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Effectiveness of Physiotherapy for Chronic Shoulder Pain

U

University of Melbourne

Status and phase

Completed
Phase 3

Conditions

Shoulder Pain

Treatments

Procedure: Physiotherapy program
Procedure: Placebo physiotherapy treatment

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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

Enrollment

120 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

120 participants in 2 patient groups, including a placebo group

Active physiotherapy
Experimental group
Description:
Manual therapy and home exercise program
Treatment:
Procedure: Physiotherapy program
Placebo physiotherapy
Placebo Comparator group
Description:
Manual therapy and home exercise program
Treatment:
Procedure: Placebo physiotherapy treatment

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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