Shoulder Pain
Conditions
Keywords
physiotherapy, exercise, manual therapy, shoulder pain, rotator cuff
Brief summary
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.
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
Interventions
PROCEDUREPhysiotherapy program
PROCEDUREPlacebo physiotherapy treatment
Sponsors
National Health and Medical Research Council, Australia
University of Melbourne
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Shoulder Pain and Disability Index | Baseline and 11 weeks |
| Participant perceived global rating of change post treatment | 11 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Australian Quality of Life Index at followup | Baseline, 11 weeks and 22 weeks |
| Isometric Shoulder strength using manual muscle tester post treatment and followup | Baseline, 11 weeks and 22 weeks |
| Shoulder Pain and Disability Index at followup | 22 weeks |
| Cost effectiveness analysis | Baseline, 11 weeks and 22 weeks |
| Participant assessment of average pain and restriction of activity post treatment and followup | Baseline, 11 weeks and 22 weeks |
| Participant perceived global rating of change at followup | 22 weeks |
Countries
Australia
Outcome results
None listed