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Effectiveness of customized insoles in patients with Morton's neuroma: a randomized, controlled, double-blind clinical trial [with consumer summary]
de Oliveira HAV, Natour J, Vassalli M, Rosenfeld A, Jennings F, Jones A
Clinical Rehabilitation 2019 Dec;33(12):1898-1907
clinical trial
7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: No; 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*

OBJECTIVE: To assess the effectiveness of customized insole in patients with Morton's neuroma. DESIGN: Double-blind randomized controlled trial with intent-to-treat analysis. SETTING: Outpatients, University Hospital. SUBJECTS: A total of 72 patients with Morton's neuroma met the inclusion criteria and were randomly allocated to either the study group (n = 36) or the control group (n = 36). INTERVENTIONS: The study group was assigned to use a customized insole with metatarsal and arch support made of ethyl vinyl acetate and the control group received a flat insole of the same material, color, and density. MAIN MEASURES: The primary outcome measure was walking pain intensity measured by the visual analogue scale. The secondary outcomes were as follows: pain at rest, palpation, and paresthesia (visual analogue scale); functional disability (6-minute walk test, Foot Function Index, and Foot Health Status Questionnaire); quality of life (Health Survey Short Form-36 (SF-36)); and foot pressure (AM Cube FootWalk Pro program). RESULTS: In the comparison between the groups over time, a statistically significant difference, with improvement in favor of the experimental group, was found for pain during walking (p = 0.048); in the general health domains (p < 0.001) and physical activity (p = 0.025) of the Foot Health Status Questionnaire; in the general Foot Function Index score (p = 0.012); and in the functional capacity domain of the SF-36 questionnaire (p = 0.046). For the other parameters, no difference was found between groups. CONCLUSION: The study demonstrated that customized insole with metatarsal and arch support relieved walking pain and improved patient-reported measures of function in patients with Morton's neuroma.

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