de Oliveira HAV, Natour J, Vassalli M, et al. Effectiveness of customized insoles in patients with Morton`s neuroma: a randomized, controlled, double-blind clinical trial. Clin Rehabil. 2019 Sep 11:269215519873949. doi: 10.1177/0269215519873949. (Original study)

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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Comments from MORE raters

Physician rater

I'm not sure if it can be fully considered double-blind, but it's still useful.

Physician rater

This study is quite small and the findings are not surprising but may serve as a nudge clinicians to refer patients to a podiatrist.
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