A Randomized Controlled Trial of Foot Orthoses in RA

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A Randomized Controlled Trial of Foot Orthoses in Rheumatoid Arthritis

JAMES WOODBURN, SHARON BARKER, and PHILIP S. HELLIWELL

ABSTRACT.

Objective. To investigate the clinical effectiveness of early foot

orthosis intervention for painful correctable valgus deformity of the

rearfoot in rheumatoid arthritis (RA).

Methods. Patients with RA were randomized to receive custom manufactured

rigid foot orthoses under podiatry supervision (n = 50) or enter a

control group (n = 48). The control group received foot orthoses only

when prescribed under normal medical care. Foot pain and disability,

using the Foot Function Index (FFI), along with disease activity,

tolerance, and adverse reactions, were serially measured over 30 mo

continuous treatment.

Results. The group assigned foot orthoses demonstrated an immediate

clinical improvement, the effect peaking at 12 mo. At 30 mo the FFI

total score was reduced by 23.1% from baseline in the intervention

group. Area under the curve analysis showed a statistically significant

reduction in FFI scores for total score (p = 0.026), foot pain (p =

0.014), and foot disability (p = 0.016) when intervention was compared

to control scores. There were no confounding effects from differences

between groups for disease activity or pharmacological or other

management strategies. Most patients (96%) used their orthoses and most

found them comfortable (97%), although minor adverse reactions, such as

tender spots, blisters, and callus, were reported in 30% of patients in

the early stages of treatment and persisted in 12% for 30 mo.

Conclusion. Custom designed foot orthoses used continuously over a 30 mo

treatment period resulted in a reduction in foot pain by 19.1%, foot

disability by 30.8%, and functional limitation by 13.5%. Clinical

effectiveness might be enhanced by their use in the early stages of

rearfoot pain and deformity. (J Rheumatol 2002;29:1377-83)