A clinical trial of specialist footwear for patients with rheumatoid arthritis

Abstract

Objectives: The structural and functional changes in the RA foot often affect the patient's gait and mobility, impacting on the patient's quality of life. Successful management of these foot pathologies and resultant problems can involve the provision of specialist therapeutic footwear. The aim of the study was to evaluate the value of a new footwear design based on patients' opinions compared with a traditional footwear design.

Method: A total of 80 patients with RA of 5 yrs or more duration, foot deformity, difficulty in being able to obtain suitable retail footwear and self-reported foot pain were recruited. Patients were randomly assigned to either an intervention group (new design) or the control group (traditional design). Patients completed two specific health-related quality of life scales (Foot Health Status Questionnaire and the Foot Function Index) at baseline and after 12 weeks.

Results: Only 36 patients completed the trial. Ten refused the footwear outright and 34 withdrew from the study after the footwear was supplied, due to either non-footwear related problems or reasons related to the footwear. Both the specific health-related quality of life scales demonstrated significant improvement from baseline to week 12 with the intervention group (P < 0.05). There was no significant difference in both specific health-related quality of life scales after week 12 with the traditional group (P > 0.05).

Conclusions: Improvement in pain and patient satisfaction with the new design of footwear for patients with RA over the traditional design indicates the importance of patient involvement in the design process and throughout the process of supplying and monitoring the footwear. The fact that the new-design shoe was based on patients' involvement in the design process in a previous study may be the most important factor in its success. In order to meet the clinical goals of this footwear the patients need to wear them, and to achieve this the patients' requirements need to be acknowledged.