Effectiveness of custom-made foot orthoses in patients with rheumatoid arthritis: a randomized controlled trial

Objective:To determine the effect of custom-made foot orthoses versus placebo insoles on pain, disability, foot functionality, and quality of life.Design:Double-blinded randomized controlled trial.Setting:University Podiatric Clinical Area.Subjects:Patients with rheumatoid arthritis.Interventions:Patients were randomly assigned to either group A, which received custom-made foot orthoses, or group B, which received placebo, flat cushioning insoles, for three months.Main measures:The primary outcome was foot pain, measured by visual analog scale. Foot functionality, foot-related disability, and quality of life were measured using the Foot Function Index, the Manchester Foot Pain and Disability Index, and 12-Item Short Form Health Survey (SF-12) questionnaires, respectively, at the beginning and at days 30, 60, and 90.Results:A total of 53 patients, aged 59.21 ± 11.38 years, received either the custom-made foot orthoses (N = 28) or the placebo (N = 25). For the analysis of the data, only participants who had...