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Effectiveness of Physiotherapy for Chronic Shoulder Pain

This study has been completed.
National Health and Medical Research Council, Australia
Information provided by (Responsible Party):
Kim Bennell, University of Melbourne Identifier:
First received: December 21, 2006
Last updated: January 15, 2013
Last verified: January 2013

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
Procedure: Placebo physiotherapy treatment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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 [ Time Frame: Baseline and 11 weeks ]
  • Participant perceived global rating of change post treatment [ Time Frame: 11 weeks ]

Secondary Outcome Measures:
  • Shoulder Pain and Disability Index at followup [ Time Frame: 22 weeks ]
  • Participant perceived global rating of change at followup [ Time Frame: 22 weeks ]
  • Australian Quality of Life Index at followup [ Time Frame: 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 ]
  • Participant assessment of average pain and restriction of activity post treatment and followup [ Time Frame: Baseline, 11 weeks and 22 weeks ]
  • Cost effectiveness analysis [ Time Frame: Baseline, 11 weeks and 22 weeks ]

Enrollment: 120
Study Start Date: March 2004
Study Completion Date: September 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00415441

Australia, Victoria
University of Melbourne
Melbourne, Victoria, Australia, 3010
Sponsors and Collaborators
University of Melbourne
National Health and Medical Research Council, Australia
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 automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Kim Bennell, Professor, University of Melbourne Identifier: NCT00415441     History of Changes
Other Study ID Numbers: 299890
Study First Received: December 21, 2006
Last Updated: January 15, 2013

Keywords provided by University of Melbourne:
manual therapy
shoulder pain
rotator cuff

Additional relevant MeSH terms:
Shoulder Pain
Joint Diseases
Musculoskeletal Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms processed this record on May 22, 2017