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ISRCTN
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ISRCTN53598448
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ClinicalTrials.gov identifier
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Public title
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A randomised controlled trial investigating the efficacy of foot orthoses in rheumatoid arthritis (RA)
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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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W0542
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Study hypothesis
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A common rearfoot problem in rheumatoid arthritis is the progressive development of valgus heel deformity. This condition is underdiagnosed and management strategies generally employed at a late stage when secondary features have developed and the deformity is uncorrectable. The mechanical cause of valgus heel deformity is excessive subtalar pronation during the contact phase of gait. Foot orthoses used by podiatrists have been shown to correct pronation but their use has not been formally evaluated in rheumatoid arthritis. The aim of this study is to evaluate the effectiveness of foot orthoses in preventing valgus heel deformity and preventing secondary features.
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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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Rheumatoid arthritis
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Participants - inclusion criteria
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1. Current history of bilateral subtalar ± ankle ± talonavicular pain, and valgus heel deformity
2. Normal range of motions was required at the ankle, subtalar and midtarsal joints
3. Passive range of motion testing was used to ensure the valgus heel deformity was correctable with 10 degrees of subtalar joint inversion past neutral
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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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11/01/1996
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Anticipated end date
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10/01/2000
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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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Not provided at time of registration
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Interventions
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Patients with RA were randomised to receive custom manufactured rigid foot orthoses under podiatry supervision or enter a control group.
The control group received foot orthoses only when prescribed under normal medical care.
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Primary outcome measure(s)
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Video gait analysis, dynamic load measurements, pain and disability assessment and evaluation of disease status will be mapped for patients over a 60 month period. Appropriate comparative analyses will be made.
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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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Arthritis Research Campaign
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Trial website
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Publications
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Contact name
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Dr
James
Woodburn
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Address
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Rheumatology & Rehabilitation Research Unit
University of Leeds
School of Medicine
University of Leeds
36 Clarendon Road
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City/town
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Leeds
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Zip/Postcode
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LS2 9NZ
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Country
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United Kingdom
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Tel
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+44 (0)113 233 4938
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Email
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mrpjw@leeds.ac.uk
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Sponsor
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Arthritis Research Campaign (ARC) (UK)
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Address
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Copeman House
St Mary's Court
St Mary's Gate
Chesterfield
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City/town
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Derbyshire
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Zip/Postcode
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S41 7TD
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Country
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United Kingdom
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Email
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info@arc.org.uk
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Sponsor website:
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http://www.arc.org.uk
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Date applied
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18/07/2002
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Last edited
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21/11/2005
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Date ISRCTN assigned
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18/07/2002
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