Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000541606
Ethics application status
Approved
Date submitted
21/09/2005
Date registered
28/09/2005
Date last updated
11/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Physiotherapy treatment of shoulder pain
Scientific title
Efficacy and cost-effectiveness of physiotherapy for chronic rotator cuff pathology
Secondary ID [1] 287865 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic shoulder rotator cuff pathology 668 0
Condition category
Condition code
Musculoskeletal 741 741 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 742 742 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A physiotherapy treatment program, comprising muscle stretches, joint mobilisation, postural taping, soft tissue massage and exercises. Both groups will attend for 10 treatment sessions over 10 weeks. The physiotherapy group will then continue with home exercises for a further 12 weeks while the placebo group will cease treatment.
Intervention code [1] 659 0
None
Comparator / control treatment
Placebo treatment.
Control group
Placebo

Outcomes
Primary outcome [1] 927 0
Shoulder pain and disability index (SPADI) which is a self-administered, shoulder-specific questionnaire.
Timepoint [1] 927 0
Measured at baseline, immediately following treatment at 10 weeks and after follow up at 22 weeks.
Secondary outcome [1] 1776 0
Patient perceived global rating of change with treatment
Timepoint [1] 1776 0
Measured at baseline, 10 weeks and 22 weeks.
Secondary outcome [2] 1777 0
Health related quality of life
Timepoint [2] 1777 0
Measured at baseline, 10 weeks and 22 weeks.
Secondary outcome [3] 1778 0
Shoulder strength.
Timepoint [3] 1778 0
Measured at baseline, 10 weeks and 22 weeks.

Eligibility
Key inclusion criteria
i) diagnosis of chronic rotator cuff pathology as evident by symptoms and signs including pain on active abduction or external rotation and positive impingement test; ii) symptoms of pain in shoulder for >3 months; iii) average movement pain >3 on a 10cm visual analogue scale.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i) severe pain at rest, defined as >7 on a visual analogue scale; ii) global restriction of shoulder movements; iii) systemic inflammatory joint disease; iv) x-ray evidence of shoulder osteoarthritis or fracture; v) calcification about the shoulder joint; vi) 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); vii) previous shoulder surgery on affected arm; viii) physiotherapy, corticosteroid injection or hydrodilation for shoulder in past 3 months; ix) commenced non-steroidal antiinflammatory medications (NSAIDs) or conservative intervention in past 2 weeks.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes kept in central location and opened at time of treatment by central administrator
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block ramdomisation, according to a computer-generated random number list and stratifies by therapist
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2004
Actual
1/03/2004
Date of last participant enrolment
Anticipated
Actual
7/06/2007
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
120
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 823 0
Government body
Name [1] 823 0
NHMRC project grant
Country [1] 823 0
Australia
Primary sponsor type
Individual
Name
Prof Kim Bennell
Address
Department of Physiotherapy
University of Melbourne
Victoria 3010
Australia
Country
Australia
Secondary sponsor category [1] 688 0
Individual
Name [1] 688 0
A/Prof Rachelle Buchbinder
Address [1] 688 0
Monash University
Victoria
Australia
Country [1] 688 0
Australia
Secondary sponsor category [2] 689 0
Individual
Name [2] 689 0
A/Prof Sally Green
Address [2] 689 0
Monash University
Victoria
Australia
Country [2] 689 0
Australia
Secondary sponsor category [3] 690 0
Individual
Name [3] 690 0
Mr Tony Harris
Address [3] 690 0
Monash University
Victoria
Australia
Country [3] 690 0
Australia
Secondary sponsor category [4] 691 0
Individual
Name [4] 691 0
A/Prof Andrew Forbes
Address [4] 691 0
Monash University
Victoria
Australia
Country [4] 691 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293841 0
Royal Melbourne Hospital Human Research Ethics Committee
Ethics committee address [1] 293841 0
Royal Melbourne Hospital
Victoria
Ethics committee country [1] 293841 0
Australia
Date submitted for ethics approval [1] 293841 0
25/03/2002
Approval date [1] 293841 0
23/04/2002
Ethics approval number [1] 293841 0
2001.115

Summary
Brief summary
Chronic rotator cuff pathology is a musculoskeletal disorder of the shoulder often characterised by pain and weakness. It involves a specific group of muscles in the shoulder, which become damaged over time leading to a chronic loss of full shoulder function and the subsequent loss of quality of life for sufferers. There are few studies comparing the shoulder function of individuals with and without the condition and this is important to help us understand why the condition develops and what treatments might be more effective.

Physiotherapy is often used to improve lost shoulder function. Physiotherapists use techniques that aim to reduce pain and weakness of the shoulder, thereby improving function. However there are very few studies that actually evaluate the effectiveness of physiotherapy for this condition.

The purpose of this project is to evaluate whether physiotherapy intervention, using current accepted techniques, is effective in reducing pain and stiffness and improving strength and shoulder function. Previous experience has shown that the benefits of physiotherapy have not been properly evaluated by good quality research, and we would like to investigate whether or not physiotherapy is a useful intervention for this condition.
Trial website
Trial related presentations / publications
BMJ. 2010; 340: c2756.
Published online 2010 Jun 8. doi: 10.1136/bmj.c2756
Efficacy of standardised manual therapy and home exercise programme for chronic rotator cuff disease: randomised placebo controlled trial
Kim Bennell, Elin Wee, Sally Coburn, Sally Green, Anthony Harris, Margaret Staples, Andrew Forbes and Rachelle Buchbinder.
Public notes

Contacts
Principal investigator
Name 36132 0
Prof Kim Bennell
Address 36132 0
Department of Physiotherapy
University of Melbourne
Country 36132 0
Australia
Phone 36132 0
+61 3 83444135
Fax 36132 0
Email 36132 0
[email protected]
Contact person for public queries
Name 9848 0
Professor Kim Bennell
Address 9848 0
School of Physiotherapy
University of Melbourne
Parkville VIC 3010
Country 9848 0
Australia
Phone 9848 0
+61 3 83444135
Fax 9848 0
+61 3 83443771
Email 9848 0
[email protected]
Contact person for scientific queries
Name 776 0
Professor Kim Bennell
Address 776 0
School of Physiotherapy
University of Melbourne
Parkville VIC 3010
Country 776 0
Australia
Phone 776 0
+61 3 83444135
Fax 776 0
+61 3 83443771
Email 776 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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