Effectiveness of Physiotherapy for Chronic Shoulder Pain

Shoulder Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00415441
• Other study ID #: 299890
• Status: Completed
• Phase: Phase 3
• First received: December 21, 2006
• Last updated: January 15, 2013
• Start date: March 2004
• Est. completion date: September 2008

Study information

• Verified date: January 2013
• Source: University of Melbourne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: National Health and Medical Research Council
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Shoulder Pain

Intervention

Procedure:
• Physiotherapy program

• Placebo physiotherapy treatment

Locations

Country	Name	City	State
Australia	University of Melbourne	Melbourne	Victoria

Sponsors (2)

Lead Sponsor	Collaborator
University of Melbourne	National Health and Medical Research Council, Australia

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shoulder Pain and Disability Index		Baseline and 11 weeks	No
Primary	Participant perceived global rating of change post treatment		11 weeks	No
Secondary	Shoulder Pain and Disability Index at followup		22 weeks	No
Secondary	Participant perceived global rating of change at followup		22 weeks	No
Secondary	Australian Quality of Life Index at followup		Baseline, 11 weeks and 22 weeks	No
Secondary	Isometric Shoulder strength using manual muscle tester post treatment and followup		Baseline, 11 weeks and 22 weeks	No
Secondary	Participant assessment of average pain and restriction of activity post treatment and followup		Baseline, 11 weeks and 22 weeks	No
Secondary	Cost effectiveness analysis		Baseline, 11 weeks and 22 weeks	No