Contact information
Type
Scientific
Primary contact
Mr Chris McCarthy
ORCID ID
Contact details
WarwickEmergency Care & Rehabilitation
Warwick University
Warwick Medical School
Gibbet Hill Campus
Coventry
CV4 7AL
United Kingdom
+44 (0)2476 575856
c.j.mccarthy@warwick.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 94/39/14
Study information
Scientific title
Acronym
Study hypothesis
The objective of the study is to determine whether an intensive regime of physiotherapy is superior to a home-based exercise programme in relation to the following key outcomes: (1) pain relief, (2) improvement in function, (3) improvement in quality of life, (4) prolongation of the period before surgical intervention is thought indicated. Eligible patients, who will be recruited from participating orthopaedic and rheumatology clinics, will be new referrals from primary care with diagnosis of osteoarthritis according to standard criteria. 180 patients will be recruited and randomised either to active physiotherapy or a home-based exercise teaching programme. All subjects, where appropriate, will be given advice on weight reduction and simple analgesics.
Outcome will be assessed at eight weeks, six months, and one year.
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: Arthritis (osteo)
Intervention
Please note that, as of 17 January 2008, the start and end date of this trial were updated from 1 February 1998 and 31 January 2001 to 1 June 1998 and 28 February 2002, respectively.
Interventions:
1 Active physiotherapy
2. Home-based exercise teaching programme.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Pain relief
2. Improvement in function
3. Improvement in quality of life
4. Prolongation of the period before surgical intervention is thought indicated
Secondary outcome measures
Not provided at time of registration.
Overall trial start date
01/06/1998
Overall trial end date
28/02/2002
Reason abandoned
Eligibility
Participant inclusion criteria
New referrals from primary care with diagnosis of osteoarthritis according to standard criteria.
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
214
Participant exclusion criteria
Not provided at time of registration.
Recruitment start date
01/06/1998
Recruitment end date
28/02/2002
Locations
Countries of recruitment
United Kingdom
Trial participating centre
WarwickEmergency Care & Rehabilitation
Coventry
CV4 7AL
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
Results - basic reporting
Publication summary
2004 HTA monograph in http://www.ncbi.nlm.nih.gov/pubmed/15527668
Publication citations
-
HTA monograph
McCarthy CJ, Mills PM, Pullen R, Richardson G, Hawkins N, Roberts CR, Silman AJ, Oldham JA, Supplementation of a home-based exercise programme with a class-based programme for people with osteoarthritis of the knees: a randomised controlled trial and health economic analysis., Health Technol Assess, 2004, 8, 46, iii-iv, 1-61.