$Superior pedal function recovery of newly designed three spike insole over total contact insole in refractory plantar fasciitis: A randomized, double-blinded, non-inferiority study.$
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Superior pedal function recovery of newly designed three spike insole over total contact insole in refractory plantar fasciitis: A randomized, double-blinded, non-inferiority study.

<h4>Introduction</h4>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 flaw...

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Autores principales:	Dong Woo Shim, Seung-Yong Sung, Whan-Yong Chung, Kyung-Yil Kang, Sung-Jun Park, Jin Woo Lee, Dong Sik Chae
Formato:	article
Lenguaje:	EN
Publicado:	Public Library of Science (PLoS) 2021
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/fd99e7d13b2349499934683d7696c992
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spelling	oai:doaj.org-article:fd99e7d13b2349499934683d7696c9922021-12-02T20:06:31ZSuperior pedal function recovery of newly designed three spike insole over total contact insole in refractory plantar fasciitis: A randomized, double-blinded, non-inferiority study.1932-620310.1371/journal.pone.0255064https://doaj.org/article/fd99e7d13b2349499934683d7696c9922021-01-01T00:00:00Zhttps://doi.org/10.1371/journal.pone.0255064https://doaj.org/toc/1932-6203<h4>Introduction</h4>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.<h4>Methods</h4>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.<h4>Results</h4>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).<h4>Conclusion</h4>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.Dong Woo ShimSeung-Yong SungWhan-Yong ChungKyung-Yil KangSung-Jun ParkJin Woo LeeDong Sik ChaePublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 16, Iss 7, p e0255064 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Dong Woo Shim Seung-Yong Sung Whan-Yong Chung Kyung-Yil Kang Sung-Jun Park Jin Woo Lee Dong Sik Chae Superior pedal function recovery of newly designed three spike insole over total contact insole in refractory plantar fasciitis: A randomized, double-blinded, non-inferiority study.
description	<h4>Introduction</h4>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.<h4>Methods</h4>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.<h4>Results</h4>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).<h4>Conclusion</h4>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.
format	article
author	Dong Woo Shim Seung-Yong Sung Whan-Yong Chung Kyung-Yil Kang Sung-Jun Park Jin Woo Lee Dong Sik Chae
author_facet	Dong Woo Shim Seung-Yong Sung Whan-Yong Chung Kyung-Yil Kang Sung-Jun Park Jin Woo Lee Dong Sik Chae
author_sort	Dong Woo Shim
title	Superior pedal function recovery of newly designed three spike insole over total contact insole in refractory plantar fasciitis: A randomized, double-blinded, non-inferiority study.
title_short	Superior pedal function recovery of newly designed three spike insole over total contact insole in refractory plantar fasciitis: A randomized, double-blinded, non-inferiority study.
title_full	Superior pedal function recovery of newly designed three spike insole over total contact insole in refractory plantar fasciitis: A randomized, double-blinded, non-inferiority study.
title_fullStr	Superior pedal function recovery of newly designed three spike insole over total contact insole in refractory plantar fasciitis: A randomized, double-blinded, non-inferiority study.
title_full_unstemmed	Superior pedal function recovery of newly designed three spike insole over total contact insole in refractory plantar fasciitis: A randomized, double-blinded, non-inferiority study.
title_sort	superior pedal function recovery of newly designed three spike insole over total contact insole in refractory plantar fasciitis: a randomized, double-blinded, non-inferiority study.
publisher	Public Library of Science (PLoS)
publishDate	2021
url	https://doaj.org/article/fd99e7d13b2349499934683d7696c992
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Superior pedal function recovery of newly designed three spike insole over total contact insole in refractory plantar fasciitis: A randomized, double-blinded, non-inferiority study.

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