Chadchavalpanichaya Navaporn, Prakotmongkol Voraluck, Polhan Nattapong, Rayothee Pitchaya, Seng-Iad Sirirat
Sirindhorn School of Prosthetics and Orthotics, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.
Prosthet Orthot Int. 2018 Apr;42(2):163-170. doi: 10.1177/0309364617698518. Epub 2017 Mar 20.
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.
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.
A prospective, randomized single-blinded controlled trial.
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.
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.
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.
硅胶脚趾分离器被认为是治疗拇外翻的一种保守疗法。预制的脚趾分离器并不适合所有人。然而，定制模具的脚趾分离器的疗效仍不明确。
研究使用定制模具的室温硫化硅胶脚趾分离器来减小拇外翻角度和缓解拇趾疼痛的效果。同时探讨脚趾分离器的依从性、并发症及满意度。
一项前瞻性、随机单盲对照试验。
泰国诗里拉吉医院足部诊所共纳入90例中度拇外翻患者。患者被随机分为两组；研究组每晚佩戴定制模具的室温硫化硅胶脚趾分离器6小时，持续12个月。两组患者均接受适当的足部护理并穿着合适的鞋子，且允许继续药物治疗。
研究组40例患者和对照组39例患者完成了研究。通过影像学测量获得拇外翻角度。在第12个月时，两组的平均拇外翻角度有显著差异，研究组减小了3.3°±2.4°，对照组增加了1.9°±1.9°。研究结束时，两组之间的拇外翻角度存在统计学显著差异（p<0.05）。研究组的拇趾疼痛减轻。
定制模具的室温硫化硅胶脚趾分离器可减小拇外翻角度并减轻疼痛，且无严重并发症。临床意义 定制模具的室温硫化硅胶脚趾分离器用于治疗拇外翻可减轻畸形和拇趾疼痛。
