Ye Hongkun, Liu Jiahui, Cheng Hongmei, He Yu, Li Chongrui, Gao Yahan, Xu Xinyin
College of Acupuncture and Orthopedics, Hubei University of Chinese Medicine, Wuhan City, Hubei Province, People's Republic of China.
Department of Research, Hubei Provincial Hospital of Traditional Chinese Medicine, Wuhan City, Hubei Province, People's Republic of China.
J Multidiscip Healthc. 2025 Jun 4;18:3179-3189. doi: 10.2147/JMDH.S512206. eCollection 2025.
Stroke can cause limb spasticity, and numerous clinical studies have demonstrated that acupuncture is an effective treatment for this condition. The round-sharp needle, a type of acupuncture needle, has been reported to shorten treatment durations and reduce the number of clinic visits compared to traditional filiform needles, the conventional acupuncture. However, clinical trial research on its efficacy remains limited. Therefore, this clinical trial is designed to investigate the short-term effects and safety of round-sharp needle therapy in treating post-stroke limb spasticity.
This research protocol outlines a randomized, single-blind, prospective, single-center pilot clinical trial to be conducted at Hubei Provincial Hospital of Traditional Chinese Medicine, scheduled to commence after completion of clinical trial registration. After the recruitment phase, eligible patients meeting the inclusion criteria will be randomly assigned to one of two groups: the round-sharp needle group (3 times per week) or the filiform needle group (5 times per week). The treatment will last for two weeks, with evaluation criteria including surface electromyography (sEMG), the Modified Ashworth Scale (MAS), the Fugl-Meyer Assessment (FMA), the Modified Barthel Index (MBI), and a safety assessment of acupuncture.
This clinical trial investigates the safety and efficacy of using round-sharp needles to treat post-stroke limb spasticity, with the results expected to provide further evidence for the future clinical application of this therapy.
Chinese Clinical Trial Registry (ChiCTR), ID: ChiCTR2400087907. Registered on 7 August, 2024.
中风可导致肢体痉挛，众多临床研究表明针灸是治疗该病症的有效方法。据报道，与传统毫针（常规针灸）相比，圆利针这种针灸针可缩短治疗时间并减少门诊就诊次数。然而，关于其疗效的临床试验研究仍然有限。因此，本临床试验旨在研究圆利针疗法治疗中风后肢体痉挛的短期效果和安全性。
本研究方案概述了一项将在湖北省中医院进行的随机、单盲、前瞻性、单中心试点临床试验，计划在完成临床试验注册后开始。在招募阶段之后，符合纳入标准的合格患者将被随机分配到两组之一：圆利针组（每周3次）或毫针组（每周5次）。治疗将持续两周，评估标准包括表面肌电图（sEMG）、改良Ashworth量表（MAS）、Fugl-Meyer评估（FMA）、改良Barthel指数（MBI）以及针灸安全性评估。
本临床试验研究使用圆利针治疗中风后肢体痉挛的安全性和有效性，预期结果将为该疗法未来的临床应用提供进一步证据。
中国临床试验注册中心（ChiCTR），标识符：ChiCTR2400087907。于2024年8月7日注册。
