Effectiveness of Physiotherapy for Chronic Shoulder Pain - Full Text View

Sponsors and Collaborators:	University of Melbourne National Health and Medical Research Council, Australia
Information provided by:	University of Melbourne
ClinicalTrials.gov Identifier:	NCT00415441

Purpose

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.

Condition	Intervention	Phase
Shoulder Pain	Procedure: Physiotherapy program	Phase III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Efficacy and Cost-Effectiveness of Physiotherapy for Chronic Rotator Cuff Pathology

Further study details as provided by University of Melbourne:

Primary Outcome Measures:

Shoulder Pain and Disability Index post treatment (10 weeks)
Participant perceived global rating of change post treatment

Secondary Outcome Measures:

Shoulder Pain and Disability Index at followup (22 weeks)
Participant perceived global rating of change at followup
Australian Quality of Life Index post treatment and followup
Isometric Shoulder strength using manual muscle tester post treatment and followup
Participant assessment of average pain and restriction of activity post treatment and followup
Cost effectiveness analysis

Estimated Enrollment:	120
Study Start Date:	March 2004
Estimated Study Completion Date:	September 2007

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00415441

Contacts

Contact: Kim L Bennell, PhD

+ 61 3 83444135 ext 44135

k.bennell@unimelb.edu.au

Locations

Australia, Victoria
University of Melbourne	Recruiting
Melbourne, Victoria, Australia, 3010
Principal Investigator: Kim L Bennell, PhD

Sponsors and Collaborators

University of Melbourne

National Health and Medical Research Council, Australia

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

More Information

Publications indexed to this study:

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.

Study ID Numbers:	299890
Study First Received:	December 21, 2006
Last Updated:	December 21, 2006
ClinicalTrials.gov Identifier:	NCT00415441
Health Authority:	Australia: National Health and Medical Research Council

Keywords provided by University of Melbourne:

physiotherapy
exercise
manual therapy
shoulder pain
rotator cuff

Study placed in the following topic categories:

Signs and Symptoms
Musculoskeletal Diseases
Shoulder Pain

Joint Diseases
Pain
Arthralgia

ClinicalTrials.gov processed this record on January 16, 2009