Condition category
Musculoskeletal Diseases
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
27/10/2010
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

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 measures

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

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

http://www.dh.gov.uk/en/index.htm

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

Results - basic reporting

Publication summary

1. 2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16181565

Publication citations

  1. 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.

Additional files

Editorial Notes