Effectiveness of Physiotherapy for Chronic Shoulder Pain

January 15, 2013 updated by: Kim Bennell, University of Melbourne

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3010
        • University of Melbourne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Melbourne

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2004

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

December 21, 2006

First Submitted That Met QC Criteria

December 21, 2006

First Posted (Estimate)

December 22, 2006

Study Record Updates

Last Update Posted (Estimate)

January 17, 2013

Last Update Submitted That Met QC Criteria

January 15, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 299890

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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