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Pilot studies of the effects of custom semi-rigid full-foot orthotics on planta-surface foot pain and anterior knee pain: towards evidence based practice
ISRCTN ISRCTN45432551
ClinicalTrials.gov identifier
Public title Pilot studies of the effects of custom semi-rigid full-foot orthotics on planta-surface foot pain and anterior knee pain: towards evidence based practice
Scientific title
Acronym N/A
Serial number at source N0544093555
Study hypothesis Orthotics treatment of foot and knee pain
Lay summary Not provided at time of registration
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Signs and Symptoms: Knee/foot pain
Participants - inclusion criteria Not provided at time of registration
Participants - exclusion criteria Not provided at time of registration
Anticipated start date 31/10/2000
Anticipated end date 21/10/2003
Status of trial Completed
Patient information material
Target number of participants 40 subjects (PROJ 10/10/2000)
Interventions Subjects will be referred via specialist orthopaedic and rheumatology clinics and will sign informed consent. They will be assessed by a Chartered Physiotherapist (Kristin Giussani) which will include measurements of strength, range of movement, and outcome measures of pain and function. They will then be fitted with either a real or placebo customised shoe insert (an orthotic) which they will use for a 1 month period. The patient will keep a diary of their pain and function over a 1-month period.
Primary outcome measure(s) Not provided at time of registration
Secondary outcome measure(s) Not provided at time of registration
Sources of funding Cambridge Consortium - Addenbrooke's (UK)
Trial website
Publications
Contact name Mr  Joshua T  Wies
  Address Box 194
Rheumatology Research Unit
Addenbrooke's NHS Trust
  City/town Cambridge
  Zip/Postcode CB2 2QQ
  Country United Kingdom
  Tel +44 (0)1223 217459
  Email
Sponsor Record provided by the NHS Trusts Clinical Trials Register - Department of Health (UK)
  Address The Department of Health
Richmond House
79 Whitehall
  City/town London
  Zip/Postcode SW1A 2NL
  Country United Kingdom
  Tel +44 (0)207 307 2622
  Fax +44 (0)207 307 2623
  Email dhmail@doh.gsi.org.uk
  Sponsor website: http://www.doh.gov.uk
Date applied 12/09/2003
Last edited 22/09/2011
Date ISRCTN assigned 12/09/2003
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