Effects of Customized Insoles for Individuals With Symptomatic Hallux Valgus

Launched by UNIVERSIDADE FEDERAL DO RIO GRANDE DO NORTE · Jun 2, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating the effects of customized insoles on people with a foot condition called hallux valgus, which is a common deformity that causes the big toe to lean towards the other toes, often leading to pain and difficulty walking. The study aims to see if these specially designed insoles can help reduce pain and improve the ability to walk or perform daily activities. While some previous research suggests that using insoles, especially when paired with toe separators, can help alleviate pain, there is still no clear agreement on the best type of insole or how long it should be worn for the best results.

To participate in the trial, individuals must be over 18 years old and have mild to moderate hallux valgus, with pain levels between 3 and 8 on a simple scale. Participants will need to wear the insoles for at least 4 hours a day and use closed-toed shoes. However, those currently undergoing physical therapy for hallux valgus or with certain medical conditions, such as rheumatoid arthritis or recent foot injuries, won't be eligible. If you join the study, you can expect to regularly evaluate how the insoles affect your pain and foot function over time. This research could help improve treatment options for many people experiencing this common foot issue.

Gender

ALL

Eligibility criteria

• 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