Effects of Customized Insoles for Individuals With Symptomatic Hallux Valgus

Study Overview
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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.

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.

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

Conditions
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Hallux Valgus, Foot Diseases, Foot Deformities

Intervention / Treatment
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* Other: Insoles


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Customized insoles group and Sham Insoles Group
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Customized insoles group<br>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. | Other: Insoles<br>* 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)<br>|
| Sham Comparator: Sham Insoles Group<br>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. | Other: Insoles<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Numerical Pain Scale (END) | Pain intensity will be assessed using the Numerical Pain Scale (END), in which individuals will classify their pain on a numerical scale from 0 to 10 points. This scale will be positioned in front of the participant and will vary from zero to ten points, with zero being the complete absence of pain and ten being the worst pain imaginable by the individual. The quantification of pain intensity will be evaluated at the first steps in the morning and throughout the day. | baseline, 6 weeks, 12 weeks, 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Foot Function Index (FFI) | Foot functionality will be measured by the Foot Function Index (FFI) questionnaire, which is capable of measuring the impact of foot pathologies related to pain, disability and activity restriction on the function. It consists of 23 items grouped into three subscales, five items related to disability, nine items related to pain and nine items about activity limitation32. The final result will be the average of all domains (the values are added and divided by three). Results can range from 0 to 100% and are directly proportional to the functional impairment of the foot. | baseline, 6 weeks, 12 weeks, 16 weeks | 
| Change in Treatment expectation | Treatment expectations will be assessed using a 5-point Likert scale. The following will be asked to participants at T0: Do you think that by using customized insoles, you will: 1- get much worse, 2 - get worse, 3 - no changes, 4 - improve, or 5 - greatly improve? | baseline | 
| Change in Self-assessment of treatment | A 5-point Likert scale will be used to assess satisfaction with the intervention. Participants will be asked the following question: How are you feeling after using the insoles?: 1- much worse, 2 - worse, 3 - no changes, 4 - better, or 5 - much better. A 5-point Likert scale will be used to assess satisfaction with the intervention. Participants will be asked the following question: How are you feeling after using the insoles?: 1- much worse, 2 - worse, 3 - no changes, 4 - better, or 5 - much better. | 16 weeks | 
| Change in Blinding test | Participants will be asked which group they believed they were allocated: CIG or SIG. This strategy has been recommended at the end of clinical trials to test whether the blinding strategy adopted was effective Blinding test | 16 weeks | 
| Change in Hours of insole use | Participants of both groups will receive an insole control diary to register the number of hours per day spent with the insole. Participants should keep the diary for 12 weeks and return it to researchers at T12. Monitoring and motivation will be performed via telephone or WhatsApp messages to prevent participants from forgetting to use the insole | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hallux valgus, insoles, pain