June 2010 - Arthritis Research UK

151 Pages·2010·1.95 MB·English

by  Nadia Corp

HORIZON SCANNING: MUSCULOSKELETAL PAIN DISORDERS
JUNE 2010

The object of these Horizon Scanning reports is to highlight recently completed and ongoing
clinical trials, research recommendations and new and emerging health technologies. After
feedback from pilot Horizon Scanning exercises and following consultation with the
Musculoskeletal pain disorders CSG lead, this first Horizon Scanning report only highlights ongoing
clinical trials or those completed during 2008/2009.

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: CLINICAL TRAILS 6
A1: Hand, Wrist, Finger & Thumb pain………………………………………………. 6
Behavioural, education & exercise including physiotherapy 6
Device 7
Drugs including biologics 8
Other including CAM therapies 12
Miscellaneous observational studies 13
A2: Elbow pain ……………………………………………………………………………….. 14
Behavioural, education & exercise including physiotherapy 14
Device 15
Drugs including biologics 16
Other including CAM therapies 17
A3: Shoulder pain ……………………………………………………………………………….. 19
Behavioural, education & exercise including physiotherapy 19
Device 22
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© Arthritis Research UK 2010
Drugs including biologics 23
Others including CAM therapies 26
Miscellaneous observational studies 29
A4: Neck pain ……………………………………………………………………………….. 29
Behavioural, education & exercise including physiotherapy 29
Device 32
Drugs including biologics 32
Other including CAM therapies 33
Miscellaneous observational studies 36
A5: Back pain…………………………………………………………………………………. 38
Behavioural, education & exercise including physiotherapy 38
Device 49
Drugs including biologics 52
Other including CAM therapies 70
Miscellaneous observational studies 83
A6: Hip pain ……………………………………………………………………………….. 87
Behavioural, education & exercise including physiotherapy 87
Drugs including biologics 87
Other including CAM therapies 87
Miscellaneous observational studies 88
A7: Knee pain ……………………………………………………………………………….. 88
Behavioural, education & exercise including physiotherapy 88
Drugs including biologics 89
Other including CAM therapies 90
Miscellaneous observational studies 91
A8: Foot, Ankle & Toe pain ………………………………………………………….. 92
Device 92
Drugs including biologics 94
Other including CAM therapies 96
Miscellaneous observational studies 97
A9: Fibromyalgia ……………………………………………………………………………….. 98
Behavioural, education & exercise including physiotherapy 98
Device 103
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Dietary Supplement 104
Drugs including biologics 105
Other including CAM therapies 114
Miscellaneous observational studies 116
A10: Chronic pain ………………………………………………………………………………. 118
Behavioural, education & exercise including physiotherapy 118
Device 122
Drugs including biologics 123
Other including CAM therapies 131
Miscellaneous observational studies 132
A11: Pain …….………..……………………………………………………………………………. 135
Behavioural, education & exercise including physiotherapy 135
Device 137
Dietry Supplement 138
Drugs including biologics 139
Other including CAM therapies 147
Miscellaneous observational studies 149

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.

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
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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: 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 completed or ongoing between May 2008 and May 2010.

RESULTS
Between May 2008 and May 2010, 792 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 = 41);
A2: Elbow pain (n = 27);
A3: Shoulder pain (n = 57);
A4: Neck pain (n = 50);
A5: Back pain (n = 310);
A6: Hip pain (n = 7);
A7: Knee pain (n = 17);
A8: Foot, Ankle and Toe pain (n = 33);
A9: Fibromyalgia (n = 126)
A10: Chronic pain (n = 112);
A11: Pain (n = 98);

For clarity each section is subdivided according to type of intervention: behavioural, device,
dietary supplement, drug, other, 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).

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ABBREVIATIONS
Adt Adult (18-65 years)
CAM Complementary and Alternative Medicine
CBT Cognitive Behavioural Therapy/Treatment
Child Child (<18 years)
Comp Completed
CT ID Clinical Trials Identifier
Expand Expanded Access Available
F-only Female only
Grps Groups
Hosp Hospital
Invite Invite only
M-only Male only
MSK Musculoskeletal
n Enrollement
N/K Not known
NR Not recruiting
OA Osteoarthritis
RA Rheumatoid arthritis
Rec Recruiting
Recruit Recruitment
Sen Senior (>65 years)
Susp Suspended.
Term Terminated
Uni. University
Wtdwn Withdrawn
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CLINICAL TRIALS
Clinical trials identity number (CT ID): Prefix of NCT denotes National Clinical Trials Identifier and ISRCTN an 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. 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 Interventions Conditions Recruit n Age Start End Sponsors URL
Phases: study design (control) Grp Date Date
CT ID
Behavioural, education & exercise including physiotherapy
SARAH: Stretching and Standard care + RA, Hand; RA, Active 480 Adt Nov-08 Apr-12 University of Warwick http://www.controlled-
Strengthening for Rheumatoid optimized exercise; Wrist Sen trials.com/ISRCTN89936343
Arthritis of the Hand: The clinical and Standard care
cost effectiveness of an exercise
programme over and above usual
care
RCT
ISRCTN89936343
Randomised and controlled study of Ergonomic Work-related Active 60 Aadt Aug-10 Apr-11 Federal University of http://www.controlled-
the effect of ergonomics orientation orientation + motor upper Juiz de Fora, Brazil trials.com/ISRCTN28200443
and motor control exercises in control training; extremity
patients with WRUED ergonomics disorders
RCT (active) orientation Nb: exclusion
ISRCTN28200443 of diagnosed
fibromyalia or
rheumatic
disease
The efficacy of a multidisciplinary Multidisciplinary Hand OA Active 150 N/K Jan-08 Jan-11 Dutch Arthritis http://www.trialregister.nl/trialreg/admin/rctvi
treatment program in patients with treatment program; Association ew.asp?TC=1191
osteoarthritis of the hands. Education +
RCT (active) instruction about
NTR1191 exercises
6
Effectiveness of Occupational Psycho-educational Rheumatoid Comp 54 Adt Jul-06 Sep-09 University of Zurich; http://ClinicalTrials.gov/show/NCT00400868
Therapy in Patients With Rheumatoid Joint protection Arthritis Sen Zürcher
Arthritis (RCT) education Rheumastifung;
RCT (active), Efficacy Study Gertrude und
NCT00400868 Wolfgang Schrader-
Dislich Stiftung;
Swiss Ligue Against
Rheumatism, Zurich,
Switzerland
Self-management, joint protection Joint protection Hand OA Comp 252 Adt Jun-06 May- Keele University http://www.controlled-
education and exercise in hand principles + usual Sen 08 trials.com/ISRCTN33870549/ISRCTN33870
osteoarthritis: a randomised care; Hand 549
controlled trial in the community exercises + usual
RCT care; Joint
ISRCTN33870549 protection + hand
exercises + usual
care; Usual care

Device
Efficacy of the Interferential Laser Interferential Laser Carpal Tunnel Rec 106 Adt Feb-10 Mar-11 Hospital Universitario http://ClinicalTrials.gov/show/NCT01093209
Therapy in Pain Reduction in Carpal Therapy Syndrome; Sen Ramon y Cajal
Tunnel Syndrome Neuropathic
Phase II: RCT (active), Efficacy Pain
Study
NCT01093209
Effect of orthoses in hand Orthosis; Exercise Carpo- Active 60 Adt Nov-08 Dec-10 Diakonhjemmet http://www.controlled-
osteoarthritis metacarpal Sen Hospital, Norway trials.com/ISRCTN40357804
RCT joint OA
ISRCTN40357804
Effect of Celliant Materials on Pain Celliant garment; Chronic Wrist Not yet 80 Adt Dec-09 Dec-10 Southern California http://ClinicalTrials.gov/show/NCT00688220
and Blood Oxygenation in Subjects Placebo celliant Pain; Chronic Rec Sen Institute for Research
With Chronic Elbow and Wrist Pain garment Elbow Pain and Education;
Prospective, Case Control Study Hologenix, LLC
NCT00688220
A Clinical Trial of Splinting for Full time splint DeQuervain's Rec 80 Adt Dec-05 Dec-10 Massachusetts http://ClinicalTrials.gov/show/NCT00438191
DeQuervain's Tenosynovitis wear; As needed Tenosynovitis Sen General Hospital
Prospective, Cohort Study splint wear
NCT00438191
7
CMC Arthritis - Neoprene Vs. Neoprene splint; Carpo- Rec 70 Adt Dec-05 Dec-10 Massachusetts http://ClinicalTrials.gov/show/NCT00438763
Thermoplast Short Opponens Thermoplast splint metacarpal Sen General Hospital
Splinting Thumb Arthritis
Prospective, Cohort Study
NCT00438763
Effect of Assistive Technology in Assistive Hand OA Comp 70 Adt Apr-08 Dec-09 Diakonhjemmet http://www.controlled-
patients with Hand OsteoArthritis: A technology + Sen Hospital, Norway trials.com/ISRCTN61534918
randomised, controlled trial education;
RCT education
ISRCTN61534918
CMC (Carpometacarpal) OA Comfort Cool thumb Osteoarthritis, Rec 48 Adt Apr-08 Dec-09 University of British http://ClinicalTrials.gov/show/NCT00705146
(Osteoarthritis) Thumb Splint Study splint by North Carpo- Sen Columbia; Vancouver
Phase II: RCT (active), Efficacy Coast Medical; metacarpal Foundation
Study Custom made
NCT00705146 thermoplastic &
neoprene splint

Drugs including biologics
Botulism Toxin Injection as a Botulinum Toxin Basilar Joint Not yet 45 Adt Jan-10 Nov-13 University of http://ClinicalTrials.gov/show/NCT01045694
Treatment for Arthritis of the Basal Type A; Arthritis; Basal Rec Sen Missouri-Columbia
Thumb Joint Triamcinolone Thumb Joint
Phase IV: RCT (placebo), Acetonide; Arthritis;
Safety/Efficacy Study Lidocaine Trapeziometa-
NCT01045694 carpal Arthritis;
Carpometa-
carpal Arthritis
Erosive Osteoarthritis of the Hands: Methotrexate; Polyarthritis Not yet 64 Adt Mar-10 Mar-12 Centre Hospitalier http://ClinicalTrials.gov/show/NCT01068405
Treatment by Methotrexate Versus Placebo Rec Sen Universitaire de Nice
Placebo
Phase III: RCT (placebo), Efficacy
Study
NCT01068405
Comparison of oral prednisolone and Prednisolone; Gouty arthritis Active 400 Adt Jan-10 Dec-11 Health, Welfare and http://www.controlled-
oral indometacin in the treatment of Indometacin Sen Food Bureau, Hong trials.com/ISRCTN45724113
acute gout-like arthritis: a multicentre Kong
double-blind randomised trial
RCT
ISRCTN45724113
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A double blind, randomised, placebo Symptomatic Early arthritis Active 200 Adt Sep-07 Sep-11 Medical Unviersity of http://www.controlled-
controlled, multicentre trial of Anti- therapy + (hand or foot Sen Vienna, Austria trials.com/ISRCTN21272423
Tumour Necrotising Factor alpha methotrexate + involvement)
(Anti-TNFα) chimeric monoclonal infliximab;
antibody (infliximab, Remicade®) in Symtomatic therapy
combination with methotrexate in + methotrexate +
patients with very early inflammatory placebo;
arthritis Symptomatic
RCT therapy + placebo
ISRCTN21272423
Prolotherapy Versus Steroids for Prolotherapy (10% Thumb Carpo- Rec 40 Adt May-08 Jul-11 Mayo Clinic http://ClinicalTrials.gov/show/NCT00685880
Thumb Carpo-metacarpal Joint dextrose solution); metacarpal Sen
Arthritis Corticosteroid Joint
RCT (active), Safety/Efficacy Study solution Osteoarthritis
NCT00685880
The efficacy of Trigger Finger Tramcinolone Trigger finger Active 490 Adt Jan-08 Jan-11 University Medical http://www.trialregister.nl/trialreg/admin/rctvi
treatment: a randomised, controlled, acetonide A-10; Sen Centre Utrecht ew.asp?TC=1135
prospective clinical multicenter trial. „open‟ surgery
RCT (active)
NTR1135
Brain Imaging To Examine The Effect Naproxen; Placebo Osteoarthritis Not yet 24 Adt May-10 Dec-10 Pfizer; King's College http://ClinicalTrials.gov/show/NCT00830050
Of Naproxen In Hand Osteoarthritis Rec Sen London
Patients
Randomized, Crossover F-
Assignment, Pharmacodynamics only
Study
NCT00830050
Efficacy Study of an Anti-Tumor Adalimumab Hand Active, 84 Adt Jan-08 Dec-10 Assistance Publique http://ClinicalTrials.gov/show/NCT00597623
Necrosis Factor (TNF) Alpha Agent in (Humira®); Placebo Osteoarthritis NR Sen Hôpitaux de Paris;
Patients With Hand Osteoarthritis Abbott
Phase III: RCT (placebo), Efficacy
Study
NCT00597623
Corticosteroid Injection for Common Dexamethasone Lateral Elbow Rec 213 Adt Apr-03 Oct-10 Massachusetts http://ClinicalTrials.gov/show/NCT00438672
Upper Extremity Problems Injection; Placebo Pain; Sen General Hospital
RCT (placebo), Efficacy Study Injection deQuervain's
NCT00438672 Tendonitis;
CMC Arthritis
9
A Study of Hyaluronan for the Synvisc (Hylan G- Osteoarthritis Rec 213 Adt Aug-06 Aug-10 Hospital for Special http://ClinicalTrials.gov/show/NCT00398866
Treatment of Osteoarthritis in the F20; hyaluronan Sen Surgery, New York;
Thumb injection); Genzyme
Phase III: RCT Bupivicaine (local
NCT00398866 anesthesia
injection); Kenalog
(triamcinolone;
corticosteroid
injection)
Open-Label Study Evaluating Synera (lidocaine Carpal Tunnel Active, 20 Adt Sep-09 Apr-10 ZARS Pharma Inc. http://ClinicalTrials.gov/show/NCT00991068
Synera® in the Treatment of Patients 70 mg and Syndrome NR Sen
With Carpal Tunnel Syndrome tetracaine 70 mg)
Phase II: Single Group topical patch
Assignment, Safety/Efficacy Study
NCT00991068
Study Comparing One Versus Two One cortisone Stenosing Rec 392 Adt May-09 ? Rothman Institute http://ClinicalTrials.gov/show/NCT00951236
Cortisone Injections for Trigger Finger injection; Two Tenosynovitis; Sen Mar-10 Orthopaedics
Parallel Assignment , Efficacy cortisone Injections Trigger Finger
Study
NCT00951236
A randomized, double blind, placebo- Etanercept 50mg; OA; Erosive Active 90 Adt Mar-08 Mar-10 Leiden University http://www.trialregister.nl/trialreg/admin/rctvi
controlled trial to evaluate the clinical Etanercept 25mg inflammatory Sen Medical Center ew.asp?TC=1192
efficacy and the structure modifying hand
properties of etanercept 50/25 mg sc
weekly in patients with erosive OA of
the interphalangeal finger joints.
RCT (placebo)
NTR1192
Safety and Efficacy of Lidoderm Lidocaine patch 5% Carpal Tunnel Term 310 Adt Nov-05 ? Endo http://ClinicalTrials.gov/show/NCT00266214
(Lidocaine Patch 5%) in Treating Syndrome Sen Feb-10 Pharmaceuticals
Moderate to Severe Pain Associated
With Carpal Tunnel Syndrome
Phase III: RCT (placebo),
Safety/Efficacy Study
NCT00266214
Efficacy Study of Condrosulf in the Chondroitin 4&6 Osteoarthrosis Active, 160 Adt Jun-05 Jan-10 IBSA Institut http://ClinicalTrials.gov/show/NCT00291499
Treatment of Symptomatic OA of the sulfate (Condrosulf); NR Sen Biochimique SA
Hand Placebo
Phase IV: RCT (placebo),
Safety/Efficacy Study
NCT00291499
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