A randomised controlled trial investigating the efficacy of foot orthoses in rheumatoid arthritis (RA)

ISRCTN	ISRCTN53598448
DOI	https://doi.org/10.1186/ISRCTN53598448
Secondary identifying numbers	W0542

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

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

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Prevention
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	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 study start date	11/01/1996
Completion date	10/01/2000

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	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

England
United Kingdom

Study participating centre

Rheumatology & Rehabilitation Research Unit

Leeds
LS2 9NZ
United Kingdom

Sponsor information

Arthritis Research Campaign (ARC) (UK)
Charity

Copeman House
St Mary's Court
St Mary's Gate
Chesterfield
Derbyshire
S41 7TD
United Kingdom

Email	info@arc.org.uk
Website	http://www.arc.org.uk
"ROR"	https://ror.org/02jkpm469

Funders

Funder type

Charity

Arthritis Research Campaign (ARC) (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	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