pain horizon scan june 2011 - keele university
TRANSCRIPT
Written by Nadia Corp for: © Arthritis Research UK 2011
1
HORIZON SCANNING: MUSCULOSKELETAL PAIN DISORDERS
UPDATE – JUNE 2011
The object of these Horizon Scanning reports is to highlight recently completed and ongoing
clinical trials, research recommendations and new and emerging health technologies. This follow
up report includes trials registered since June 2008 together with research recommendations for
guidelines published since June 2008.
Details of all material included in this report are shown in the appendix, sorted according to
anatomical region involved. Further details of each study can be obtained via the links given to the
relevant webpage.
CONTENTS
SEARCH METHODOLOGY 3
RESULTS 4
ABBREVIATIONS 5
APPENDIX 6
A: Clinical Trails 6
A1: Hand, Wrist, Finger & Thumb pain………………………………………………. 6
Behavioural, education & exercise including physiotherapy 6
and manual therapy
Device 7
Dietary supplements 7
Drugs including biologics 7
Miscellaneous observational studies 8
A2: Elbow pain ……………………………………………………………………………….. 8
Behavioural, education & exercise including physiotherapy 8
Device 9
A3: Shoulder pain ……………………………………………………………………………….. 9
Behavioural, education & exercise including physiotherapy 9
and manual therapy
Drugs including biologics 10
2
Procedures 10
Others including CAM therapies 11
Miscellaneous observational studies 11
A4: Neck pain ……………………………………………………………………………….. 12
Behavioural, education & exercise including physiotherapy 12
and manual therapy
Drugs including biologics 15
Procedures 15
Other including CAM therapies 16
A5: Back pain…………………………………………………………………………………. 17
Behavioural, education & exercise including physiotherapy 17
and manual therapy
Device 20
Dietary supplements 22
Drugs including biologics 22
Other including CAM therapies 24
Procedures 25
Miscellaneous observational studies 26
A6: Hip pain ……………………………………………………………………………….. 28
Behavioural, education & exercise including physiotherapy 28
and manual therapy
A7: Knee pain ……………………………………………………………………………….. 28
Behavioural, education & exercise including physiotherapy 28
and manual therapy
Dietary supplement 29
Device 29
A8: Foot, Ankle & Toe pain ………………………………………………………….. 30
Behavioural, education & exercise including physiotherapy 30
and manual therapy
Device 31
Dietary supplements 31
Drugs including biologics 32
Other including CAM therapies 32
3
A9: Fibromyalgia ……………………………………………………………………………….. 33
Behavioural, education & exercise including physiotherapy 33
and manual therapy
Device 34
Dietary supplements 34
Drugs including biologics 35
Other including CAM therapies 36
Miscellaneous observational studies 36
A10: Chronic pain ………………………………………………………………………………. 38
Behavioural, education & exercise including physiotherapy 38
and manual therapy
Device 39
Drugs including biologics 40
Miscellaneous observational studies 40
A11: Pain …….………..……………………………..……………………………………. 41
Behavioural, education & exercise including physiotherapy 41
and manual therapy
Device 42
Dietary Supplement 42
Drugs including biologics 42
Other including CAM therapies 45
Miscellaneous observational studies 45
B: Research Recommendations 46
REFERENCES 51
SEARCH METHODOLOGY
Databases Searched
Australian New Zealand Clinical Trials Registry; ClinicalTrials.gov; German Clinical Trials Register;
ISRCTN register; MRC Clinical Trials Unit; Nederlands Trials Register; UKCRN Portfolio Database.
Keywords searched
Hand pain; Wrist pain; Finger pain; Thumb pain; [Meta]carpal pain; Phalangeal pain; Elbow pain;
Epicondylitis; Tennis/Golfer’s Elbow; Shoulder pain; Neck pain; Cervical pain; Back pain; Sciatica;
Sacroiliac pain; Hip pain; Knee pain; Ankle pain; Foot pain; Toe pain; [Meta]tarsal pain; Chronic
[widespread] pain; Fibromyalgia; Pain (as a [musculoskeletal] condition); Musculoskeletal pain.
4
Keywords and phrases were used separately or in combination; truncation was used where
possible/applicable.
Note: in the case of the Australian New Zealand Clinical Trials Registry the joint/anatomical region
was always searched for under the category of musculoskeletal.
Conditions excluded from this search
1. Surgical interventions and subsequent rehabilitation programmes, except when
compared to non-surgical interventions
2. Peri- and post-operative pain
3. Pain resulting from trauma e.g. fracture, dislocation, rotator cuff tears and whiplash
4. Pain primarily associated with a non-musculoskeletal condition e.g. pelvic pain,
cancer-related pain, infection, pregnancy, hemiplegic/post-stroke etc. including
somatoform pain
5. Pain syndromes e.g. Patellofemoral Pain Syndrome
6. Neuropathic pain
7. Headache
8. Facial pain including Temporomandibular Joint disorders
9. Pain associated with osteoarthritis of the knee or hip (except for research
recommendations from guidelines): these areas attract a substantial amount of
research and are included in the Osteoarthritis and related disorders CSG’s Horizon
Scanning report, available via the Arthritis Research UK website. Note however,
pain associated with osteoarthritis of other joints and in general is included in this
report.
Date limits
This report includes trials that were registered from June 2010 onwards including those completed
since June 2008.
RESULTS
A: Clinical Trials
Since December 2010, 208 completed or ongoing clinical trails were identified for musculoskeletal
pain: these are tabulated in the appendix divided into anatomically distinct sections:
A1: Hand, Wrist, Finger and Thumb pain (n = 12);
A2: Elbow pain (n = 2);
A3: Shoulder pain (n = 15);
A4: Neck pain (n = 24);
A5: Back pain (n = 60);
A6: Hip pain (n = 1);
A7: Knee pain (n = 7);
A8: Foot, Ankle and Toe pain (n = 9);
A9: Fibromyalgia (n = 29)
A10: Chronic pain (n = 20);
A11: Pain (n = 26);
5
For clarity each section is subdivided according to type of intervention: behavioural, device,
dietary supplement, drug, other interventions and miscellaneous observational studies, within
which clinical trials are ordered by completion date. Unless otherwise stated in the table trials
involve participants of both genders. Each clinical trial has a weblink which can be followed for
further details of the study.
In the general pain section (A11), diagnosed rheumatic conditions were only included when the
focus of the study was pain associated with the pathology as opposed to the treatment of the
disease as a whole (this is particularly pertinent to the drug/biologic trials).
B: Research Recommendations
Recent, current clinical guidelines (June 2008 onwards) pertaining to musculoskeletal pain,
including osteoarthritis, are reported in Section B of the appendix with any corresponding
research recommendations or specialist adviser comments (NICE) detailed.
ABBREVIATIONS
Adt Adt (18-65 years)
CAM Complementary and Alternative Medicine
CBT Cognitive Behavioural Therapy/Treatment
Child Child (<18 years)
Comp Completed
CT ID Clinical Trials Identifier
F-only Female only
Grps Groups
Invite Invite only
M-only Male only
n Enrollement
N/K Not known
OA Osteoarthritis
RA Rheumatoid arthritis
Rec Recruiting
Recruit Recruitment
Sen Senior (>65 years)
6
A: CLINICAL TRIALS
Clinical trials identity number (CT ID): Prefix of NCT denotes National Clinical Trials Identifier; ISRCTN - International Standard Randomized Controlled Trial
Number; UKCRN – UK Clinical Research Network; ACTRN – Australian New Zealand Clinical Trials Registry; NTR – Nederland Trial Register; DRK – German clinical
Trials Register; UMIN – University Hospital Medical Information Network; JMA - Japan Medical Association Center for Clinical Trials Register; JapicCTI - Japan
Pharmaceutical Information Center Clinical Trials Identifier. Note: Where no end date was given the following were used: completion date for primary outcome
measure – italics; last update – preceeded with a ?; start date + final timepoint of outcomes – preceeded with a >.
A1: HAND, WRIST, FINGER & THUMB PAIN
Title Phases: study design (control) CT ID
Interventions Conditions Recruit n Age Grp
Start Date
End Date
Sponsors URL
Behavioural, education & exercise incl. physiotherapy & manual therapy
Effect of exercises for persons with Hand OsteoArthritis. RCT (active) ISRCTN79019063
Hand exercise; treatment as usual (no exercise)
Hand OA Ongoing 80 Adt Sen
Feb-11 Jun-14 Martina Hansens Hospital (Norway)
http://www.controlled-trials.com/ISRCTN79019063
A randomised controlled trial of forearm strengthening exercises in osteoarthritis of the small joints of the hand RCT (active) ACTRN12611000102976
Forearm strengthening exercises; usual pain medication (no exercise)
Primary OA of small joints of the hand
Active 66 Adt Sen
Mar-11 > Jun-11
Westmead Hospital, NSW, Australia
http://www.anzctr.org.au/trial_view.aspx?ID=336457
Hypoalgesic and motor effects of Kaltenborn mobilization on elderly patients with secondary thumb carpometacarpal osteoarthritis RCT (placebo) ISRCTN06361999
Kaltenborn mobilization of posterior-anterior gliding with distraction of the carpometacarpal joint; placebo
Carpo-metacarpal OA
Ongoing 29 Sen May-11 Jun-11 Azienda Sanitaria Locale (ASL) 3 (Italy)
http://www.controlled-trials.com/ISRCTN06361999
Radial nerve mobilization decreases pain sensitivity and improves motor performance in patients with thumb carpometacarpal osteoarthritis RCT (placebo) ISRCTN81771317
Radial nerve mobilization; placebo
Thumb carpo-metacarpal OA
Comp 60 Adt Sen
Sep-10 May-11 Azienda Sanitaria Locale (ASL) 3 (Italy)
http://www.controlled-trials.com/ISRCTN81771317
7
Does thumb joint mobilization decrease hyperalgesia in elderly patients with secondary thumb carpometacarpal osteoarthritis? RCT (placebo) ISRCTN70578774
Mobilization of posterior-anterior gliding of the trapezio-metacarpal joint; sham
Thumb carpo-metacarpal OA
Comp 28 Sen Dec-09 Sep-10 Azienda Sanitaria Locale (ASL) 3 (Italy)
http://www.controlled-trials.com/ISRCTN70578774
Device
Splinting to Treat Hand Osteoarthritis Phase II: Non-randomized, parallel assignment, efficacy study NCT01249391
Splinting Hand OA Rec 45 Adt Sen
Sep-10 Sep-11 Imperial College London; National Institute for Health Research, United Kingdom
http://ClinicalTrials.gov/show/NCT01249391
To Investigate the Therapeutic Effect of Aculife Magnetic Therapist on Carpal Tunnel Syndrome Non-randomized, parallel assignment, efficacy study NCT01277003
Aculife Magnetic Wave Therapist; TENS
Carpal Tunnel Syndrome
Rec 30 Child Adt
Sem
Dec-10 Feb-11 China Medical University Hospital
http://ClinicalTrials.gov/show/NCT01277003
Dietary supplements
A Study to Determine if Aquamin Modulates Inflammatory Biomarkers in the Blood of Osteoarthritis and Healthy Subjects Phase II: RCT (active), bio-availability study NCT01321281
AquaCal; AquaPT OA Rec 36 Adt
F-only
Mar-11 Oct-11 University College Cork; Marigot Ltd.
http://ClinicalTrials.gov/show/NCT01321281
Drugs including biologics
A multiple-center, randomized, double-blind, placebo-controlled, parallel-group comparison study in idiopathic carpal tunnel syndrome Phase II: RCT (placebo) JapicCTI-111500
OP-1206alpha-CD
Idiopathic carpal tunnel syndrome
Active 150 Adt Sen
Apr-11 Jul-12 Ono Pharmaceutical Co., Ltd. (japan)
via http://www.clinicaltrials.jp/user/ctiMain_e.jsp
8
An open-label study to assess the safety, tolerability and multiple-dose phamacokinetics of AA4500 0.58 mg in subjects with Dupuytren's contractures Single group assignment, safety and pharmokinetics study ACTRN12610001045000
AA4500 Dupuytren's contracture
? 12 Adt Sen
Dec-10 > Mar-11
Auxilium Phamaceuticals, Inc. (US); Novotech Pty Ltd (Australia)
http://www.anzctr.org.au/trial_view.aspx?ID=336238
A short course of low dose steroid tablets as a treatment for painful hand osteoarthritis- does it work? RCT (placebo) ISRCTN99697616
Prednisolone 5mg.day-1; placebo
Painful hand OA
Comp 70 Adt Sen
Aug-09 Dec-10 University of Leeds (UK)
http://www.controlled-trials.com/ISRCTN99697616
Miscellaneous observational studies
Norwegian Very Early Arthritis Clinic (NOR-VEAC): spectrum of arthritides, disease course and predictors of outcomes Multicentre cohort study ISRCTN05526276
RA; un-differentiated arthritis
Ongoing 2000 Adt Sen
Aug-10 Jan-17 Diakonhjemmet Hospital (Norway)
http://www.controlled-trials.com/ISRCTN05526276
A2: ELBOW PAIN
Title Phases: trial design (control) CT ID
Interventions Conditions Recruit n Age Grp
Start Date
End Date
Sponsors URL
Behavioural, education & exercise including physiotherapy & manual therapy
Eccentric Training With or Without Elbow Brace for Epicondylitis Phase III: RCT (active), efficacy study NCT01273688
Eccentric training (Flex-Bar); EpiHit elbow brace
Epicondylitis; Tendinopathy; Pain
Not yet Rec
90 Adt Sen
Feb-11 Nov-11 Hannover Medical School
http://ClinicalTrials.gov/show/NCT01273688
9
Device
VIBration Training in EpicondylitiS Phase III: RCT (active), efficacy study NCT01269879
Flexi-Bar vibration device only; Flexi-Bar + XCO-Trainer
Epicondylitis; Pain; Tendinopathy
Not yet Rec
70 Adt Jan-11 Sep-11 Hannover Medical School
http://ClinicalTrials.gov/show/NCT01269879
A3: SHOULDER PAIN
Title Phases: trial design (control) CT ID
Interventions Conditions Recruit n Age Grp
Start Date
End Date
Sponsors URL
Behavioural, education & exercise including physiotherapy & manual therapy
Subacromial impingement syndrome and pain: a randomised controlled trial of exercise and injection (the SUPPORT trial) RCT (active) ISRCTN42399123
Ultrasound-guided or unguided cortico-steroid injection, with either physiotherapist-led individualised, supervised & progressed exercise or an advice & exercise leaflet
Subacromial impingement syndrome
Active 252 Adt Sen
Mar-11 Sep-13 Keele University (UK)
http://www.controlled-trials.com/ISRCTN42399123
Supervised Exercise Therapy vs Home Exercises for Patients With Subacromial Impingement RCT (active), efficacy study NCT01257113
Supervised exercise; Home-based exercises
Shoulder Impingement Syndrome
Rec 46 Adt Jan-11 Dec-11 Norwegian University of Science and Technology
http://ClinicalTrials.gov/show/NCT01257113
Effectiveness of Transverse Friction Massage in Latent Myofascial Trigger Points in Anterior Deltoid Muscle RCT (active), efficacy study NCT01275482
Transverse friction massage (TFM)
Myofascial Trigger Points; Myofascial Pain
Comp 40 Adt Sen
M-
only
Jan-11 Mar-11 University of Castilla-La Mancha
http://ClinicalTrials.gov/show/NCT01275482
10
Progressive Resistance Training of the Biceps in Subacromial Impingement Syndrome RCT (active), efficacy study NCT01314196
Therapeutic exercises; Biceps resistance training and therapeutic exercises
Shoulder Impingement Syndrome
Comp 60 Adt Dec-08 Dec-10 Federal University of São Paulo
http://ClinicalTrials.gov/show/NCT01314196
Comparison of Lidocaine Injection, Therapeutic Exercise and Two of Them for Myofascial Pain Treatment Phase IV RCT (active), efficacy study NCT01250184
Physical therapy; Blocking the MTP with lidocaine injection; Blocking the MTP plus physical therapy
Myofascial Pain Syndrome; Pain; Myofascial Trigger Point; Anesthetics, Local; Physical Therapy Modalities
Rec 150 Adt May-09 Nov-10 Grupo Rehabilitacion en Salud; Universidad de Antioquia
http://ClinicalTrials.gov/show/NCT01250184
Drugs including biologics
Does subacromial injection influence shoulder strength? RCT (placebo) ISRCTN50853594
Local anesthetic; Placebo
Shoulder pain; Active 10 Adt Apr-11 Apr-12 Balgrist University Hospital (Switzerland)
http://www.controlled-trials.com/ISRCTN50853594
Amitriptyline Regarding Nimesulide in Acute Idiopathic Adhesive Capsulitis Phase II: RCT (active), efficacy study NCT01306708
Amitriptyline Adhesive Capsulitis
Rec 34 Adt Sen
Feb-11 Jul-11 Universidade do Sul de Santa Catarina
http://ClinicalTrials.gov/show/NCT01306708
"MILNACIPRAN" in Subjects With Chronic Shoulder Pain Phase IV: RCT (placebo), safety/efficacy study NCT01289236
Milnacipran; Placebo
Shoulder Pain Chronic
Active, NR
40 Adt Sen
Oct-09 Jun-11 Delray Research Associates; Forest Laboratories
http://ClinicalTrials.gov/show/NCT01289236
Procedure
Accuracy of Needle Placement Into The Subacromial Space of The Shoulder RCT (active), efficacy study NCT01330641
Injection of Subacromial Bursa
Rotator Cuff Tendonitis
Comp 75 Adt Sen
Sep-08 Mar-11 University of California, Davis
http://ClinicalTrials.gov/show/NCT01330641
11
Comparison of Lidocaine Injection, Therapeutic Exercise and Two of Them for Myofascial Pain Treatment Phase IV: RCT (active), efficacy study NCT01250184
Physical therapy; Blocking the MTP with lidocaine injection; Blocking the MTP plus physical therapy
Myofascial Pain Syndrome; Pain; Myofascial Trigger Point; Anesthetics, Local; Physical Therapy Modalities
Rec 150 Adt May-09 Nov-10 Grupo Rehabilitacion en Salud; Universidad de Antioquia
http://ClinicalTrials.gov/show/NCT01250184
Other including CAM therapies
Massage in Treating Painful Shoulder RCT (active) NCT01307826
Massage Shoulder Pain Syndrome; Pain; Frozen Shoulder
Comp N/K Adt Sen
Jan-08 Sep-10 University School of Physical Education in Wroclaw
http://ClinicalTrials.gov/show/NCT01307826
Miscellaneous observational studies
Validation of a Score for Shoulder Function Evaluation Based on Movement Analysis Observational: Prospective cohort study NCT01281085
Shoulder Pain Comp 16 Adt Sen
Oct-10 Apr-11 Haute Ecole Cantonale Vaudoise de Santé; Réseau d'études appliquées des pratiques de Santé de Réadapation (ré)insertion
http://ClinicalTrials.gov/show/NCT01281085
Burden of Shoulder Disorders in Primary Health Care Observational: Prospective cohort study NCT01300091
Shoulder Pain; Shoulder Mobility Impairment
Active, not Rec
128 ChildAdt Sen
Oct-07 Mar-11 Central Finland Hospital District; The Regional State Administrative Agency
http://ClinicalTrials.gov/show/NCT01300091
Symptoms of Degeneration in Shoulder of Wheelchair-users Observational: Prospective cohort study NCT01263184
Degeneration; Shoulder Pain
Rec 60 Adt Nov-09 ? Nov-10
Hannover Medical School
http://ClinicalTrials.gov/show/NCT01263184
12
Evaluation of the Difference in the Acromion Humerus Gap at Sitting,Lying Observational: Cross-sectional, case-only study NCT01264926
Shoulder Impingement Syndrome.
Not yet Rec
Adt Sen
? Dec-10
Hadassah Medical Organization
http://ClinicalTrials.gov/show/NCT01264926
A4: NECK PAIN
Title Phases: trial design (control) CT ID
Interventions Conditions Recruit n Age Grp
Start Date
End Date
Sponsors URL
Behavioural, education & exercise including physiotherapy & manual therapy
To Investigate the Effectiveness of Manual Therapy on Head-repositioning Accuracy and Static Postural Balance in Patients With Non-traumatic Chronic Mechanical Neck Pain Phase I: RCT (active), safety/efficacy study NCT01310595
Manual mobilization on cervical spine; Infra-red therapy with self exercise pamphlet
Neck Pain Rec 180 Adt Jan-10 Dec-13 The Hong Kong Polytechnic University
http://ClinicalTrials.gov/show/NCT01310595
Assessing the effectiveness of a lateral glide cervical spine mobilisation on cervicobrachial (neck and arm) pain RCT (active) ISRCTN62431186
Self−management protocol with lateral glide mobilization; self−management protocol
Musculoskeletal pain; Neck and arm; cervicobrachial pain
Ongoing 96 Adt Jun-09 Jun-12 University of Birmingham (UK)
http://www.controlled-trials.com/ISRCTN62431186
The effectiveness of physiotherapy on patients with dizziness and pain caused by a neck problem RCT (placebo) ACTRN12611000073909
Cervical Sustained Natural Apophyseal Glides; Passive joint mobilisation; Placebo
Dizziness and pain from cervical spine problems
Ongoing 90 Adt Sen
Apr-10 > Apr-12
University of Newcastle, NSW (Australia)
http://www.anzctr.org.au/trial_view.aspx?ID=335421
13
The effect of exercise program for prevention of musculoskeletal disorders in the neck, upper back and low back among office workers RCT ISRCTN16436892
Exercise program; normal activity
Non-specific neck, upper back and low back pain
Active 1004 Adt Jan-11 Mar-12 Social Security Office of Thailand (Thailand)
http://www.controlled-trials.com/ISRCTN16436892
Effects of Sensomotoric Training on Neck/Scapular Pain in People With Visual Disability Phase IV: RCT (active), efficacy study NCT01361906
Sensomotoric training
Neck/Scapular Pain
Active, NR
52 Adt Sen
Sep-10 Feb-12 Centre for Rehabilitation Research, Örebro; Örebro County Council Centre for Musculoskeletal Research, University of Gävle
http://ClinicalTrials.gov/show/NCT01361906
Exercise rehabilitation programs for chronic low back pain RCT (active) ACTRN12611000229976
Exercise rehabilitation program (pilates based); general exercise
Chronic non-specific low back pain
Active 52 Adt Apr-11 > Jun-11
University of Western Sydney (Australia)
http://www.anzctr.org.au/trial_view.aspx?ID=336620
Exploring the effectiveness of chiropractic care for spinal pain and measuring any side effects from that care. RCT (placebo), efficacy study ACTRN12611000542998
Usual Chiropractic Care; Sham
Non-specific spinal pain: pain associated with cervical, thoracic, or lumbar spine.
Ongoing 180 Adt Sen
Jun-11 >
Jun-11
Murdoch University (Australia)
http://www.anzctr.org.au/trial_view.aspx?ID=336774
Effects of compression on myofascial trigger points in patients with acute-subacute neck or low back pain: randomized controlled trials. RCT (active) UMIN000005332
Trigger point massage; non-trigger point massage; superficial massage
Low back pain; acute-subacute neck pain
Active 120 Child Adt
Apr-11 > Apr-11
University of Toyama (Japan)
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&type=summary&recptno=R000006336&language=E
Dose Optimisation for Spinal treatment Effectiveness (The DOSE Study): A randomised controlled pilot trial investigating the effects of high and low mobilisation forces in patients with neck pain RCT (placebo) ACTRN12611000374965
High force mobilisation; Low force mobilisation; Laser. Out of these three interventions, one will be placebo.
Chronic non-specific neck pain
Ongoing 66 Adt Apr-11 > Apr-11
The University of Newcastle, NSW (Australia)
http://www.anzctr.org.au/trial_view.aspx?ID=336708
14
Short-Term Effects of Combined Manual Therapy to the Cervical and Thoracic Spine RCT (active), efficacy study NCT01318720
Manual Therapy Neck Pain Rec 64 Adt Nov-09 Apr-11 Masefield and Cavallaro Physical Therapy
http://ClinicalTrials.gov/show/NCT01318720
Strain-counterstrain to treat restrictions of the mobility of the cervical spine - a randomized trial RCT (placebo) DRKS00000691
Strain-counterstrain (osteopathy); sham
Cervicalgia; limited cervical mobility and neck pain
Ongoing 60 Adt Feb-11 > Feb-11
Institut für Allgemeinmedizin Klinikum rechts der Isar der TU München
https://drks-neu.uniklinik-freiburg.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00000691
A comparison of conventional physiotherapy to physiotherapy and behavioural treatment for patients with chronic neck pain RCT (active) ISRCTN27611394
Progressive neck exercise programme (PNEP) only; PNEP with interactive behavioural modification therapy
Chronic non-specific neck pain
Comp 56 Child Adt Sen
Mar-08 Feb-11 Pennine Acute Hospitals NHS Trust (UK)
http://www.controlled-trials.com/ISRCTN27611394
Comparison of Lidocaine Injection, Therapeutic Exercise and Two of Them for Myofascial Pain Treatment Phase IV: RCT (active), efficacy study NCT01250184
Physical therapy; Blocking the MTP with lidocaine injection; blocking the MTP plus physical therapy
Myofascial Pain Syndrome; Pain; Myofascial Trigger Point; Anesthetics, Local; Physical Therapy Modalities
Rec 150 Adt May-09 Nov-10 Grupo Rehabilitacion en Salud; Universidad de Antioquia
http://ClinicalTrials.gov/show/NCT01250184
Patient-Oriented versus Prescription-Oriented rehabilitation in the management of chronic mechanical neck pain: a randomized controlled trial. RCT (active) ACTRN12611000107921
Patient-oriented rehabilitation (physical therapy responsive to patient needs); Prescription-oriented rehabilitation (physical therapy prescribed at referral and not adjusted)
Chronic mechanical neck pain
Comp 200 Adt Sen
Jun-10 > Aug-10
Sapienza University (Italy)
http://www.anzctr.org.au/trial_view.aspx?ID=336467
15
Drugs including biologics
Efficacy and Safety of Diclofenac 1.16% Gel in Subjects With Acute Neck Pain Phase IV: RCT (placebo), safety/efficacy study NCT01335724
Diclofenac diethylamine 1.16% gel; Placebo gel
Neck Pain Rec 72 Adt Sen
Apr-11 Aug-11 Novartis http://ClinicalTrials.gov/show/NCT01335724
A randomized comparative study of Celecoxib and Limaprost alfadex on the patients with lumber spinal stenosis for the effectiveness for symptoms and QOL Phase III: RCT (active) UMIN000004825
Lecoxib; Limaprost alfadex
Lumbar spine stenosis
134 Adt Sen
Jan-11 > Mar-11
University of Tsukuba (Japan)
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&type=summary&recptno=R000005745&language=E
Procedures
Dry Needling Versus Strain-counterstrain on the Upper Trapezius RCT (placebo), efficacy study NCT01290653
Dry needling; Strain-counterstrain technique; Placebo manual technique
Neck Pain Not yet rec
60 Adt Sen
Feb-11 Jul-11 Cardenal Herrera University
http://ClinicalTrials.gov/show/NCT01290653
The use of a three dimensional ultrasound-based measurement device for the evaluation of subjects with and without neckpain Non-randomized, controlled diagnostic study DRKS00000794
3-D ultrasound-based device
Cervicalgia Ongoing 180 Adt Sen
Apr-10 > Apr-11
Philipps-Universität Marburg Fachbereich Medizin Physiotherapie
https://drks-neu.uniklinik-freiburg.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00000794
Development of evaluation and management for returning to work in workers on sick leave because of chronic low back pain Single group assignment UMIN000004472
Evaluation and management
Chronic low back pain
N/K 30 Adt Oct-10 > Oct-10
Kanto Rosai Hospital (Japan)
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&type=summary&recptno=R000005351&language=E
16
Efficacy of the novel comprehensive management program for low back pain in care workers Non-randomized, parallel assignment, efficacy study UMIN000004473
Novel comprehensive management program; Self-management with the evidence-based booklet.
Low back pain Invite 300 Adt Sen
Oct-10 > Oct-10
Kanto Rosai Hospital (Japan)
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&type=summary&recptno=R000005350&language=E
Other including CAM therapies
Study Evaluating the Benefit of Dry Needling for Patients With Neck Pain RCT (active), efficacy study NCT01301170
Dry needling Neck Pain Rec 66 Adt Feb-11 Mar-12 Integrated Therapy Practice PC
http://ClinicalTrials.gov/show/NCT01301170
Hatha yoga (Iyengar Yoga) for neck and cervical spine pain: a randomized controlled trial RCT (active), efficacy study DRKS00000454
Iyengar yoga; neck & cervical spine exercise
Cervicalgia Comp 56 Adt Feb-10 Aug-10 Abteilung für Naturheilkunde der Charité im Immanuel-Krankenhaus Berlin-Wannsee
https://drks-neu.uniklinik-freiburg.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00000454
Effects of Thermotherapy on Chronic Neck Pain RCT, efficacy study NCT01304368
Thermotherapy Neck Pain Comp 50 Adt Sen
Aug-09 Aug-10 Universität Duisburg-Essen
http://ClinicalTrials.gov/show/NCT01304368
The Effect of 5 Times Dry Cupping in the Treatment of Chronic Neck Pain RCT (active), efficacy study NCT01289964
Dry Cupping or fire cupping
Neck Pain; Neck Pain Musculoskeletal; Mechanical/Motor Problems With Neck and Trunk
Comp 50 Adt Sen
Jul-09 Dec-09 Universität Duisburg-Essen
http://ClinicalTrials.gov/show/NCT01289964
17
A5: BACK PAIN
Title Phases: trial design (control) CT ID
Interventions Conditions
Recruit N Age Grp
Start Date
End Date
Sponsors URL
Behavioural, education & exercise incl. physiotherapy & manual therapy
Yoga vs. Physical Therapy for Chronic Low Back Pain in Minority Populations Phase I: RCT (active), efficacy study NCT01343927
Yoga Class; Physical therapy; Education
Chronic Non-Specific Low Back Pain
Not yet rec
416 Adt May-11 Aug-15 Boston Medical Center
http://ClinicalTrials.gov/show/NCT01343927
Mechanisms of Specific Trunk Exercises in Low Back Pain Phase I/II: RCT (active), efficacy study NCT01362049
Physical Therapy rehabilitation: Stabilization exercises.; Physical Therapy rehabilitation. Movement System Impairment (MSI) classification based exercise
Low Back Pain Rec 92 Adt Mar-10 Jul-13 University of Vermont; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
http://ClinicalTrials.gov/show/NCT01362049
Collaborative Care for Older Adults With Back Pain (COCOA) Phase II: RCT (active), efficacy study NCT01312233
Medical Care; Dual Care; Shared Care
Low Back Pain Rec 120 Adt Sen
Mar-11 Aug-12 Palmer College of Chiropractic; Health Resources and Services Administration; Genesis Family Medical Center; University of Iowa; Thomas Jefferson University
http://ClinicalTrials.gov/show/NCT01312233
Online Cognitive Behavioral Therapy (CBT) Workbook Phase II: RCT (active), efficacy study NCT01337843
Wellness Workbook; Pain Management Print Materials
Low Back Pain Not yet rec
198 Adt Sen
Apr-11 Jul-12 Talaria, Inc; National Institute of Arthritis and Musculoskeletal and Skin Diseases
http://ClinicalTrials.gov/show/NCT01337843
18
Supporting Decision Making for Musculoskeletal Preference-Sensitive Care RCT, Health Services Research NCT01345123
Condition specific DVD & Pamphlet on Shared Decision Making plus Telephonic outreach & support by Health Coach; Telephonic outreach only; No intervention
Knee Pain Chronic; Arthritis (Hip); Arthritis (Knee); Back Pain
Rec 18000 Adt Sen
Feb-11 Mar-12 Health Dialog; Foundation for Informed Medical Decision Making; University of Massachusetts, Boston
http://ClinicalTrials.gov/show/NCT01345123
The effect of exercise program for prevention of musculoskeletal disorders in the neck, upper back and low back among office workers RCT (active), efficacy study ISRCTN16436892
Exercise program; normal activity
Non-specific neck, upper back and low back pain
Active 1004 Adt Jan-11 Mar-12 Social Security Office of Thailand (Thailand)
http://www.controlled-trials.com/ISRCTN16436892
Recurrent Low Back Pain: Linking Mechanism to Outcomes (RCT) RCT (active), efficacy study NCT01360359
Physical Therapy Exercise Program
Low Back Pain Rec 30 Adt May-11 Mar-12 Drexel University; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
http://ClinicalTrials.gov/show/NCT01360359
Investigating a psychological intervention for people with long-term lower back pain Phase II: RCT (active) ISRCTN43733490
Contextual CBT; Physiotherapy-led treatment
Low Back Pain Active 92 Adt Sen
Jun-11 Feb-12 Royal Holloway, University of London (UK)
http://www.controlled-trials.com/ISRCTN43733490
Yoga and Qigong for Elderly Patients With Chronic Low Back Pain Phase II/III: RCT (active), efficacy study NCT01303588
Yoga; Qigong; Waiting Group
Low Back Pain Not yet rec
180 Adt Sen
Feb-11 Dec-11 Charite University, Berlin, Germany
http://ClinicalTrials.gov/show/NCT01303588
Acupuncture and manual therapy for low back pain RCT (active) ISRCTN05293321
Acupuncture; Manual therapy; Acupuncture & Manual therapy; Usual care
Low back pain Active 80 Adt Apr-11 Oct-11 University of York (UK)
http://www.controlled-trials.com/ISRCTN05293321
19
Can motor performance of chronic low back pain patients be improved via motivating feedback by means of gaming? RCT (crossover) NTR2785
Provoking position whilst gaming; Neutral position whilst gaming.
Chronic Low back pain
Active 45 Adt Sen
Jul-10 Jul-11 Roessingh Research and Development b.v. (The Netherlands)
http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2785
Exploring the effectiveness of chiropractic care for spinal pain and measuring any side effects from that care. RCT (placebo), efficacy study ACTRN12611000542998
Usual Chiropractic Care; Sham
Non-specific spinal pain: pain associated with cervical, thoracic, or lumbar spine.
Ongoing 180 Adt Sen
Jun-11 > Jun-11
Murdoch University (Australia)
http://www.anzctr.org.au/trial_view.aspx?ID=336774
Evaluation of Isostretching Effects in Patients With Mechanical and Postural Chronic Low Back Pain RCT (active), efficacy study NCT01314157
Isostretching Chronic Low Back Pain
Not yet rec
54 Adt Mar-11 Jun-11 Federal University of São Paulo
http://ClinicalTrials.gov/show/NCT01314157
Effects of compression on myofascial trigger points in patients with acute-subacute neck or low back pain: randomized controlled trials. RCT (active) UMIN000005332
Trigger point massage; non-trigger point massage; superficial massage
Low back pain; acute-subacute neck pain
Active 120 Child Adt
Apr-11 > Apr-11
University of Toyama (Japan)
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&type=summary&recptno=R000006336&language=E
Development and evaluation of a patient education intervention to improve health literacy (HL) for patients with chronic illness Non-randomized controlled trial (historical) DRKS00000655
Health education intervention; no health education.
Chronic back pain; arthrosis
Active 500 Adt Sen
Apr-11 > Apr-11
Universitätaklinikum Freiburg Abteilung für Qualitätsmanagement und Sozialmedizin (Germany)
https://drks-neu.uniklinik-freiburg.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00000655
Evaluation of the effectiveness of a consumer pamphlet for low back pain RCT (active), efficacy study ACTRN12611000053921
Pamphlet only; Pamphlet & education; No pamplet
Low Back Pain Active 360 Adt Sen
Feb-11 > Apr-11
Curtin University (Australia); Musculoskeletal Health Network (Australia)
http://www.anzctr.org.au/trial_view.aspx?ID=336417
20
Osteopathic Evaluation on Patients With Non-specific Back Pain: An Inter-examiner Reliability Study Observational: Cross-sectional, case-only study NCT01258543
General Osteopathic Evaluation
Inter-examiner Reliability; Location and Nature of Restriction or Lesion; Non-specific Back Pain
Rec 20 Adt Nov-10 Jan-11 Kirnan, Jaime http://ClinicalTrials.gov/show/NCT01258543
Massage for Low Back Pain in Nursing Staff Single group assignment, efficacy study NCT01315197
Massage Low Back Pain Comp 18 Adt Oct-10 Dec-10 University of Sao Paulo
http://ClinicalTrials.gov/show/NCT01315197
Effectiveness of Fascial Manipulation for Chronic Low Back Pain RCT (active), efficacy study NCT01269983
Fascial Manipulation
Low Back Pain Rec 50 Adt Apr-09 Dec-10 University of Bologna
http://ClinicalTrials.gov/show/NCT01269983
Impact of a Balance Reeducation Protocol on Pain, Function and Postural Control of Low Back Pain Patients RCT (active), efficacy study NCT01342432
General exercise only; Balance reeducation plus general exercise
Low Back Pain Comp 35 Adt Sen
Jan-09 Oct-09 Centro Universitari Fieo; University of Sao Paulo
http://ClinicalTrials.gov/show/NCT01342432
Device
Safety and Performance of the Elaspine System in the Treatment of the Lumbar Spine Single group assignment, safety/efficacy study NCT01323543
Elaspine™ Lower Back Pain Rec 40 Adt Sen
Aug-10 Dec-20 Spinelab AG; MDT Medical Device Testing GmbH
http://ClinicalTrials.gov/show/NCT01323543
Study of Barricaid Device Phase IV: RCT (active) NCT01283438
Barricaid; Standard of Care
Lumbar Disc Herniation
Rec 400 Adt Sen
Dec-10 May-14 Intrinsic Therapeutics
http://ClinicalTrials.gov/show/NCT01283438
21
Safety and Efficacy of the TransDiscal System Versus Medical Management in Treating Chronic Discogenic Low Back Pain Phase IV: RCT (active), safety/efficacy study NCT01263054
TransDiscal System; Medical Management
Back Pain Rec 136 Adt Sen
Dec-10 May-13 Kimberly-Clark Corporation
http://ClinicalTrials.gov/show/NCT01263054
Safety and Effectiveness Study of the AO-1000 Device to Treat Contained Herniated Discs Phase I: Single group assignment, safety/efficacy study NCT01339377
AO-1000 Disk, Herniated Not yet rec
40 Adt Sen
May-11 Jul-12 ActiveO Inc. http://ClinicalTrials.gov/show/NCT01339377
Senza™ spinal cord stimulation system for the treatment of chronic back and leg pain in failed back surgery syndrome (FBSS) patients RCT (placebo) ISRCTN33292457
Permanent spinal cord stimulation implant
Chronic back and leg pain in failed back surgery syndrome (FBSS) patients
Active 20 Adt Sen
Apr-11 Apr-12 Nevro Corporation (USA)
http://www.controlled-trials.com/ISRCTN33292457
Effectiveness evaluation of automatic thermomechanic massage system (SMATH System) in subacute and chronic low back pain treatment RCT (placebo) ISRCTN08714168
Automatic thermomechanic massage system (SMATH System); Sham
Subacute and chronic Low Back Pain
Active 72 Adt Jan-11 Jan-12 Physiotherapy and Specialised Rehabilitation Department of Cremona Hospital (Italy)
http://www.controlled-trials.com/ISRCTN08714168
Comparative Study of Static and Dynamic Back Supports for Lower Back Pain Non-randomized, parallel group assignment, efficacy study NCT01269619
Dynamic back support; Static back support
Low Back Pain, Mechanical
Not yet rec
20 Adt Feb-11 Apr-11 Wolfson Medical Center
http://ClinicalTrials.gov/show/NCT01269619
Pilot study on the effect of Intradiscal Pulsed RadioFrequency treatment for the management of low back pain and ischialgia of discogenic origin Prospective longitudinal observational trial ISRCTN46778702
Intradiscal Pulsed RadioFrequency treatment
Discogenic low back pain
Comp 50 Adt Sen
Mar-08 Feb-11 Orbis Medical Centre Sittard-Geleen (Netherlands)
http://www.controlled-trials.com/ISRCTN46778702
22
The role of leg length discrepancy in low back pain RCT (placebo) ISRCTN11898558
Corrective soles; Soles without correction
Low Back Pain Comp 42 Adt Sen
Feb-09 Feb-10 South Ostrobothnia Central Hospital (Finland)
http://www.controlled-trials.com/ISRCTN11898558
The Effect of AposTherapy on the Level of Pain, Function and Quality of Life in Patients With Neuro-muscular and Neurological Disorders Single group assignment, efficacy study NCT01266382
AposTherapy OA; Spinal Diseases; Ligament Rupture; Lower Extremity Fracture; Neurological Disorders
Rec Adt Sen
N/K ? Jul-09
Assaf-Harofeh Medical Center; Apos Medical and Sports Technology LTD.
http://ClinicalTrials.gov/show/NCT01266382
Dietary supplements
A Study to Determine if Aquamin Modulates Inflammatory Biomarkers in the Blood of Osteoarthritis and Healthy Subjects Phase II: RCT (active), bio-availability study NCT01321281
AquaCal; AquaPT OA Rec 36 Adt
F-only
Mar-11 Oct-11 University College Cork; Marigot Ltd.
http://ClinicalTrials.gov/show/NCT01321281
Drugs including biologics
Lumbar Infiltration With Steroids - Effects on Pain Reduction Observational: Prospective, case-only study NCT01330875
Steroids Low Back Pain Rec 100 Adt Sen
Dec-10 Jan-15 University of Zurich http://ClinicalTrials.gov/show/NCT01330875
Longterm Safety Study of BEMA Buprenorphine in Subjects With Chronic Pain Phase III: Single group assignment, safety/efficacy study NCT01298765
BEMA Buprenorphine
Pain; Low Back Pain; OA; Neuralgia
Rec 300 Adt Sen
Mar-11 Sep-12 BioDelivery Sciences International
http://ClinicalTrials.gov/show/NCT01298765
23
Efficacy and Safety of Oxycodone/Naloxone Controlled-release Tablets (OXN) Compared to Placebo in Opioid-experienced Subjects With Moderate to Severe Chronic Low Back Pain Phase III: RCT (placebo), safety/efficacy study NCT01358526
Oxycodone/ Naloxone controlled-release; Placebo
Low Back Pain Rec 600 Adt Sen
May-11 Aug-12 Purdue Pharma LP http://ClinicalTrials.gov/show/NCT01358526
Primary Care Identification Of Patients With Chronic Neuropathic Low Back Pain Study Phase IV: Single group assignment, safety/efficacy study NCT01298466
Pregabalin Low Back Pain; Neuralgia
Not yet rec
600 Adt Sen
Sep-11 Jun-12 Pfizer http://ClinicalTrials.gov/show/NCT01298466
The Efficacy of Zoledronic Acid in Modic Changes-related Low Back Pain (LBP) Phase II: RCT (placebo), efficacy Study NCT01330238
Zoledronic acid; placebo
Low Back Pain Rec 40 Adt Sen
Dec-08 Mar-12 University of Oulu; Novartis Pharmaceuticals
http://ClinicalTrials.gov/show/NCT01330238
Comparison of Increasing Doses of Tapentadol Versus a Combination of Tapentadol and Pregabalin Phase IV: RCT (active), efficacy study NCT01352741
Tapentadol PR; Tapentadol PR with Pregabalin; Tapentadol PR open label maintenance
Low Back Pain; Neuropathic Pain
Rec 500 Adt Sen
Mar-11 Jan-12 Grünenthal GmbH http://ClinicalTrials.gov/show/NCT01352741
A Clinical Trial to Study the Effects of a Fixed Dose Combination of Diclofenac and Eperisone Hydrochloride With Plain Eperisone Hydrochloride in Patients With Low Back Pain Phase III: RCT (active), safety/efficacy study NCT01300312
Eperisone hydrochloride & Diclofenac sodium; Eperisone hydrochloride
Acute Musculoskeletal Spasm Due to Low Back Pain
Rec 240 Adt Feb-11 Nov-11 Eisai Co., Ltd. http://ClinicalTrials.gov/show/NCT01300312
24
Evaluation of the Efficacy and Tolerability of Etoricoxib Monotherapy Versus Combination Oxycodone-etoricoxib in Moderate to Severe Pain From Chronic Low Back Pain Phase IV: RCT (active), safety/efficacy study NCT01344720
Etoricoxib; Oxycodone
Low Back Pain Not yet rec
250 Adt Sen
May-11 Jun-11 Azienda Sanitaria Locale 4, Teramo
http://ClinicalTrials.gov/show/NCT01344720
Efficacy and Safety Study of BEMA Buprenorphine in Subjects With Low Back Pain Phase III: RCT (placebo), safety/efficacy study NCT01256450
BEMA Buprenorphine; BEMA Placebo
Pain; Low Back Pain
Active, NR
300 Adt Sen
Dec-10 Jun-11 BioDelivery Sciences International
http://ClinicalTrials.gov/show/NCT01256450
Other including CAM therapies
Integrated Chiropractic and Acupuncture Treatment for Low Back Pain Phase II: RCT (active), efficacy study NCT01357343
Chiropractic; Acupuncture
Low Back Pain Rec 100 Adt Sen
Feb-11 Aug-13 Southern California University of Health Sciences
http://ClinicalTrials.gov/show/NCT01357343
The influence of a non-invasive electrical stimulation over an area of the brain on pain and disability in patients with long-standing back pain RCT (placebo), efficacy study ISRCTN89874874
Anodal transcranial direct current stimulation; sham
Chronic low back pain
Ongoing 135 Adt Feb-11 Aug-11 University Medical Center Hamburg-Eppendorf (Germany)
http://www.controlled-trials.com/ISRCTN89874874
Motion Style Treatment (MST) Acupuncture for Low Back Pain With Severe Disability RCT (active), efficacy study NCT01315561
Acupuncture, injection
Complete Immobility Due to Severe Physical Disability
Rec 58 Adt Apr-11 Aug-11 Jaseng Hospital of Oriental Medicine
http://ClinicalTrials.gov/show/NCT01315561
Cryoneurolysis versus steroid infiltration for treatment of lumbar facet joint syndrome: a randomized controlled double-blind study RCT (active) DRKS00000659
Cryoneurolysis; steroid infiltration
Chronic low back pain
N/K 30 Adt Sen
Jan-11 > Jan-11
Interdisziplinäres Schmerzzentrum Universitätsklinikum Freiburg (Germany)
https://drks-neu.uniklinik-freiburg.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00000659
25
Procedures
Safety and Preliminary Efficacy Study of Mesenchymal Precursor Cells (MPCs) in Subjects With Chronic Discogenic Lumbar Back Pain Phase II: RCT (placebo), safety/efficacy study NCT01290367
MPCs Injection; Saline injection
Degenerative Disc Disease
Not yet rec
80 Adt Sen
May-11 May-15 Mesoblast, Ltd. http://ClinicalTrials.gov/show/NCT01290367
Surgery Versus Standardized Non-operative Care for the Treatment of Lumbar Disc Herniations: A Canadian Trial Phase III: RCT (active), efficacy study NCT01335646
Lumbar Microdiscectomy; Physiotherapy, Epidural injections, Education, Pain Medications, Anti-inflammatories
Lumbar Spine Disc Herniation; Lumbar Radiculopathy
Rec 140 Adt Feb-10 Mar-15 The London Spine Centre; The Physicians' Services Incorporated Foundation; Lawson Health Research Institute
http://ClinicalTrials.gov/show/NCT01335646
Preliminary Study of the Sagittal Alignment of the Lumbo-pelvic Complex in a Sitting Position Observational: Prospective, case control study NCT01323127
Sagital X-rays Back Pain; Low Back Pain
Not yet rec
20 Adt Sen
May-11 Dec-11 Centre Hospitalier Universitaire de Nīmes
http://ClinicalTrials.gov/show/NCT01323127
Structural Integration for Chronic Low Back Pain RCT (active), efficacy study NCT01322399
Structural Integration; Usual care
Back Pain Lower Back Chronic
Rec 40 Adt Dec-10 Oct-11 Spaulding Rehabilitation Hospital; National Center for Complementary and Alternative Medicine (NCCAM)
http://ClinicalTrials.gov/show/NCT01322399
An Alternative Technique for Lumbar Medial Branch Radiofrequency: Comparison With the Empirical Technique RCT (active), safety/efficacy study NCT01300715
Lumbar medial branch radiofrequency neurotomy
Low Back Pain; Lumbar Facet Joint Pain; Arthropathy
Rec 100 Adt Sen
Nov-10 May-11 Seoul National University Bundang Hospital
http://ClinicalTrials.gov/show/NCT01300715
26
Miscellaneous observational studies
Observational Cohort Study of Chronic Low Back Pain Observational: Prospective cohort study NCT01355237
Back Pain Lower Back Chronic
Not yet rec
300 Adt Sen
Jun-11 Jun-15 Brigham and Women's Hospital; Harvard University; Beth Israel Deaconess Medical Center
http://ClinicalTrials.gov/show/NCT01355237
Pain Quality Study Observational: Cross-sectional, case-only study NCT01321190
Low Back Pain; Headache; Fibromyalgia
Not yet rec
300 Adt Sen
Jun-11 Mar-13 University of Washington; Merck
http://ClinicalTrials.gov/show/NCT01321190
Maverick Total Disc Replacement in a 'Real World' Patient Population Observational: Prospective, case-only study NCT01338493
Degenerative Disc Disease
Active, NR
150 Child Adt Sen
Feb-09 Feb-13 Medtronic Spinal & Biologics ECA
http://ClinicalTrials.gov/show/NCT01338493
A Study of Genetic Variation Influencing Pain and Response to Opioid Medications in Patients With Chronic Pain Observational: Prospective cohort study NCT01293994
Pain; Chronic low back pain
Invite 500 Adt Sen
Feb-09 Dec-12 Stanford University http://ClinicalTrials.gov/show/NCT01293994
ATLAS – Assessment and Treatment of Leg pain Associated with the Spine Observational: Cohort Study UKCRN 9961
Low back pain and radiating leg pain
Active 500 Adt Sen
N/K Nov-12 Keele University http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=9961
Adjacent Segment Disc Degeneration (ASDD) Multicentre Observational: Cohort study UKCRN 9656
Fusion and non-operative care
Chronic low back pain;
Active 600 N/K N/K May-12 Nuffield Orthopaedic Centre NHS Trust
http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=9656
Patients’ treatment beliefs in back pain UKCRN 9683
Persistent non-specific low back pain
Active 380 N/K N/K Jan-12 University of Southampton
http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=9683
JOBA® & Chronic LOw BAck Pain Observational: Case Control NCT01259167
Low Back Pain; Invite 50 Adt Sen
Jan-11 Jun-11 Catholic University of the Sacred Heart
http://ClinicalTrials.gov/show/NCT01259167
27
Clinicians' treatment beliefs in back pain Qualitative study UKCRN 9490
Persistent Non-Specific Low Back Pa
Active 40 Adt N/K Jun-11 University of Southampton
http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=9490
Validity of the Fingertip-to-floor test DRKS00003075
Dorsopathies Comp 55 Adt Mar-11 May-11 Philipps-Universität Marburg, Fachbereich Medizin, Studiengang Physiotherapie Master (Germany)
https://drks-neu.uniklinik-freiburg.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00003075
Patient-oriented outcome measurement: Health valuations and the assessment of the participation relevance of treatment effects by chronically ill patients (POEM) DRKS00000744
Chronic back pain; Spondylosis; Spondylopathies; Collapsed vertebra; intervertebral disc disorders; dorsopathies; Dorsalgia; Persistent somatoform pain disorder
Comp 600 Adt Sen
Apr-08 Feb-11 Universitätsklinikum Freiburg Abteilung Qualitätsmanagement und Sozialmedizin (Germany)
https://drks-neu.uniklinik-freiburg.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00000744
28
A6: HIP PAIN
Title Phases: study design (control) CT ID
Interventions Conditions Recruit n Age Grp
Start Date
End Date
Sponsors URL
Behavioural, education & exercise incl. physiotherapy & manual therapy
Supporting Decision Making for Musculoskeletal Preference-Sensitive Care RCT (active), health services research NCT01345123
Condition specific DVD & Pamphlet on Shared Decision Making plus Telephonic outreach & support by Health Coach; Telephonic outreach only; No intervention
Knee Pain Chronic; Arthritis (Hip); Arthritis (Knee); Back Pain
Rec 18000 Adt Sen
Feb-11 Mar-12 Health Dialog; Foundation for Informed Medical Decision Making; University of Massachusetts, Boston
http://ClinicalTrials.gov/show/NCT01345123
A7: KNEE PAIN
Title Phases: study design (control) CT ID
Interventions Conditions Recruit n Age Grp
Start Date
End Date
Sponsors URL
Behavioural, education & exercise incl. physiotherapy & manual therapy
Supporting Decision Making for Musculoskeletal Preference-Sensitive Care RCT (active), health services research NCT01345123
Condition specific DVD & Pamphlet on Shared Decision Making plus Telephonic outreach & support by Health Coach; Telephonic outreach only; No intervention
Knee Pain Chronic; Arthritis (Hip); Arthritis (Knee); Back Pain
Rec 18000 Adt Sen
Feb-11 Mar-12 Health Dialog; Foundation for Informed Medical Decision Making; University of Massachusetts, Boston
http://ClinicalTrials.gov/show/NCT01345123
29
Exercise and Pain Sensitivity RCT (active) NCT01351558
Knee muscle strengthening exercises; Upper extremity strengthening exercises; Cardiovascular fitness exercises
Knee Pain Rec 120 Adt May-11 Mar-12 Frederiksberg University Hospital
http://ClinicalTrials.gov/show/NCT01351558
The Effect of Experimental Knee Pain During Strengthening Exercises on Muscle Strength Gain RCT (active) NCT01346995
Experimental knee pain; Non-painful control injections
Muscle Strength Comp 36 Adt Feb-10 Aug-10 Frederiksberg University Hospital
http://ClinicalTrials.gov/show/NCT01346995
Dietary supplement
Effect of Yogurts Supplemented With Mobilee on Joint Function in Healthy Individuals With Joint Discomfort RCT (active), safety/efficacy study NCT01303432
Yogurt supplemented with Mobilee; Yogurt
Low Intensity Knee Gonalgia
Active, NR
80 Adt Sen
Sep-10 Mar-11 Bioiberica; Technological Centre of Nutrition and Health
http://ClinicalTrials.gov/show/NCT01303432
Vitamin D and Fish Oil for Autoimmune Disease, Inflammation and Knee Pain Phase IV: RCT (placebo), efficacy study NCT01351805
Fish Oil; Vitamin D; placebo pill
Autoimmune Diseases; Systemic Inflammation; Knee Pain; OA; RA
Rec 20000
Adt Sen
Jan-11 Dec-16 Brigham and Women's Hospital; National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
http://ClinicalTrials.gov/show/NCT01351805
Device
The use of in-shoe foot orthoses in the short-term treatment of anterior knee pain RCT, efficacy study ACTRN12611000492954
Prefabricated, full length in-shoe orthoses; wait and see
Anterior knee pain
Comp 40 Adt Sep-09 > Oct-09
University of Queensland;
Australian Institute of Sport
http://www.anzctr.org.au/trial_view.aspx?ID=336918
30
The Effect of AposTherapy on the Level of Pain, Function and Quality of Life in Patients With Neuro-muscular and Neurological Disorders NCT01266382
AposTherapy OA; Spinal Diseases; Ligament Rupture; Lower Extremity Fracture; Neurological Disorders
Rec Adt Sen
N/K ? Jul-09
Assaf-Harofeh Medical Center;
Apos Medical and Sports
Technology LTD.
http://ClinicalTrials.gov/show/NCT01266382
A8: FOOT, ANKLE & TOE PAIN
Title Phases: study designs (control) CT ID
Interventions Conditions Recruit n Age Grp
Start Date
End Date
Sponsors URL
Behavioural, education & exercise incl. physiotherapy & manual therapy
A Study on Exercise After Achilles Tendon Rupture Phase II: RCT (active), safety/efficacy study NCT01298024
Early Neuromuscular Exercise
Achilles Tendon Rupture
Rec 30 Adt Mar-11 Oct-12 Region Skane; Lund University
http://ClinicalTrials.gov/show/NCT01298024
Exercise Versus Corticosteroid Randomized Clinical Trial for Plantar Fasciitis Phase II/III: RCT (crossover), efficacy study NCT01297686
Multi-element exercise protocol involving static and dynamic stretches, deep massage, and balance training; Gastrocnemius & soleus stretching and Dexamethasone
Fasciitis, Plantar
Not yet rec
100 Adt May-11 Apr-12 University of British Columbia
http://ClinicalTrials.gov/show/NCT01297686
31
Device
Augment™ Injectable Bone Graft Compared to Autologous Bone Graft as a Bone Regeneration Device in Hindfoot Fusions Phase III: RCT (active), safety/efficacy study NCT01305356
Augment(tm) Injectable Bone Graft; Autologous bone graft
Degenerative Joint Disease; Congenital Deformity; Arthritis; OA; RA
Rec 201 Adt Sen
Mar-11 Mar-14 BioMimetic Therapeutics
http://ClinicalTrials.gov/show/NCT01305356
Footwear Minimalism Study Phase II: RCT (active), efficacy study NCT01334346
Nike Pegasus; Nike Free 3.0; Vibram Five Fingers Shoe
Healthy Runners
Not yet rec
144 Adt Jul-11 Jul-12 University of British Columbia; Nike Inc.
http://ClinicalTrials.gov/show/NCT01334346
Orthotics in the treatment of plantar fasciitis. A prospective randomized trial to compare three different biomechanical concepts of orthotics. RCT (active), efficacy study DRKS00000742
Thin, prefabricated, over the counter insert; foam insert (classic treatment); heel insert with thin self-supporting plastic core, central plantar heel recess & plantar fanning.
Plantar fasciitis Comp 30 Adt Sen
Mar-09 Jul-10 Zentrum für Fuß- und Sprunggelenkchirurgie Schön Klinik München Harlaching (Germany)
https://drks-neu.uniklinik-freiburg.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00000742
Dietary supplements
A Study to Determine if Aquamin Modulates Inflammatory Biomarkers in the Blood of Osteoarthritis and Healthy Subjects Phase II: RCT (active), bio-availability study NCT01321281
AquaCal; AquaPT OA Rec 36 Adt
F-only
Mar-11 Oct-11 University College Cork; Marigot Ltd.
http://ClinicalTrials.gov/show/NCT01321281
32
Drugs including biological
A Study to Characterize the Phenotype in Patients With Morton's Neuroma and to Explore the Effect of Local Administration of Xylocaine (Lidocaine) RCT (placebo), pharmacodynamics study NCT01298310
Xylocaine; Placebo Morton's Metatarsalgia
Rec 30 Adt Sen
Feb-11 Jun-11 AstraZeneca http://ClinicalTrials.gov/show/NCT01298310
NRD101 Phase II Dose finding study on plantar fasciitis patients Phase II: RCT (placebo) JapicCTI-101090
Sodium Hyaluronate; Placebo
Plantar fasciitis Comp 150 Adt Sen
Apr-10 Jun-11 Chugai Pharmaceutical Co., Ltd.
Via http://www.clinicaltrials.jp/user/cte_main_e.jsp
Other including CAM therapies
Prolotherapy for the Treatment of Plantar Fasciitis Phase IV: RCT (active), efficacy study NCT01326351
Regenerative injection therapy; Dry needle injection; Exercise
Plantar Fasciitis
Not yet rec
60 Adt Sen
May-11 Feb-12 Réseau de Santé Vitalité Health Network
http://ClinicalTrials.gov/show/NCT01326351
33
A9: FIBROMYALGIA
Title Phases: trial design (control) CT ID
Interventions Conditions Recruit n Age Grp
Start Date
End Date
Sponsors URL
Behavioural, education & exercise incl. physiotherapy & manual therapy
Qigong Exercise May Benefit Patients With Fibromyalgia RCT (placebo, crossover), efficacy study NCT01333566
Qigong Fibromyalgia Rec 80 Adt Sen
Jul-09 Jul-12 University of Kansas
http://ClinicalTrials.gov/show/NCT01333566
The Functional Neuroanatomy of Catastrophizing: an fMRI Study RCT (active) NCT01345344
CBT; Education Fibromyalgia Rec 60 Adt Sen
Aug-10 Dec-11 Brigham and Women's Hospital; Massachusetts General Hospital; Arthritis Foundation
http://ClinicalTrials.gov/show/NCT01345344
Fibromyalgia pain reproduction by manual stimulation of active myofascial trigger points as compared to latent myofascial trigger points in health controls in pain intensity and pain area RCT (active) ISRCTN43167547
Active stimulation of myofascial trigger points; latent myofascial trigger points.
Fibromyalgia Comp 60 Adt Sen
Jan-09 Dec-10 The American Fibromyalgia Syndrome Association, Inc. (AFSA) (USA)
http://www.controlled-trials.com/ISRCTN43167547
Improvement of the Health-related Quality of Life of Patients With Fibromyalgia Using Multidisciplinary Treatment Phase II: RCT (active), efficacy study NCT01266733
Interdisciplinary treatment of fibromyalgia; Usual treatment
Fibromyalgia Comp 153 Adt Sen
Feb-07 Feb-10 Hospital Galdakao-Usansolo
http://ClinicalTrials.gov/show/NCT01266733
Men With Fibromyalgia or Chronic Widespread Pain - Effect of Exercise on Symptoms and Body Functions RCT (active) NCT01278641
Graded strength resistance training program; Temperate pool exercise program
Fibromyalgia; Pain
Comp 44 Adt
M-only
Jan-08 Nov-09 Göteborg University
http://ClinicalTrials.gov/show/NCT01278641
34
Device
Repetitive Transcranial Magnetic Stimulation in Fibromyalgia RCT (active), efficacy study NCT01308801
Active rTMS + rehabilitation exercise; placebo rTMS+ rehabilitation exercise
Fibromyalgia Not yet rec
60 Adt Sen
Apr-11 Nov-13 University Hospital, Grenoble; APICIL foundation
http://ClinicalTrials.gov/show/NCT01308801
Occipital Nerve (C2) Stimulation in the Treatment of Fibromyalgia RCT (crossover), safety/efficacy study NCT01298609
Occipital Nerve Stimulation
Fibromyalgia Rec 40 Adt Sen
Jun-10 Mar-12 St. Jude Medical http://ClinicalTrials.gov/show/NCT01298609
Evaluation of Magnetic Fields to Treat Fibromyalgia Phase II: RCT (active), efficacy study NCT01262131
Resonator Fibromyalgia Comp 30 Adt Sen
Dec-10 May-11 pico-tesla Magnetic Therapies, LLC
http://ClinicalTrials.gov/show/NCT01262131
Influence of Transcranial Direct Current Stimulation of the Primary Motor Cortex on Pain Sensation in Patients Suffering From Fibromyalgia Syndrome Phase IV: RCT (placebo), efficacy study NCT01261650
Transcranial direct current stimulation; sham treatment
Fibromyalgia Rec 50 Adt Sen
Dec-10 ? Dec-10
Karl Landsteiner Institute of Remobilization and Functional Health
http://ClinicalTrials.gov/show/NCT01261650
Dietary supplements
The Impact of Omega-3 Fatty Acid Supplements on Fibromyalgia Symptoms Phase II: RCT (placebo), efficacy study NCT01352013
Omega-3 oil; Fatty Acids (placebo)
Fibromyalgia Not yet rec
40 Adt
F-only
Jun-11 Dec-12 McGill University Health Center; Alan Edwards Centre for Research on Pain
http://ClinicalTrials.gov/show/NCT01352013
D-Ribose for Fatigue in Subjects With Fibromyalgia Phase II: RCT (placebo), safety/efficacy study NCT01315210
D-Ribose Powder; Placebo
Fibromyalgia Not yet rec
100 Adt Sen
May-11 Jul-12 Bioenergy, Inc. http://ClinicalTrials.gov/show/NCT01315210
35
Drugs including biologics
Combination drug therapy for fibromyalgia pain RCT (placebo), efficacy study ISRCTN20173707
Duloxetine & Pregabalin; Duloxetine; Pregabalin
Fibromyalgia Active 69 Adt Sen
Feb-11 Jan-14 Queen's University (Canada)
http://www.controlled-trials.com/ISRCTN20173707
The Effect of Milnacipran on Fatigue and Quality of Life in Lupus Patients Phase IV: RCT (placebo), efficacy study NCT01359826
Milnacipran; Placebo
Systemic Lupus Erythematosus; Widespread Pain; Fibromyalgia
Not yet rec
50 Adt Sen
Jun-11 Nov-13 Loma Linda University; Forest Laboratories
http://ClinicalTrials.gov/show/NCT01359826
Mechanism-based Choice of Therapy: Can Treatments Success in Fibromyalgia Patients be Coupled to Psychophysical Pain Modulation Profile? RCT (active), efficacy study NCT01268631
Duloxetine; Pregabalin
Fibromyalgia Not yet rec
150 Adt Sen
Jan-11 Jan-13 Tel-Aviv Sourasky Medical Center; University of California, Davis; Rambam Health Care Campus
http://ClinicalTrials.gov/show/NCT01268631
Effect of Milnacipran on Pain in Fibromyalgia Phase IV: Single group assignment, efficacy study NCT01288807
Milnacipram Fibromyalgia Not yet rec
10 Adt Sen
F-only
Feb-11 Dec-12 University of California, San Diego; Forest Laboratories; Department of Veterans Affairs
http://ClinicalTrials.gov/show/NCT01288807
Study Of A Controlled Release Formulation Of Pregabalin In Fibromyalgia Patients Phase II/III: RCT (placebo), safety/efficacy study NCT01271933
Pregabalin; placebo
Fibromyalgia Rec 290 Adt Sen
Mar-11 May-12 Pfizer http://ClinicalTrials.gov/show/NCT01271933
Effects of Milnacipran on Widespread Mechanical and Thermal Hyperalgesia of Fibromyalgia Patients RCT (placebo), efficacy study NCT01294059
Milnacipran Fibromyalgia Rec 50 Adt Nov-09 Mar-12 University of Florida; Forest Laboratories
http://ClinicalTrials.gov/show/NCT01294059
36
Study To Assess The Clinical Benefit Of Droxidopa And Droxidopa/Carbidopa In Subjects With Fibromyalgia Phase II: RCT (placebo), efficacy study NCT01323374
Droxidopa; Carbidopa; Droxidopa/ carbidopa; Placebo
Fibromyalgia Rec 120 Adt Sen
Jan-09 Dec-11 Chelsea Therapeutics
http://ClinicalTrials.gov/show/NCT01323374
Examination of Pregabalin Access for Treatment of Indicated Pain Disorders: the ExPAND Study Phase IV: Observational, Prospective cohort study NCT01280747
Fibromyalgia; Painful Diabetic Peripheral Neuropathy
Active, NR
2288 Adt Sen
Jan-11 Dec-11 Pfizer http://ClinicalTrials.gov/show/NCT01280747
A double-blind, placebo-controlled phase II study of Org 3770 (mirtazapine) in patients with fibromyalgia Phase II: RCT (placebo) JapicCTI-101176
Mirtazapine (Org 3770); placebo
Fibromyalgia Active 120 Adt Jun-10 Jun-11 Meiji Seika Kaisha, Ltd (Japan)
Via http://www.clinicaltrials.jp/user/cte_main_e.jsp
Other including CAM therapies
Interdisciplinary Rehabilitation of Patients With Chronic Widespread Pain RCT (active), efficacy study NCT01352052
Interdisciplinary rehabilitation; Wait list control
Chronic Widespread Pain; Fibromyalgia
Invite 176 Adt Sen
F-only
May-11 Oct-12 Frederiksberg University Hospital; Oak Foundation
http://ClinicalTrials.gov/show/NCT01352052
Efficacy of Shiatsu in Individuals With Fibromyalgia: a Randomized Clinical Trial Phase II: RCT (active), efficacy study NCT01291043
Shiatsu Fibromyalgia Active, NR
34 Adt Jul-10 Dec-11 University of Sao Paulo General Hospital
http://ClinicalTrials.gov/show/NCT01291043
Miscellaneous observational studies
Pain Quality Study Observational: Cross-sectional, case-only study NCT01321190
Low Back Pain; Headache; Fibromyalgia
Not yet rec
300 Adt Sen
Jun-11 Mar-13 University of Washington; Merck
http://ClinicalTrials.gov/show/NCT01321190
37
Understanding Day to Day Experiences, Activity and Mood UKCRN9707
Bipolar Disorder; Fibromyalgia, High HPS Scorers
Active 200 Adt Sen
N/K Nov-12 Lancaster University
http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=9707
Effect of Temperature on Pain and Brown Adipose Activity in Fibromyalgia Observational: Prospective, case control study NCT01322425
Fibromyalgia; Pain
Rec 25 Adt
F-only
Jul-10 Dec-11 University of Minnesota - Clinical and Translational Science Institute
http://ClinicalTrials.gov/show/NCT01322425
Is a good mood linked to a good nights sleep? UKCRN9706
Fibromyalgia; Bipolar Disorder
Active 700 Adt Sen
N/K Nov-11 Lancaster University
http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=9706
An Assessment of the Health Economic Impact of Fibromyalgia UKCRN 10240
Fibromyalgia Active 90 Adt Sen
N/K Oct-11 Poole Hospital NHS Foundation Trust
http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=10240
The Pathogenesis of Idiopathic Dry Eyes Observational: Cross-sectional, case control study NCT01254201
Dry Eye; Fibromyalgia
Comp 84 Adt Sen
F-only
Jun-08 Sep-10 University of Michigan
http://ClinicalTrials.gov/show/NCT01254201
Epidemiology of Fibromyalgia in Japan UMIN000003550
Fibromyalgia Comp 300,000 Child Adt Sen
Apr-10 ? May-11
Tokyo-Eki Center-building Clinic (Japan)
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&type=summary&recptno=R000004282&language=E
38
A10: CHRONIC PAIN
Title Phases: trial design (control) CT ID
Interventions Conditions Recruit n Age Grp
Start Date
End Date
Sponsors URL
Behavioural, education & exercise incl. physiotherapy & manual therapy
Impact of Exercise Training on Pain and Brain Function in Gulf War Veterans Phase II: RCT (active), efficacy study NCT01350492
Resistance Exercise Training
Chronic Musculoskeletal Pain
Not yet rec
68 Adt Sep-11 Aug-16 Department of Veterans Affairs
http://ClinicalTrials.gov/show/NCT01350492
Engaging older people and their careres to develop and deliver interventions for self management of chronic pain (EPIC) Observational: cohort study UKCRN 9346
All conditions; chronic pain
Active 2800 Sen N/K Aug-14 University of Aberdeen
http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=9346
Interdisciplinary Intervention Versus Brief Intervention for Patients With Musculoskeletal Pain RCT (active), efficacy study NCT01346423
Interdisciplinary intervention; Brief Intervention
Musculoskeletal Pain
Rec 300 Adt Mar-11 Jan-14 Sykehuset Innlandet HF; University of Bergen
http://ClinicalTrials.gov/show/NCT01346423
Returning to Work. Efficacy of "Tailored Physical Activity or" "Chronic Pain Self-management Program" in Sicklisted Citizens With Chronic Musculoskeletal Pain Phase I/II: RCT (active), efficacy study NCT01356784
Tailored Physical Activity; “Chronic Pain Self-management Programme"; Health counselling
Musculoskeletal Pain
Rec 225 Adt Sen
May-11 Jul-13 University of Southern Denmark; DK-Sønderborg Municipality
http://ClinicalTrials.gov/show/NCT01356784
Effectiveness of community-wide promotion of aerobic, flexibility, and muscle-strengthening activities on musculoskeletal pain and physical activity in middle- and old- aged people: a cluster RCT Non-randomized, parallel assignment, efficacy study UMIN000002683
Community-wide campaign; as usual
Physical inactivity and musculoskeletal pain
Active NR
3000 Adt Sen
Oct-09 Feb-13 Physical Education and Medicine Research Center UNNAN; Tokyo Medical University
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&type=summary&recptno=R000003271&language=E
39
Improving the self management of chronic pain Pragmatic RCT (active) ISRCTN24426731
Self-management chronic pain course; usual GP care
Chronic musculoskeletal pain
Ongoing 700 Adt Sen
Jun-11 Jan-13 Queen Mary University of London (UK)
http://www.controlled-trials.com/ISRCTN24426731
Stanford Chronic Pain Self-Management Programme in Danish Chronic Pain Patients RCT (active), efficacy study NCT01306747
The Stanford Chronic Pain Self-Management Programme
Chronic Pain Rec 500 Adt Sen
Feb-11 Jan-13 University of Aarhus; TRYG Foundation; The Danish Committee for Health Education
http://ClinicalTrials.gov/show/NCT01306747
PREPARE- (Cost-) effectiveness of a pre-pain rehabilitation treatment, a Motivational interviewing (MI)-based nurse-led intervention in chronic non-specific musculoskeletal pain patients: A randomized controlled trial (RCT). RCT (active), efficacy study NTR2841
Motivational interviewing (MI)-based nurse-led intervention; PIL control condition
Chronic non-specific musculoskeletal pain
Ongoing 200 Adt Jun-11 Dec-12 University Maastricht (UM)
http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2841
Reducing Long-Term Disability Related to Pain: Evaluation of the Pain Disability Prevention Program in the Irish health service RCT (active) ISRCTN61650533
Community based rehabilitation programme for chronic pain; Medical treatment as usual
Chronic Pain Ongoing 210 Adt Sen
Jan-11 Dec-12 National University of Ireland, Galway (NUIG) (Ireland)
http://www.controlled-trials.com/ISRCTN61650533
Acceptance-Based Behavioural Therapy (ABBT) in chronic pain. Pilot study: Single group assignment NTR2868
Acceptance-Based Behavioural Therapy
Chronic Musculoskeletal Pain
Active 8 Adt May-11 May-12 Roessingh Research and Development b.v.
http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2868
Device
A novel neuromodulation technique in the treatment of chronic pain. Single group assignment, efficacy study NTR2825
Neuromodulation Chronic neuropathic pain
Active 30 Adt Sen
Mar-11 Sep-12 Spinal Modulation, Inc.
http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2825
40
Treatment With Spinal Cord Stimulation: Effect on Sensory Parameters RCT (placebo), efficacy study NCT01261468
Active SCS; Deactivated
Chronic Pain Rec 20 Adt Sen
Jan-11 Jul-11 Danish Pain Research Center
http://ClinicalTrials.gov/show/NCT01261468
Drugs including biologics
Study to Evaluate the Efficacy of Milnacipran in the Treatment of Pain Due to Osteoarthritis Phase IV: RCT (placebo), efficacy study NCT01329406
Milnacipran; Placebo
OA Not yet rec
50 Adt Sen
Apr-11 Sep-12 Analgesic Solutions; Forest Laboratories
http://ClinicalTrials.gov/show/NCT01329406
Longterm Safety Study of BEMA Buprenorphine in Subjects With Chronic Pain Phase III: Single group assignment, safety/efficacy study NCT01298765
BEMA Buprenorphine
Pain; Low Back Pain; OA; Neuralgia
Rec 300 Adt Sen
Mar-11 Sep-12 BioDelivery Sciences International
http://ClinicalTrials.gov/show/NCT01298765
Sedation in Endoscopic Retrograde Cholangiopancreatography (ERCP) With or Without Opioids RCT (placebo), safety/efficacy study NCT01304342
Remifentanil; Fentanyl; Normal saline
Chronic Pain Rec 180 Adt Sen
Feb-11 May-12 University of Athens
http://ClinicalTrials.gov/show/NCT01304342
Long-term study of HFT-290 in patients with chronic pain. Phase III: uncontrolled trial JapicCTI-101348
HFT-290 (fentanyl citrate patch)
Chronic Pain ? N/K N/K Nov-10 > Nov-10
Hisamitsu Pharmaceutical Co., Inc.
via http://www.clinicaltrials.jp/user/cteSearch_e.jsp
Miscellaneous observational studies
Effects of Multimodal Pain Therapy in Patients With Mixed Chronic Pain Syndromes Observational: Retrospective cohort study NCT01346202
Chronic Pain Rec 260 Adt Jan-11 Mar-12 Klinikum St. Georg gGmbH
http://ClinicalTrials.gov/show/NCT01346202
41
Acupuncture and Chiropractic Care for Chronic Pain in an Integrated Health Plan Observational: Prospective cohort study NCT01345409
Chronic Pain Invite 1320 Adt Sen
Dec-10 Aug-15 Kaiser Permanente; University of Arizona; Oregon Health and Science University
http://ClinicalTrials.gov/show/NCT01345409
The Healing Context in Complementary and Alternative Medicine (CAM): Instrument Development and Initial Validation Observational: Cross-sectional, ecologic or community study NCT01266304
Community Members Regardless of Medical Conditions.
Rec 72 Adt Sen
Jan-11 Aug-15 University of Pittsburgh
http://ClinicalTrials.gov/show/NCT01266304
A Study of Genetic Variation Influencing Pain and Response to Opioid Medications in Patients With Chronic Pain Observational: Prospective cohort study NCT01293994
Pain Invite 500 Adt Sen
Feb-09 Dec-12 Stanford University
http://ClinicalTrials.gov/show/NCT01293994
A11: PAIN
Title Phases: study design (control) NCT ID
Interventions Conditions Recruit n Age Grp
Start Date
End Date
Sponsors URL
Behavioural, education & exercise incl. physiotherapy & manual therapy Neurofeedback and Pain Observational: Prospective cohort study NCT01278225
EEG biofeedback; Wait-List
Pain; Peripheral Neuropathy
Rec 72 Adt Sen
Feb-11 Mar-14 M.D. Anderson Cancer Center
http://ClinicalTrials.gov/show/NCT01278225
Soccer and Zumba as health promoting activities among Norwegian hospital employees Cluster RCT ISRCTN61986892
Soccer; Zumba General health condition, including musculoskeletal pain
Ongoing 115 Adt Jan-11 Dec-11 Nordland Hospital Bodø (Norway)
http://www.controlled-trials.com/ISRCTN61986892
42
Interdisciplinary Intervention Versus Brief Intervention for Patients With Musculoskeletal Pain RCT (active), efficacy study NCT01346423
Interdisciplinary intervention; Brief Intervention
Musculoskeletal Pain
Rec 300 Adt Mar-11 Jan-14 Sykehuset Innlandet HF; University of Bergen
http://ClinicalTrials.gov/show/NCT01346423
Device A Prospective Clinical Outcomes Registry Observational: prospective NCT01305525
St. Jude Medical Spinal Cord Stimulation Systems
Pain Rec 600 Adt Sen
Jun-09 ? May-11
Advanced Neuromodulation Systems
http://ClinicalTrials.gov/show/NCT01305525
Tolerability Study of the Application of a 3M Microstructure Transdermal System Phase I: RCT (placebo), safety study NCT01257763
Transdermal Microchannel Skin System; Sham device
Healthy Comp 54 Adt Sen
May-10 Apr-11 Northwestern University; 3M
http://ClinicalTrials.gov/show/NCT01257763
Dietary Supplements Effect of Vitamin D Supplementation on Muscular Strength, Musculoskeletal Pain and Headache Phase IV: RCT (placebo), efficacy study NCT01263288
Cholecalciferol; Placebo
Vitamin Deficiency
Rec 300 Adt Jan-11 Jan-13 University of Oslo; Norwegian School of Sport Sciences; Norwegian Institute of Public Health
http://ClinicalTrials.gov/show/NCT01263288
A Study to Determine if Aquamin Modulates Inflammatory Biomarkers in the Blood of Osteoarthritis and Healthy Subjects Phase II: RCT (active), bio-availability study NCT01321281
AquaCal; AquaPT OA Rec 36 Adt F-
only
Mar-11 Oct-11 University College Cork; Marigot Ltd.
http://ClinicalTrials.gov/show/NCT01321281
Drugs including biologics Non-cancer Pain and Cognitive Impairment: A Disabling Relationship RCT (active), safety/efficacy study NCT01264965
Long acting oxycodone; Extra strength acetaminophen
Arthritis; Pain; Cognitive Impairment
Not yet rec
155 Adt Sen
Jan-11 Aug-13 University of Chicago
http://ClinicalTrials.gov/show/NCT01264965
43
Study With Chondroitin Sulfate and Glucosamine Sulfate (in Dosage Capsule and Sachet) in Treating Osteoarthritis Phase III: RCT (active), safety/efficacy study NCT01293305
Chondroitin sulfate + Glucosamine sulfate; Chondroitin sulfate + Glucosamine sulphate
OA Not yet rec
320 Adt Sen
Nov-11 Dec-12 L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
http://ClinicalTrials.gov/show/NCT01293305
Surveillance Trial to Evaluate a Shortened Infusion Time of Intravenous Ibuprofen Phase IV: Single group assignment, safety/efficacy study NCT01334944
Intravenous ibuprofen
Pain; Fever Active, NR
150 Adt Sen
Apr-11 Jun-12 Cumberland Pharmaceuticals
http://ClinicalTrials.gov/show/NCT01334944
Conversion From Fast Acting Oral Opioids to Abstral® Phase IV: Single group assignment, efficacy study NCT01315886
SL Fentanyl Pain Rec 71 Adt Sen
Feb-11 Feb-12 Orexo AB http://ClinicalTrials.gov/show/NCT01315886
Hyaluronan in the Treatment of Painful Tendinopathy Single group assignment, safety/efficacy study NCT01290510
Hyaluronic acid sodium salt
Tendinopathy Rec 80 Adt Sen
Feb-11 Dec-11 TRB Chemedica AG
http://ClinicalTrials.gov/show/NCT01290510
Study of CG100649 Versus Celecoxib in Osteoarthritis Patients Phase II: RCT (active), safety/efficacy study NCT01341405
CG100649; Celecoxib
OA Rec 132 Adt Sen
Apr-11 Nov-11 CrystalGenomics, Inc.
http://ClinicalTrials.gov/show/NCT01341405
Analgesic and Antihyperalgesic Effects of Morphine and Buprenorphine RCT (active), pharmacokinetics study NCT01296334
Morphine; Buprenorphine; saline
Pain Active, NR
34 Adt Feb-11 Oct-11 University of Copenhagen; Norpharma A/S
http://ClinicalTrials.gov/show/NCT01296334
Study of Etoricoxib for the Treatment of Muscle Pain and Inflammation Induced by Eccentric Exercise Phase I: RCT (placebo) NCT01271348
Etoricoxib; placebo Muscle Pain Rec 50 Adt Sen
Jan-11 Oct-11 X-pert Med GmbH http://ClinicalTrials.gov/show/NCT01271348
44
A Safety and Efficacy Study of Oral Tapentadol Extended-release in Japanese Patients Phase III: RCT (active), safety/efficacy study NCT01309386
Morphine SR; Tapentadol
Pain; Analgesics; Neoplasms
Rec 100 Adt Sen
Aug-10 Jul-11 Janssen Pharmaceutical K.K.
http://ClinicalTrials.gov/show/NCT01309386
Analgesic Effect of Different Combinations of Dexketoprofen Trometamol With Tramadol Hydrochloride in a Model of Moderate to Severe Pain Phase II: RCT (placebo), safety/efficacy study NCT01307020
Dexketoprofen Trometamol; Tramadol Hydrochloride; Ibuprofen; Placebo
Pain Rec 600 Adt Sen
Feb-11 Jun-11 Menarini Group; PRA International
http://ClinicalTrials.gov/show/NCT01307020
A Study to Test Bioequivalence Between One Test Formulation of Ibuprofen and Two Reference Treatments Phase I: RCT (active), bio-equivalence study NCT01316978
Ibuprofen Pain Comp 30 Adt Feb-11 Mar-11 Johnson & Johnson Consumer & Personal Products Worldwide
http://ClinicalTrials.gov/show/NCT01316978
A Single Dose Escalation Study In Healthy Volunteers To Determine The Pharmacokinetics, Safety And Tolerability Of PF-05089771 In Healthy Volunteers. Phase I: RCT (active), safety study NCT01259882
PF-05089771 Pain Rec 32 Adt Dec-10 Mar-11 Pfizer http://ClinicalTrials.gov/show/NCT01259882
Efficacy of Buprenorphine for Treatment of Acute Pain Phase IV: RCT (active), safety/efficacy study NCT01298297
Buprenorphine; Morphine
Acute Pain Rec 80 Child Adt Sen
Feb-10 Mar-11 Tehran University of Medical Sciences
http://ClinicalTrials.gov/show/NCT01298297
A multi center, randomized, single blind study to evaluate the efficacy and safety of K-103-PA compared with indomethacin patch in the treatment of soft tissue pain Phase III: RCT (active), safety/efficacy study JapicCTI-101254
K-103-PA; ? Soft tissue pain Comp 340 Adt Sen
Sep-10 May-11 Kowa Co., Ltd. http://www.clinicaltrials.jp/user/cteSearch_e.jsp
45
Oxytocin and Arginine Vasopressin in Pain Relief Controlled trial (placebo), efficacy study NCT01328561
Placebo Analgesia
Rec 60 Adt Mar-11 ? Jan-11
National Institute of Mental Health (NIMH)
http://ClinicalTrials.gov/show/NCT01328561
Other including CAM therapies Assessing the Feasibility of Integrating Ear Acupuncture Into the Aeromedical Evacuation System From RAB to AAFB Observational: Prospective cohort study NCT01278355
Ear acupuncture Musculoskeletal Pain
Rec 40 Adt Jan-11 ? Jan-11
Samueli Institute for Information Biology
http://ClinicalTrials.gov/show/NCT01278355
Miscellaneous observational studies Assessment of Pain Management in Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis Patients Who Are About to be Treated With Adalimumab Observational: Prospective cohort study NCT01273519
RA; Ankylosing Spondylitis; Psoriatic Arthritis
Rec 240 Adt Sen
Jan-11 Jan-13 Abbott; Raffeiner GmbH
http://ClinicalTrials.gov/show/NCT01273519
Finding Early Rheumatoid Arthritis Observational: Prospective cohort study NCT01341314
Joint Pain; Stiffness
Rec 200 Adt Sen
Jan-10 Jan-13 Brigham and Women's Hospital
http://ClinicalTrials.gov/show/NCT01341314
Pain Sensitivity in Acute Inflammatory Pain Single Group Assignment, basic science study NCT01345877
Healthy Volunteers Are Studied
Comp 100 Adt Feb-10 Feb-11 University of Copenhagen; Norpharma A/S
http://ClinicalTrials.gov/show/NCT01345877
46
B: RESEARCH RECOMMENDATIONS
Date published
Guideline Research recommendations (italicized recommendations have been taken verbatim from their respective publications)
June 2011 (Epub)
Ottawa panel evidence-based clinical practice guidelines for patient education programmes in the management of osteoarthritis (Brosseau & Ottawa panel members, 2011)
None
June 2011 How to explain central sensitization to patients with `unexplained' chronic musculoskeletal pain: Practice guidelines (Nijs et al, 2011)
None
June 2011 Ottawa Panel Evidence-Based Clinical Practice Guidelines for the Management of Osteoarthritis in Adults Who Are Obese or Overweight (Brosseau et al., 2011).
Research recommendations identified were:
• to examine other alternative therapies for weight reduction not included in review (which focused on diet and physical activity).
• to examine the differences in aerobic versus resistance training activity: this would help address more-specific activity prescriptions.
• to investigate how programs for managing OA in individuals with obesity can be optimized to ensure maximum benefits for various levels of knee OA disability.
May-June 2011
Practice guidelines for the management of low back pain (Guevara-López, et al., 2011)
None
May 2011 Joint Pain, Severe Cartilage Destruction, and Chondrolysis: Guidelines for Improving Diagnostic Differentiation and Clinical Management (SS-22) (Cole et al., 2011)
Unable to access full document
47
January 2011
Evidence-based clinical guidelines for the diagnosis, assesment and physiotherapy management of contacted (frozen) shoulder (Hanchard et al., 2011).
Future studies to:
• report interventions and comparators in sufficient detail to remove ambiguity;
• focus on a specific stage of contracted (frozen) shoulder e.g. ‘pain-predominant’ or ‘stiffness-predominant’, with pain taking primacy in ambiguous cases or to
• subgroup results by the condition’s stage.
• examine whether steroid injections are more efficacious in studies/subgroups of pain-predmoniant stage
• examine the efficacy of interventions in different care settings.
• consider conducting multi-centre trials to ensure sufficient sample sizes to allow precise effect to be calculated
• investigate physiotherapy modalities especially short wave diathermy, TENS, interferential and ultrasound, as part of therapeutic packages in care settings (rather than as standalone modalities).
December 2010
Health Care Guideline: Adult Low Back Pain (ICSI, 2010) None
December 2010
New guidelines for topical NSAIDs in the osteoarthritis treatment paradigm (Altman, 2010).
Unable to access full document
48
September 2010
Opioid Pharmacotherapy for Chronic Non-Cancer Pain in the United States: A Research Guideline for Developing an Evidence-Base (Chapman, et al., 2010).
There was recognition of the need for a strategic interdisciplinary approach with basic scientists and clinicians cooperating to resolve urgent issues and generate a comprehensive evidence base. Recommendations were suggested in 3 key areas:
• A research strategy for studying the effectiveness of long-term opioid pharmacotherapy • Improvements in evidence-generation methodology • Potential research topics for generating new evidence.
With regards to the effectiveness of opioids for chronic non-cancer pain two significant research gaps were identified:
1. the long-term benefit of opioid therapy 2. the incidence and severity of adverse drug events associated with opioid therapy
however, other research topics were also idenfied, including: • opioid induced hyperalgesia • opioid induced endocrine deficiencies • unexplained deaths • opioid pharmacotherapy and sleep • immunological impact of opioids • populations issues • opioid tolerance • benefits and risks of opioid rotation • interindividual variation in dose requirements • breakthrough pain • safe behaviours for patients using opioid medication • criteria for stable treatment effect and for treatment failure • combination opioid therapies and opioids combined with nonpharmacological interventions • clinical pharmacology of opioid medications
May/June 2010
Consensus guidelines for the selection and implantation of patients with noncancer pain for intrathecal drug delivery (Deer et al., 2010)
None
May 2010 Va/Dod Clinical Practice Guideline For Management Of Opioid Therapy For Chronic Pain (Clark et al., 2010)
“Future studies examining the results of clinical practice guidelines such as these may lead to the development of new practice-based evidence.” p.7
49
2010 American Osteopathic Association guidelines for osteopathic manipulative treatment (OMT) for patients with low back pain (AOA: Clinical Guideline Subcommittee on Low Back Pain, 2010)
None
January 2010
National guidelines for evaluating pain--Patients' legal right to prioritised health care at multidisciplinary pain clinics in Norway implemented 2009 (Hara & Borchgrevink, 2010)
None
January 2010
OARSI recommendations for the management of hip and knee osteoarthritis: part III: Changes in evidence following systematic cumulative update of research published through January 2009 (Zhang et al., 2010).
None
November 2009
Guidelines for the proper use of epidural steroid injections for the chronic pain patient (Deer et al., 2009)
“Further studies are needed to properly evaluate interlaminar ESIs [epidural steroid injections] in the treatment of spinal stenosis and axial back pain syndromes. All future studies investigating ESIs as well as all neuroaxial procedures should employ fluoroscopy as well as radiopaque contrast to confirm proper needle placement and prevent intravascular and intrathecal injections. All physicians performing these procedures should be properly trained in the use of multiplanar fluoroscopy.” p.293
November 2009
Health Care Guideline: Assessment and Management of Chronic Pain (ICSI, 2009).
None
July 2009 Pharmacological management of persistent pain in older persons (American Geriatrics Society Panel on Pharmacological Management of Persistent Pain in Older Persons, 2009).
“Many other agents for specific pain syndromes may require caution in older persons and merit further research (e.g., glucosamine, chondroitin, cannabinoids, botulinum toxin, alpha-2 adrenergic agonists, calcitonin, vitamin D, bisphosphonates, ketamine) (low quality of evidence, weak recommendation).” p.1343
Summer 2009; also 2011
Over-the-counter pain management guidelines (Whittaker, 2009; 2011)
None
March 2009 Utah Clinical Guidelines on Prescribing Opioids for Treatment of Pain (Utah Department of Health, 2009)
None
February 2009
Clinical Guidelines for the Use of Chronic Opioid Therapy in Chronic Noncancer Pain (Chou, Fanciullo et al., 2009)
“Critical research gaps are present in methods for providing informed consent, effective components of opioid management plans, balancing risks and benefits of high-dose opioid therapy, utility of opioid rotation, and treatment of breakthrough pain. More research is also needed on how policies that govern prescribing and use of COT [chronic opioid therapy] affect clinical outcomes.” p.124
50
February 2009
Research Gaps on Use of Opioids for Chronic Noncancer Pain: Findings From a Review of the Evidence for an American Pain Society and American Academy of Pain Medicine Clinical Practice Guideline (Chou, Ballantyne, et al., 2009)
“Critical research gaps on use of opioids for chronic noncancer pain include: lack of effectiveness studies on long-term benefits and harms of opioids (including drug abuse, addiction, and diversion); insufficient evidence to draw strong conclusions about optimal approaches to risk stratification, monitoring, or initiation and titration of opioid therapy; and lack of evidence on the utility of informed consent and opioid management plans, the utility of opioid rotation, the benefits and harms specific to methadone or higher doses of opioids, and treatment of patients with chronic noncancer pain at higher risk for drug abuse or misuse.” p.147 Specifically highlighted in the discussion is the need for studies to:
• determine effectiveness and long-term outcomes in less selective populations to evaluate benefits & harms.
• clarify optimal opioid dosing strategies • identify optimal approaches in initiating and titrating opioid rotation • determine if and how benefits and harms associated with methoadone or other specific
opioids differ • validate diagnostic accuracy of risk assessment and monitoring instruments across different
settings using standardised definitions of clinically aberrant drug related behaviours: and to establish whether these instruments improve outcomes.
• develop and validate instruments to assess potential benefits and opioid-related adverse effects alongside aberrant drug related behaviours.
• quantify risks associated high dose opioids • evaluate if high dose opioids are associated with different or unique harms compared to low
dose opioids • determine whether patient characteristics can predict lack of response to high dose opioids
other areas identified as ‘research gaps’ either were lacking evidence: • benefits and harms of opioid management plans • different methods of providing informed consent • driving and work-related risks in patients prescribed chronic opioid therapy
or had no current evidence base: • benefits and harms of chronic opioid therapy for chronic noncancer pain during pregnancy • how policies related to opioid prescribing affect outcomes
51
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