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A randomised controlled trial of intensive physiotherapy vs a home-based exercise treatment programme in knee osteoarthritis
ISRCTN ISRCTN86233347
DOI 10.1186/ISRCTN86233347
ClinicalTrials.gov identifier
EudraCT number
Public title A randomised controlled trial of intensive physiotherapy vs a home-based exercise treatment programme in knee osteoarthritis
Scientific title
Acronym N/A
Serial number at source HTA 94/39/14
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.
Lay summary
Ethics approval Not provided at time of registration.
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Musculoskeletal diseases: Arthritis (osteo)
Participants - inclusion criteria New referrals from primary care with diagnosis of osteoarthritis according to standard criteria.
Participants - exclusion criteria Not provided at time of registration.
Anticipated start date 01/06/1998
Anticipated end date 28/02/2002
Status of trial Completed
Patient information material
Target number of participants 214
Interventions 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.
Primary outcome measure(s) 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 measure(s) Not provided at time of registration.
Sources of funding NIHR Health Technology Assessment Programme - HTA (UK)
Trial website
Publications 2004 HTA monograph in http://www.ncbi.nlm.nih.gov/pubmed/15527668
Contact name Mr  Chris  McCarthy
  Address WarwickEmergency Care & Rehabilitation
Warwick University
Warwick Medical School
Gibbet Hill Campus
  City/town Coventry
  Zip/Postcode CV4 7AL
  Country United Kingdom
  Tel +44 (0)2476 575856
  Fax +44 (0)2476 5758694/ 574 657
  Email c.j.mccarthy@warwick.ac.uk
Sponsor Department of Health (UK)
  Address Quarry House
Quarry Hill
  City/town Leeds
  Zip/Postcode LS2 7UE
  Country United Kingdom
  Tel +44 (0)1132 545 843
  Email Sheila.Greener@doh.gsi.gov.uk
  Sponsor website: http://www.dh.gov.uk/en/index.htm
Date applied 25/04/2003
Last edited 27/08/2009
Date ISRCTN assigned 25/04/2003
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