Randomized controlled trial for clinical effects of varying types of insoles combined with specialized shoes in patients with rheumatoid arthritis of the foot

Objective: To determine the effects of specialized shoes with insoles in patients with rheumatoid arthritis and the differences in terms of type of insole and anatomical location of foot pathology. Design: Single-blinded randomized controlled trial. Setting: Outpatients of physical medicine and rehabilitation clinic at university hospital. Subjects: Forty-two patients with rheumatoid foot lesions were randomly assigned to two different orthotic intervention groups. The anatomical locations of the foot lesions were recorded (hindfoot or forefoot). Intervention: Participants were provided with an extra deep forefoot-rockered shoe and either a custom-made semi-rigid insole or a ready-made simple soft insole. They wore the provided footwear for at least 3 hours a day over six months. Main outcome measures: Primary outcome measures were foot pain visual analogue scale (VAS) scores and Foot Function Index (FFI). Secondary outcome measures were erythrocyte sedimentation rate and C-reactive protein levels in blood, amounts of medications and active joint counts. These were checked at baseline and post intervention. Results: Eight patients dropped out at follow-up after six months of treatment. At six-month follow-ups, VAS scores and total Foot Function Index scores had decreased significantly in both groups versus baseline but intergroup comparison showed no significant differences in view of type of insoles and anatomical locations of foot pathology. Conclusions: We were unable to identify differences between the types of insoles in terms of their clinical effects or between anatomical locations of foot lesions in the two groups, but both groups improved. Therapeutic shoes plus soft insoles might be effective enough in terms of foot pain and foot function for specific patients with rheumatoid foot problems regardless of the location of foot pathology.