Evaluating the effects of a three-dimensional printed silicone toe separator for the treatment of hallux valgus: a quasi-experimental study

Background/Aims Hallux valgus is a common musculoskeletal foot disorder, presenting with pain and a progressive valgus deformity of the first ray. The toe separator is one of the choices of treatment; however, research on their effectiveness is limited. The aim of this study was to evaluate the effects of a silicone toe separator, made using three-dimensional printing technology, on pain, foot function and hallux valgus angle in patients with painful hallux valgus. Methods A total of 26 participants were asked to wear a custom-made, three-dimensional printed silicone toe separator for a minimum of 4 hours overnight. The pain score and foot function index were rated by patients at baseline, and after 2 and 12 weeks of use. The hallux valgus angle was radiographically measured before and after 12 weeks of use. Results The mean pain score was significantly reduced after the intervention (baseline: 6.2 ± 1.7; 12 weeks: 2.2 ± 2.2, P<0.05). The mean Foot Function Index scores significantly decreased in regards to pain (baseline: 43.5 ± 17.6; 12 weeks: 15.5 ± 14.8, P<0.05), disability (baseline: 37.9 ± 22.2; 12 weeks: 12.3 ± 11.9, P<0.05) and activity limitation (baseline: 9.0 ± 15.7; 12 weeks: 2.2 ± 6.3, P<0.05). The mean hallux valgus angle decreased by 1.6° by the end of the intervention (baseline: 28.6 ± 8.2; 12 weeks: 27.0 ± 9.3, P<0.05). Conclusions The silicone toe separator significantly reduced pain, and improved foot function and hallux valgus angle. It was considered an alternative treatment for patients with hallux valgus deformity. Implications for practice Findings from this study support the use of custom-made silicone toe separators to prevent the progression of hallux valgus deformity. Orthotists may consider employing three-dimensional printing technology to deliver personalised treatment that not only improves patient comfort and functional outcomes, but also reduces fabrication time.