Effectiveness of the custom-mold room temperature vulcanizing silicone toe separator on hallux valgus: A prospective, randomized single-blinded controlled trial

Background:Silicone toe separator is considered as a conservative treatment for hallux valgus. The prefabricated toe separator does not fit all. However, effectiveness in prescription of the custom-mold toe separator is still unknown.Objectives:To investigate the effect of using a custom-mold room temperature vulcanizing silicone toe separator to decrease hallux valgus angle and hallux pain. The compliances, complications, and satisfactions of toe separator were also explored.Study design:A prospective, randomized single-blinded controlled trial.Methods:A total of 90 patients with a moderate degree of hallux valgus were enrolled in a study at the Foot Clinic, Siriraj Hospital, Thailand. Patients were randomized into two groups; the study group was prescribed a custom-mold room temperature vulcanizing silicone toe separator for 6 h per night for 12 months. Patients in both groups received proper foot care and shoes and were permitted to continue drug treatment.Results:In total, 40 patients in the study gro...