The Efficacy of Graded Arch Support Insoles in Patients with Common Foot Ailments; A Clinical Trial
Authors: Taseh Atta , Detels Kelsey , Ghandour Samir , Karaismailoglu Bedri , Ashkani-Esfahani Soheil , Landsman Adam S. 
Published: December 2024

Category:

Midfoot/Forefoot; Hindfoot

Introduction/Purpose:

Arch-support insoles are frequently used as part of the treatment protocol for a variety of common foot ailments including metatarsalgia, and plantar fasciitis. While custom-molded insoles are considered to be the most efficacious ones, prefabricated insoles are still preferred due to their lower price and availability. However, there's ongoing skepticism about their capacity to meet the diverse and changing biomechanical requirements of every individual over time. In this study, we investigated the effect of a patient-specific, three-level-graded arch support system for the treatment of common foot ailments using patient-reported outcome measures of pain.

Methods:

A single-armed clinical trial was conducted including patients aged >18 years with a diagnosis of plantar fasciitis or metatarsalgia. Based on initial measurements, each participant was given three specific arch support orthotics (Good Feet™, Dr.’s Own, LLC) with varying arch heights, to be worn at tolerance, along with a pair of sneakers for standardization of the footwear condition. Symptomatic relief was measured at the baseline-, fourth-, eighth-, and twelfth-week appointments using the Patient Reported Outcomes Measurement System (PROMIS) for pain Intensity, pain Interference, and the American Orthopaedic Foot and Ankle Society (AOFAS) questionnaire. Moreover, the structural changes of the foot were also measured using Weight-bearing Computed Tomography (WBCT) scans, and X-rays of the foot with and without the insoles at the initial visit. Data were analyzed employing the T-test, Wilcoxon Signed Rank, and Friedman tests where applicable. A p-value below 0.05 was considered to be statistically significant.

Results:

A total of 43 patients with a mean (SD) age of 41.69 (12.21) years, a female-to-male ratio of 1.3:1, and a body mass index (SD) of 25 (4.04) were included in the study. PROMIS pain interference and intensity scores improved significantly starting from the fourth week (p=0.017, and 0.003, respectively). Additionally, the AOFAS questionnaire demonstrated enhanced scores notably on the lesser metatarsophalangeal-interphalangeal, and midfoot subscales with p-values of 0.001, and < 0.001, respectively (Figure 1.). Moreover, the navicular height on WBCT and the talo-navicular angle on lateral view X-rays increased when the insoles were utilized (p=0.046, and < 0.001, respectively; Figure 2.).

Conclusion:

This study revealed the significance of prefabricated graded arch supports for the symptomatic relief of patients with plantar fasciitis and metatarsalgia. These clinical improvements were also supported by discernable anatomical changes as evidenced by foot radiography and WBCT assessments. Given these findings, we believe future research should be focused on evaluating the efficacy of these insoles in managing additional foot pathologies. Moreover, it is imperative to explore the biomechanical ramifications of such supports on the dynamic alignment of the foot, to further understand their role in altering foot structure and function.