| Source of record | UK Trials |
| ISRCTN | ISRCTN53598448 |
| Date ISRCTN assigned | 18/07/2002 |
| Local reference number(s) | W0542 |
| Public title | A randomised controlled trial investigating the efficacy of foot orthoses in rheumatoid arthritis (RA) |
| Scientific title |
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| Acronym | N/A |
| Disease/condition/study domain | Rheumatoid arthritis |
| 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. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - 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 |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 11/01/1996 |
| Anticipated end date | 10/01/2000 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | 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. |
| Primary outcome measure(s) | 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. |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Arthritis Research Campaign |
| Sponsor name | Arthritis Research Campaign (UK) |
| Sponsor details | Copeman House
St Mary's Court
St Mary's Gate
Chesterfield
Derbyshire
United Kingdom
S41 7TD |
| Sponsor email | info@arc.org.uk |
| Sponsor website | http://www.arc.org.uk |
| Contact name | Dr James Woodburn |
| Contact details | Rheumatology & Rehabilitation Research Unit
University of Leeds
School of Medicine
University of Leeds
36 Clarendon Road
Leeds
United Kingdom
LS2 9NZ |
| Contact telephone | +44 (0)113 233 4938 |
| Contact email | mrpjw@leeds.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN53598448 |
| Date last extracted from ISRCTN register | 17/04/2008 |
