A randomised controlled trial investigating the efficacy of foot orthoses in rheumatoid arthritis (RA)
| ISRCTN | ISRCTN53598448 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN53598448 |
| Protocol serial number | W0542 |
| Sponsor | Arthritis Research Campaign (ARC) (UK) |
| Funder | Arthritis Research Campaign (ARC) (UK) |
- Submission date
- 18/07/2002
- Registration date
- 18/07/2002
- Last edited
- 16/09/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr James Woodburn
Scientific
Scientific
Rheumatology & Rehabilitation Research Unit
University of Leeds
School of Medicine
University of Leeds
36 Clarendon Road
Leeds
LS2 9NZ
United Kingdom
| Phone | +44 (0)113 233 4938 |
|---|
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
1. Video gait analysis |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 10/01/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 98 |
| Key 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 |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 11/01/1996 |
| Date of final enrolment | 10/01/2000 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Rheumatology & Rehabilitation Research Unit
Leeds
LS2 9NZ
United Kingdom
LS2 9NZ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2002 | Yes | No |
