Contact information
Type
Scientific
Primary contact
Mrs Heather Epps
ORCID ID
Contact details
Department of Physiotherapy
The Childrens Trust
Tadworth Court
Surrey
KT20 5RU
United Kingdom
+44 (0)207 636 8333 ext. 2151
hepps@thechildrenstrust.org.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 96/32/08
Study information
Scientific title
Acronym
Study hypothesis
The primary objective of the project is to assess the effects of hydrotherapy and land physiotherapy versus land physiotherapy alone on the quality of life and outcome disease for children with rheumatic disorders. The secondary objective is to analyse the cost effectiveness of the use of hydrotherapy as a treatment modality. A multicentre randomised, blinded study will be performed on 200 patients with rheumatic disease for at least 3 months. 200 patients (age 5-19) will be enrolled from rheumatology clinics.
In each group 100 subjects will receive standardised land physiotherapy treatment and 100 subjects will receive additional hydrotherapy. Internationally agreed outcome measures, as well as muscle strength and physical fitness will be recorded prior to the treatment period and at 2 and 6 months follow up clinic visits. A cost utility analysis will be undertaken and quality of life measures analysed relating cost to benefit of intervention.
Ethics approval
Not provided at time of registration.
Study design
Multicentre blind 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: Arthritis (rheumatoid)
Intervention
1. Hydrotherapy and land physiotherapy
2. Land physiotherapy only
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Quality of life and disease outcome
Secondary outcome measures
Not provided at time of registration.
Overall trial start date
01/09/1999
Overall trial end date
31/12/2001
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Children with rheumatic disorders
Participant type
Patient
Age group
Child
Gender
Not Specified
Target number of participants
200
Participant exclusion criteria
Not provided at time of registration.
Recruitment start date
01/09/1999
Recruitment end date
31/12/2001
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Physiotherapy
Surrey
KT20 5RU
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NIHR Health Technology Assessment Programme - HTA (UK)
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
Basic results (scientific)
Publication list
1. 2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16181565
Publication citations
-
Results
Epps H, Ginnelly L, Utley M, Southwood T, Gallivan S, Sculpher M, Woo P, Is hydrotherapy cost-effective? A randomised controlled trial of combined hydrotherapy programmes compared with physiotherapy land techniques in children with juvenile idiopathic arthritis., Health Technol Assess, 2005, 9, 39, iii-iv, ix-x, 1-59.