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

BackgroundThere 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 6months.MethodsParticipants 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 6months. 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.ResultsBaseline foot pain scores were low, and no differences in foot pain scores were observed between groups over 6months (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 2months, but not at 4 or 6months. 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 6months. Similar improvements were observed for footwear comfort at 2 and 4months. No other differences in secondary outcomes measured were observed at 6months (P>0.05).ConclusionsAddition 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 registrationACTRN12614000209695. Registered 27 February 2014, http://www.anzctr.org.au/TrialSearch.aspx?searchTxt=ACTRN12614000209695&isBasic=True