Wang Shaosong, Ma Tingting, Wang Linpeng, Liu Lu, Liu Huilin, Li Bin, Fu Yuanbo
Acupuncture and Moxibustion Department, Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, Backstreet Gallery No. 23, Dongcheng District, Beijing, China.
Trials. 2017 Jun 24;18(1):292. doi: 10.1186/s13063-017-2013-5.
The incidence of cerebral infarction has been growing year by year in China and around the world. According to clinical observation, acupuncture utilizing the "waking up the spirit" needling method is widely used in patients with cerebral infarction, though the underlying mechanisms remain unclear. Additionally, a number of studies have begun to focus on the relationship between cerebrovascular reserve (CVR) and cerebral infarction. The present study aims to investigate whether CVR is one of potential mechanisms underpinning this effect of acupuncture on patients with cerebral infarction.
This is a single-centre, prospective, single-blinded, randomized controlled pilot study. Sixty eligible patients will be randomized into an intervention group (waking up the spirit acupuncture) and a control group (hand and foot 12-meridian acupuncture) in a 1:1 ratio. All treatments will be conducted once a day on weekdays followed by a 2-day rest period on the weekend, over a total treatment course of 2 weeks. The primary outcome measures are cerebrovascular reserve (CVR) capacity and Breath-holding Index (BHI) which will be evaluated at baseline and 2 weeks after the first acupuncture treatment, and the secondary outcome measures are National Institutes of Health Stroke Scale (NIHSS) and Barthel Index scores which will be used to further evaluate the efficacy of the intervention.
Cerebrovascular reserve is an independent risk factor for the occurrence, progression, and recurrence of cerebral infarction that requires attention. This trial aims to investigate whether acupuncture utilizing the waking up the spirit needling method can improve CVR capacity in patients with acute cerebral infarction, thus reducing NIHSS scores and preventing further progression of the disease. Furthermore, data and evidence gained from this study will be utilized in the development of future research projects regarding the effects of acupuncture in patients with acute cerebral infarction.
ISRCTN, ID: ISRCTN99117074 . Registered on 20 April 2016.
在中国乃至全球，脑梗死的发病率逐年上升。据临床观察，采用“醒脑”针法的针灸疗法在脑梗死患者中广泛应用，但其潜在机制尚不清楚。此外，一些研究已开始关注脑血管储备（CVR）与脑梗死之间的关系。本研究旨在探讨CVR是否是针灸对脑梗死患者产生这种作用的潜在机制之一。
这是一项单中心、前瞻性、单盲、随机对照试验研究。60例符合条件的患者将按1:1的比例随机分为干预组（醒脑针灸）和对照组（手足十二经脉针灸）。所有治疗将在工作日每天进行1次，周末休息2天，总疗程为2周。主要观察指标为脑血管储备（CVR）能力和屏气指数（BHI），将在基线时及首次针灸治疗后2周进行评估，次要观察指标为美国国立卫生研究院卒中量表（NIHSS）和巴氏指数评分，将用于进一步评估干预效果。
脑血管储备是脑梗死发生、发展和复发的独立危险因素，值得关注。本试验旨在研究采用醒脑针法的针灸是否能改善急性脑梗死患者的CVR能力，从而降低NIHSS评分并预防疾病进一步发展。此外，本研究获得的数据和证据将用于未来关于针灸对急性脑梗死患者影响的研究项目的开展。
国际标准随机对照试验编号（ISRCTN），ID：ISRCTN99117074。于2016年4月20日注册。
