Effectiveness of Prefabricated Silicone Toe Separator on Hallux Valgus


  • Kandang C Bangplee Hospital, Samutprakarn
  • Phakamas Tanvijit Department of Rehabilitation Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand
  • Harnphadungkit K Department of Rehabilitation Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand
  • Chadchavalpanichaya N Department of Rehabilitation Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand


hallux, hallux valgus, pain, orthotic device, foot


Objectives: To determine effectiveness of a prefabricated silicone toe separator to decrease hallux valgus angle (HVA) |and hallux pain, and also investigate possible complications, compliance, and users’ satisfaction.

Study design: Prospective cohort analytical study design

Setting: Foot Clinic, Department of Rehabilitation Medicine, Faculty of Medicine Siriraj Hospital

Subjects: Forty patients with hallux valgus deformity at moderate level (HVA 20°- 40°) were recruited from February to March 2019.

Methods: The participants were asked to wear a prescribed prefabricated silicone toe separator in proper shoes 6 hours a day for 12 months, and continue their current medication and treatment regimen. They had to record the duration of wearing the toe separator and complications in a logbook on a weekly basis. Follow-up pain numeric rating scale (pain NRS) and HVA measured from radiography were evaluated at 6 months, and 12 months after receiving the device.

Results: Thirty-eight participants returned for follow-up at a 6-month and 33 participants continued until the end of the study. Based on per protocol and intention to treat analyses, the results showed no progression of HVA. Pain at the 1st metatarsophalangeal joint decreased with a statistically significant difference (p < 0.001) at 12 months. Nearly 60% of participants had minor complications. The common complication was discomfort at the 1st web space.

Conclusion: Wearing a prefabricated silicone toe separator in proper shoes for a year in patients with a moderate degree of hallux valgus could prevent the progression of hallux valgus angle and decrease hallux pain without serious complications.

Keywords: hallux, hallux valgus, pain, orthotic device, foot


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