Condition category
Musculoskeletal Diseases
Date applied
18/07/2002
Date assigned
18/07/2002
Last edited
16/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr James Woodburn

ORCID ID

Contact details

Rheumatology & Rehabilitation Research Unit
University of Leeds
School of Medicine
University of Leeds
36 Clarendon Road
Leeds
LS2 9NZ
United Kingdom
+44 (0)113 233 4938

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

http://www.arc.org.uk

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

  1. Results

    Woodburn J, Barker S, Helliwell PS, A randomized controlled trial of foot orthoses in rheumatoid arthritis., J. Rheumatol., 2002, 29, 7, 1377-1383.

Additional files

Editorial Notes