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 group and 39 patients in the control group completed the study. The hallux valgus angle was obtained through radiographic measurement. At month 12, both groups had significant differences in mean hallux valgus angle with a decrease of 3.3° ± 2.4° for the study group and increase of 1.9° ± 1.9° for the control group. There were statistically significant differences of hallux valgus angle between the two groups ( p < 0.05) at the end of the study. Hallux pain was decreased in the study group.

CONCLUSION

A custom-mold room temperature vulcanizing silicone toe separator can decrease hallux valgus angle and pain with no serious complications. Clinical relevance The custom-mold room temperature vulcanizing silicone toe separator for treatment of hallux valgus reduces deformity and hallux pain.