Effects of a footwear intervention on foot pain and disability in people with gout: a randomised controlled trial

BACKGROUND: There is limited evidence supporting the long-term effect of a foot care package that includes footwear for people with gout. The aim of this study was to investigate the effectiveness of a footwear intervention on foot pain and disability in people with gout over 6 months. METHODS: Participants with gout (n = 94) were randomly allocated to either a control group (podiatric care and gout education) or footwear intervention group (podiatric care and gout education plus a commercially available athletic shoe). Measurements were undertaken at baseline and 2, 4, and 6 months. Primary outcome was foot pain severity. Secondary outcomes were overall pain, foot impairment/disability, footwear comfort, fit, ease and weight. Data were analysed using repeated measures models. RESULTS: Baseline foot pain scores were low, and no differences in foot pain scores were observed between groups over 6 months (adjusted effect estimate: − 6.7, 95% CI − 16.4 to 2.9, P = 0.17). Improvements between groups in overall pain scores (adjusted effect estimate: − 13.2, 95% CI − 22.2 to − 4.3, P < 0.01) and foot impairment/disability scores (− 4.7, 95% CI − 9.1 to − 0.3, P = 0.04) favouring the footwear intervention were observed at 2 months, but not at 4 or 6 months. Improvements between groups in footwear fit (adjusted effect estimate: − 11.1, 95% CI − 21.1 to − 1.0, P = 0.03), ease (− 13.2, 95% CI − 23.8 to − 2.7, P = 0.01) and weight (− 10.3, 95% CI − 19.8 to − 0.8, P = 0.03) favouring the footwear intervention were also observed over 6 months. Similar improvements were observed for footwear comfort at 2 and 4 months. No other differences in secondary outcomes measured were observed at 6 months (P > 0.05). CONCLUSIONS: Addition of footwear to a foot care package did not improve foot pain in people with gout. Short-term improvements in overall pain and foot impairment/disability and more durable improvements in footwear comfort and fit were observed with the footwear intervention. TRIAL REGISTRATION: ACTRN12614000209695. Registered 27 February 2014, http://www.anzctr.org.au/TrialSearch.aspx?searchTxt=ACTRN12614000209695&isBasic=True ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13075-019-1886-y) contains supplementary material, which is available to authorized users.