Rehabilitation Center.
Brain Function and Neurorehabilitation Laboratory, Second Affiliated Hospital of Heilongjiang University of Chinese Medicine, Nangang District.
Medicine (Baltimore). 2021 May 14;100(19):e25731. doi: 10.1097/MD.0000000000025731.
Acupuncture has a long history in China and is currently widely used in clinical practice. However, there is no large sample data confirming the effectiveness of acupuncture in treating stroke and its sequelae. This article presents a study protocol for a multicenter, randomized, controlled trial for evaluating the efficacy of acupuncture in treating post-stroke dysphagia.
METHODS/DESIGN: A randomized controlled trial will be conducted in three hospitals in Heilongjiang, Changchun, and Beijing. A total of 252 patients with post-stroke swallowing ability will be randomly divided into two groups; specifically, the experimental group, which will receive acupuncture treatment, and the control group, which will undergo rehabilitation training for 2 weeks. The main results will be evaluated using the standard swallowing function scale, videofluoroscopic swallowing examination, and functional magnetic resonance imaging. The secondary observation indexes will include surface electromyography signal analysis and the modified Barthel index. Measurements will be obtained before treatment, as well as 1 week, 2 weeks, and 1 month after treatment.
This trial could clarify the effectiveness of acupuncture in stroke; moreover, it will determine whether acupuncture can improve swallowing function.
Chinese Clinical Trial Registry (ChiCTR), ChiCTR2000030994.
针灸在中国历史悠久，目前在临床实践中广泛应用。然而，目前尚无大样本数据证实针灸治疗中风及其后遗症的有效性。本文介绍了一项多中心、随机、对照临床试验的研究方案，旨在评估针灸治疗中风后吞咽困难的疗效。
方法/设计：将在黑龙江、长春和北京的 3 家医院进行一项随机对照试验。将 252 名具有中风后吞咽能力的患者随机分为两组，即实验组（接受针灸治疗）和对照组（接受 2 周康复训练）。主要结果将使用标准吞咽功能量表、视频透视吞咽检查和功能磁共振成像进行评估。次要观察指标包括表面肌电图信号分析和改良巴氏指数。治疗前、治疗后 1 周、2 周和 1 个月进行测量。
这项试验可以阐明针灸在中风中的疗效，同时确定针灸是否可以改善吞咽功能。
中国临床试验注册中心（ChiCTR），ChiCTR2000030994。
