The effects of a new foot-toe orthosis in treating painful hallux valgus

Objective: To assess the effects of a new foot-toe orthosis on painful hallux valgus. Design: Uncontrolled intervention study. Setting: An outpatient clinic in a tertiary medical center with an orthotic laboratory in Taiwan. Participants: Seventeen patients with painful hallux valgus. Intervention: Application of a new total contact insole with fixed toe separator. Main Outcome Measures: The hallux valgus angle, an 11-point numeric rating scale (NRS-11) for pain assessment, and walking ability scale. Results: The average hallux valgus angle reduction ± standard deviation was 6.5°±3.8° after insole application (P<.001). An improvement on the NRS-11 pain scale from 4.06±2.8 to 0.88±1.17 (P<.001) was noted after immediate insole application and was .42±.67 (P=.002) 3 months later for the 12 patients who completed the study. The walking ability scale improved at least 1 grade or more after the insole was worn for 3 months (P=.002). All patients tolerated the insole well without any clinical evidence of skin ulcers or blisters. Conclusion: Our new total contact insole with fixed toe separator reduced pain, and improved walking ability and the hallux valgus angle. It is an effective alternative treatment for patients with painful hallux valgus.