Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
W0542
Study information
Scientific title
Acronym
Study hypothesis
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.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Prevention
Patient information sheet
Condition
Rheumatoid arthritis
Intervention
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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Video gait analysis
2. Dynamic load measurements
3. Pain and disability assessment
Evaluation of disease status will be mapped for patients over a 60 month period. Appropriate comparative analyses will be made.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
11/01/1996
Overall trial end date
10/01/2000
Reason abandoned
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
98
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
11/01/1996
Recruitment end date
10/01/2000
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Rheumatology & Rehabilitation Research Unit
Leeds
LS2 9NZ
United Kingdom
Sponsor information
Organisation
Arthritis Research Campaign (ARC) (UK)
Sponsor details
Copeman House
St Mary's Court
St Mary's Gate
Chesterfield
Derbyshire
S41 7TD
United Kingdom
-
info@arc.org.uk
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Arthritis Research Campaign (ARC) (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2002 results in http://www.ncbi.nlm.nih.gov/pubmed/12136891
Publication citations
-
Results
Woodburn J, Barker S, Helliwell PS, A randomized controlled trial of foot orthoses in rheumatoid arthritis., J. Rheumatol., 2002, 29, 7, 1377-1383.