Effectiveness of customized insoles in patients with Morton’s neuroma: a randomized, controlled, double-blind clinical trial

Effectiveness of customized insoles in patients with Morton’s neuroma: a randomized, controlled, double-blind clinical trial

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...

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Bibliographic Details
Published in:Clinical rehabilitation Vol. 33; no. 12; pp. 1898 - 1907
Main Authors: de Oliveira, Hilda Alcântara Veiga, Natour, Jamil, Vassalli, Mariana, Rosenfeld, Andre, Jennings, Fabio, Jones, Anamaria
Format: Journal Article
Language:English
Published: London, England SAGE Publications 01-12-2019
Sage Publications Ltd
Subjects:
Adult
Clinical research
Clinical trials
Density
Disability
Double-Blind Method
Double-blind studies
Female
Foot Orthoses
Functional status
Gait
Health status
Health surveys
Humans
Male
Middle Aged
Morton Neuroma - therapy
Outpatients
Pain
Patient Satisfaction
Physical activity
Quality of Life
Questionnaires
Surveys and Questionnaires
Tumors
Visual Analog Scale
Walking
Weight-Bearing
insole
foot function
foot pain
pressure
Morton’s neuroma
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Summary: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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ISSN:0269-2155
1477-0873
DOI:10.1177/0269215519873949