Effects of Customized Insoles for Individuals With Symptomatic Hallux Valgus

Universidade Federal do Rio Grande do Norte

Status: Begins enrollment this month

Conditions: Hallux Valgus; Foot Diseases; Foot Deformities

Treatments: Other: Insoles

Study type: Interventional

Funder types: Other

Identifiers

NCT05408156

UFRNHáluxValgus

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups

Customized insoles group

Experimental group

Description:

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.

Treatment:

Other: Insoles

Sham Insoles Group

Sham Comparator group

Description:

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.

Treatment:

Other: Insoles