Effectiveness of a 3D-printed silicone medial arch support on foot pain in individuals with pes planus: A randomized controlled trial.

BACKGROUND

Pes planus, a foot deformity that causes foot pain and functional limitations, is often treated with custom-made foot orthoses as a conservative approach to managing symptoms. In this study, silicone medial arch orthotics produced by 3D printing technology were evaluated for their ability to reduce pain and improve foot function, compared to conventional Total Contact Insoles (TCI).

OBJECTIVES

To assess the effectiveness of 3D-printed orthoses made from soft and hard silicone by evaluating primary outcomes (pain and foot function) and secondary outcomes (plantar pressure, heel valgus angle, and satisfaction), in comparison to those of TCI.

METHODS

A total of 78 participants were randomized into 3 groups: soft and hard 3D-printed arch supports, and TCI. Outcomes were assessed at baseline and 2, 6, and 12 weeks after orthotic wear using various tools, including numeric pain scales, Foot Function Index (FFI) questionnaires, plantar pressure measurements, goniometric measurements of heel valgus angle, and satisfaction surveys.

RESULTS

All 3 groups showed a significant reduction in pain after a 12-week intervention (P < 0.001), with no significant difference between orthotic types. FFI demonstrated progressive and comparable improvement in all groups, with an advantage for TCI. Redistribution of plantar pressure was observed, with no significant difference between the orthoses. The heel valgus angle showed no significant change from baseline in all groups. High satisfaction scores (over 80 %) were achieved for all groups, with no significant differences between them.

CONCLUSION

The 3D-printed arch supports are as effective as TCI in reducing foot pain and improving foot function in participants with pes planus. They represent a viable alternative, but without demonstrated superiority.

TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ACTRN12624000330549).