Status:
NOT_YET_RECRUITING
Effects of Customized Insoles for Individuals With Symptomatic Hallux Valgus
Lead Sponsor:
Universidade Federal do Rio Grande do Norte
Conditions:
Hallux Valgus
Foot Diseases
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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 t...
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): custo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05408156
Start Date
August 1 2025
End Date
June 1 2026
Last Update
May 21 2024
Active Locations (1)
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1
Marcelo Cardoso de Souza
Natal, Rio Grande do Norte, Brazil, 59200-000