Henan University of Chinese Medicine, No. 156 East Jinshui Road, Zhengzhou, 450046, China.
Rehabilitation Center, The First Affiliated Hospital of Henan University of Chinese Medicine, No. 19 Renmin Road, Zhengzhou, 450000, China.
Trials. 2021 Jan 6;22(1):27. doi: 10.1186/s13063-020-04959-y.
BACKGROUND: Cognitive impairment is a common dysfunction after stroke that seriously affects the overall recovery of patients. Cognitive rehabilitation training is currently the main treatment to improve cognitive function, but its curative effect is limited. Acupuncture is a core component of traditional Chinese medicine (TCM), and some previous clinical studies have shown that it might be effective in treating post-stroke cognitive impairment (PSCI), but further evidence from large-sample studies is needed. The overall objective of this trial is to obtain further data to develop an optimized acupuncture treatment for PSCI by comparing the effects of different acupuncture treatment methods on cognitive function in PSCI patients. METHODS/DESIGN: In this multicenter, prospective, randomized controlled trial, 206 eligible stroke inpatients who meet the trial criteria will be randomly assigned to 2 groups: an electroacupuncture (EA) plus needle retention (NR) group and an EA group. Both groups of patients will undergo the same routine cognitive rehabilitation treatments. All treatments will be given 5 times per week for 8 weeks. The primary outcomes will be assessed using the Mini-Mental State Examination (MMSE) and the Montreal Cognitive Assessment scale (MOCA). The secondary outcome will be measured by the Barthel Index (BI). All outcomes will be evaluated at baseline, week 4, week 8, and the third and sixth month after the end of treatment. DISCUSSION: Our aim is to evaluate the effects of two different acupuncture treatment methods for treating PSCI patients. This study is expected to provide data to be used in developing an optimized acupuncture treatment method for PSCI treatment. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR1900027849. Registered on 30 November 2019, http://www.chictr.org.cn/showproj.aspx?proj=46316.
背景:认知障碍是中风后常见的功能障碍,严重影响患者的整体康复。认知康复训练是目前改善认知功能的主要治疗方法,但疗效有限。针灸是中医药的核心组成部分,一些先前的临床研究表明,它可能对治疗中风后认知障碍(PSCI)有效,但需要更多大样本研究的证据。本试验的总体目标是通过比较不同针刺治疗方法对 PSCI 患者认知功能的影响,获得进一步的数据,为 PSCI 开发优化的针刺治疗方法。
方法/设计:在这项多中心、前瞻性、随机对照试验中,将 206 名符合试验标准的中风住院患者随机分为电针(EA)加针留针(NR)组和 EA 组。两组患者均接受相同的常规认知康复治疗。所有治疗每周 5 次,持续 8 周。主要结局指标将使用简易精神状态检查(MMSE)和蒙特利尔认知评估量表(MOCA)进行评估。次要结局将通过巴氏指数(BI)测量。所有结果将在基线、第 4 周、第 8 周以及治疗结束后第 3 个月和第 6 个月进行评估。
讨论:我们的目的是评估两种不同的针刺治疗方法治疗 PSCI 患者的效果。这项研究有望提供数据,用于开发 PSCI 治疗的优化针刺治疗方法。
试验注册:中国临床试验注册中心 ChiCTR1900027849。注册于 2019 年 11 月 30 日,网址:http://www.chictr.org.cn/showproj.aspx?proj=46316。
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