3873s1 06 borenstein

7/28/2019 3873s1 06 Borenstein

1/34

BACK PAIN - CHRONICISSUES

David Borenstein, MDClinical Professor of Medicine

Arthritis and Rheumatism Associates

The George Washington University

Medical Center

Washington, DC

7/28/2019 3873s1 06 Borenstein

2/34

Chronic Low Back PainIssues for Discussion

1. Define the forms of chronic low back pain andits prevalence (Is it frequent and important

enough to study?)

2. Will patient selection including etiology and

severity influence the performance of drugs in

development? (Is it possible to identify and

separate the individuals with back pain?)

3. Which are the appropriate outcome measures?(Can improvements in back pain related to

therapy be determined?)

7/28/2019 3873s1 06 Borenstein

3/34

Chronic Low Back Pain

Issues for Discussion

4. Will a general indication be useful for different

labeling claims? (somatic v. neuropathic v.chronic headache)

5. Chronic low back pain - serve as a measure of

efficacy for a general chronic pain indication or

specific indication for chronic low back pain

alone

7/28/2019 3873s1 06 Borenstein

4/34

WHAT IS CHRONICLOW BACK PAIN

And

ITS PREVALENCE?

7/28/2019 3873s1 06 Borenstein

5/34

LOW BACK PAIN -

DEFINITIONPain that occurs in an area with boundaries

between the lowest rib and the crease of the

buttocks

7/28/2019 3873s1 06 Borenstein

6/34

Chronic Low Back Pain

Duration greater than 3 months

Pain that persists longer than theexpected time period for healing

7/28/2019 3873s1 06 Borenstein

7/34

Epidemiology of Low Back Pain

20% of the US population develops back

pain yearly

Back pain -second most common cause of

disability in the US (leading cause among

men) accounting for 16.5% of the totaldisabilities in > 18 yo in 1999

Workers compensation 1986-1996 - > 1

year 8.8% of claims - 64.9%-84.7% ofannual costs

___________________________________

CDC. MMWR 2001;50:120-125Hashemi L et al: J Occup Environ Med 1998;40:1110-1119

7/28/2019 3873s1 06 Borenstein

8/34

Natural History of Low Back Pain

443 LBP subjects postal questionnaire 12 months

15 general practices Amsterdam, Netherlands

269 completed survey - less pain answered less often

7 weeks-median time to recover

At 12 weeks-35%, 52 weeks-10% had LBP

75% had 1 or more relapses during study

Pain and disability was less during relapses

Time to relapse-median 7 weeks, duration-median 6weeks

__________________________________________van den Hoogen et al: Ann Rheum Dis 1998;57:13-19

7/28/2019 3873s1 06 Borenstein

9/34

Low Back Pain - Disorders

Mechanical Referred

Rheumatologic Hematologic

Infectious NeurologicNeoplastic Psychiatric

Endocrinologic Miscellaneous

(N > 60)

_____________________________________Borenstein D, Wiesel S, Boden S: Low Back Pain: Medical Diagnosis and

Comprehensive Management. 1995

7/28/2019 3873s1 06 Borenstein

10/34

Low Back Pain - Disorders

Mechanical - 85% of all low back pain

Muscle, ligament, tendon strain

Discogenic disorders including herniated disc

Apophyseal joint arthritis

Spinal stenosis

Spondylolysis, spondylolisthesis

Scoliosis

7/28/2019 3873s1 06 Borenstein

11/34

Sources of Low Back Pain

Superficial somatic - skin

Deep somatic - muscle, joint, tendon, bursa,

fascia

Radicular - nerve root

Visceral referred - sympathetic afferents

Neurogenic - mixed motor sensory nerves

Psychogenic - cerebral cortex

7/28/2019 3873s1 06 Borenstein

12/34

Pain Intensity

Minimal - mentioned in passing, normal

function

Mild - component of symptoms, mild

dysfunction

Moderate - major component of symptoms,

alters function

Severe - the disease symptom,

incapacitating function

7/28/2019 3873s1 06 Borenstein

13/34

Diagnostic Evaluation

Diagnosis of low back pain is unspecified

in 80% of patients

_________________________________________Dillane JB et al: Acute back syndrome: a study from general practice.

BMJ. 1966;2:82-84Rowe ML: Low back pain in industry: a position paper. J Occup Med

1969;11:161-169

White AA, Gordon S. Symposium on Idiopathic Low Back Pain.

Mosby Co. 1982

7/28/2019 3873s1 06 Borenstein

14/34

LOW BACK PAIN -

DIAGNOSIS Specific diagnosis is possible

Differentiation of muscle, joint,

ligamentous structures

Mechanical versus systemic disorders is

possible

Categorize by clinical symptoms

Subtyping will improve therapy

_____________________________________Abraham I, Killackey-Jones B: Arch Intern Med 2002;162:1442-1444

7/28/2019 3873s1 06 Borenstein

15/34

LOW BACK PAIN -

DIAGNOSIS Specific diagnosis is impossible

Anatomic abnormalities in asymptomatic

individuals

Overutilization of imaging techniques

Inconsistency of physical findings

Non-specific therapy is effective

____________________________________Deyo RA: Arch Intern Med 162:1444-1446, 2002

7/28/2019 3873s1 06 Borenstein

16/34

LOW BACK PAIN -

DIAGNOSIS Somatic v. neuropathic v. radicular pains

can be differentiated

Specific pain generators (individual joint ormuscle) are difficult to identify but

localization is not essential for effective

therapy

7/28/2019 3873s1 06 Borenstein

17/34

Chronic Back Pain - Outcome

Measures Back specific function

Pain

Patient global satisfaction

7/28/2019 3873s1 06 Borenstein

18/34

Back Pain - Outcome Measures

Back Specific Function

Roland Morris Disability

Questionnaire

Oswestry Disability Index

7/28/2019 3873s1 06 Borenstein

19/34


Roland-Morris Disability Questionnaire -

function assessment

24 items from the Sickness Impact Profile

Functions affected by back pain that day

Scores added ( 0-no disability to 24 -

maximum disability)

Validated and reproducible instrument

___________________________________Roland M, Morris R: Spine 1983;8:141-144

7/28/2019 3873s1 06 Borenstein

20/34


Oswestry Disability Index - pain and functionassessment

10 sections on various functions with 6

levels of assessment

Physical and social functions that day

Scores added (0-no disability to 100-

maximum disability) Validated and reproducible instrument

_____________________________________

Fairbank J, Pynsent P: Spine 2000; 25:2940-2953

7/28/2019 3873s1 06 Borenstein

21/34


Pain Measurement

SF-36 pain scale

Visual analog scale (VAS)

Brief Pain Inventory (BPI)

Treatment Outcomes in Pain Survey (TOPS)

7/28/2019 3873s1 06 Borenstein

22/34


Global Satisfaction

Extremely, very, somewhat satisfied

Mixed

Somewhat, very, extremely dissatisfied

7/28/2019 3873s1 06 Borenstein

23/34


(Optional) General health status

SF-36

Depression

Beck Depression scale

7/28/2019 3873s1 06 Borenstein

24/34


Instruments exist to measure the effect of

drug interventions on chronic back pain for:

function

pain

global satisfaction

general health status

7/28/2019 3873s1 06 Borenstein

25/34

Chronic Low Back Pain Therapy

- Multimodality

Back exercises - flexion and/or extension

Aerobic exercise

Medications

Counterirritant topical therapiesStress management

7/28/2019 3873s1 06 Borenstein

26/34

Chronic Low Back Pain - Medications

NSAIDsMuscle relaxants

Analgesics

AntidepressantsAnticonvulsants

Alpha-2 adrenergic agonists

Miscellaneous

NONE ARE INDICATED FOR CHRONIC

LOW BACK PAIN!

7/28/2019 3873s1 06 Borenstein

27/34

Chronic Low Back Pain -

Medications - NSAIDS Short half-life

acute exacerbations, quick onset

Long half-life

sustained effect

Cox - 2 inhibitors

equal efficacy - decreased toxicity

van Tulder et al: Spine 2000;25:2501-2513

7/28/2019 3873s1 06 Borenstein

28/34


Medications - Muscle Relaxants Cyclobenzaprine

Orphenadrine

Metaxolone

Chlorzoxazone

Methocarbamol

7/28/2019 3873s1 06 Borenstein

29/34


Medications - Analgesics Nonnarcotic

Acetaminophen

Tramadol

Narcotic

Short acting

Long acting

7/28/2019 3873s1 06 Borenstein

30/34

Case Study - Chronic Somatic

Pain - Mild To Moderate 52 year old person - work-related

myofascial injury

Treatment regimen Change of NSAID - diclofenac 100mg QD

Maintain methocarbamol 750mg BID

Diclofenac 50mg prn acute exacerbations

maintain exercises program

7/28/2019 3873s1 06 Borenstein

31/34


Pain - Mild to Moderate 67 year old person - facet arthritis

Treatment regimen

Rofecoxib 25mg QD

Cyclobenzaprine 10 mg QHS

7/28/2019 3873s1 06 Borenstein

32/34


Pain - Moderate to Severe 72 year old person - s/p laminectomy with

fractured screw

Treatment regimen Celecoxib 200mg BID

Nortriptyline 50mg QHS

Fentanyl patch 50 mcg

Hydrocodone 5 mg prn

7/28/2019 3873s1 06 Borenstein

33/34

Case Study - Chronic

Neuropathic Pain - Moderate to

Severe 42 year old person - traumatic neuropathy -

sciatic nerve

Treatment regimen Ketoprofen - long acting - 200mg QD

Gabapentin - 100mg TID

Oxycodone - long acting - 40mg TID

Hydrocodone - 7.5mg PRN

7/28/2019 3873s1 06 Borenstein

34/34


Summary Model for chronic pain

Outcome tools are available

Somatic pain is identifiable

Degree of pain - effect on study design

mild to moderate - single drug v. placebo

(active comparator)

moderate to severe - stable multidrug regimen -

flare with withdrawal

3873s1 06 borenstein

Documents