Comparing Prefabricated and 3D-Printed Foot Orthoses for the Management of Flat Foot Condition: A Randomized Controlled Trial.

Objective: The aim of the study is to investigate the short-term effects of 3D-printed and prefabricated foot orthoses on the management of flat feet.

Design: In this single-blinded study, 63 patients with flat feet were enrolled via convenience sampling. They were randomly assigned to the control and experimental groups, receiving prefabricated and customized 3D-printed foot orthoses, respectively. The assessment tools included a visual analog scale and a modified Quebec User Evaluation of Satisfaction with Assistive Technology questionnaire. The patients scored their pain at weeks 0 and 4 using the visual analog scale. At the end of week 4, patients completed the modified version of the Quebec User Evaluation of Satisfaction with Assistive Technology questionnaire to record their satisfaction with the orthosis.

Results: Visual analog scale scores at week 0 for the two groups were not statistically significant ( P > 0.05). At week 4, the visual analog scale scores of the experimental group reduced significantly ( P < 0.001), whereas the visual analog scale scores of the control group remained statistically insignificant ( P > 0.05). Modified Quebec User Evaluation of Satisfaction with Assistive Technology questionnaire analysis revealed higher satisfaction with orthosis comfort and effectiveness in the experimental group than in the control, while factors like orthosis dimensions, weight, and durability did not differ significantly between groups.

Conclusions: Customized 3D-printed orthoses effectively reduced pain and enhanced patient satisfaction with comfort and effectiveness in 4 wks.