Objectives: To compare clinical outcomes between using a prefabricated foot-toe orthosis, a toe sleeve and a toe separator in treating painful hallux valgus/bunion.

Study design: A single-blinded randomized controlled trial.

Setting: Ramathibodi Hospital, Bangkok, Thailand.

Subjects: Patients with painful hallux valgus/bunion aged between 25 and 70 years old

Methods: Patients were randomly divided into two groups: a toe separator and a toe sleeve group, both received the same treatment protocols. Primary outcomes were pain using a visual analog scale (VAS) and functions using visual analog scale-foot and ankle (VAS-FA) at one- and three-month follow-ups, and patient compliance with adherence to daily use of the orthosis as a secondary outcome.

Results: Compared with the baseline, the mean VAS at one- and three-month follow-ups statistically significantly decreased in both groups [the toe sleeve group: 55.72, 21.72 and 19.33 (p < 0.01); the toe separator group: 66.00, 42.67 and 42.17 (p < 0.01) respectively]. The mean VAS-FA at both follow-ups statistically significantly increased in both groups [the former toe sleeve group:75.89, 88.67 and 83.83 (p = 0.01), the toe separator group: 53.72, 65.33 and 71.17 (p < 0.01), respectively]. The toe sleeve group showed significantly lower VAS scores than the toe separator group at both follow-ups, whereas the VAS-FA did not differ.