Skip to main content
OpenTrials
Completed

NCT Number: NCT00415441

Effectiveness of Physiotherapy for Chronic Shoulder Pain

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Melbourne

Melbourne, Victoria, 3010, Australia

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

physiotherapy program

Procedure

Placebo physiotherapy treatment

Procedure

Primary outcomes

  1. Shoulder Pain and Disability Index

    Time frame: Baseline and 11 weeks

  2. Participant perceived global rating of change post treatment

    Time frame: 11 weeks

Secondary outcomes

  1. Shoulder Pain and Disability Index at followup

    Time frame: 22 weeks

  2. Participant perceived global rating of change at followup

    Time frame: 22 weeks

  3. Australian Quality of Life Index at followup

    Time frame: Baseline, 11 weeks and 22 weeks

  4. Isometric Shoulder strength using manual muscle tester post treatment and followup

    Time frame: Baseline, 11 weeks and 22 weeks

  5. Participant assessment of average pain and restriction of activity post treatment and followup

    Time frame: Baseline, 11 weeks and 22 weeks

  6. Cost effectiveness analysis

    Time frame: Baseline, 11 weeks and 22 weeks

Sponsors and collaborators

Lead sponsor

University of Melbourne

Other

Collaborators

  • National Health and Medical Research Council, Australia

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Dec 22, 2006
Registry last updated
Jan 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.