Hongkun Ye,1 Jiahui Liu,1 Hongmei Cheng,1 Yu He,1 Chongrui Li,1 Yahan Gao,2 Xinyin Xu3– 5 

1College of Acupuncture and Orthopedics, Hubei University of Chinese Medicine, Wuhan City, Hubei Province, People’s Republic of China; 2Department of Research, Hubei Provincial Hospital of Traditional Chinese Medicine, Wuhan City, Hubei Province, People’s Republic of China; 3Department of Acupuncture, Hubei Provincial Hospital of Traditional Chinese Medicine, Wuhan City, Hubei Province, People’s Republic of China; 4The First Clinical College, Hubei University of Chinese Medicine, Wuhan City, Hubei Province, People’s Republic of China; 5Hubei Shizhen Laboratory, Wuhan City, Hubei Province, People’s Republic of China

Correspondence: Xinyin Xu, Department of Acupuncture, Hubei Provincial Hospital of Traditional Chinese Medicine, No. 4, Huayanshan, Wuhan, Hubei Province, 430065, People’s Republic of China, Email 31345978@qq.com Yahan Gao, Department of Research, Hubei Provincial Hospital of Traditional Chinese Medicine, No. 4, Huayanshan, Wuhan, Hubei Province, 430065, People’s Republic of China, Email kasha0814@163.com

Objective: 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.
Methods and Analysis: 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.
Conclusion: 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.
Trial Registration: Chinese Clinical Trial Registry (ChiCTR), ID: ChiCTR2400087907. Registered on 7 August, 2024.

Keywords: acupuncture, randomized controlled trial, round-sharp needle, spasm, stroke, study protocol