Clinical trial NCT00415441: Effectiveness of Physiotherapy for Chronic Shoulder Pain
Official title: Efficacy and Cost-effectiveness of Physiotherapy for Chronic Rotator Cuff Pathology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Shoulder Pain
Keywords: physiotherapy
exercise
manual therapy
shoulder pain
rotator cuff
Lead sponsor: University of Melbourne
Sponsor class: OTHER
Collaborators: name: National Health and Medical Research Council, Australia
First posted: 2006-12-22
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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.

Primary outcomes:
measure: Shoulder Pain and Disability Index
timeFrame: Baseline and 11 weeks
measure: Participant perceived global rating of change post treatment
timeFrame: 11 weeks
Secondary outcomes:
measure: Shoulder Pain and Disability Index at followup
timeFrame: 22 weeks
measure: Participant perceived global rating of change at followup
timeFrame: 22 weeks
measure: Australian Quality of Life Index at followup
timeFrame: Baseline, 11 weeks and 22 weeks
measure: Isometric Shoulder strength using manual muscle tester post treatment and followup
timeFrame: Baseline, 11 weeks and 22 weeks
measure: Participant assessment of average pain and restriction of activity post treatment and followup
timeFrame: Baseline, 11 weeks and 22 weeks
measure: Cost effectiveness analysis
timeFrame: Baseline, 11 weeks and 22 weeks
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: University of Melbourne
state: Victoria
Study officials:
affiliation: University of Melbourne, Australia
name: Kim L Bennell, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Monash University, Australia
name: Rachelle Buchbinder, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Monash University
name: Sally Green, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Monash University
name: Anthony Harris
role: PRINCIPAL_INVESTIGATOR
affiliation: Monash University
name: Andrew Forbes
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bennell K, Wee E, Coburn S, Green S, Harris A, Staples M, Forbes A, Buchbinder R. Efficacy of standardised manual therapy and home exercise programme for chronic rotator cuff disease: randomised placebo controlled trial. BMJ. 2010 Jun 8;340:c2756. doi: 10.1136/bmj.c2756.
citation: Bennell K, Coburn S, Wee E, Green S, Harris A, Forbes A, Buchbinder R. Efficacy and cost-effectiveness of a physiotherapy program for chronic rotator cuff pathology: a protocol for a randomised, double-blind, placebo-controlled trial. BMC Musculoskelet Disord. 2007 Aug 31;8:86. doi: 10.1186/1471-2474-8-86.