Effectiveness of Physiotherapy for Chronic Shoulder Pain

This study has been completed.
Sponsor:
Collaborator:
National Health and Medical Research Council, Australia
Information provided by (Responsible Party):
Kim Bennell, University of Melbourne
ClinicalTrials.gov Identifier:
NCT00415441
First received: December 21, 2006
Last updated: January 15, 2013
Last verified: January 2013
  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
Procedure: Placebo physiotherapy treatment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Cost-effectiveness of Physiotherapy for Chronic Rotator Cuff Pathology

Resource links provided by NLM:


Further study details as provided by University of Melbourne:

Primary Outcome Measures:
  • Shoulder Pain and Disability Index [ Time Frame: Baseline and 11 weeks ] [ Designated as safety issue: No ]
  • Participant perceived global rating of change post treatment [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Shoulder Pain and Disability Index at followup [ Time Frame: 22 weeks ] [ Designated as safety issue: No ]
  • Participant perceived global rating of change at followup [ Time Frame: 22 weeks ] [ Designated as safety issue: No ]
  • Australian Quality of Life Index at followup [ Time Frame: Baseline, 11 weeks and 22 weeks ] [ Designated as safety issue: No ]
  • Isometric Shoulder strength using manual muscle tester post treatment and followup [ Time Frame: Baseline, 11 weeks and 22 weeks ] [ Designated as safety issue: No ]
  • Participant assessment of average pain and restriction of activity post treatment and followup [ Time Frame: Baseline, 11 weeks and 22 weeks ] [ Designated as safety issue: No ]
  • Cost effectiveness analysis [ Time Frame: Baseline, 11 weeks and 22 weeks ] [ Designated as safety issue: No ]

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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Australia, Victoria
University of Melbourne
Melbourne, Victoria, Australia, 3010
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

No publications provided by University of Melbourne

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

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

Additional relevant MeSH terms:
Shoulder Pain
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on August 26, 2014