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Clinical Trial Summary

Objective: The aim of the present study was to assess the effectiveness of insole with metatarsal support on pain in patients with Morton`s neuroma and the impact of this insole on function, load distribution in the plantar region, gait variables, quality of life and satisfaction with insole use.

Methods: A randomized, controlled, double-blind, clinical trial with intent-to-treat analysis. Seventy-two patients with Morton`s neuroma were randomly allocated into a study group and control group. One week following the baseline evaluation, the study group received insole with metatarsal support made of ethyl vinyl acetate and the control group received a flat insole of the same material, color and density. The groups were evaluated after 6, 12 and 24 weeks of insole use. The following assessment parameters employed: pain when walking and at rest (END); quality of life (SF-36); foot function (FFI and FHSQ); six-minute walk test (6MWT) and foot pressure analysis using the AM Cube FootWalk Pro program.


Clinical Trial Description

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Study Design


Related Conditions & MeSH terms


NCT number NCT03511677
Study type Interventional
Source Federal University of São Paulo
Contact
Status Completed
Phase N/A
Start date June 1, 2015
Completion date March 31, 2018

See also
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Recruiting NCT03046108 - Blind and Ultrasound Guided Injection in Morton Neuroma Phase 4
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