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ISRCTN
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ISRCTN86233347
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ClinicalTrials.gov identifier
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Public title
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A randomised controlled trial of intensive physiotherapy vs a home-based exercise treatment programme in knee osteoarthritis.
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Scientific title
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Acronym
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N/A
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Serial number at source
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HTA 94/39/14
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Study hypothesis
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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.
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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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New referrals from primary care with diagnosis of osteoarthritis according to standard criteria.
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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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01/06/1998
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Anticipated end date
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28/02/2002
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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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214
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Interventions
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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.
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Primary outcome measure(s)
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1. Pain relief
2. Improvement in function
3. Improvement in quality of life
4. Prolongation of the period before surgical intervention is thought indicated
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Secondary outcome measure(s)
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Not provided at time of registration.
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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=15527668
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Contact name
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Mr
Chris
McCarthy
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Address
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WarwickEmergency Care & Rehabilitation
Warwick University
Warwick Medical School
Gibbet Hill Campus
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City/town
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Coventry
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Zip/Postcode
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CV4 7AL
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Country
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United Kingdom
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Tel
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+44 (0)2476 575856
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Fax
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+44 (0)2476 5758694/ 574 657
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Email
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c.j.mccarthy@warwick.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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17/01/2008
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Date ISRCTN assigned
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25/04/2003
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