Effectiveness of Prefabricated and Custom-Made Insole on Pes Planus

Abstract

Background: Pes planus, or flat foot, is a structural deformity characterized by a collapsed medial longitudinal arch, abnormal talar rotation, and altered foot biomechanics, often leading to pain, fatigue, and functional limitations. Foot orthoses, including custom-made and prefabricated insoles, are widely prescribed for conservative management, but their comparative clinical effectiveness remains debated, particularly in adult-acquired flatfoot deformity (AAFD). Objective: To compare the effectiveness of custom-made versus prefabricated insoles on pain, physical function, and quality of life in patients with adult-acquired pes planus. Methods: A randomized controlled trial was conducted at Rehman Medical Institute, Peshawar, from April to July 2021. Seventy participants (aged 12–65 years) with symptomatic flexible pes planus were randomly allocated into two groups (n = 35 each) receiving either custom-made or prefabricated insoles, worn 12–14 hours daily for eight weeks. Pain intensity (Numeric Pain Scale, NPS), foot function (Foot Function Index, FFI), and quality of life (EQ-5D) were measured at baseline, 4 weeks, and 8 weeks. Independent samples t-tests were used to compare outcomes, with p < 0.05 considered significant. Results: Both groups showed significant improvements in pain, functional outcomes, and quality of life over eight weeks (p < 0.05). NPS scores decreased from 6.33 ± 1.39 to 3.77 ± 2.36 in the custom-made group and from 7.67 ± 1.16 to 3.67 ± 5.16 in the prefabricated group. FFI pain scores improved from 63.3 ± 4.09 to 21.6 ± 6.66 and from 53.33 ± 2.88 to 20.67 ± 3.69, respectively. EQ-5D domains showed comparable improvements in both groups. No statistically significant between-group differences were observed at final follow-up across any primary outcomes (p > 0.05). Conclusion: Custom-made and prefabricated insoles are equally effective in reducing pain, enhancing physical function, and improving quality of life in adult-acquired pes planus. Prefabricated insoles offer a cost-effective, accessible alternative to custom orthoses for most patients, with comparable clinical outcomes over short-term follow-up.