NCT05408156

Effects of Customized Insoles for Individuals With Symptomatic Hallux Valgus

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Universidade Federal do Rio Grande do Norte · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Hallux Valgus
• Foot Diseases
• Foot Deformities

Interventions

Type	Name	Description
OTHER	Insoles	semi-flexible non-moulded insole with a 2.5mm coverage with Shore A 28, a 5mm retrocapital bar with a Shore A 22 and a 2mm infracapital bar of the first metatarsal with a Shore A 35, produced in acetate ethylene vinyl (EVA)

Timeline

• Start date: 2025-08-01
• Primary completion: 2025-12-01
• Completion: 2026-06-01
• First posted: 2022-06-07
• Last updated: 2024-05-21

Locations

1 site across 1 country: Brazil