Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000336482
Ethics application status
Approved
Date submitted
19/03/2007
Date registered
22/06/2007
Date last updated
12/01/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised trial of the effectiveness of soft tissue massage in the treatment of shoulder pain
Scientific title
In patients with non-specific shoulder pain, is soft tissue massage and exercise as good as or better than exercise alone for relief of pain and improvement in shoulder function?
Secondary ID [1] 288289 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Shoulder pain 1887 0
Condition category
Condition code
Musculoskeletal 1982 1982 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: Soft tissue massage (10 minutes, seven sessions, manual therapy) plus stretching and strengthening exercise (20 minutes, seven sessions, therapist prescribed/patient administered). Treatment received over four week period with no more than one treatment per day (2 treatment sessions per week in weeks 1 to 3, then 1 treatment session only in week 4).
Intervention code [1] 1658 0
Treatment: Other
Comparator / control treatment
Comparator:stretching and strengthening exercise (20 minutes, seven sessions, therapist prescribed/patient administered). Treatment received over four week period with no more than one treatment per day (2 treatment sessions per week in weeks 1 to 3, then 1 treatment session only in week 4).
Control group
Active

Outcomes
Primary outcome [1] 2803 0
Change in pain score measured by the Short Form McGill Pain Questionnaire
Timepoint [1] 2803 0
Measured at start of treatment, end of treatment sessions (four weeks from start of trial) and three months after cessation of treatment.
Secondary outcome [1] 4727 0
Change in functional ability measured by the Shoulder Pain and Disability Index (SPADI)
Timepoint [1] 4727 0
Measured at start of treatment, end of treatment sessions (four weeks from start of trial) and three months after cessation of treatment.
Secondary outcome [2] 4728 0
Shoulder range of motion as measured by photograph and then protractor.
Timepoint [2] 4728 0
Measured at start of treatment, end of treatment sessions (four weeks from start of trial) and three months after cessation of treatment.

Eligibility
Key inclusion criteria
Referred to physiotherapy for management of shoulder pain * Able to understand spoken English* Both male and female
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Shoulder pain due to trauma in the previous 4 weeks* Shoulder pain is reproduced with any neck movement.* Shoulder pain due to neoplasm* Shoulder pain due to acute inflammatory condition* Other serious pathology* Worker’s Compensation claim relating to the shoulder pain

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
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table from a statistic book
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Assessor, data analyst
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2007
Actual
1/02/2008
Date of last participant enrolment
Anticipated
Actual
30/09/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
80
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 5022 0
Concord Repatriation Hospital - Concord
Recruitment hospital [2] 5023 0
The Sutherland Hospital - Caringbah

Funding & Sponsors
Funding source category [1] 2122 0
University
Name [1] 2122 0
Faculty of Health Sciences, University of Sydney.
Country [1] 2122 0
Australia
Primary sponsor type
Individual
Name
Paul van den Dolder
Address
43 Rosewall Drive
Menai NSW 2234
Country
Australia
Secondary sponsor category [1] 1929 0
None
Name [1] 1929 0
Nil
Address [1] 1929 0
Country [1] 1929 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3915 0
Concord Hospital
Ethics committee address [1] 3915 0
Ethics committee country [1] 3915 0
Australia
Date submitted for ethics approval [1] 3915 0
Approval date [1] 3915 0
07/04/2006
Ethics approval number [1] 3915 0
CH62/6/2005-109

Summary
Brief summary
The experimental hypothesis is that the addition of specific soft tissue massage will improve range of motion and reported function and reduce reported pain. The findings of this study will assist therapists to decide whether to add specific soft tissue massage to a rotator cuff exercise programme when treating patients with shoulder pain of local mechanical origin.
Trial website
Trial related presentations / publications
van den Dolder PA, Ferreira PH2, Refshauge KM. The effectiveness of soft tissue massage for non-specific shoulder pain. A randomized controlled trial. Phys Ther. 2015 Nov;95(11):1467-77. doi: 10.2522/ptj.20140350. Epub 2015 May 28.
van den Dolder PA, Ferreira PH2, Refshauge KM. Study protocol of a trial into the effectiveness of soft tissue massage for shoulder pain. J Man and Manip Th 2010; 18(1):50-4. doi: 10.1179/106698110X12595770849687.
Public notes

Contacts
Principal investigator
Name 27761 0
Dr Paul van den Dolder
Address 27761 0
43 Rosewall Dr
Menai NSW 2234
Country 27761 0
Australia
Phone 27761 0
61 2 9543 3838
Fax 27761 0
Email 27761 0
paul.vandendolder@sesiahs.health.nsw.gov.au
Contact person for public queries
Name 10847 0
Dr Paul van den Dolder
Address 10847 0
43 Rosewall Dr
Menai NSW 2234
Country 10847 0
Australia
Phone 10847 0
61 2 9543 3838
Fax 10847 0
61 2 4221 6722
Email 10847 0
paul.vandendolder@sesiahs.health.nsw.gov.au
Contact person for scientific queries
Name 1775 0
Prof Kathryn Refshauge
Address 1775 0
Faculty of Health Sciences
University of Sydney
Cumberland Campus (C42)
Lidcombe NSW 2141
Country 1775 0
Australia
Phone 1775 0
+61 2 90367305
Fax 1775 0
+61 2 90367303
Email 1775 0
K.Refshauge@usyd.edu.au

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
SourceTitleYear of PublicationDOI
EmbaseEffectiveness of Soft Tissue Massage for Nonspecific Shoulder Pain: Randomized Controlled Trial.2015https://dx.doi.org/10.2522/ptj.20140350
N.B. These documents automatically identified may not have been verified by the study sponsor.