Effectiveness of Physiotherapy for Chronic Shoulder Pain

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Efficacy and Cost-effectiveness of Physiotherapy for Chronic Rotator Cuff Pathology

Conditions
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Shoulder Pain

Intervention / Treatment
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* Procedure: Physiotherapy program
* Procedure: Placebo physiotherapy treatment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active physiotherapy<br>Manual therapy and home exercise program | Procedure: Physiotherapy program<br> <br> |
| Placebo Comparator: Placebo physiotherapy<br>Manual therapy and home exercise program | Procedure: Placebo physiotherapy treatment<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shoulder Pain and Disability Index |  | Baseline and 11 weeks | 
| Participant perceived global rating of change post treatment |  | 11 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shoulder Pain and Disability Index at followup |  | 22 weeks | 
| Participant perceived global rating of change at followup |  | 22 weeks | 
| Australian Quality of Life Index at followup |  | Baseline, 11 weeks and 22 weeks | 
| Isometric Shoulder strength using manual muscle tester post treatment and followup |  | Baseline, 11 weeks and 22 weeks | 
| Participant assessment of average pain and restriction of activity post treatment and followup |  | Baseline, 11 weeks and 22 weeks | 
| Cost effectiveness analysis |  | Baseline, 11 weeks and 22 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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physiotherapy, exercise, manual therapy, shoulder pain, rotator cuff