Dong Woo Shim1, Seung-Yong Sung1, Whan-Yong Chung1, Kyung-Yil Kang2, Sung-Jun Park3, Jin Woo Lee4, Dong Sik Chae1. 1. Department of Orthopedic Surgery, International St. Mary's Hospital, Catholic Kwandong University College of Medicine, Incheon, South Korea. 2. Department of Medicine, Catholic Kwandong Graduate School, Gangneungsi, Gangwondo, South Korea. 3. School of Mechanical, Automotive and Aeronautical Engineering Korea National University of Transportation, Chungju, Chungbuk, South Korea. 4. Department of Orthopaedic Surgery, Yonsei University College of Medicine, Seoul, South Korea.
Abstract
INTRODUCTION: Plantar fasciitis is one of the common foot complaints that is chronic and can induce dysfunction. Total contact insole (TCI) is simple but effective in treating plantar fasciitis. Despite its effect, the cost and long duration for production have been the major flaws. Therefore, we developed a newly designed three-spike insole (TSI) that can be commercially productive and compared its clinical outcomes to TCI. METHODS:Patients with plantar fasciitis refractory to conservative treatment for more than 6 weeks were candidates. We produced insoles with hardness of 58 ± 5 Shore-A. Twenty-eight patients were randomized with equal allocation to either TSI or TCI. The following assessment tools were used: visual analog scale (VAS), American Orthopaedic Foot and Ankle score, Foot and Ankle Outcome Score, Karlsson-Peterson (KP) score, Short Form-36 for quality of life, and Foot Function Index. Non-inferiority was declared if VAS was within the statistical variability of minimal important difference. A blinded assessor evaluated the groups at baseline and after 6, 12, and 24 weeks. RESULTS: The groups were homogenous for majority of variables at baseline. Overall patient-reported satisfaction showed improvement from mean 5.2 (range, 1-12) weeks of wearing and all clinical outcome scores showed significant improvements in both groups over time on Friedman test (p ≤.032). TSI showed non-inferiority to TCI at each time point. Post hoc analysis revealed that many scales showed significant superiority of TSI at 3 month (p ≤.008) and KP score at 6 month (p < .001). CONCLUSION: We reaffirmed that semi-rigid insole is effective in refractory plantar fasciitis and showed TSI restores pedal function more rapidly than TCI. TSI can be not only effective in deriving better clinical outcomes but also be manufactured for popularization to lower the price and producing time of orthosis.
RCT Entities:
INTRODUCTION:Plantar fasciitis is one of the common foot complaints that is chronic and can induce dysfunction. Total contact insole (TCI) is simple but effective in treating plantar fasciitis. Despite its effect, the cost and long duration for production have been the major flaws. Therefore, we developed a newly designed three-spike insole (TSI) that can be commercially productive and compared its clinical outcomes to TCI. METHODS:Patients with plantar fasciitis refractory to conservative treatment for more than 6 weeks were candidates. We produced insoles with hardness of 58 ± 5 Shore-A. Twenty-eight patients were randomized with equal allocation to either TSI or TCI. The following assessment tools were used: visual analog scale (VAS), American Orthopaedic Foot and Ankle score, Foot and Ankle Outcome Score, Karlsson-Peterson (KP) score, Short Form-36 for quality of life, and Foot Function Index. Non-inferiority was declared if VAS was within the statistical variability of minimal important difference. A blinded assessor evaluated the groups at baseline and after 6, 12, and 24 weeks. RESULTS: The groups were homogenous for majority of variables at baseline. Overall patient-reported satisfaction showed improvement from mean 5.2 (range, 1-12) weeks of wearing and all clinical outcome scores showed significant improvements in both groups over time on Friedman test (p ≤.032). TSI showed non-inferiority to TCI at each time point. Post hoc analysis revealed that many scales showed significant superiority of TSI at 3 month (p ≤.008) and KP score at 6 month (p < .001). CONCLUSION: We reaffirmed that semi-rigid insole is effective in refractory plantar fasciitis and showed TSI restores pedal function more rapidly than TCI. TSI can be not only effective in deriving better clinical outcomes but also be manufactured for popularization to lower the price and producing time of orthosis.
Authors: Elena Arce; Rosa Devesa-Rey; Andrés Suárez-García; David González-Peña; Manuel García-Fuente Journal: Materials (Basel) Date: 2022-10-07 Impact factor: 3.748