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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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/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
Other publications