation in the lumbar spine is adequate to support the use of this procedure provided that normal arrangements are in place for clinical governance, consent and audit. Patients selected for the procedure should be limited to those with severe pain refractory to conservative treatment, in whom imaging studies have shown bulging of an intact disc, and who do not have neurological deficit requiring surgical decompression.”

GRADE assessment

Low



Yes



Summary of findings: Multidisciplinary interventions

Summary of findings: systematic reviews




Population Intervention

Comparator Outcome measures Primary




OCEBM level

Comments

Scascighini (2008) (217) Multidisciplinary treatment for chronic pain: a systematic review of interventions and outcomes


Adults with chronic non-specific musculoskeletal pain for example low back pain or back pain and fibromyalgia

Multidisciplinary treatments

No treatment, standard medical treatment

Pain intensity, QoL, disability, coping, physical capacity, sick leave, drug intake, pain behaviour, use of health care professionals

Inclusion of many studies with diverse interventions meant that meta-analysis was not possible. The quality of included studies varied with only 6 studies being rated as high Evidence was strong for MDI being more effective than control group treatment in 15 studies, 5 studies showed no difference 3 studies that compared in-patient vs out-patient

Multidisciplinary pain management programmes offer safe and effective option for many chronic pain conditions Unclear as to which of the components of MDI are responsible for benefit

Not Cochrane review PRISMA: 9 items missing AMSTAR: Good

Level 1 Multi-disciplinary pain management programmes should be commissioned










OCEBM level

Comments

treatment found moderate evidence for better long term outcomes with intensive in-patient MDI

Minimum standard for MDI comprises specific individual exercising, regular training in relaxation techniques, group therapy led by a clinical psychologist, patient education sessions, physiotherapy training sessions and clinician delivered










OCEBM level

Comments

information about pain physiology

Van Geen (2007) (218) The long-term effect of multidisciplinary back training: a systematic review

8 RCTs, included; total of 1958 participants


Adults with back pain or chronic low back pain for at least 6 months

Multidisciplinary back training

Standard treatment?

Work participation, experienced pain, functional status, QOL

One high quality study found effectiveness for low intensive multidisciplinary treatment compared to control, but not for intensive multidisciplinary treatment The other (low quality) studies found no effectiveness compared to controls 3 high quality RCTs found effectiveness for some outcome measures (but not all) for intensive compared to non-intensive programmes

4/8 RCTs described as low quality


Level 1 Multidisciplinary back training has a positive impact on work participation of people with CLBP. The evidence for a positive effect on quality of life is limited. Intensity of treatment is not associated with treatment effectiveness Further research should be carried out with clearer definitions of










OCEBM level

Comments

chronic low back pain, intensity of treatment and multidisciplinary back training



Citation

Chou R, Qaseem A, Snow V, Casey D, Cross JT, Shekelle P et al. Diagnosis and treatment of low back pain: a joint clinical practice guidelines from the American College of Physicians and the American Pain Society. Ann Int Med 2007; 147: 478-491.


Treatment: Multi-disciplinary pain programmes

PICOT summary

Pop: Adults with acute and chronic LBP not associated with major trauma Int: Multi disciplinary pain programmes Comp: Usual care, normal activities, exercise therapy, Out: Pain


Study designs: Systematic reviews and RCTs Searching: Comprehensive search strategy. Studies were selected which matched the

inclusion/exclusion criteria. Validity: Each paper was assessed for quality and critically appraised.


Interdisciplinary rehabilitation more effective than usual care for sub-acute back pain (a) Intensive (>100 hours), daily interdisciplinary rehabilitation moderately superior to non-interdisciplinary rehabilitation or usual care for short-and long-term functional status, and for pain outcomes (at 3-4 months in two trials). Long-term pain and return to work outcomes inconsistent. (b) Less intensive interdisciplinary rehabilitation was no better than non-interdisciplinary rehabilitation or usual care Functional restoration with a CBT component was more effective than usual care, normal activities or standard exercise therapy for reducing time lost from work. Little evidence that functional restoration without a CBT component is effective.

GRADE assessment

High


Yes

Comments



Citation



Treatment: Multi-disciplinary pain programmes

PICOT summary

Pop: People aged 18 or older with symptoms of non-specific low back pain (LBP) which has not resolved within 6weeks of initial onset, consultation or exacerbation up to a period of 12 months. Int: Multi disciplinary pain management programmes (education, back school, exercises, plus a psychological component such as CBT, coping skills, problem solving training). Comp: Usual care in general practice, physiotherapy, spinal stabilisation. Out: Pain


Study designs: RCTs Searching: Comprehensive search strategy. Studies were selected which matched the inclusion/exclusion criteria. Validity: Each paper was assessed for quality and critically appraised using the Institute’s criteria for quality assessment.


Low intensity programme Pain management programme (education, group exercises, CBT, 8 sessions of 90 minutes) versus individual physiotherapy (up to 12 sessions of 30 minutes) versus spinal stabilisation (specific muscle training and group exercise, up to 8 sessions of 90 minutes) All groups had improved on the Roland Morris Disability Questionnaire (RMDQ) at 18 months (not stated if significantly). No significant difference between groups at 18 months. Attrition rate between 17% and 32%. Comments Although also shown to be cost-effective, NICE did not make a recommendation for low intensity combined physical and psychological interventions due to the high attrition rate and the fact that there was no significant difference between groups. Low intensity programme (women only) Back school + usual care (a four day, five session programme, education, coping skills and exercises) versus usual care (medication with paracetamol, NSAIDs or chlordiazepoxide) Statistically significant difference on SF-36 in favour of back school, but results or p-values not presented. High intensity programme (at least one full day of five sessions a wk over at least 3 wks. Functional restoration programmes compared to other interventions/usual care (3 RCTs) or compared to physical training (1 RCT) Three of four RCTs found significant improvements in pain/disability for patients in the FR group compared to less intensive interventions. Follow-up was up to 5 years in one RCT (statistically significant difference in function but not pain at 5 years; difference in function and pain significant at 1 and 2 years). Format of interventions varied widely, but best evidence was considered to be that for programmes of >100 hours of exposure. High intensity programme Multidisciplinary programmes versus physiotherapy or no treatment. No significant differences in pain disability or depression (low risk of bias RCT); significantly better pain and function scores with the multidisciplinary approach in one study; one study did


not conduct statistical analyses. High intensity programme Exercise and motivational programme versus exercise only. Pain and function statistically significantly improved in intervention group only at 12 months (pain only at 5 years)-NB unclear whether between group difference was statistically significant. High intensity programme Combination of physical training, graded activity and problem solving versus individual treatments No significant differences between groups at 12 months. Guideline: Consider referral for a combined physical and psychological treatment programme, comprising around 100 hours over a maximum of 8 weeks, for people who have received at least one less intensive treatment and have high disability and/or significant psychological distress. Combined physical and psychological treatment programmes should include a cognitive behavioural approach and exercise

GRADE assessment

High


Yes


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