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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
72
Customized insole
Placebo flat insole
Change in pain
Measured by visual analogue scale from 0 cm to 10 cm
Time frame: Baseline, after 6, 12 and 24 weeks
Change in function and foot health
Measured by Foot function index questionnaire
Time frame: Baseline, after 6, 12 and 24 weeks
Change in function, foot healt and quality of life
Measured by Foot Health Status questionnaire
Time frame: Baseline, after 6, 12 and 24 weeks
Change in function
Measured by the distance in the six minute walking test
Time frame: Baseline, after 6, 12 and 24 weeks
Quality of life
Measured by the Short Form -36 questionnaire
Time frame: Baseline, after 6, 12 and 24 weeks
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