Condition category
Musculoskeletal Diseases
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
08/04/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Gill Drake

ORCID ID

Contact details

Department of Physiotherapy
Franklin Hospital
Exeter
EX2 9HS
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0620129098

Study information

Scientific title

Acronym

Study hypothesis

The project aims to demonstrate that people with chronic musculo-skeletal pain benefit from group exercises in a social setting in terms of pain relief, reduced disability, improved general well being and ability to cope with symptoms.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Musculoskeletal Diseases: Chronic musculo-skeletal pain

Intervention

The project intends to randomly allocate patients referred by their GP for physiotherapy to a treatment group and a control group.
The control group will wait three months before the water exercise sessions.
The treatment group will be invited to the exercise sessions with no delay.
As this is a pragmatic study, patients in both groups will be able to continue drug and other treatments as their GP/others suggest.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Measures will be taken at 3 months to compare control with treatment and again at 6 months to compare both treatment groups. Measures will be Oswestry Disability Index, SF 36, a visual analogue scale for pain, a pain self efficacy questionnaire and a patient satisfaction questionnaire. Questionnaires will be distributed by the physiotherapist at baseline and by post at 3 and 6 months.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

07/07/2003

Overall trial end date

31/07/2005

Reason abandoned

Eligibility

Participant inclusion criteria

150 subjects minimum age 18, no upper age limit

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

150

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

07/07/2003

Recruitment end date

31/07/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Physiotherapy
Exeter
EX2 9HS
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Exeter Primary Care Trust (UK), NHS R&D Support Funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes