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ISRCTN
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ISRCTN36824298
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ClinicalTrials.gov identifier
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Public title
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Randomised controlled trial of the cost-effectiveness of water-based therapy for lower limb osteoarthritis
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Scientific title
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Acronym
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ROAR
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Serial number at source
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HTA 96/32/99
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Study hypothesis
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Hydrotherapy is believed to be an effective treatment for osteoarthritis (OA). Many physiotherapy centres have specialise hydrotherapy pools but, most remain under utilised because they are not cost-effective to run. Thus a valued service is unrealised on cost grounds. In recent years, aqua- aerobics has become a popular mode of exercise and is used by many people who suffer from "joint" problems. Despite this growth in popularity, neither the efficacy nor the cost-effectiveness of community-based water therapy in the rehabilitation of OA has been evaluated in a well-designed trial. The potential value of this form of treatment to the NHS, therefore, remains unknown.
A randomised controlled trial is proposed, to determine:
1. The efficacy of water exercise in the treatment of OA of the lower limb
2. The cost-effectiveness of such an approach
3. The longer term implications of such intervention
Stages 2. and 3. will be contingent on the outcome of stage 1.
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Ethics approval
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Not provided at time of registration.
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Musculoskeletal diseases: Arthritis (osteo)
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Participants - inclusion criteria
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Patients suffering lower limb osteoarthritis
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Participants - exclusion criteria
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Not provided at time of registration.
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Anticipated start date
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01/04/2000
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Anticipated end date
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30/09/2003
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Status of trial
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Completed
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Patient information material
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Target number of participants
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106
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Interventions
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1. Hydrotherapy
2. Standard care
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Primary outcome measure(s)
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Pain score on the Western Ontario and McMaster Universities OA index (WOMAC).
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Secondary outcome measure(s)
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Additional outcome measures were included to evaluate effects on quality of life, cost-effectiveness and physical function measurements.
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Sources of funding
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NIHR Health Technology Assessment Programme - HTA (UK)
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Trial website
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Publications
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http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16095546
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Contact name
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Prof
Tom
Cochrane
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Address
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Sport Health & Exercise
University of Staffordshire
Leek Road
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City/town
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Stafford
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Zip/Postcode
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ST4 2DF
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Country
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United Kingdom
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Tel
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+44 (0)1782 295 855
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Fax
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+44 (0)1782 294 321
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Email
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t.cochrane@staffs.ac.uk
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Sponsor
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Department of Health (UK)
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Address
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Quarry House
Quarry Hill
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City/town
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Leeds
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Zip/Postcode
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LS2 7UE
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Country
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United Kingdom
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Email
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Sheila.Greener@doh.gsi.gov.uk
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Sponsor website:
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http://www.dh.gov.uk/en/index.htm
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Date applied
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25/04/2003
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Last edited
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14/01/2008
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Date ISRCTN assigned
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25/04/2003
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