Foot and Ankle Surgery Group, Orthopaedics and Traumatology Unit, Prevent Senior, São Paulo, Brazil.
Department of Orthopaedics and Traumatology, Prevent Senior, São Paulo, Brazil.
PLoS One. 2021 Jun 24;16(6):e0250768. doi: 10.1371/journal.pone.0250768. eCollection 2021.
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. 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.
The 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.
Recruitment and data collection will begin in November 2020, with completion scheduled for November 2022 and final publication available in March 2023.
This trial will evaluate the effects of a single ultrasound-guided HA injection for the treatment of chronic plantar fasciitis.
Brazilian Clinical Trials Registry (Register Number: RBR-97vkx4) http://www.ensaiosclinicos.gov.br/rg/RBR-97vkx4/.
足底筋膜炎是足跟足底区域最常见的疼痛原因，体外冲击波疗法（ESWT）是保守治疗失败后的选择之一。透明质酸（HA）最初用于骨关节炎，是一种治疗选择，因为它已应用于关节外区域，如肌腱、韧带和筋膜。本研究的目的将是评估 HA 单次注射后疼痛、功能和个人满意度的结果，并将结果与慢性足底筋膜炎患者的 ESWT 结果进行比较。
该研究将包括 80 名患者，他们将随机分为三组：接受 ESWT 三次（n = 40）或单次超声引导下足底筋膜 HA 注射（n = 40）。结果将包括视觉模拟疼痛量表评分、美国矫形足踝协会（AOFAS）评分和足部和踝关节结局评分（FAOS）。所有评估将在基线以及治疗后 3、6 和 12 个月进行。主要和次要结局的统计分析将使用重复测量方差分析（方差检验）进行，还将使用 Fisher 的最小显著差异，即事后检验。我们将使用 R 软件进行统计分析、随机化和样本量计算。
招募和数据收集将于 2020 年 11 月开始，预计于 2022 年 11 月完成，最终发表将于 2023 年 3 月。
本试验将评估单次超声引导下 HA 注射治疗慢性足底筋膜炎的效果。
巴西临床试验注册中心（注册号：RBR-97vkx4）http://www.ensaiosclinicos.gov.br/rg/RBR-97vkx4/。
