Clinical Outcomes between Using Prefabricated Toe Sleeve versus Toe Separator in Patients with Painful Hallux Valgus: A Single-Blinded Randomized Control Trial

Sukij Laohajaroensombat; Satetha Vasaruchapong; Jakrapong Orapin; Suwimol Prusmetikul

Authors

Sukij Laohajaroensombat Department of Orthopedics, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand
Satetha Vasaruchapong Chakri Naruebodindra Medical Institute, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Samut Prakan, Thailand
Jakrapong Orapin Department of Orthopedics, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand
Suwimol Prusmetikul Department of Orthopedics, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand

Keywords:

bunion, foot orthoses, hallux valgus, pain

Abstract

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.

Conclusions: The toe sleeve significantly reduced pain better than the toe separator did in patients with hallux valgus at 1 and 3 months after usage. The VAS-FA also significantly improved in both groups without a significant inter-group difference. Both, a toe sleeve and a toe separator, improved functions.

Keywords: bunion, foot orthoses, hallux valgus, pain

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