Effects of Customized Insoles for Individuals With Symptomatic Hallux Valgus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-01

Study Completion Date

2026-06-01

Brief Summary

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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.

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Detailed Description

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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

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Hallux Valgus Foot Diseases Foot Deformities

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Customized insoles group and Sham Insoles Group

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

All assessments will be performed by researcher A, who will not be involved with the interventions and will remain blind to the identification of groups. The results of the evaluations will be delivered to researcher C, a researcher with experience in making the insoles, so that they can be made. GPC participants will receive the insoles according to the assessment measurements, five days after the assessment start date.

Each participant will remain identified by numbers and not names. Participants will be informed about the purpose of the study to compare the two interventions using customized insoles. In order not to compromise the blinding of the study, all participants will be submitted to the same evaluation before the production and delivery of the insoles. When the insoles are ready, participants will be scheduled for removal at different times, avoiding possible meetings or exchange of information.

Study Groups

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Customized insoles group

The participant allocated in the CIG will receive a 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) and manufactured by researcher C. The insole will be used on both feet to maintain symmetry between the limbs and generate greater comfort, since this will not be a corrective intervention.

Group Type EXPERIMENTAL

Insoles

Intervention Type OTHER

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)

Sham Insoles Group

The SIG will receive the same unmolded insole with a semi-flexible base and 2.5mm coverage with Shore A 28, but without the bars used in the intervention group.

Group Type SHAM_COMPARATOR

Insoles

Intervention Type OTHER

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)

Interventions

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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)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Individuals of both sexes aged over 18 years;
* Presence of mild to moderate hallux valgus, according to the Manchester scale;
* Presenting no hallux with intensity greater than or equal to 3 points up to 8 points, according to the Numerical Pain Scale (END);
* Be available to actively use the insole for at least 4 hours/day;
* Commitment to wear closed shoes, for example (sneakers, shoes used by the patient, due to: wide toe cap and heel height of 2 to 3 cm) during the study.

Exclusion Criteria

* Being in physical therapy treatment for hallux valgus concomitantly with the research;
* Previous hallux valgus surgeries performed in the last 5 years;
* Presence of foot wounds and wounds, dislocations or metatarsophalangeal fractures in the foot with HV, in the last 5 years
* Presence of diseases such as rheumatoid arthritis, decompensated diabetes, gout, neurodegenerative diseases;
* Cognitive and mental disorder being unable to respond; those related to the study

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No