Validation and Utility of a Novel Foot Offloading Device: Improving Pain and Function

Abstract

Background: Foot pain is a common presentation, and management is generally geared toward pressure offloading. Although several pressure offloading devices exist on the market, the search for the optimal device is ongoing. Methods: We recently developed PopSole, an inexpensive, simple, balanced offloading insole focused on reducing targeted foot pain. We conducted a prospective validation study of patients with foot pain lasting longer than 6 months to assess the durability and efficacy of the device with follow-up scheduled at 2 weeks, 4 weeks, 2 months, and 3 months. Patient-reported outcomes were collected using multiple validated surveys. Fifteen patients were enrolled in this study. Results: At 4 weeks, pain, function, and quality of life across all surveys showed statistically significant improvement. For the 6 patients with long-term outcomes (3 months), patients reported improvement in their pain, function, and quality of life across all surveys, which were significant in the Mayo survey (P = .018), the Manchester Foot Pain and Disability Index (P = .014), the American Orthopaedic Foot and Ankle Society ankle-hindfoot scale (P = .032), the Foot and Ankle Ability Measure activities of daily living (P = .009), and the Pittsburgh foot survey (P = .01); the Foot and Ankle Ability Measure sports approached statistical significance (P = .058). Conclusions: The PopSole is a durable and effective device to relieve foot pain, improve function, and improve quality of life for up to 3 months of use.