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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00415441




Registration number
NCT00415441
Ethics application status
Date submitted
21/12/2006
Date registered
22/12/2006
Date last updated
17/01/2013

Titles & IDs
Public title
Effectiveness of Physiotherapy for Chronic Shoulder Pain
Scientific title
Efficacy and Cost-effectiveness of Physiotherapy for Chronic Rotator Cuff Pathology
Secondary ID [1] 0 0
299890
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Shoulder Pain 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Physiotherapy program
Treatment: Surgery - Placebo physiotherapy treatment

Experimental: Active physiotherapy - Manual therapy and home exercise program

Placebo Comparator: Placebo physiotherapy - Manual therapy and home exercise program


Treatment: Surgery: Physiotherapy program


Treatment: Surgery: Placebo physiotherapy treatment
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Shoulder Pain and Disability Index
Timepoint [1] 0 0
Baseline and 11 weeks
Primary outcome [2] 0 0
Participant perceived global rating of change post treatment
Timepoint [2] 0 0
11 weeks
Secondary outcome [1] 0 0
Shoulder Pain and Disability Index at followup
Timepoint [1] 0 0
22 weeks
Secondary outcome [2] 0 0
Participant perceived global rating of change at followup
Timepoint [2] 0 0
22 weeks
Secondary outcome [3] 0 0
Australian Quality of Life Index at followup
Timepoint [3] 0 0
Baseline, 11 weeks and 22 weeks
Secondary outcome [4] 0 0
Isometric Shoulder strength using manual muscle tester post treatment and followup
Timepoint [4] 0 0
Baseline, 11 weeks and 22 weeks
Secondary outcome [5] 0 0
Participant assessment of average pain and restriction of activity post treatment and followup
Timepoint [5] 0 0
Baseline, 11 weeks and 22 weeks
Secondary outcome [6] 0 0
Cost effectiveness analysis
Timepoint [6] 0 0
Baseline, 11 weeks and 22 weeks

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2008
Sample size
Target
Accrual to date
Final
120
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
University of Melbourne - Melbourne
Recruitment postcode(s) [1] 0 0
3010 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
University of Melbourne
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00415441
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kim L Bennell, PhD
Address 0 0
University of Melbourne, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00415441