Randomised controlled trial of the cost-effectiveness of water-based therapy for lower limb osteoarthritis

ISRCTN	ISRCTN36824298
DOI	https://doi.org/10.1186/ISRCTN36824298
Secondary identifying numbers	HTA 96/32/99

Submission date: 25/04/2003
Registration date: 25/04/2003
Last edited: 08/11/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Tom Cochrane
Scientific

Sport Health & Exercise
University of Staffordshire
Leek Road
Stafford
ST4 2DF
United Kingdom

Phone	+44 (0)1782 295 855
Email	t.cochrane@staffs.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title	Randomised controlled trial of the cost-effectiveness of water-based therapy for lower limb osteoarthritis
Study acronym	ROAR
Study objectives	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.
Ethics approval(s)	Not provided at time of registration.
Health condition(s) or problem(s) studied	Musculoskeletal diseases: Arthritis (osteo)
Intervention	1. Hydrotherapy 2. Standard care
Intervention type	Other
Primary outcome measure	Pain score on the Western Ontario and McMaster Universities OA index (WOMAC).
Secondary outcome measures	Additional outcome measures were included to evaluate effects on quality of life, cost-effectiveness and physical function measurements.
Overall study start date	01/04/2000
Completion date	30/09/2003

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Both
Target number of participants	106
Key inclusion criteria	Patients suffering lower limb osteoarthritis
Key exclusion criteria	Not provided at time of registration.
Date of first enrolment	01/04/2000
Date of final enrolment	30/09/2003

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Sport Health & Exercise

Stafford
ST4 2DF
United Kingdom

Sponsor information

Department of Health (UK)
Government

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom

Phone	+44 (0)1132 545 843
Email	Sheila.Greener@doh.gsi.gov.uk
Website	http://www.dh.gov.uk/en/index.htm
"ROR"	https://ror.org/03sbpja79

Funders

Funder type

Government

NIHR Health Technology Assessment Programme - HTA (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	HTA monograph	01/08/2005		Yes	No

Editorial Notes

08/11/2022: Internal review.