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Acupuncture lowering blood pressure for secondary prevention of stroke: a study protocol for a multicenter randomized controlled trial

机译：针灸降低血压以中风的二级预防：一项多中心随机对照试验的研究方案

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Background Stroke is the prime cause of morbidity and mortality in the general population, and hypertension will increase the recurrence and mortality of stroke. We report a protocol of a pragmatic randomized controlled trial (RCT) using blood pressure (BP)-lowering acupuncture add-on treatment to treat patients with hypertension and stroke. Methods This is a large-scale, multicenter, subject-, assessor- and analyst-blinded, pragmatic RCT. A total of 480 patients with hypertension and ischemic stroke will be randomly assigned to two groups: an experimental group and a control group. The experimental group will receive “ HuoXueSanFeng ” acupuncture combined with one antihypertensive medication in addition to routine ischemic stroke treatment. The control group will only receive one antihypertensive medication and basic treatments for ischemic stroke. HuoXueSanFeng acupuncture will be given for six sessions weekly for the first 6?weeks and three times weekly for the next 6?weeks. A 9-month follow-up will, thereafter, be conducted. Antihypertensive medication will be adjusted based on BP levels. The primary outcome will be the recurrence of stroke. The secondary outcomes including 24-h ambulatory BP, the TCM syndrome score, the Short Form 36-item Health Survey (SF-36), the National Institute of Health Stroke Scale (NIHSS), as well as the Barthel Index (BI) scale will be assessed at baseline, 6?weeks and 12?weeks post initiating treatments; cardiac ultrasound, carotid artery ultrasound, transcranial Doppler, and lower extremity ultrasound will be evaluated at baseline and 12?weeks after treatment. The safety of acupuncture will also be assessed. Discussion We aim to determine the clinical effects of controlling BP for secondary prevention of stroke with acupuncture add-on treatment. Trial registration ClinicalTrials.gov, ID: NCT02967484 . Registered on 13 February 2017; last updated on 27 June 2017.
机译：背景技术中风是普通人群发病和死亡的主要原因，高血压会增加中风的复发和死亡率。我们报告了一种实用的随机对照试验（RCT）方案，该方案使用降血压（BP）的针灸附加疗法治疗高血压和中风患者。方法这是一个大型，多中心，主题，评估者和分析者盲目的实用RCT。总共480名高血压和缺血性中风患者将被随机分为两组：实验组和对照组。除常规的缺血性中风治疗外，实验组还将接受“活血三丰”针灸结合一种降压药的治疗。对照组仅接受一种抗高血压药物和缺血性中风的基本治疗方法。活血三丰针灸疗法将在头6周内每周进行六次针灸，在接下来的6周内每周进行3次针刺。此后将进行9个月的随访。降压药物将根据血压水平进行调整。主要结果将是中风的复发。次要结局包括24小时动态血压，TCM综合征评分，简短的36项健康调查（SF-36），美国国立卫生研究院卒中量表（NIHSS）以及巴特尔指数（BI）量表将在开始治疗后的6周和12周进行基线评估;在治疗基线和治疗后12周，将评估心脏超声，颈动脉超声，经颅多普勒超声和下肢超声。针灸的安全性也将得到评估。讨论我们的目的是确定通过控制针灸附加治疗来控制血压对卒中的二级预防的临床效果。试用注册ClinicalTrials.gov，ID：NCT02967484。 2017年2月13日注册;最后更新于2017年6月27日。

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