- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00415441
Effectiveness of Physiotherapy for Chronic Shoulder Pain
Efficacy and Cost-effectiveness of Physiotherapy for Chronic Rotator Cuff Pathology
The purpose of this study is to investigate whether a physiotherapy program reduces pain and improves disability and quality-of-life in people with chronic shoulder pain.
The main study hypotheses are that (i) A 10-week physiotherapy treatment will result in significantly greater reductions in pain and disability than placebo treatment in individuals with chronic shoulder pain (ii) Improvements in pain and disability following a 10-week physiotherapy treatment will be maintained at a 3-month follow-up.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Chronic rotator cuff pathology (CRCP) is a common cause of musculoskeletal morbidity in the community. Physiotherapy is often the first line of management for this condition. However, the effectiveness of physiotherapy for CRCP has not been well studied. Thus this project primarily aims to investigate the effect of a multimodality physiotherapy program to treat CRCP where effect is measured in terms of pain, disability and health-related quality of life. The secondary aim is to evaluate the cost-effectiveness of physiotherapy as a treatment for CRCP.
Comparison: physiotherapy program comprising stretches, exercises, manual techniques versus placebo physiotherapy
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Victoria
-
Melbourne, Victoria, Australia, 3010
- University of Melbourne
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- diagnosis of CRCP as evident by symptoms and signs including pain on active abduction or external rotation and positive impingement test;
- symptoms of pain in shoulder for > 3 months;
- average movement pain > 3 on a 10 cm visual analogue scale;
- aged ≥ 18 years;
- able to understand written and spoken English.
Exclusion Criteria:
- severe pain at rest, defined as > 7 on a visual analogue scale;
- global restriction of shoulder movements;
- systemic inflammatory joint disease;
- x-ray evidence of shoulder osteoarthritis or fracture;
- calcification about the shoulder joint;
- reason to suspect a complete rotator cuff rupture (eg. weakness of arm elevation, a positive "drop arm sign", a high riding humerus visible on x-ray or a complete tear on ultrasound);
- previous shoulder surgery on affected arm;
- physiotherapy, corticosteroid injection or hydrodilatation for shoulder in past 3 months;
- commenced non-steroidal antiinflammatory medication (NSAIDs) or conservative intervention in past 2 weeks.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active physiotherapy
Manual therapy and home exercise program
|
|
Placebo Comparator: Placebo physiotherapy
Manual therapy and home exercise program
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Shoulder Pain and Disability Index
Time Frame: Baseline and 11 weeks
|
Baseline and 11 weeks
|
Participant perceived global rating of change post treatment
Time Frame: 11 weeks
|
11 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Shoulder Pain and Disability Index at followup
Time Frame: 22 weeks
|
22 weeks
|
Participant perceived global rating of change at followup
Time Frame: 22 weeks
|
22 weeks
|
Australian Quality of Life Index at followup
Time Frame: Baseline, 11 weeks and 22 weeks
|
Baseline, 11 weeks and 22 weeks
|
Isometric Shoulder strength using manual muscle tester post treatment and followup
Time Frame: Baseline, 11 weeks and 22 weeks
|
Baseline, 11 weeks and 22 weeks
|
Participant assessment of average pain and restriction of activity post treatment and followup
Time Frame: Baseline, 11 weeks and 22 weeks
|
Baseline, 11 weeks and 22 weeks
|
Cost effectiveness analysis
Time Frame: Baseline, 11 weeks and 22 weeks
|
Baseline, 11 weeks and 22 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kim L Bennell, PhD, University of Melbourne, Australia
- Principal Investigator: Rachelle Buchbinder, MPH, Monash University, Australia
- Principal Investigator: Sally Green, PhD, Monash University
- Principal Investigator: Anthony Harris, Monash University
- Principal Investigator: Andrew Forbes, Monash University
Publications and helpful links
General Publications
- Bennell K, Wee E, Coburn S, Green S, Harris A, Staples M, Forbes A, Buchbinder R. Efficacy of standardised manual therapy and home exercise programme for chronic rotator cuff disease: randomised placebo controlled trial. BMJ. 2010 Jun 8;340:c2756. doi: 10.1136/bmj.c2756.
- Bennell K, Coburn S, Wee E, Green S, Harris A, Forbes A, Buchbinder R. Efficacy and cost-effectiveness of a physiotherapy program for chronic rotator cuff pathology: a protocol for a randomised, double-blind, placebo-controlled trial. BMC Musculoskelet Disord. 2007 Aug 31;8:86. doi: 10.1186/1471-2474-8-86.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 299890
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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