Effectiveness of Physiotherapy for Chronic Shoulder Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2008-09-30

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.

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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

Conditions

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Shoulder Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Active physiotherapy

Manual therapy and home exercise program

Group Type EXPERIMENTAL

Physiotherapy program

Intervention Type PROCEDURE

Placebo physiotherapy

Manual therapy and home exercise program

Group Type PLACEBO_COMPARATOR

Placebo physiotherapy treatment

Intervention Type PROCEDURE

Interventions

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Physiotherapy program

Intervention Type PROCEDURE

Placebo physiotherapy treatment

Intervention Type PROCEDURE

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No