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Effects of Customized Insoles for Individuals With Symptomatic Hallux Valgus

Hallux Valgus Clinical Trial

Official title:
Effects of Customized Insoles for Individuals With Symptomatic Hallux Valgus: Protocol for a Sham-controlled Randomized Trial

Clinical Trial Summary

Hallux valgus is one of the most common forefoot deformities. Its prevalence increases with age, representing approximately 23% in adulthood, being more common in females. Some studies indicate that the use of the insole associated with the finger separator promotes pain relief and that this may be related to better alignment of the hallux. However, there is still no consensus about the ideal insole or how long it should be used to relieve pain or improve function in patients with hallux valgus. Therefore, the objective of this study will be to evaluate the effect of the customized insole on pain and function of individuals with symptomatic hallux valgus.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05408156
Study type Interventional
Source Universidade Federal do Rio Grande do Norte
Contact Marcelo C de Souza, PT, PhD
Phone 558432912411
Email marcelo.cardoso@ufrn.br
Status Not yet recruiting
Phase N/A
Start date August 1, 2024
Completion date December 1, 2025
View Details
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