Background Therapeutic footwear is recommended in guidelines for the treatment of foot problems in patients with rheumatoid arthritis (RA) and commonly prescribed and frequently used, especially in patients with established RA, foot deformities or erosions in foot joints.
Objectives The objectives of this study were to summarize the effectiveness of therapeutic footwear on foot function, pain, physical functioning, health-related quality of life, adherence, adverse events and patient satisfaction in patients with RA.
Methods All randomized controlled trials, randomized controlled cross-over trials, (quasi-experimental) clinical trials, and uncontrolled studies investigating the effect of therapeutic footwear in patients with RA related foot problems were included. Therapeutic footwear consists of custom-made or ready-made shoes. A literature search was conducted in The Cochrane Central Registry for Controlled Trials (CENTRAL), PubMed, EMBASE and PEDro up to January 19, 2017. Selection and inclusion of articles, data extraction (using a standardized template) and assessment of methodological quality (using a checklist for between-group and within-group comparisons) was conducted by two independent reviewers. Quantitative data analyses was conducted, when quantitative data analysis was not possible qualitative data analysis was performed.
Results Thirteen studies were identified. In five studies, one of which was of high quality, between-group differences were reported. In twelve studies, of which two were of high quality, within-group differences were reported. Qualitative data-syntheses for the within-group differences of custom-made therapeutic footwear resulted in weak evidence for the reduction of foot pain and improvement of physical functioning. Quantitative data-analyses of the within-group differences of ready-made therapeutic footwear resulted in a medium to large effect for the reduction of foot pain (SMD -0.68, 95% CI -1.00 to -0.37; P=0.0001; 162 participants), and a small to medium effect for the improvement of physical functioning (SMD -0.32, 95% CI -0.62 to -0.02; P=0.04; 128 participants). Qualitative data-analyses of the between-group differences of ready-made therapeutic footwear resulted in inconclusive evidence for foot pain and physical functioning.
Conclusions In within-group designs, there is weak evidence for the reduction of foot pain and improvement of physical functioning after wearing custom-made therapeutic footwear. Furthermore, in within-group designs there is a medium to large effect of ready-made therapeutic footwear on the reduction of foot pain, and a small to medium effect on the improvement of physical function. Controlled, between-group designs resulted in inconclusive evidence. A definite RCT is necessary to investigate the between-group effectiveness of therapeutic footwear in patients with RA.
Disclosure of Interest None declared
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