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ISRCTN
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ISRCTN73264439
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ClinicalTrials.gov identifier
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Public title
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Feasibility study to evaluate the clinical and cost effectiveness of foot orthoses in the management of plantar heel pain
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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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RRC300/SG
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Study hypothesis
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Not provided at time of registration
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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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Plantar heel pain
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Participants - inclusion criteria
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48 patients clinically diagnosed with plantar heel pain. The inclusion criteria included the following:
1. Unilateral plantar heel pain of at least 2-months duration
2. A history of night-time or early morning pain, which decreases after walking, and/or increases after exercise or prolonged periods of standing
3. Heel pain severe enough to either cause a reduction in physical activity, a visit to a health professional, or the use of medication
4. Good general health
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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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01/01/2001
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Anticipated end date
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01/01/2002
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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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48
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Interventions
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Two types of foot orthoses (based on costs and function) were measured at baseline, 4 and 8 weeks using general (EQ5D), specific (Foot Health Status Questionnaire) outcome measures together with an economic questionnaire
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Primary outcome measure(s)
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Not provided at time of registration
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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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Department of Health (UK) - Directorate of Health & Social Care
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Trial website
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Publications
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Results in http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=retrieve&db=pubmed&list_uids=15153583
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Contact name
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Dr
Keith
Rome
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Address
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University of Teesside
School of Health and Social Care
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City/town
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Middlesbrough
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Zip/Postcode
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TS1 3BA
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Country
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United Kingdom
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Tel
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+44 (0)1642 384977
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Fax
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+44 (0)1642 384105
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Email
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K.Rome@tees.ac.uk
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Sponsor
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North Tyneside AHA Trust Research Unit (UK)
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Address
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North Tyneside General Hospital
Research Support Unit
Rake Lane
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City/town
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North Shields
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Zip/Postcode
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NE29 8NH
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Country
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United Kingdom
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Date applied
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18/12/2002
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Last edited
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09/10/2007
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Date ISRCTN assigned
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18/12/2002
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