Effects of customized insoles for people with symptomatic hallux valgus: Protocol for a randomized controlled sham trial
Hallux Valgus. Insoles. Orthoses. Conservative Treatment.
Introduction: Hallux valgus is one of the most recurrent deformities in the forefoot, its prevalence increases with age, representing approximately 23% in adulthood, being more common in females. Some studies indicate that the use of insole with toe separator promotes pain relief and that this may be related to better hallux alignment. 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. Objective: To evaluate the effect of customized insole on pain in people with symptomatic hallux valgus. Methods: This is a protocol for a controlled, randomized, blinded clinical trial. Eighty participants with hallux valgus pain will be evaluated and randomized into two intervention groups: custom insole or sham insole. Assessments will be performed at baseline (T0), after six (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 outcomes will be: foot function, assessed by the Foot Function Index questionnaire; the quality of life, by the SF-36; and pain catastrophizing using the Pain Catastrophizing Scale. 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. Ethics and disclosure: This protocol will be submitted to the UFRN/FACISA Ethics Committee. The results of the study will be disseminated to participants and submitted to a peer-reviewed journal and scientific meetings.