ANZCTR - Registration

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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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Shoulder pain

Condition category

Condition code

Musculoskeletal

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]

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]

Change in pain score measured by the Short Form McGill Pain Questionnaire

Timepoint [1]

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]

Change in functional ability measured by the Shoulder Pain and Disability Index (SPADI)

Timepoint [1]

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]

Shoulder range of motion as measured by photograph and then protractor.

Timepoint [2]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Concord Repatriation Hospital - Concord

Recruitment hospital [2]

The Sutherland Hospital - Caringbah

Funding & Sponsors

Funding source category [1]

University

Name [1]

Faculty of Health Sciences, University of Sydney.

Address [1]

East St, Lidcombe, NSW, Australia, 2141.

Country [1]

Australia

Primary sponsor type

Individual

Name

Paul van den Dolder

Address

43 Rosewall Drive
Menai NSW 2234

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Nil

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Concord Hospital

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

07/04/2006

Ethics approval number [1]

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

Dr Paul van den Dolder

Address

43 Rosewall Dr
Menai NSW 2234

Country

Australia

Phone

61 2 9543 3838

Fax

paul.vandendolder@sesiahs.health.nsw.gov.au

Contact person for public queries

Name

Paul van den Dolder

Address

43 Rosewall Dr
Menai NSW 2234

Country

Australia

Phone

61 2 9543 3838

Fax

61 2 4221 6722

paul.vandendolder@sesiahs.health.nsw.gov.au

Contact person for scientific queries

Name

Kathryn Refshauge

Address

Faculty of Health Sciences
University of Sydney
Cumberland Campus (C42)
Lidcombe NSW 2141

Country

Australia

Phone

+61 2 90367305

Fax

+61 2 90367303

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

Source	Title	Year of Publication	DOI
Embase	Effectiveness of Soft Tissue Massage for Nonspecific Shoulder Pain: Randomized Controlled Trial.	2015	https://dx.doi.org/10.2522/ptj.20140350

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically