Effects of Customized Insoles for Individuals With Symptomatic Hallux Valgus
80 patients around the world
Available in Brazil
This is a protocol for a randomized, controlled, blinded clinical trial. Eighty participants
with hallux valgus pain will be evaluated and randomized into two intervention groups (40 per
group): customized insole group or sham insole group. Assessments will be performed at
baseline (T0), after six weeks (T6) and twelve weeks (T12) of insoles use, in addition to the
follow-up that will be performed four weeks after the end of the intervention (T16). The
primary outcome will be pain, assessed by the Numerical Pain Scale and the secondary outcome
will be foot functionality, assessed by the Foot Function Index questionnaire. Statistical
analysis: For normal data, analysis of variance with a mixed design will be considered, and
for non-normal data, the Friedman test will be used, in addition to the interaction of time
per group and intergroup and intragroup differences. The Bonferroni test will be performed in
post hoc analyses. Intent-to-treat analysis will be used. A significance level of 5% and CI
95% will be adopted for all statistical analyses.
Universidade Federal do Rio Grande do Norte
80Patients around the world
This study is for people with
Hallux Valgux
Requirements for the patient
To 75 Years
All Gender
Medical requirements
SponsorUniversidade Federal do Rio Grande do Norte