Comparison of the effect of hyaluronic acid injection versus extracorporeal shockwave therapy on chronic plantar fasciitis: Protocol for a randomized controlled trial.

Gabriel Ferraz Ferreira,Miguel Viana Pereira Filho,Luiz Carlos Nogueira Junior,Gustavo Gonçalves Arliani,Davy Sevilla,Victor Otávio Oliveira,Carolinne Nascimento Oliveira,Walid Kamal Abdelbasset

doi:10.1371/journal.pone.0250768

Abstract

BackgroundPlantar fasciitis is the most common cause of pain in the plantar region of the heel, and extracorporeal shockwave therapy (ESWT) is an option used in cases where conservative treatment fails. Hyaluronic acid (HA), initially used for osteoarthrosis, is a treatment option because it has been applied to extra-articular regions, such as tendons, ligaments, and fascia. The aim of the present study will be to evaluate the outcomes of pain, function, and personal satisfaction after a single injection of HA and to compare the results with those of ESWT in patients with chronic plantar fasciitis.MethodsThe study will include 80 patients who will be randomized to receive three sessions of ESWT (n = 40) or a single ultrasound-guided HA injection in the plantar fascia (n = 40). The outcomes will include the visual analog pain scale score, American Orthopaedic Foot and Ankle Society (AOFAS) score, and Foot and Ankle Outcome Score (FAOS). All of the assessments will be performed at baseline and 3, 6, and 12 months after treatment. Statistical analysis will be performed using the repeated measures ANOVA (analysis of variance test) for primary and secondary outcomes and also Fisher’s Least Significant Difference, a Post-Hoc test. We will use R software for statistical analysis, randomization, and sample size calculation.ResultsRecruitment and data collection will begin in November 2020, with completion scheduled for November 2022 and final publication available in March 2023.ConclusionThis trial will evaluate the effects of a single ultrasound-guided HA injection for the treatment of chronic plantar fasciitis.Trial registrationBrazilian Clinical Trials Registry (Register Number: RBR-97vkx4) http://www.ensaiosclinicos.gov.br/rg/RBR-97vkx4/.

Highlights

BackgroundPlantar fasciitis is the most common cause of pain in the plantar region of the heel, especially in middle-aged and elderly patients [1], and is often described as an overload of the plantar fascia [2,3]
Plantar fasciitis is the most common cause of pain in the plantar region of the heel, and extracorporeal shockwave therapy (ESWT) is an option used in cases where conservative treatment fails
The aim of the present study will be to evaluate the outcomes of pain, function, and personal satisfaction after a single injection of Hyaluronic acid (HA) and to compare the results with those of ESWT in patients with chronic plantar fasciitis

Summary

Introduction

Plantar fasciitis is the most common cause of pain in the plantar region of the heel, especially in middle-aged and elderly patients [1], and is often described as an overload of the plantar fascia [2,3]. Extracorporeal shockwave therapy (ESWT) has emerged as an option for recalcitrant cases of plantar fasciitis without improvement with conventional conservative treatment. This modality showed satisfactory results in a placebo-controlled study [11] but was dependent on the intensity, pulse cycle, and shockwave modality [12]. Plantar fasciitis is the most common cause of pain in the plantar region of the heel, and extracorporeal shockwave therapy (ESWT) is an option used in cases where conservative treatment fails. The aim of the present study will be to evaluate the outcomes of pain, function, and personal satisfaction after a single injection of HA and to compare the results with those of ESWT in patients with chronic plantar fasciitis

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Conclusion