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Effects of a footwear intervention on foot pain and disability in people with gout: a randomised controlled trial
Frecklington M, Dalbeth N, McNair P, Morpeth T, Vandal AC, Gow P, Rome K
Arthritis Research & Therapy 2019 Apr 24;21(104):Epub
clinical trial
7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

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.

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