Effectiveness of Physiotherapy for Chronic Shoulder Pain

Phase 3

Completed

• Conditions: Shoulder Pain
• Interventions: Procedure: Physiotherapy program; Procedure: Placebo physiotherapy treatment

• Registration Number: NCT00415441
• Lead Sponsor: University of Melbourne

Brief Summary

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

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 Timeline

• Study Start: 2004-03
• Study First Submitted: 2006-12-21
• Study First Submitted QC: 2006-12-21
• Study First Posted: 2006-12-22
• Primary Completion: 2008-06
• Study Completion: 2008-09
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-15
• Last Update Posted: 2013-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active physiotherapy	Physiotherapy program	Manual therapy and home exercise program
Placebo physiotherapy	Placebo physiotherapy treatment	Manual therapy and home exercise program

Primary Outcome Measures

Name	Time	Method
Shoulder Pain and Disability Index	Baseline and 11 weeks
Participant perceived global rating of change post treatment	11 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Melbourne; 🇦🇺 Melbourne, Victoria, Australia