HORIZON SCANNING MUSCULOSKELETAL PAIN ......Effectiveness of ultrasound imaging in general practice: Optimising the management of patients with non-chronic shoulder complaints. Maastricht

1

© Arthritis Research UK 2010

HORIZON SCANNING: MUSCULOSKELETAL PAIN DISORDERS

UPDATE - DECEMBER 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. This follow up report includes trials registered since June 2009 together with research recommendations for guidelines published since 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

Device 6

Drugs including biologics 7

Other including CAM therapies 8

A2: Elbow pain ……………………………………………………………………………….. 8

Device 8


A3: Shoulder pain ……………………………………………………………………………….. 9


Device 10


Others including CAM therapies 11

2

A4: Neck pain ……………………………………………………………………………….. 12


Device 13



A5: Back pain…………………………………………………………………………………. 15


Device 19



Miscellaneous observational studies 23

A6: Hip pain ……………………………………………………………………………….. 26



A7: Knee pain ……………………………………………………………………………….. 26




A8: Foot, Ankle & Toe pain ………………………………………………………….. 28


Device 29




A9: Fibromyalgia ……………………………………………………………………………….. 31


Device 32




A10: Chronic pain ………………………………………………………………………………. 36


Device 37

3




A11: Pain …….………..……………………………..……………………………………. 42


Device 42

Dietry Supplement 42




B: Research Recommendations 48

REFERENCES 54

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

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

4

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 May 2008.

RESULTS

A: Clinical Trials

Since July 2010, 217 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 = 11); A4: Neck pain (n = 15); A5: Back pain (n = 63); A6: Hip pain (n = 2); A7: Knee pain (n = 5); A8: Foot, Ankle and Toe pain (n = 15); A9: Fibromyalgia (n = 27) A10: Chronic pain (n = 29); A11: Pain (n = 36);

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 (2008-2010 inclusive) 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.

5

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 MSK Musculoskeletal n Enrollement N/K Not known OA Osteoarthritis RA Rheumatoid arthritis Rec Rec Recruit Recruitment Sen Senior (>65 years) Susp Suspended. Term Terminated Wtdwn Withdrawn

6

A: 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 Phases: study design (control) CT ID

Interventions Conditions Recruit n Age Grp

Start Date

End Date

Sponsors URL

Behavioural, education & exercise including physiotherapy

The MUST Hand OA Exercise Trial Randomized, parallel assignment NCT01245842

Hand exercise program

Hand OA Not yet Rec

150 Adt Sen

Jan-11 Aug-12 Diakonhjemmet Sykehus; Norwegian Fund for Postgraduate Training in Physiotherapy

http://ClinicalTrials.gov/show/NCT01245842

Vibration Training and Muscle Strength Development RCT (active), efficacy study NCT01139606

Vibration resistance training

Muscle Strength; Disabilities of the Arm, Shoulder and Hand

Not yet Rec

60 Adt Jun-10 Nov-10 Wingate Institute http://ClinicalTrials.gov/show/NCT01139606

Device

Dupuytren's Disease and Extracorporeal Shockwave Therapy (DupuyShock-2010) Phase II: RCT (placebo), efficacy study NCT01184586

ESWT Storz Duolith [0.35mJ/mm2]; SHAM-ESWT Storz Duolith [0.01mJ/mm2]

Dupuytren Contracture

Not yet Rec

60 Adt Sen

Nov-10 Jan-12 Hannover Medical School


Pharmacological Treatment in Osteoarthritis. RCT (placebo) NTR2378

Hydroxychloroquine sulphate; placebo

Hand OA Active 200 Adt Sen

Jul-10 Dec-11 Maasstad zeikenhuis (Netherlands)

http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2378

http://clinicaltrials.gov/show/NCT01245842





7

Efficacy of Telerehabilitation Intervention Program Using Telebiofeedback Among Computer Operators Non-randomized, parallel assignment, efficacy study NCT01178983

Surface electromyography

Work Related Musculo-skeletal Disorders, upper limb

Not yet Rec

50 Adt Aug-10 Oct-11 Sheba Medical Center


Drugs including biologics

Treatment Of Dupuytren's Contracture With Collagenase Clostridium Histolyticum Injection (Xiapex) Phase III: Single group assignment, efficacy study NCT01229436

Xiapex Dupuytren's Contracture

Not yet Rec

250 Adt Sen

Nov-10 Oct-12 Pfizer http://ClinicalTrials.gov/show/NCT01229436

Pharmacological Treatment In Osteoarthritis Phase III: Non-randomized, parallel assignment, efficacy study NCT01148043

Cellulose; Hydroxy-chloroquine

OA Rec 200 Adt Sen

Jul-10 Jun-12 Maasstad Hospital http://ClinicalTrials.gov/show/NCT01148043

Efficacy Study of Apremilast (CC-10004) in Subjects With Erosive Hand Osteoarthritis Phase II: RCT (placebo), efficacy study NCT01200472

Apremilast; Placebo Erosive OA of the Hand

Rec 30 Adt Sen

Aug-10 Dec-11 University of Erlangen-Nürnberg Medical School; Celgene Corporation


Botulinum Toxin in the Treatment of Raynaud's RCT (placebo), efficacy study NCT01233999

Botulinum toxin A Raynaud's Syndrome

Rec 6 Adt Sen

Oct-10 Oct-11 Emory University http://ClinicalTrials.gov/show/NCT01233999

Chondroitin Sulphate Treatment Efficacy in Rhizarthrosis. Phase IV: RCT (placebo) NCT01233739

Chondroitin sulfate; Placebo

Rhizarthrosis Not yet Rec

108 Adt Sen

? ? Oct-10

Hospital Clinic of Barcelona








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 study ACTRN12610001045000

AA4500 0.58 mg Dupuytren’s contractures

Not yet rec

12 Adt Sen

Dec-10 > Mar-11

Auxilium Phamaceuticals, Inc; Novotech Pty Ltd

http://www.anzctr.org.au/trial_view.aspx?ID=336238

Other including CAM therapies

Outcome Measures in Surgical and Non-Surgical Management of Trapeziometacarpal Osteoarthritis: A Systematic Literature Review.

Surgery; Any non-surgical intervention

Trapezio-metacarpal OA

N/A N/A N/A Nov-10 Jan-11 Schulthess Klinik (Netherlands)


A2: ELBOW PAIN

Title Phases: trial design (control) CT ID


Start Date

End Date

Sponsors URL

Device




Not yet Rec








9


TENDOSHOCK-2010 Combination Therapy for Athletic Tendinopathies Phase II: Single group assignment, safety/efficacy study NCT01185951

Focused extracorporeal shock wave therapy + Topical NO; Polidocanol + Painful eccentric training in achilles tendinopathy OR for patella tendinopathy on 25° decline board OR for elbow tendinopathy using TheraBand FlexBar

Tendinopathy; Epicondylitis

Active, NR

114 Adt Sen

Jan-07 Dec-10 Hannover Medical School


A3: SHOULDER PAIN



Start Date

End Date

Sponsors URL


A Manual Physical Therapy Approach Versus Subacromial Corticosteroid Injection for Treatment of Shoulder Impingement Syndrome RCT (active), efficacy study NCT01190891

Manual Physical Therapy; Corticosteroid Injection

Shoulder Impingement Syndrome

Rec 75 Adt Sen

May-10 Jan-12 Madigan Army Medical Center; University of Puget Sound; Franklin Pierce University


An evaluation of a game for the rehabilitation of pain patients (Pilot Study). Prospective cohort study NTR2471

Playmacer game Chronic low back pain, chronic shoulder pain, chronic neck pain

Active 15 Adt Sen

Sep-10 Sep-11 Roessingh Research and Development b.v.






10

Work Place Adjusted Intelligent Physical Exercise Reducing Musculoskeletal Pain in Shoulder and Neck (VIMS) - Shoulder Function RCT (active), efficacy study NCT01205542

Behavioral: Training; Behavioral: Reference

Rehabilitation; Neck Pain; Shoulder Pain; Scapular Dyskinesis; Muscle Activation

Not yet Rec

50 Adt Sep-10 Jan-11 National Research Centre for the Working Environment, Denmark; University of Southern Denmark


Vibration Training and Muscle Strength Development RCT (active), efficacy study NCT01139606

Vibration resistance training

Muscle Strength; Disabilities of the Arm, Shoulder and Hand

Not yet Rec

60 Adt Jun-10 Nov-10 Wingate Institute http://ClinicalTrials.gov/show/NCT01139606

Device

Effectiveness of ultrasound imaging in general practice: Optimising the management of patients with non-chronic shoulder complaints. Maastricht Ultrasound Shoulder pain Trial Diagnosis: RCT (active), efficacy study NTR2403

Ultrasound used to tailor intervention; usual treatment

Chronic shoulder pain

Active 226 Adt Oct-10 Sep-13 CAPHRI; The Research Institute of the University Maastricht; University Hospital Maastricht





Not yet Rec




Comparative Analysis of Intra-articular Injection of Steroid and/or Sodium Hyaluronate in Adhesive Capsulitis Randomized, parallel assignment, efficacy study NCT01144533

Steroid; Sodium hyaluronate; Steroid + sodium hyaluronate

Adhesive Capsulitis of the Shoulder

Rec 60 Adt Sen

Jun-10 Dec-11 Seoul National University Hospital








11

MRX-7EAT Etodolac-Lidocaine Topical Patch in the Treatment of Tendonitis and Bursitis of the Shoulder Phase III: RCT (placebo), efficacy study NCT01161615

MRX-7EAT Acute Tendonitis; Bursitis

Rec 350 Child Adt Sen

Jul-10 Jun-11 IL Pharma Inc.; MEDRx Co., Ltd.


Treatment of the Rotator Cuff Disease With Platelet Rich Plasma Injection RCT (active), efficacy study NCT01123889

Platelet rich plasma injection; Corticosteroid injection

Subacromial Impingement Syndrome; Partial Thickness Rotator Cuff Tear

Rec 50 Adt Sen

May-10 May-11 Loma Linda University



The effect of cost information on patient outcomes RCT (active) ISRCTN84082441

Behavioural economics

Shoulder pain (about to undergo arthroscopy)

Active 180 Adt Sen

Jul-10 Jul-11 Imperial College London

http://www.controlled-trials.com/ISRCTN84082441

A Randomized, Placebo-Controlled Double-Blinded Comparative Clinical Trial of Five Over-The-Counter Non-pharmacological Topical Analgesics for Myofascial Pain: single session findings RCT (placebo), efficacy study ISRCTN54672559

Professional Therapy Muscle Care Roll-on; Professional Therapy Muscle Care Ointment; Bengay Ultra Strength Muscle Pain ointment; Icy Hot Extra Strength Cream; Biofreeze roll-on gel; Non-medicinal placebo cream

Myofascial Pain, Shoulder pain, Neck pain.

Comp 120 Child Adt Sen

Jul-09 Jul-09 Canadian Memorial Chiropractic College








12

A4: NECK PAIN



Start Date

End Date

Sponsors URL


Dosing Study of Massage for Neck Pain RCT (dose comparison), safety/efficacy study NCT01122836

Massage Chronic Neck Pain Not yet Rec

228 Adt Jun-10 Aug-12 Group Health Cooperative




Active 15 Adt Sen



The Effectiveness of a Mechanical Manual Therapy Device in the Treatment of Neck Pain Phase I/II: Randomized, parallel assignment, efficacy study NCT01168986

Pulstar Multiple Impulse Therapy; Exercise; Natural history

Neck Pain Rec 66 Adt Sep-09 Sep-11 University of Florida http://ClinicalTrials.gov/show/NCT01168986

Diffuse Noxious Inhibitory Controls (DNIC): Nociceptive Modulation and Interaction With Neurocognitive Performance in Chronic Pain Observational: Cross-sectional, case-crossover NCT01172795

Relaxation session; Neurocognitive test battery

Fibromyalgia; Whiplash; Chronic Pain

Rec 100 Adt Jul-10 Aug-11 Vrije Universiteit Brussel; Research Foundation Flanders (FWO)


Identify Patients With Neck Pain Likely to Benefit From Education and Exercise Single group assignment, efficacy study NCT01144884

Education and exercise

Neck Pain Rec 90 Adt Sen

Aug-09 Jun-11 University of Central Florida; Nova Southeastern University; Franklin Pierce University; Florida Hospital








13

Work Place Adjusted Intelligent Physical Exercise Reducing Musculoskeletal Pain in Shoulder and Neck (VIMS) - Shoulder Function RCT (active), efficacy study NCT01205542

Training; Reference

Rehabilitation; Neck Pain; Shoulder Pain; Scapular Dyskinesis; Muscle Activation

Not yet Rec

50 Adt Sep-10 Jan-11 National Research Centre for the Working Environment, Denmark; University of Southern Denmark


Effects of Hatha Yoga on Chronic Neck Pain Randomized, parallel assignment NCT01171274

Hatha Yoga; Information regarding exercises and behaviour

Neck Pain Active, NR

56 Adt Aug-10 Dec-10 Universität Duisburg-Essen


Effectiveness of mindfulness meditation for neck pain: a randomized controlled trial RCT (active), efficacy study DRKS00000460

Mindfulness meditation; exercise

Neck pain with co-existing stress

Susp 55 Adt Apr-10 > Jun-10

Abteilung für Naturheilkunde der Charité im Immanuel-Krankenhaus Berlin-Wannsee

http://www.drks.de/DRKS00000460

Device



Work Related Musculoskeletal Disorders, upper limb

Not yet Rec



Computerized Mobilization of the Cervical Spine Utilizing the Occiflex Device for the Treatment of Chronic Neck Pain Phase I/II: Single group assignment, safety/efficacy study NCT01216566

Occiflex Device Neck Pain Not yet Rec

10 Adt Dec-10 May-11 Hillel Yaffe Medical Center; Headway Ltd.







14


Efficacy of Topical Capsaicin on Chronic Neck Pain RCT (placebo), efficacy study NCT01200745

Capsaicin patch Chronic Neck Pain Not yet Rec

60 Adt Sep-10 Feb-11 Kyunghee University Medical Center



Effectiveness of Community-Based Physiotherapy Versus General Practice Phase I: RCT (active) NCT01172483

Promotion physical activity from primary care; General practice in primary care and education

Cardiovascular Risk; Chronic Disorders; Cardiorespiratory; Musculoskeletal; Neurologic; back pain, neck pain, fibromyalgia, OA lower limbs

Rec 100 Adt Dec-09 Aug-11 University of Malaga; Andaluz Health Service


The Effect of East-West Collaborative Medicine on Chronic Cervical Pain RCT (active), efficacy study NCT01205958

Acupuncture Chronic Neck Pain Rec 45 Adt Dec-09 Feb-11 Kyunghee University Medical Center


Effects of Gua Sha and Thermotherapy on Chronic Neck Pain RCT (active) NCT01233180

Gua Sha; Thermotherapy

Neck Pain Rec 50 Adt Sen

Sep-10 Jan-11 Universität Duisburg-Essen


A Randomized, Placebo-Controlled Double-Blinded Comparative Clinical Trial of Five Over-The-Counter Non-pharmacological Topical Analgesics for Myofascial Pain: single session findings RCT (placebo), efficacy study ISRCTN54672559

Professional Therapy Muscle Care Roll-on; Professional Therapy Muscle Care Ointment; Bengay Ultra Strength Muscle Pain ointment; Icy Hot Extra Strength Cream; Biofreeze roll-on gel; Non-medicinal placebo cream

Myofascial Pain, Shoulder pain, Neck pain.

Comp 120 Child Adt Sen

Jul-09 Jul-09 Canadian Memorial Chiropractic College








15

A5: BACK PAIN


Interventions Conditions

Recruit

n Age Grp

Start Date

End Date

Sponsors URL


ADAPT: Addressing Depression and Pain Together Phase IV: RCT (active), efficacy study NCT01124188

Problem Solving Therapy for Depression and Pain & higher-dose venlafaxine; Supportive management & higher-dose venlafaxine

Depression; Back Pain

Rec 250 Adt Sen

May-10 Mar-15 University of Pittsburgh


Chiropractic Manipulation and Medical Care for Low Back Pain RCT (active), efficacy study NCT01211613

Mechanically-assisted manipulation; Standard Medical Care

Low Back Pain Rec 105 Adt Sen

Nov-10 Nov-13 University of Pittsburgh; University of Western States


Low Back Study to Compare Traditional Physical Therapy With Combined Therapy Protocol RCT (active), efficacy study NCT01236092

Conservative therapy - traction, vibration, exercise

Radiculopathy; Low Back Pain

Not yet Rec

36 Adt Jan-11 Dec-12 Legend Healthcare http://ClinicalTrials.gov/show/NCT01236092

Dare to Move: Treatment of Movement Phobia in Patient With Low Back Pain Randomized, parallel assignment, efficacy study NCT01158339

CBGT-ISE; CBGT Low Back Pain Active, NR

120 Adt Jan-10 Dec-12 Norwegian University of Science and Technology; Levanger Hospital


Spinal Cord Evoked Potentials as a Tool to Investigate Sensorimotor Processing Observational: Prospective, cohort study NCT01208805

Recording spinal cord evoked potentials

Intractable Pain. Not yet Rec

10 Adt Sen

Nov-10 Jul-12 Universitaire Ziekenhuizen Leuven







16

Effects of Myofascial Release on Pain, Disability and Electromyography of Erector Spinae in Chronic Low Back Pain RCT (placebo), efficacy study NCT01241071

Myofascial treatment; Other: Placebo

Low Back Pain; Disability; Motor Activity; Range of Motion

Not yet Rec

60 Adt Jan-11 Jan-12 Cardenal Herrera University; Hospital Arnau de Vilanova


Effect of community-based fitness program for people with chronic disease on health outcomes: randomised controlled trial RCT (active), efficacy study ACTRN12610001035011

6 week health-service based exercise program followed with a community-based fitness program vs telephone-based follow up (usual care)

Cardiovascular disease; Diabetes; Arthritis; Chronic Low back pain

Active 114 Adt Sen

Nov-10 > Nov-11

Cranbourne Integrated Health Service, Victoria (Australia)




Active 15 Adt Sen



The Mechanisms of Manual Therapy in the Treatment of Low Back Pain Phase I/II: RCT (active), efficacy study NCT01168999

Spinal manipulation; Sham spinal manipulation; Natural history

Low Back Pain Rec 88 Adt Sep-09 Sep-11 University of Florida http://ClinicalTrials.gov/show/NCT01168999

Neural Dynamics Technique for the Treatment of Chronic Radicular Low Back Pain RCT (placebo), efficacy study NCT01145105

Neural dynamics techniques treatment; Placebo treatment

Low Back Pain; Sciatica

Not yet Rec

60 Adt Jul-10 Aug-11 Clalit Health Services















17

Trigger Point Therapy Versus Manipulation Correcting Thoracic Manipulable Lesion Phase II: RCT (active) NCT01123226

Spinal manipulation; Trigger point therapy

Spinal Manipulable Lesion; Somatic Dysfunction

Not yet Rec

60 Adt Sep-10 Jun-11 Anglo-European College of Chiropractic


A randomised controlled trial of a brief walking intervention RCT (active) ISRCTN95932902

Motivation and volition to walk intervention; Usual care (Information provision and pedometer)

Chronic conditions which benefit from physical activity including OA, osteoporosis, fibromyalgia, low back pain

Active N/K Adt Dec-09 May-11 Coventry University (UK)


Cost-effectiveness of an individual on line real-life computer-tailored physical activity and educational intervention at work-site to secondary prevention of non-specific sub acute or recurrent low back pain on office workers: "Look after your back" RCT (active) ISRCTN40949689

Individual real-life computer-tailored physical activity and educational intervention at work-site with/without an e-mail reminder

Non-specific low back pain

Active 100 Adt Jun-10 Feb-11 University of Extremadura (Spain)


The efficacy of the addition of the Pilates Method over a minimal intervention on disability, kinesiofobia, pain intensity and global-perceived effect in patients with chronic non-specific low back pain: A randomised controlled trial. RCT (active), efficacy study ACTRN12610000523000

Pilates (Mat version); Leaflet with information on back pain

Chronic non-specific low back pain

Not yet Rec

86 Adult Aug-10 > Feb-11

UNICID Universidade Cidade de Sao Paulo


The Effect of Mckenzie and Back School’s techniques in patients with chronic low back pain: A randomized controlled trial RCT (active), efficacy study ACTRN12610000435088

McKenzie technique; Back school classes

Chronic low back pain

Not yet Rec

148 Adt Sen

Jul-10 > Jan-11

UNICID University City of Sao Paulo











18

Influence of therapeutic alliance on function improvement in chronic nonspecific low back pain patients after eight weeks of lumbar stabilization program Single group assignment ACTRN12610000829011

Lumbar stabilization program

Low back pain Active 10 Adt Oct-10 > Dec-10

São Paulo State University


Evaluation of a work place directed intervention to enhance vocational prognosis among low back patients RCT (active) ISRCTN13071157

Interview and counselling with occupational practitioner; usual care (information or GP)

Low back pain Comp 300 Child Adt

Jan-07 Nov-09 Danish Research Fund for the Working Environment (Denmark)


Efficacy of Classification Based 'Cognitive Functional Therapy' in Patients With Non Specific Chronic Low Back Pain RCT (active) NCT01129817

Cognitive Functional Therapy; Manual therapy and exercise

Chronic Low Back Pain

Comp 121 Adt Mar-06 Nov-09 University of Bergen; Norwegian Fund for Postgraduate Training in Physiotherapy


Effectiveness of mindfulness meditation for low back pain: a randomized controlled trial RCT (active), efficacy study DRKS00000373

Mindfulness meditation; exercise

Low back pain Active NR

56 Adt Oct-09 > Oct-09

Else Kröner-Fresenius-Stiftung (Germany)


Lumbar Stabilization, Strengthening and Stretching in Chronic Low Back Pain Randomized, parallel assignment, efficacy study NCT01124201

Stabilization , strengthening and stretching


Comp 45 Adt Feb-07 Jun-09 University of Sao Paulo General Hospital; Fundação de Amparo à Pesquisa do Estado de São Paulo


A Pragmatic Randomised Controlled Trial of a Protocol of Evidence-Based Conservative Care Compared to Usual Chiropractic Care for Acute Non-Specific Low Back Pain – An Exploratory Pilot Randomised Controlled Trial RCT (active), efficacy study ACTRN12610000530022

Evidence-Based Conservative Chiropractic Care; Usual Chiropractic Care

Acute Non-Specific Low Back Pain

Comp 98 Adt Dec-08 > Jan-09

King's College London











19

Device

Study Of The Efficacy Of Neurolysis In Functional Recovery From Chronic Nonspecific Low Back Pain RCT (placebo), efficacy study NCT01190033

Neurotome OFF; neurolysis

Low Back Pain Rec 40 Adt Aug-10 Jul-13 University of Sao Paulo


Trial Comparing Treatment With

SInergy™ System to Conservative

Treatment for Chronic Sacroiliac Joint Pain Randomized, parallel assignment NCT01158092

Treatment with SInergy™ System; Other: Conservative Treatment

Chronic Sacroiliac Joint Pain

Rec 40 Adt Sen

Jul-10 Jul-12 Baylis Medical Company


Safety and Efficacy of MRgFUS for the Treatment of Low Back Pain Phase II: Single group assignment, safety/efficacy study NCT01232582

Exablate treatment

Lower Back Pain, Facets Joints OA

Rec 50 Adt Sen

Oct-09 Jun-12 InSightec http://ClinicalTrials.gov/show/NCT01232582

Radiofrequency Nerve Ablation Versus Sham to Treat Chronic Low Back Pain Caused by Sacroiliac Joint Dysfunction Observational: Prospective, case-crossover NCT01104051

Sacroiliac Joint Dysfunction

Rec 39 Adt Sen

Apr-10 Apr-12 Coastal Orthopedics & Sports Medicine




Work Related Musculoskeletal Disorders

Not yet Rec



Assess the Effectiveness of Pulse RadioFrequency in Patients With Chronic Lumbar Radicular Pain RCT (placebo), safety/efficacy study NCT01117870

Pulsed RadioFrequency; Placebo

Chronic; Back Pain

Rec 32 Adt Sen

Jul-10 Aug-11 McMaster University








20

Cognitive-Behavioral Physical Therapy Intervention Phase I/II: RCT (placebo), efficacy study NCT01131611

CBPT; Physical Therapy

Spinal Stenosis Active, NR

70 Adt Sen

May-10 Aug-11 Vanderbilt University


Comparison of a Multiple Thrust Instrument to a Single Thrust Instrument in Treating the Low Back Phase I; Phase II RCT (active), efficacy study NCT01180686

Activator IV single impulse instrument; Multiple thrust Impulse adjusting instrument

Low Back Pain Not yet Rec

40 Adt Sep-10 Mar-11 Anglo-European College of Chiropractic


The Outcome Effect of Shoe Lift for Individuals With Low Back Pain and Pronated Foot Due to Anatomical Leg Length Discrepancy Single group assignment NCT01187693

Shoe lift Low Back Pain; Flatfoot; Leg Length Inequality

Not yet Rec

60 Adt Aug-10 Mar-11 National Taiwan University Hospital


Investigation of Trunk Muscle Size and Function in Older Adts With Chronic Low Back Pain Parallel assignment NCT01221233

Neuromuscular Electrical Stimulation plus Lumbar Stabilization Exercises; Lumbar Stabilization Exercises

Low Back Pain Rec N/K Adt Sen

Oct-10 ? Oct-10

University of Delaware



Care Management for the Effective Use of Opioids Randomized, parallel assignment, efficacy study NCT01236521

Analgesic and co-analgesic therapy; Behavioral: Pain self-management/ coping skills treatment

Low Back Pain; Pain

Not yet Rec

450 Adt Sen

Jul-11 Jun-15 Department of Veterans Affairs


Involvement of Transverso-sacral- Neo- Articulations or of Transverso-iliac Articulations in Chronic Lumbago Phase IV: RCT (placebo), efficacy study NCT01206699

Corticoid (altim® 1.5 ml); physiological solution (1.5 ml)

Subjects Suffering of Lateralized Lumbago on Side of the Malformation (Neo-articulation)

Rec 60 Adt Sen

Sep-10 Sep-14 Nantes University Hospital








21

Lumbar Epidural Steroid Injections for Spinal Stenosis Multicenter Randomized, Controlled Trial (LESS Trial) Phase IV: RCT (active), efficacy study NCT01238536

Epidural steroid with local anesthetic injection; Epidural local anesthetic injection

Spinal Stenosis; Low Back Pain

Not yet Rec

400 Adt Sen

Feb-11 Sep-13 University of Washington; Kaiser Permanente; University of California, San Francisco; Henry Ford Hospital; Harvard Pilgrim Health Care; Harvard Vanguard Medical Associates


Intradiscal Methylene Blue Injection Treatment for Chronic Discogenic Low back pain. RCT (placebo), efficacy study NTR2547

Methylene blue + lidocaine hydrochloride; isotonic saline + lidocaine hydrochloride

Low back pain, intradiscal

Not yet Rec

63 Adt Feb-11 Jul-13 Maastricht University Medical Centre


Morphine Versus Morphine-promethazine Combination for Acute Low Back Pain Relief in the Adt Emergency Department Phase IV: RCT (active), safety/efficacy study NCT01129934

Morphine-Promethazine; morphine

Low Back Pain Not yet Rec

200 Adt May-10 Jan-13 Tel-Aviv Sourasky Medical Center


Study to Evaluate the Safety and Efficacy of CEP-37247 Administered by the Transforaminal Epidural Route for the Treatment of Patients With Lumbosacral Radicular Pain Associated With Disk Herniation Phase I/II: RCT (placebo) NCT01240876

CEP-37247; Placebo

Sciatica Not yet Rec

230 Adt Sen

Dec-10 Jul-12 Cephalon http://ClinicalTrials.gov/show/NCT01240876

Linking altered central pain processing and genetic polymorphism to drug efficacy in chronic low back pain Phase III: RCT (active), efficacy study NCT01179828

Oxycodone 15mg; Clobazam; Imipramine; Tolterodine

Low Back Pain Rec 150 Adt Sen

Jul-10 Jul-12 University Hospital Inselspital, Berne; CTU Bern, Clinical Trials Unit, Bern; University of Zurich; Aalborg University








22

Pharmacokinetics and Tolerability Study of Tapentadol for Postsurgical Pain in Children and Adolescents Phase II: Single group assignment, pharmacokinetics study NCT01134536

Tapentadol (OS) Oral Solution

Pain, Postoperative; Postoperative Pain

Not yet Rec

44 Child N/K Feb-12 Johnson & Johnson Pharmaceutical Research & Development, L.L.C.; GrÃ¼nenthal GmbH


Study to Evaluate the Efficacy and Safety of Hydrocodone Bitartrate Extended-Release Tablets (CEP-33237) for Relief of Moderate to Severe Pain in Patients With Osteoarthritis or Low Back Pain Who Require Opioid Treatment for an Extended Period of Time Phase III: RCT (placebo) NCT01240863

Hydrocodone; Placebo

Pain, Low back pain

Not yet Rec

470 Adt Sen

Nov-10 Jan-12 Cephalon http://ClinicalTrials.gov/show/NCT01240863

Pain Assessment and Quality of Life in Back Pain Patients: Role of Milnacipran Phase III: Single group assignment, safety/efficacy study NCT01221740

Milnacipran/ Savella

Back pain Rec 66 Adt Sen

Aug-10 Aug-11 Brigham and Women's Hospital; Forest Laboratories


Comparison of the Efficacy of Duloxetine With Placebo in Patients With Chronic Low Back Pain With a Radicular Component Phase IV: RCT (placebo), efficacy study NCT01166048

Duloxetine; Chronic Low Back Pain

Rec 70 Adt May-10 May-11 Medical University of Vienna


Tolerability study of Maxigesic in patients with Mild to Severe Pain Phase IV: RCT (dose comparison), safety study ACTRN12610000598088

Maxigesic (paracetamol and ibuprofen combination)

Acute pain; chronic pain including OA, RA, low back pain

Not yet Rec

600 Adt Sen

Oct-10 Jan-11 AFT Pharmaceuticals Ltd (New Zealand)


Prolotherapy versus placebo injections to improve pain and function in patients with form failure of load transfer of the sacroiliac joint Phase II/III: RCT (placebo) ACTRN12610000823077

Inejction of 1.0ml of 20% Dextrose in 0.5% Bupivicaine; Placebo – dry needle

Sacro-iliac joint dysfunction

Active 80 Adt Sen

Sep-10 > Dec-10

N/K http://www.anzctr.org.au/trial_view.aspx?ID=335978









23

Neuract® cream versus placebo in the relief of neuropathic lower back pain RCT (placebo), efficacy study ISRCTN38072382

Topical Neuract®; placebo

Lower back pain, neuropathic

Active 60 Adt Sen

Jun-10 Dec-10 Origin Biomed, Inc (Canada)


Efficacy and Safety of Extended Release Tramadol HCl/Acetaminophen for the Treatment of Chronic Low-back Pain Phase III: RCT (placebo), safety/efficacy study NCT01112267

Placebo; Tramadol HCl/acetaminophen Extended Release; Placebo

Low Back Pain Comp 222 Adt Sen

May-09 Oct-09 Janssen Korea, Ltd., Korea


A Pilot Trial of IV Pamidronate for Low Back Pain Phase I/II: RCT (placebo), safety/efficacy study NCT01210599

Pamidronate Chronic Low Back Pain

Comp 44 Adt Sen

Apr-04 Oct-09 Pappagallo, Marco, M.D.



An investigation of the screening properties of the Coping Strategies Questionnaire 24 (CSQ24) through a randomised trial methodology UKCRN ID 8654

Screening with Coping Strategies Questionnaire 24 (CSQ24)

Back pain categorisation

Active 300 Child Adt Sen

N/K Feb-13 Friarage Hospital, Northallerton

http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=8654

Study to the effectiveness of audio-visual aids for patients with a lumbar disc herniation. RCT NTR2333

Audio-visual aids; Webpage

Unilateral lumbosacralis radiculair syndrome

Active 300 Adt Sen

Jul-09 Jul-11 Leiden University Medical Center (LUMC)


Miscellaneous observational studies

Perceptions of sickness certification in back pain (v2): Health professionals' and employer representatives' perceptions of sickness certification in back pain UKCRN ID 8678

Back pain Active 36 Adt N/K Apr-11 Keele University (UK)












24

Non-Specific Chronic Back Pain; Insight From Spatial Aspects of Lumbar Spinal Muscle Activation Phase I: Observational: Prospective, case-control NCT01214213

Low Back Pain Invite 60 Adt Sep-09 Jan-12 Oslo University Hospital


Kinematical Evaluation of Lumbar Rotation in Chronic Low Back Pain Observational: Cross-sectional, case-control NCT01217554

Low Back Pain; Disability

Not yet Rec

50 Adt Nov-10 Dec-11 Clalit Health Services


Isolation and Authentication of Mesenchymal Stem Cell-like Progenitor Cells From the Degenerated Intervertebral Disc of Lumbar Spine Observational: Prospective, case-only NCT01213953

Lower Back Pain; Disc Degeneration

Active, NR

20 Adt Sen

Sep-10 Dec-11 Taipei Medical University WanFang Hospital


Extending Ultrasound Elastography to Manual Treatment Methods Observational: cohort study NCT01221155

Back Pain Rec 45 Adt Dec-07 ? Oct-10

Canadian Memorial Chiropractic College


Measuring the clinical validity of the nerve root sedimentation sign in magnetic resonance imaging for the diagnosis of lumbar spinal Stenosis Observational: retrospective, natural history ACTRN12610000567022

Suspected lumbar spinal stensosis

Active 220 Child Adt Sen

Aug-10 > Aug-10

Asklepios Klinikum Uckermark (Germany); The University of Sydney


CYP450 Pharmacokinetic DDIs Among Patients With Chronic Low Back Pain Taking Opioids Observational: Retrospective, case-control NCT01177241


Comp N/K Adt N/K ? Aug-10

NEMA Research, Inc.









25

Prevalence of Potential CYP450 Pharmacokinetic Incident Drug-Drug Interactions Among Chronic Low Back Pain Patients Taking Opioid Analgesics and Associated Economic Outcomes Observational: Retrospective, case-control NCT01177280



NEMA Research, Inc.


Exposure to Potential CYP450 Pharmacokinetic Drug-Drug Interactions Among Osteoarthritis Patients: Incremental Risk of Multiple Prescriptions Observational: Retrospective, case-control NCT01177254



NEMA Research, Inc.


Clinical assessment of patients with low back-related leg pain in primary care. A consensus study Cross-sectional UKCRN 8065

Low back pain with associated leg pain

Active 60 Adt Sen

N/K Aug-10 Keele University (UK)


The influence of 'significant others' on back pain disability: a qualitative pilot study UKCRN ID 9428

Back pain disability

Active NR

10 Adt Sen

N/K Jul-10 University of Huddersfield


Utility of the History and Physical Exam in the Emergency Department Observational: Prospective NCT01154517

Abdominal Pain; Back Pain; Dyspnea; Headache; Weakness

Comp 128 Adt Sen

Jul-09 Jun-10 Henry Ford Health System


Validation of two devices for time-linking TENS and pain report. V 1 UKCRN ID 9164

Chronic back pain Comp 40 Adt Sen

N/K May-10 University of Leicester











26

A6: HIP PAIN



Start Date

End Date

Sponsors URL


Effectiveness and Safety of Early Treatment With Infliximab for Hip Arthritis Associated With Ankylosing Spondylitis (P06451) Phase IV NCT01148901

Infliximab Hip arthritis; Ankylosing Spondylitis

Rec 70 Adt Sen

Jun-10 Sep-11 Schering-Plough; Hospital Reina Sofía de Córdoba; Hospital de Alta Resolución Puente Genil



Hip biomechanic in patients with femoroacetbular impingement Diagnostic, observational study DRKS00000338

Dynamic 4-D volume computed tomography & plain radiographs

Femoro-acetbular impingment

Active 100 Adt Sen

Feb-10 > Feb-10

Klinik für Orthopädie, CMSC Berlin (Germany)


A7: KNEE PAIN



Start Date

End Date

Sponsors URL


Individualising exercise for knee pain: developing an evidence-based impairment-targeted intervention Single group assignment ISRCTN61638364

Home-based impairment-targeted exercises

Knee pain Comp 80 Adt Sen

May-09 Feb-10 Keele University (UK)





27


Comparison between intraarticular ozone and placebo in the treatment of knee arthritis RCT (placebo), efficacy study ISRCTN55861167

Intraarticular ozone; Placebo

Knee arthritis Active 108 Adt Sen

Oct-10 Oct-12 Sao Paolo Medical School (Escola Paulista de Medicina) (Brazil)


Seronegative Oligoarthritis of the Knee Study (SOKS) Phase II: RCT (active), efficacy study NCT01216631

Methyl-prednisolone; Infliximab

Spondyl-arthropathies

Rec 30 Adt Sen

Sep-10 Sep-12 University of Leeds; Centocor, Inc.


Study Evaluating a Heated Lidocaine and Tetracaine Topical Patch in the Treatment of Patients With Patellar Tendinopathy Phase II: Single group assignment, safety/efficacy study NCT01111773

Heated Lidocaine and Tetracaine Patch

Patellar Tendinopathy

Rec 20 Adt Sen

Jun-10 Oct-10 ZARS Pharma Inc. http://ClinicalTrials.gov/show/NCT01111773


Ultrasound detected inflammation in knee joints Observational, crosssectional study UKCRN ID 9229

Knee OA; Knee pain

Active 200 Adt Sen

N/K Feb-12 University of Nottingham








28

A8: FOOT, ANKLE & TOE PAIN

Title Phases: study designs (control) CT ID

Interventions Conditions Recruit

n Age Grp

Start Date

End Date

Sponsors URL


Evaluation of the Arthritis Foundation Tai Chi Program RCT (active), efficacy study NCT01184924

Evaluation of the Arthritis Foundation Tai Chi Program

Arthritis Active, NR

358 Adt Sen

Sep-08 Aug-11 University of North Carolina, Chapel Hill; Arthritis Foundation


Eccentric Exercise for Chronic Mid-portion Achilles Tendinopathy Randomized, parallel assignment, efficacy study NCT01225497

Standard eccentric exercise; Experimental: Eccentric exercise

Achilles Tendon; Tendinopathy

Not yet Rec

52 Adt Sen

Nov-10 Feb-11 Queen Margaret University


Comparing Manipulation and Rehabilitation to Rehabilitation Only, in the Management of Chronic Ankle Instability Randomized, parallel assignemnt, safety/efficacy study NCT01196949

Manipulative and Rehabilitative Therapy; Rehabilitative Therapy

Chronic Ankle Instability

Rec 30 Adt Aug-10 Nov-10 Cleveland Chiropractic College; Durban University of Technology South Africa


The Effect of Manipulation on Dysfunction of the Talo-crural Joint RCT (placebo), efficacy study NCT01121952

Chiropractic (HVLA) manipulation

Biomechanical Lesions; Talo-crural Joint Dysfunction

Active, NR

19 Child Adt Sen

F-only

Nov-09 Apr-10 Scandinavian College of Chiropractic


Eccentric loading versus shock-wave therapy for insertional Achilles tendinopathy: a randomised controlled trial RCT (active), efficacy study ISRCTN87901404

Eccentric calf muscle training; Shock-wave therapy

Chronic recalcitrant insertional Achilles tendinopathy

Comp 150 Adt Sen

Jan-08 Dec-09 OrthoTrauma Evaluation Centre (Germany)








29

Device

A phase 1 study to evaluate the potential role of mesenchymal stem cells in the treatment of chronic refractory tendinopathy Phase 1: Non-randomized, dose comparison, safety study ACTRN12610000985088

Intratendon injection of mesenchymal stem cells

Chronic Refractory Tendinopathy; Achilles Tendinopathy

Not yet Rec

9 Adt Sen

Jun-11 Dec-11 MMRI (Australia) http://www.anzctr.org.au/trial_view.aspx?ID=336156

The Outcome Effect of Shoe Lift for Individuals With Low Back Pain and Pronated Foot Due to Anatomical Leg Length Discrepancy Single group assignment NCT01187693

Shoe lift Low Back Pain; Flatfoot; Leg Length Inequality

Not yet Rec

60 Adt Aug-10 Mar-11 National Taiwan University Hospital


Ankle Equinus Contracture Treated With Dynamic Splinting RCT (active), efficacy study NCT01238484

Dynasplint; Standard of care

Ankle Equinus; Ankle Contracture; Diabetes Mellitus

Rec 50 Adt Sen

Aug-10 Jan-11 Dynasplint Systems, Inc.


Pathological processes and candidate interventions in mechanically induced foot pain: a single centre randomised interventional screening and treatment trial RCT (active) ISRCTN77862746

Functional foot orthoses; Inert cushioning orthoses

Mechanical foot pain

Active 120 Adt Sen

May-09 Jan-11 University of Leeds (UK)


Drugs including biological

Treatment of Palmar Plantar Erythrodysesthesia (PPE) With Topical Sildenafil Phase I: RCT (placebo), safety/efficacy study NCT01219023

Sildenafil citrate Hand Foot Syndrome; Palmar Plantar Erythrodyses-thesia

Rec 30 Adt Sen

Jun-10 Sep-12 Duke University http://ClinicalTrials.gov/show/NCT01219023








30

Intralesional Autologous Platelet Rich Plasma Injection Compared to Corticosteroid Injection for the Treatment of Chronic Plantar Fasciitis. A Prospective, Randomised, Controlled Trial. RCT (active), efficacy study ACTRN12610000899044

Intralesional Autologous Platelet Rich Plasma Injection; Corticosteroid Injection

Plantar Fasciitis Not yet Rec

75 Adt Sen

Nov-10 > Jun-11

Flinders Medical Centre


Treatment of Plantar Fasciitis With Platelet Rich Plasma RCT (active), efficacy study NCT01127672

Platelet rich plasma; corticosteroid injection


50 Adt Sen

May-10 May-11 Loma Linda University



Effectiveness of dry needling for plantar heel pain (plantar fasciitis): a randomised controlled trial RCT (placebo), efficacy study ACTRN12610000611022

Dry needling; Sham dry needling

Plantar heel pain (plantar fasciitis)

Not yet Rec

80 Adt Sen

Oct-10 > Dec-10

La Trobe University http://www.anzctr.org.au/trial_view.aspx?ID=335736


Influence of fatigue on rearfoot motion, foot-loading and muscle activity in runners with Achilles tendinopathy DRKS00000406

Achilles tendinopathy

N/KJ 70 Adt Jul-10 > Jul-10

Universitäts-klinikum Münster (Germany)


Reliability of Functional Outcome Measures in Plantar Fascitis Patients Observational: Prospective, case-only NCT01145118


80 Adt Jul-10 Oct-11 Clalit Health Services







31

A9: FIBROMYALGIA


Interventions Conditions Recruit

n Age Grp

Start Date

End Date

Sponsors URL


Self-Directed Exercise Program for Adts With Arthritis Phase II: RCT (active), safety/efficacy study NCT01172327

Multicomponent exercise; Nutrition

Arthritis; OA; RA; Fibromyalgia

Rec 400 Adt Sen

Sep-09 Jul-12 University of South Carolina; Centers for Disease Control and Prevention


Diffuse Noxious Inhibitory Controls (DNIC): Nociceptive Modulation and Interaction With Neurocognitive Performance in Chronic Pain Cross-sectional, case-crossover NCT01172795





A randomised controlled trial of a brief walking intervention RCT (active) ISRCTN95932902

Motivation and volition to walk intervention; Usual care (Information provision and pedometer)

Chronic conditions which benefit from physical activity including OA, osteoporosis, fibromyalgia, low back pain

Active N/K Adt Dec-09 May-11 Coventry University (UK)


Peer Mentorship: An Intervention To Promote Effective Pain Self-Management In Adolescents Randomized, parallel assignment, efficacy study NCT01118988

Mentorship Irritable Bowel Syndrome (IBS); Functional Abdominal Pain; Fibromyalgia; Complex Regional Pain Syndrome (CRPS); Myofacial Pain; Chronic Daily Headaches; Migraine Headaches; Chronic Pain

Rec 56 Child Adt

Dec-09 Apr-11 University of California, Los Angeles







32

The Effects of Training and Relaxation on Fibromyalgia. Randomized, parallel assignment NCT01226784

Physcial activity Fibromyalgia Invite 240 Adt

F-only

Oct-10 Oct-10 Karolinska Institutet; Sahlgrenska University Hospital, Sweden; Linköpings University


Device

Treatment of Fibromyalgia Using Deep Shaped-Field Transcranial Magnetic Stimulation a Clinical Feasibility Study RCT (placebo), safety/efficacy study NCT01229852

DSF-rTMS; Sham DSF-rTMS

Fibromyalgia Rec 42 Adt Aug-10 May-11 NeoStim, Inc. http://ClinicalTrials.gov/show/NCT01229852

Does a three week treatment with microcurrents improve the functional level of people with fibromyalgia syndrome? RCT (placebo), efficacy study ISRCTN04459421

Microcurrent; placebo

Fibromyalgia Comp 44 Adt Sen

Mar-06 May-10 University Rovira i Virgili (Spain)


Effect of high voltage pulsed current stimulation on pain, quality of life, and electrical activity of the anterior temporal and masseter muscles in females with fibromyalgia, temporomandibular disorders and sleep disorders. RCT (placebo) ACTRN12610000517077

High Voltage Pulsate Stimulation; Placebo

Temporo-mandibular disorders; Fibromyalgia; Sleep disorders

N/K 50 Adt

F-only

Jan-10 > Jan-10

Piracicaba Dental School State University of Campinas (Brazil); Clinical Hospital of University of Sao Paulo;


The Clinical Effect of Low-Intensity Electromagnetic Field Neurostimulation in Fibromyalgia Syndrome Patients RCT (placebo), efficacy study NCT01180244

Noninvasive cortical electrical stimulation; Sham treatment

Fibromyalgia Comp 91 Adt Jan-02 Jul-08 McLaren Regional Medical Center; Kettering University







33


A Study of Duloxetine in Adolescents With Juvenile Primary Fibromyalgia Syndrome Phase III: RCT (placebo), safety/efficacy study NCT01237587

Duloxetine; Placebo

Fibromyalgia Not yet Rec

210 Child Feb-11 Apr-15 Eli Lilly and Company


Efficacy Trial of Oral Tetrahydrocannabinol in Patients With Fibromyalgia RCT (placebo), safety/efficacy study NCT01149018

Tetrahydrocannabinol; Placebo

Fibromyalgia Rec 80 Adt Sen

Jun-10 Oct-12 Hadassah Medical Organization; Hebrew University of Jerusalem


Pain Inhibition in Patients With Rheumatoid Arthritis and Central Sensitivity Syndromes RCT (placebo) NCT01154647

Citalopram; 1 ml 0.9 % NaCl

Fatigue Syndrome, Chronic; Fibromyalgia; Arthritis, Rheumatoid

Not yet Rec

70 Adt

F-only

Sep-10 Sep-12 Vrije Universiteit Brussel; Research Foundation Flanders (FWO); Universiteit Antwerpen; University Hospital, Antwerp; Artesis University College, Antwerp


Study of Fibromyalgia Treated With Milnacipran Phase IV: Non-randomized, parallel assignment, safety/efficacy study NCT01125423

Milnacipran; Procedure: Skin biopsy


F-only

May-10 May-12 Albany Medical College; Forest Laboratories


The Effects of Milnacipran on Sleep Disturbance in Fibromyalgia Phase IV: Randomized, crossover assignment, efficacy study NCT01234675

Milnacipran Sleep Disorders; Fibromyalgia; Sleep

Rec 20 Adt Sen

Nov-10 Mar-12 Cleveland Sleep Research Center; Forest Laboratories


A Study to Evaluate the Effects of Milnacipran on Pain Processing and Functional MRI in Patients With Fibromyalgia Phase IV: RCT (placebo) NCT01173055

Milnacipran, then placebo; Placebo, then milnacipran


F-only

Jun-10 Jan-12 University of Michigan; Forest Laboratories








34

Study to Assess Mechanisms in Peripheral Tissue Innervation for Fibromyalgia Non-randomized, parallel assignment, safety study NCT01127490

Duloxetine; Procedure: Skin biopsy

Fibromyalgia; Female

Rec 30 Adt Sen

F-only

May-10 Jul-12 Albany Medical College


Fixed Versus Flexible Dosing of Pregabalin in Patients With Fibromyalgia Phase IV: Randomized, parallel assignment, safety/efficacy study NCT01226667

Pregabalin Fibromyalgia Rec 172 Adt

F-only

Jul-10 Sep-11 Osteoporosis Medical Center, Beverly Hills, CA; Pfizer


L-Tyrosine Supplementation in Patients With Fibromyalgia RCT (placebo), safety/efficacy study NCT01219049

Tyrosine; Placebo Fibromyalgia Rec 30 Adt Sen

Jan-10 Jan-11 Mount Sinai School of Medicine


Lyrica (Pregabalin) Korean Post Marketing Surveillance Study Phase IV: Observational: Prospective, ecologic or community study NCT01220180

Pregabalin (Lyrica);

Epilepsy; Neuropathic Pain; Fibromyalgia; Post-market Surveillance

Invite 4500 Adt Sen

Jul-06 Jan-11 Pfizer http://ClinicalTrials.gov/show/NCT01220180


Effects of acupuncture on patients with fibromyalgia RCT (placebo), efficacy study ISRCTN60217348

Acupuncture; Sham acupuncture

Fibromyalgia Active 150 Adt Oct-10 Apr-13 Carlos III Institute of Health (Instituto de Salud Carlos III) (Spain)


Trial of Acupuncture in the Treatment of Fibromyalgia Randomized, parallel assignment, efficacy study NCT01189994

Acupuncture; Fibromyalgia; Diffuse Myofascial Pain Syndrome; Fibromyalgia-Fibromyositis Syndrome; Fibromyositis-Fibromyalgia Syndrome

Rec 60 Adt Sep-10 Dec-11 Santa Casa da Misericordia do Rio de Janeiro Hospital









35







Stimulating Self Management in Patients With Fibromyalgia Through Web-based Situational Feedback Randomized, parallel assignment, efficacy study NCT01236209

Webpage and situation feedback; Webpage

Fibromyalgia Active, NR

140 Adt Sen

F-only

Mar-09 Sep-12 Oslo University College; The Research Council of Norway; University of Oslo; St. Olavs Hospital


Peripheral Arterial Tonometry (PAT) Evaluation of Sleep in Fibromyalgia Observational: Prospective, case-control NCT01151163


100 Adt Sen

Jul-10 Jul-12 Tel-Aviv Sourasky Medical Center


Palpitations and Tachycardia in Fibromyalgia Syndrome Prospective NCT01147263

Evaluation of autonomic parameters

Fibromyalgia Syndrome

Not yet Rec

100 Adt Sen

Jul-10 Jun-12 Tel-Aviv Sourasky Medical Center


Immune Patterns in Pain Patients DSM-IV Observational: Prospective, cohort study NCT01106339

Somatoform Disorders; Fibromyalgia; Myofascial Pain Syndrome, Diffuse; Depression; Chronic Fatigue Syndrome

Rec 100 Adt Sen

Aug-07 Jul-11 University of Ulm; University Hospital Ulm


Prevalence of Fibromyalgia in Israel NCT01203865


1200 Adt Sen

Oct-10 Jun-11 Tel-Aviv Sourasky Medical Center; Pfizer








36

A10: CHRONIC PAIN



Start Date

End Date

Sponsors URL


Cognitive Behavioral Therapy for Arthritis Pain and Insomnia in Older Adults RCT (active), efficacy study NCT01142349

CBT for Pain and Insomnia; CBT for Pain; Osteoarthritis Education

Pain Dysfunction; Sleep Disturbance; OA

Rec 375 Adt Sen

Jan-09 Aug-13 University of Washington; Group Health Research Institute


A Cognitive-Behaviour Therapy (CBT) Self-Management Approach for Insomnia in Chronic Pain: A Randomized Control Trial RCT, efficacy study NCT01188460

Sleep diary; Self-help manual for insomnia

Insomnia; Chronic Pain

Rec 60 Adt Apr-10 Jul-12 Ottawa Hospital Research Institute; The Ottawa Hospital


Evaluation of the Arthritis Foundation Tai Chi Program RCT (active), efficacy study NCT01184924

Evaluation of the Arthritis Foundation Tai Chi Program

Arthritis Active, NR

358 Adt Sen

Sep-08 Aug-11 University of North Carolina, Chapel Hill; Arthritis Foundation


Diffuse Noxious Inhibitory Controls (DNIC): Nociceptive Modulation and Interaction With Neurocognitive Performance in Chronic Pain Observational: Cross-sectional, case-crossover study NCT01172795









37

Peer Mentorship: An Intervention To Promote Effective Pain Self-Management In Adolescents Randomized, Parallel Assignment, Efficacy study NCT01118988

Mentorship Irritable Bowel Syndrome; Functional Abdominal Pain; Fibromyalgia; Complex Regional Pain Syndrome; Myofacial Pain; Chronic Daily Headaches; Migraine Headaches; Chronic Pain

Rec 56 Child Adt

Dec-09 Apr-11 University of California, Los Angeles


Cognitive behavioural pain management programmes: impact on sleep quality in patients with chronic pain Wait-list controlled clinical trial ISRCTN74913595

CBT Pain Management Programme: Waiting list

Chronic non-malignant pain

Comp 50 Adt Sen

Feb-09 May-10 Pfizer Healthcare Ireland (PHI) (Ireland)


Device

Spinal Cord Evoked Potentials as a Tool to Investigate Sensorimotor Processing Observational: prospective cohort study NCT01208805

Recording spinal cord evoked potentials

Studying Spinal Cord Evoked Potentials in Patients With Intractable Pain.

Not yet Rec

10 Adt Sen

Nov-10 Jul-12 Universitaire Ziekenhuizen Leuven


Transcranial Direct Current Stimulation for Chronic Pain Relief RCT (placebo) NCT01220323

Direct current stimulation

Chronic Pain Patients

Not yet Rec

100 Adt Sen

Nov-10 Nov-11 Tel-Aviv Sourasky Medical Center


The Effect of Transcranial Direct Current Stimulation for Chronic Pain on Ophthalmologic Parameters Single group assignment NCT01226082

Transcranial Direct Current Stimulation

Chronic Pain Not yet Rec

30 Adt Sen

Nov-10 Nov-11 Tel-Aviv Sourasky Medical Center








38


Effectiveness, Safety, and Tolerability Study of Oxymorphone Immediate Release (IR) Oral Liquid in Opioid Tolerant Pediatric Subjects Phase III: Single group assignment, safety/efficacy study NCT01206907

Oxymorphone IR Chronic Pain Not yet Rec

24 Child Oct-10 Dec-13 Endo Pharmaceuticals


Study to Evaluate the Long-Term Safety of Hydrocodone Bitartrate Extended-Release Tablets (CEP-33237) in Patients Who Require Opioid Treatment for an Extended Period of Time Phase III: Single group assignment NCT01223365

Hydrocodone bitartrate extended-release tablets

Chronic Pain Rec 220 Adt Sen

Oct-10 Sep-13 Cephalon http://ClinicalTrials.gov/show/NCT01223365

Milnacipran for Treatment of Pain in Older Adults With Rheumatoid Arthritis Phase IV: Single group assignment, safety/efficacy study NCT01225991

Milnacipran Pain in RA in Older Adults

Not yet Rec

30 Adt Sen

Nov-10 Mar-13 University of California, Los Angeles; Forest Laboratories


Open-Label Trial Comparing Oxycodone Medications Phase IV: RCT (active), efficacy study NCT01162304

Extended Release Oxycodone; Immediate release oxycodone


Mar-10 Dec-12 University of Rochester


Conversion to Embeda With Rescue Trial Phase IV: Single group assignment NCT01179191

Morphine sulfate and naltrexone hydrochloride

Pain; Chronic Disease

Rec 1300 Adt Sen

Aug-10 Jan-12 Alpharma Pharmaceuticals LLC, a subsidiary of King Pharmaceuticals, Inc.


Long-Term Study of Hydrocodone Bitartrate Controlled-release Capsules in Subjects With Chronic Pain Phase III: Single group assignment, safety study NCT01115569

Hydrocodone bitartrate


May-10 Dec-11 Zogenix, Inc. http://ClinicalTrials.gov/show/NCT01115569







39

A Double-blind, Randomised, Placebo-controlled, Flexible-dose of 50 mg/day to 400 mg/day, Phase IIIb Study of the Efficacy and Safety of Quetiapine Fumarate (Seroquel XR) as an Add-on Therapy in Patients with Chronic Somatoform Pain Disorder RCT (placebo), safety/efficacy study ACTRN12610000603011

Quetiapine Fumarate XR; Placebo

Chronic Somatoform Pain Disorder

Not yet Rec

58 Adt Nov-10 Feb-11 Neurotherapy Victoria (NTVIC)





Not yet Rec

600 Adt Sen



Safety Study to Assess Opiate Withdrawal Signs and Symptoms in Opioid Dependent Patients Phase IV: Randomized, crossover assignment, pharmacodynamics study NCT01100437

EMBEDA™ (morphine sulfate/naltrexone hydrochloride) whole; EMBEDA™ crushed


Apr-10 Dec-10 Alpharma Pharmaceuticals LLC, a subsidiary of King Pharmaceuticals, Inc.


An Efficacy and Safety Study for Tapentadol ER (JNS024ER) in Chronic Pain Patients Phase II: RCT (placebo), safety/efficacy study NCT01124604

Tapentadol ER; Placebo

Pain; Low Back Pain; Back Pain; Osteoarthritis

Active, NR

88 Adt Sen

Apr-10 Dec-10 Janssen Pharmaceutical K.K.


A Study To Observe The Performance Of A Tablet Form Of PF-04531083 As Evidenced By The Concentration Of PF-04531083 In The Blood With Time Following Oral Administration To Healthy Volunteers. Phase I: Non-randomized, parallel assignment, pharmacokinetics study NCT01119235

PF-04531083 Chronic Pain Comp 24 Adt May-10 Jul-10 Pfizer http://ClinicalTrials.gov/show/NCT01119235








40

Comparison of the effects of intermittent boli to simple continuous infusion on patients' global perceived effect in intrathecal therapy for pain RCT (cross-over), efficacy study ISRCTN61628624

Bolus or continuous infusion via ITDD programmable device

Severe chronic pain

Active 34 Adt Sep-10 Sep-12 South Tees Hospitals NHS Trust (UK)



Engaging older people and their careres to develop and deliver interventions for self management of chronic pain (EPIC) Observational: cohort study UKCRN ID 9346

Self management of managing pain

Chronic pain Active 2800 Sen N/K Aug-14 University of Aberdeen


Multicentre non-randomised interventional process of care trial of self-management of chronic conditions supported by assistive, rehabilitation and telecare technology Non-randomized study ISRCTN31254396

Self-management of chronic conditions supported by assistive, rehabilitation and telecare technology

Stroke; Congestive heart failure; Chronic pain

Active

150 Adt Sen

Jan-08 Dec-11 University of Sheffield (UK)


Acupuncture for Chronic Pain Single group assignment, efficacy study NCT01149317

Acupuncture Chronic Pain Rec 200 Adt Sen

May-08 Sep-11 Albert Einstein College of Medicine of Yeshiva University; National Center for Complementary and Alternative Medicine (NCCAM)



Towards culturally competent pain management for older people Observational: qualitative study UKCRN ID 9185

Chronic pain Not yet Rec

52 Sen N/K Mar-13 University of Leeds











41

Prospective Study on the Use of Transdermal Analgesic Buprenorphine Patches for Chronic Pain in the UK Observational: prospective cohort study NCT01225861

Chronic Pain Not yet Rec

750 Adt Sen

Nov-10 Sep-11 Mundipharma Research Limited


Effect of Spinal Cord Stimulation on Pain Thresholds and Sensory Perception in Chronic Pain Patients Observational: Cross-Sectional, case-only study NCT01137617


Jun-10 Jun-11 Massachusetts General Hospital


BraveNet Multi-Center Study on Integrative Medicine Treatment Approaches for Pain Observational: prospective cohort study NCT01186341

Chronic Pain Active, NR

400 Adt Sen

Jun-09 Jun-11 Duke University; The Bravewell Collaborative; Alliance Institute for Integrative Medicine; Allina Hospitals and Clinics; University of Maryland; Beth Israel Medical Center; Thomas Jefferson University; University of California, San Francisco; Scripps Clinic; Venice Family Clinic Simms/Mann Health and Wellness Center


A Prospective Natural History Study of Patients With Syringomyelia Time Perspective: Prospective NCT01150708

Syringomyelia; Arnold Chiari Deformity

Rec 120 Adt Sen

Jun-10 ? Jun-10

National Institute of Neurological Disorders and Stroke (NINDS)






42

A11: PAIN

Title Phases: study design (control) NCT ID


Start Date

End Date

Sponsors URL


Patient and Provider Interventions for Managing Osteoarthritis in Primary Care Randomized, parallel assignment, efficacy study NCT01130740

Osteoarthritis Intervention

Osteoarthritis Not yet Rec

300 Adt Sen

Jan-11 Sep-13 Department of Veterans Affairs


Effectiveness of Tailored Activity Pacing for Symptomatic Osteoarthritis RCT (active), efficacy study NCT01192516

Tailored Activity Pacing; General Activity Pacing

Osteoarthritis; Pain

Not yet Rec

172 Adt Sen

Oct-10 Sep-13 Department of Veterans Affairs


Self-Directed Exercise Program for Adults With Arthritis Phase II: RCT (active), safety/efficacy study NCT01172327

Multicomponent exercise; Nutrition

Arthritis; Osteoarthritis; RA; Fibromyalgia

Rec 400 Adt Sen

Sep-09 Jul-12 University of South Carolina; Centers for Disease Control and Prevention


Device

Pilot Study of the Effect of Transcutaneous Stimulation of the Vagus Nerve on Pain Perception and Parameters of the Autonomic Nervous System RCT (placebo), efficacy study NCT01174498

Cerbomed t-VNS® transcutaneous stimulation; t-VNS Sham stimulation

Pain Rec 48 Adt Sen

Nov-09 Sep-10 Cerbomed GmbH http://ClinicalTrials.gov/show/NCT01174498

Dietry Supplement

Oxidative Stress and Nutritional Supplementation Intervention Study Phase II: Randomized, parallel assignment, safety/efficacy study NCT01234506

Secoisolariciresinol diglucoside

Oxidative Stress; Inflammation; Aging; Dementia; Pain

Rec 154 Adt Sen

Oct-10 Jun-13 University of Saskatchewan; Saskatchewan Health Research Foundation







43


Care Management for the Effective Use of Opioids Randomized, parallel assignment, efficacy study NCT01236521

Analgesic and co-analgesic therapy; Pain self-management/coping skills treatment

Low Back Pain; Pain

Not yet Rec

450 Adt Sen

Jul-11 Jun-15 Department of Veterans Affairs


Pain Modulation in Rheumatoid Arthritis (RA) - Influence of Adalimumab RCT (placebo), basic science NCT01197144

Adalimumab; Placebo

Arthritis, Rheumatoid; Pain; Fatigue

Not yet Rec

90 Adt Sen

Sep-10 Mar-13 Karolinska Institutet; Abbott; Swedish Foundation for Strategic Research; The Swedish Research Council


Milnacipran for Treatment of Pain in Older Adults With Rheumatoid Arthritis Phase IV: Single group assignment, safety/efficacy study NCT01225991

Milnacipran Pain in RA in Older Adults

Not yet Rec

30 Adt Sen

Nov-10 Mar-13 University of California, Los Angeles; Forest Laboratories


Hydromorphone Pharmacokinetic-Pharmacodynamic Fingerprint Single group assignment, pharmacokinetics/dynamics study NCT01123486

Hydromorphone Pain; Ventilatory Depression

Not yet Rec

24 Adt May-10 Dec-12 Northwestern University


Morphine Modulation of The Brain's Pain Matrix Phase IV: RCT (placebo), pharmacokinetics/dynamics study NCT01245244

Morphine; Orange juice

Pain Rec 40 Adt Oct-10 Dec-12 University of Aarhus


PET Brain and Whole Body Distribution Studies for Nociceptin/Orphanin FQ Peptide (NOP) Receptor Using [11C]NOP-1A Single group assignment, pharmacokinetics study NCT01198197

NOP-1A Pain; Anxiety; Depression

Rec 35 Adt Sep-10 Sep-12 National Institute of Mental Health (NIMH)








44

Pharmacological Treatment In Osteoarthritis Phase III: Non-randomized (placebo), efficacy study NCT01148043

Hydroxy-chloroquine; cellulose

Osteoarthritis Rec 200 Adt Sen

Jul-10 Jun-12 Maasstad Hospital http://ClinicalTrials.gov/show/NCT01148043

Milnacipran in the Treatment of Widespread, Non-Joint Pain in Rheumatoid Arthritis Phase IV: RCT (placebo), efficacy study NCT01207453

Milnacipran Arthritis, Rheumatoid

Not yet Rec

43 Adt Sen

Oct-10 Jun-12 Brigham and Women's Hospital; Forest Laboratories; National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)


Study to Evaluate the Efficacy and Safety of Hydrocodone Bitartrate Extended-Release Tablets (CEP-33237) for Relief of Moderate to Severe Pain in Patients With Osteoarthritis or Low Back Pain Who Require Opioid Treatment for an Extended Period of Time Phase III: RCT (placebo) NCT01240863

Hydrocodone; Placebo

Pain Not yet Rec

470 Adt Sen

Nov-10 Jan-12 Cephalon http://ClinicalTrials.gov/show/NCT01240863

Attenuation of Pain in Men and Women RCT (placebo), basic science NCT01220414

Naltrexone; Placebo

Pain Rec 60 Adt Sep-10 Jan-12 University of Wisconsin, Madison


Conversion to Embeda With Rescue Trial Phase IV: Single group assignment NCT01179191

Morphine sulfate and naltrexone hydrochloride

Pain; Chronic Disease

Rec 1300 Adt Sen

Aug-10 Jan-12 Alpharma Pharmaceuticals LLC


Efficacy of Tinoridine in Treating Pain and Inflammation in Adults Phase IV: RCT (placebo), efficacy study NCT01224756

Tinoridine HCl; Placebo

Pain; Inflammation

Not yet Rec

334 Adt Oct-10 Oct-11 P.T. Takeda Indonesia








45

Oxycodone/Naloxone (OXN) Combination in Moderate to Severe Non-malignant Pain Phase III: Single group assignment, safety/efficacy study NCT01167699

Oxycodone and naloxone

Pain Rec 180 Adt Sen

Jun-09 Jun-11 Mundipharma Pharmaceuticals B.V.


Oxycodone/Naloxone (OXN) Combination in Moderate to Severe Non-malignant Pain Phase III: Single group assignment, safety/efficacy study NCT01167127

Oxycodone hydrochloride and naloxone hydrochloride combination, prolonged release

Pain Rec 180 Adt Sen

Jun-09 Jun-11 Mundipharma Pharmaceuticals B.V.





Not yet Rec

600 Adt Sen



To Investigate Safety, Tolerability, and Pharmacokinetics of Treatment With BI 660848 Rising Single Doses (From 2 mg to 600 mg) Administered as Oral Drinking Solution (Powder in Bottle). Phase I: RCT (placebo), safety study NCT01145014

BI 660848; Placebo Pain; Healthy Susp 72 Adt May-10 Jan-11 Boehringer Ingelheim Pharmaceuticals


A Clinical Study for Assessment of the Efficacy and Safety of Mirtazapine (Smilon) in Depression Patients With Pain Phase IV: RCT (placebo), safety/efficacy study NCT01119924

Smilon®; Placebo Depression; Pain Rec 30 Adt Dec-09 Nov-10 Nang Kuang Pharmaceutical Co., Ltd.; Buddhist Tzu Chi General Hospital


Safety Extension Study Of Tanezumab When Administered By Subcutaneous Injection To Patients With Osteoarthritis Phase III: Randomized, parallel assignment, safety study NCT01127893

Tanezumab Osteoarthritis Susp 1 Adt Sen

Jun-10 Oct-10 Pfizer http://ClinicalTrials.gov/show/NCT01127893








46

Evaluate Analgesic Efficacy of Fast Release Aspirin Phase III: RCT (placebo), efficacy study NCT01122602

Acetylsalicyclic acid (Fast acting Aspirin, BAY1019036); Acetylsalicyclic acid (Aspirin, BAYE4465); Placebo

Drugs, Investigational

Comp 500 Child|Adt

Apr-10 Jul-10 Bayer http://ClinicalTrials.gov/show/NCT01122602

Evaluate Analgesic Efficacy of Fast Release Aspirin Phase III: RCT (placebo), efficacy study NCT01117636

Acetylsalicylic Acid (Aspirin, BAY1019036); Acetylsalicylic Acid (Aspirin, BAYE4465); Placebo

Drugs, Investigational

Comp 535 Child|Adt

Apr-10 Jul-10 Bayer http://ClinicalTrials.gov/show/NCT01117636

Acute Osteoarthritis Experimental Model Study. Phase II: RCT (placebo), pharmacodynamics study NCT01231490

Placebo; Naproxen Osteoarthritis Comp 53 Child|Adt Sen

Sep-08 Mar-09 GlaxoSmithKline http://ClinicalTrials.gov/show/NCT01231490

Bioequivalency Study of Oxymorphone Hydrochloride 10 mg Tablets Under Fasted Conditions Randomized, crossover, bioequivalence study NCT01210638

Oxymorphone Pain Comp 42 Adt Jun-08 Jun-08 Roxane Laboratories



Safety and Efficacy of Autologous Bone Marrow Stem Cells for Treating Osteoarthritis Phase I/II: Single group assignment, safety/efficacy study NCT01152125

Autologous bone marrow stem cells


Jan-10 Jan-11 International Stemcell Services Limited



Interactions between brain opioids and pain in Arthritis Observational: qualitative study UKCRN ID 9138

Arthritis, OA, RA Active 40 Adt Sen

N/K Jan-14 Hope Hospital, Salford (UK)









47

Influence of Oxidative Dysbalance on Secondary Osteoarthritis Prospective NCT01228487


Oct-10 Nov-13 Heinrich-Heine University, Duesseldorf


An investigation of psychological characteristics linked to physical activity, sleep, pain and fatigue in RA UKCRN ID 9081

RA Active 250 N/K N/K Jan-12 Kings College London


Pressure and pain in Scleroderma an evaluation of a simple intervention UKCRN ID 9449

Scleroderma Active 140 Adt Sen

N/K Jan-12 Chapel Allerton Hospital (UK)


Pain Across the Adult Life Span Observational: cohort study UKCRN ID 8894

MSK pain Rec 300 N/K N/K Sep-11 University of Manchester


Observational Study on Non-steroid Anti-inflammatory Drugs (NSAIDs) Treated Patients With Arthritic Disorder Observational: prospective cohort study NCT01176682

Osteoarthritis; RA; Ankylosing Spondylitis

Rec 3600 Adt Sen

Aug-10 Jul-11 AstraZeneca http://ClinicalTrials.gov/show/NCT01176682

Evaluation of the Effectiveness, Compliance of Ibuprofen in a Sustained Release Form in the Treatment of Egyptian Osteoarthritic Patients Prospective NCT01226095

Osteoarthritis; Pain; Morning Stiffness

Rec 518 Adt Sen

Jun-10 May-11 Abbott; Clintek http://ClinicalTrials.gov/show/NCT01226095

Brain Activation During Accommodation to Painful Stimulation With FMRI Observational: cross-sectional, case-only study NCT01242540

Pain Rec 20 Adt Nov-10 Mar-11 University of Pittsburgh












48

B: RESEARCH RECOMMENDATIONS

Date published

Guideline Research recommendations (please note these recommendations have been taken verbatim from their respective publications)

Nov 2010 American Osteopathic Association Guidelines for Osteopathic Manipulative Treatment (OMT) for Patients with Low Back Pain (Clinical Guideline Subcommittee on Low Back Pain, 2010).

None

Sept 2010 Achilles pain, stiffness, and muscle power deficits: achilles tendinitis.(Carcia, Martin, Houck, & Wukich, 2010)

None

March 2010 EULAR Evidence Based Recommendations for the Diagnosis of Knee Osteoarthritis (Zhang et al., 2010)

1. Development of internationally agreed criteria sets for diagnosis of knee OA for clinical practice, clinical trials and epidemiological studies

2. Development of a scoring system for accurate diagnosis of knee OA based on the sensitivity and specificity of risk factors and symptoms and signs

3. Delineation of the attributable risk factor profile, both for development and progression, for each suggested subset of knee OA.

4. Development of diagnostic criteria for early symptomatic knee OA (e.g. by prospective investigation of people with knee pain who fulfil criteria of knee OA several years later)

5. Investigation of whether individual pain patterns (usage-related, episodic, night pain) have different utility as diagnostic markers of knee OA

6. Determination of clinical, diagnostic and prognostic relevance of MRI changes in knee OA 7. Determination of the utility of ultrasonography in the diagnosis and prognosis of knee OA 8. Assessment of the possible role of biomarkers (including genetic markers) in the early diagnosis,

phenotypic characterisation, and prediction of outcome of knee OA 9. Assessment of the accuracy of red flags in identifying serious pathology in patients presenting with

knee symptoms Jan 2010 Low back pain (University of Michigan Health System,

2010)

http://www.med.umich.edu/1info/fhp/practiceguides/back/back.pdf

None



49

Dec 2009 Clinical practice guidelines for rest orthosis, knee sleeves, and unloading knee braces in knee osteoarthritis (Beaudreil et al., 2009)

1. Bracing: RCTs still required. 2. Rest orthosis: High quality CTs into congestive knee OA needed. 3. Knee sleeves: High quality CTs. The following design is suggested:

a. with and without knee sleeves b. knee sleeves with and without peripatellar alignment or frontal stabilizing devices.

4. Unloading orthosis: High quality CTs required to examine: a. clinical predictive factors for safety, observance and responsiveness b. optimal duration of orthosis wear c. biomechanical ways of actions, considering especially femoro-tibial angle, adductor moment,

foot strike force and vertical propulsive force.

July-Aug 2009

Comprehensive Evidence-Based Guidelines for Interventional Techniques in the Management of Chronic Spinal Pain (Manchikanti et al., 2009)

None

July 2009 Guideline for the non-surgical management of hip and knee osteoarthritis (Brand et al., 2009)

http://www.racgp.org.au/Content/NavigationMenu/ClinicalResources/RACGPGuidelines/Guidelineforthenonsurgicalmanagementofhipandkneeosteoarthritis/RACGP_OA_guideline.pdf

None

May 2009 Low back pain: early management of persistent non-specific low back pain (Savigny et al., 2009)

http://www.nice.org.uk/nicemedia/live/11887/44334/44334.pdf

1. What is the clinical and cost effectiveness of using screening protocols to target treatments for patients with non-specific low back pain?

2. How can education be effectively delivered for people with chronic non-specific low back pain? 3. What is the effectiveness and cost effectiveness of sequential interventions (manual therapy,

exercise and acupuncture) compared with single interventions on pain, functional disability and psychological distress, in people with chronic non-specific back pain of between six weeks and one year?

4. What is the effectiveness and cost effectiveness of psychological treatments for non-specific low back pain greater than six weeks?

5. What is the effectiveness and cost-effectiveness of facet-joint injections and radiofrequency lesioning for people with persistent non-specific low back pain?

6. Is Transcutaneous Electrical Nerve Stimulation (TENS) an effective therapy for the management of non-specific chronic low back pain?

April 2009 Heel pain--plantar fasciitis: clinical practice guildelines linked to the international classification of function, disability, and health from the orthopaedic section of the American Physical Therapy Association.(McPoil et al., 2009)

None







50

April 2009 Hip pain and mobility deficits - hip osteoarthritis: clinical practice guidelines linked to the international classification of functioning, disability, and health from the orthopaedic section of the American Physical Therapy Association.(Cibulka et al., 2009)

None

March 2009 Managing chronic non-terminal pain including prescribing controlled substances (University of Michigan Health System, 2009)

http://www.med.umich.edu/1info/FHP/practiceguides/pain/pain.pdf

None

Jan 2009 EULAR evidence-based recommendations for the diagnosis of hand osteoarthritis: report of a task force of ESCISIT (Zhang et al., 2009)

1. The relative utility of imaging techniques (plain x rays, MRI, ultrasonography, scintigraphy) in early diagnosis and evaluation of progression of the HOA subsets needs to be determined.

2. Risk factors for development and long-term clinical outcome of the different subsets of HOA need to be determined.

3. Potential biomarkers of bone, cartilage, synovium and inflammation should be examined in HOA subsets for utility in terms of early diagnosis, assessment of disease activity and prediction of outcome.

4. Diagnostic and classification criteria to better define HOA and its subsets need to be developed and validated.

5. Further studies are required to confirm the associations between HOA and systemic risk factors such as menopausal state, bone density, obesity and metabolic syndrome, and to explain the mechanisms that underlie such associations.

6. The genetic factors that predispose to the different phenotypes of HOA need to be identified. 7. The population incidence and prevalence of HOA and its subtypes (symptomatic and asymptomatic),

standardised by age and gender, need to be confirmed. 8. Studies should be undertaken to determine whether erosive HOA is a discrete subset with specific

risk factors and pathogenesis, or a subgroup of HOA with a worse outcome. 9. The association between the different HOA phenotypes and large joint OA (ie generalised OA) needs

further examination.

2009 Chiropractic management of fibromyalgia syndrome: Summary of Clinical Practice (Commission of the Council on Chiropractic Guidelines and Practice Parameters, 2009a)

http://www.ccgpp.org/downloads/chiropractic_management_fibromyalgia.pdf

Additional research is recommended to improve the base of evidence for which anecdotal evidence indicates chiropractic intervention may be appropriate





51

2009 Chiropractic management of tendinopathy: Summary of Clinical Practice (Commission of the Council on Chiropractic Guidelines and Practice Parameters, 2009b)

http://www.ccgpp.org/downloads/chiropractic_management_tendinopathy.pdf

Additional research is recommended to improve the base of evidence for which anecdotal evidence indicates chiropractic intervention may be appropriate.

2009 Manipulative therapy of lower extremity conditions: Summary of Clinical Practice (Commission of the Council on Chiropractic Guidelines and Practice Parameters, 2009c)

http://www.ccgpp.org/downloads/manipulative_therapy_lower_extremity.pdf

Additional research is recommended to improve the base of evidence for which anecdotal evidence indicates chiropractic intervention may be appropriate.

Nov 2008 Chiropractic management of low back disorders: report from a consensus process (Globe, Morris, Whalen, Farabaugh, & Hawk, 2008).

None

Sept 2008 Neck pain: Clinical practice guidelines linked to the International Classification of Functioning, Disability, and Health from the Orthopedic Section of the American Physical Therapy Association (Childs et al., 2008).

None

July 2008 Ottawa Panel evidence-based clinical practice guidelines for strengthening exercises in the management of fibromyalgia: part 2 [with systematic review] (Brosseau, Wells, Tugwell, Egan, Wilson, Dubouloz, Casimiro, Robinson, McGowan, Busch, Poitras, Moldofsky, Harth, Finestone, Nielson, Haines-Wangda, Russell-Doreleyers, Lambert, Marshall, & Veilleux, 2008a)

None

July 2008 Ottawa Panel evidence-based clinical practice guidelines for aerobic fitness exercises in the management of fibromyalgia: part 1 [with systematic review] (Brosseau, Wells, Tugwell, Egan, Wilson, Dubouloz, Casimiro, Robinson, McGowan, Busch, Poitras, Moldofsky, Harth, Finestone, Nielson, Haines-Wangda, Russell-Doreleyers, Lambert, Marshall, & Veilleux, 2008b)

None





52

May 2008 Assessment: Botulinum neurotoxin in the treatment of autonomic disorders and pain (an evidence-based review): report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology (Naumann et al., 2008).

Includes use for low back pain. Pertinent recommendations:

Larger placebo-controlled trials are needed to evaluate the efficacy and safety of BoNT for several hypersecretory disorders (palmar hyperhidrosis, drooling), neuro-urologic indications, and pain. Double-blind, placebo-controlled, randomized studies are needed to determine the effect of BoNT in different subsets of headache. Additionally, head-to-head studies of BoNT vs and combined with other proven effective therapies should be undertaken.

April 2008 EULAR evidence-based recommendations for the management of fibromyalgia syndrome.(Carville et al., 2008)

None

April 2008 Standards of Care for People with Musculoskeletal Foot Health problems (Podiatry Rheumatic Care Association, 2008).

http://www.prcassoc.org.uk/files/Full%20Colour%20Foot%20Health%20Standards.pdf

None

March 2008 Opioids in the management of chronic non-cancer pain: an update of American Society of the Interventional Pain Physicians' (ASIPP) Guidelines (Trescot et al., 2008)

None

Feb 2008 The Bone and Joint Decade 2000–2010 Task Force on Neck Pain and Its Associated Disorders (Guzman et al., 2008)

Future research should be directed to assessing the impact of modifiable risk factors through innovative treatment approaches. Changes in public policy which address these risk factors may significantly reduce the burden and cost of neck pain in society.



53

Feb 2008 CG059: Osteoarthritis: National clinical guideline for care and management in adults (Full Guideline) (The National Collaborating Centre for Chronic Conditions, 2008).

http://www.nice.org.uk/nicemedia/pdf/CG059FullGuideline.pdf

1. What are the factors influencing, and methods of improving, adherence to OA therapies? 2. What are the short- and long-term benefits of non-pharmacological and pharmacological OA

therapies in the very elderly? 3. What are the benefits of combination (non-pharmacological and pharmacological) OA therapies and

how can they be included in clinically useful, cost-effective algorithms for long term use? 4. What are the predictors of good outcome following total and partial joint replacement? 5. What are the benefits of individual and combination OA therapies in people with multiple joint region

pain? 6. Is it possible to identify subsets of people with OA in whom existing treatments are more beneficial

and cost effective (for example, acupuncture or hyaluronans)? 7. Who are the people with OA who would benefit from devices (including footwear, insoles, braces and

splints)? 8. What are effective strategies for weight loss in people with painful knee or hip OA, and how much

weight should they lose? 9. What are the benefits of treatment of comorbidities (for example, depression) in people with OA? 10. What social and psychological outcome measures are the most effective indicators to identify patient-

perceived benefits of effective self-management strategies for OA? 11. For individuals with knee and hip OA, what benefits can be achieved using a patient centred

approach to information giving and pain management compared with group self-management programmes (as measured by pain, changes in prescriptions for symptom control, positive health-seeking behaviours and participation in activities of daily living, quality of life)?

Feb 2008 OARSI recommendations for the management of hip and knee osteoarthritis, part II: OARSI evidence-based, expert consensus guidelines (Zhang et al., 2008)

None



54

REFERENCES

Beaudreil, J., Bendaya, S., Faucher, M., Coudeyre, E., Ribinik, P., Revel, M., & Rannouf, F. (2009). Clinical practice guidelines for rest orthosis, knee sleeves, and unloading knee braces in knee osteoarthritis. Joint Bone Spine, 76(6), 629-636.

Brand, C., Buchbinder, R., Wluka, A., Jones, K., Ruth, D., McKenzie, S., et al. (2009). Guideline for the non-surgical management of hip and knee osteoarthritis. Melbourne: The Royal Australian College of General Practitioners.

Brosseau, L., Wells, G. A., Tugwell, P., Egan, M., Wilson, K. G., Dubouloz, C., et al. (2008a). Ottawa panel evidence-based clinical practice guidelines for strengthening exercises in the management of fibromyalgia: Part 2 [with systematic review]. Physical Therapy, 88(7), 873-886.

Brosseau, L., Wells, G. A., Tugwell, P., Egan, M., Wilson, K. G., Dubouloz, C., et al. (2008b). Ottawa panel evidence-based clinical practice guidelines for aerobic fitness exercises in the management of fibromyalgia: Part 1 [with systematic review]. Physical Therapy, 88(7), 857-871.

Carcia, C. R., Martin, R. L., Houck, J., & Wukich, D. K. (2010). Achilles pain, stiffness, and muscle power deficits: Achilles tendinitis. Journal of Orthopaedic Sports and Physical Therapy, 40(9), A1-A29.

Carville, S. F., Arendt-Nielsen, S., Bliddal, H., Blotman, F., Branco, J. C., Buskila, D., et al. (2008). EULAR evidence-based recommendations for the management of fibromyalgia syndrome. Annals of Rheumatic Diseases, 67(4), 536-541.

Childs, J. D., Cleland, J. A., Elliott, J. M., Teyhen, D. S., Wainner, R. S., Whitman, J. M., et al. (2008). Neck pain: Clinical practice guidelines linked to the international classification of functioning, disability, and health from the orthopedic section of the american physical therapy association. Journal of Orthopaedic & Sports Physical Therapy, 38(9), A1-A34.

Cibulka, M. T., White, D. M., Woehrle, J., Harris-Hayes, M., Enseki, K., Fagerson, T. L., et al. (2009). Hip pain and mobility deficits - hip osteoarthritis: Clinical practice guidelines linked to the international classification of functioning, disability, and health from the orthopaedic section of the american physical therapy association. Journal of Orthopaedic & Sports Physical Therapy, 39(4), A1-A25.

Clinical Guideline Subcommittee on Low Back Pain (2010). American osteopathic association guidelines for osteopathic manipulative treatment (OMT) for patients with low back pain. The Journal of the American Osteopathic Association, 110(11), 653-666.

Commission of the Council on Chiropractic Guidelines and Practice Parameters. (2009a). Chiropractic management of fibromyalgia syndrome: Summary of clinical practice. Available online at: http://www.ccgpp.org/downloads/chiropractic_management_fibromyalgia.pdf [Accessed 17th December 2010]

Commission of the Council on Chiropractic Guidelines and Practice Parameters. (2009b). Chiropractic management of tendinopathy: Summary of clinical practice. Available online at: http://www.ccgpp.org/downloads/chiropractic_management_tendinopathy.pdf [Accessed 17th December 2010]

Commission of the Council on Chiropractic Guidelines and Practice Parameters. (2009c). Manipulative therapy of lower extremity conditions: Summary of clinical practice. Available online at: http://www.ccgpp.org/downloads/manipulative_therapy_lower_extremity.pdf [Accessed 17th December 2010]




55

Globe, G. A., Morris, C. E., Whalen, W. M., Farabaugh, R. J., & Hawk, C. (2008). Chiropractic management of low back disorders: Report from a consensus process. Journal of Manipulative and Physiological Therapeutics, 31(9), 651-658.

Guzman, J., Haldeman, S., Carroll, L. J., Carragee, E. J., Hurwitz, E. L., Peloso, P., et al. (2008). The bone and joint decade 2000–2010 task force on neck pain and its associated disorders. Spine, 33(45), 55-57.

Manchikanti, L., Boswell, M. V., Singh, V., Benyamin, R. M., Fellows, B., Abdi, S., et al. (2009). Comprehensive evidence-based guidelines for interventional techniques in the management of chronic spinal pain. Pain Physician, 12(4), 699-802.

McPoil, T. G., Martin, R. L., Cornwall, M. W., Wukich, D. K., Irrgang, J. J., & Godges, J. J. (2009). Heel pain--plantar fasciitis: Clinical practice guildelines linked to the international classification of function, disability, and health from the orthopaedic section of the american physical therapy association. Journal of Orthopaedic & Sports Physical Therapy, 38(4), A1-A18.

Naumann, M., So, Y., Argoff, C. E., Childers, M. K., Dykstra, D. D., Gronseth, G. S., et al. (2008). Assessment: Botulinum neurotoxin in the treatment of autonomic disorders and pain (an evidence-based review): Report of the therapeutics and technology assessment subcommittee of the american academy of neurology. Neurology, 70(19), 1707-1714.

Podiatry Rheumatic Care Association. (2008). Standards of care for people with musculoskeletal foot health problems. London: Podiatry Rheumatic Care Association.

Savigny, P., Kuntze, S., Watson, P., Underwood, M., Ritchie, G., Cotterell, M., et al. (2009). Low back pain: Early management of persistent non-specific low back pain. London: National Collaborating Centre for Primary Care and Royal College of General Practitioners.

The National Collaborating Centre for Chronic Conditions,. (2008). Osteoarthritis: National clinical guideline for care and management in adults. London: The Royal College of Physicians.

Trescot, A. M., Helm, S., Hansen, H., Benyamin, R., Glaser, S. E., Adlaka, R., et al. (2008). Opioids in the management of chronic non-cancer pain: An update of american society of the interventional pain physicians' (ASIPP) guidelines. Pain Physician, 11(2 Supplement), S5-S62.

University of Michigan Health System. (2009). Managing chronic non-terminal pain including prescribing controlled substances. Ann Arbor (MI): University of Michigan Health System.

University of Michigan Health System. (2010). Low back pain. Ann Arbor (MI): University of Michigan Health System.

Zhang, W., Doherty, M., Leeb, B. F., Alekseeva, L., Arden, N. K., Bijlsma, J. W., et al. (2009). EULAR evidence-based recommendations for the diagnosis of hand osteoarthritis: Report of a task force of ESCISIT. Annals of Rheumatic Diseases, 68(1), 8-17.

Zhang, W., Doherty, M., Peat, G., Bierma-Zeinstra, M., Arden, N., Bresnihan, B., et al. (2010). EULAR evidence based recommendations for the diagnosis of knee osteoarthritis Annals of Rheumatic Diseases, 69(3), 483-489.

Zhang, W., Moskowitz, R. W., Nuki, G., Abramson, S., Altman, R. D., Arden, N., et al. (2008). OARSI recommendations for the management of hip and knee osteoarthritis, part II: OARSI evidence-based, expert consensus guidelines. Osteoarthritis & Cartilage, 16(2), 137-62.

Documents

HORIZON SCANNING MUSCULOSKELETAL PAIN ......Effectiveness of ultrasound imaging in general practice: Optimising the management of patients with non-chronic shoulder complaints. Maastricht