Shi Jiaxiang, Jiao Ruimin, Liu Yan, Liu Xinkun, Sun Yingxin, Shi Hangyu, Gao Ning, Liu Zhishun, Liang Jun, Wang Weiming
Department of Acupuncture, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China.
Department of Traditional Chinese Medicine, Beijing Friendship Hospital, Capital Medical University, Beijing, China.
Contemp Clin Trials Commun. 2024 Aug 24;41:101355. doi: 10.1016/j.conctc.2024.101355. eCollection 2024 Oct.
Plantar fasciitis (PF) is one of the most common causes of plantar heel pain, and previous studies found that acupuncture is effective for relieving pain in patients with PF. Nevertheless, the impact of different sessions of electroacupuncture on PF has not been investigated through randomized, controlled trials.
METHODS/DESIGN: This is a two parallel-group, assessor-blinded, randomized controlled trial, consisting of a four-week treatment phase followed by a 12-week follow-up. Eighty patients with chronic PF will be recruited and randomly allocated to receive 12 (three sessions per week; the multiple electroacupuncture weekly treatment group (group M)) or four (one session per week; single electroacupuncture weekly treatment group (group S)) sessions of electroacupuncture treatment in a 1:1 ratio. The primary outcome to be studied is the response rate, defined as a minimum of 50 % improvement in most severe pain intensity with first steps in the morning, compared with baseline. We will perform all analyses based on the intention-to-treat principle, with differences considered significant when the value < 0.05 on a two-sided basis.
This prospective trial will provide high-quality evidence on evaluating the efficacy and safety of different electroacupuncture sessions (one session per week versus three sessions per week) for chronic PF. This study aims to contribute in produce up-to-date, rigorous evidence on the most effective frequency of electroacupuncture in managing chronic PF.Trial registration Clinicaltrials.gov Identifier: NCT06284993. Registered on February 17, 2024.
足底筋膜炎（PF）是足跟底部疼痛最常见的原因之一，既往研究发现针刺疗法可有效缓解PF患者的疼痛。然而，不同疗程的电针疗法对PF的影响尚未通过随机对照试验进行研究。
方法/设计：这是一项双平行组、评估者盲法的随机对照试验，包括为期四周的治疗阶段，随后是为期12周的随访。将招募80例慢性PF患者，并按1:1的比例随机分配，分别接受12次（每周三次；每周多次电针治疗组（M组））或4次（每周一次；每周单次电针治疗组（S组））电针治疗。待研究的主要结局指标为缓解率，定义为与基线相比，早晨第一步时最严重疼痛强度至少改善50%。我们将根据意向性分析原则进行所有分析，双侧检验时P值<0.05则认为差异具有统计学意义。
这项前瞻性试验将为评估不同疗程（每周一次与每周三次）电针治疗慢性PF的疗效和安全性提供高质量证据。本研究旨在为确定电针治疗慢性PF的最有效频率提供最新、严谨的证据。试验注册Clinicaltrials.gov标识符：NCT06284993。于2024年2月17日注册。
