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

Trials

Wen-long Gu¹  Hai-zhen Zheng¹  Xue-min Shi¹  Cheng-Ting Wang¹  Hai-peng Ban¹  Xiang-gang Meng¹  Yu-zheng Du¹  Mao-ti Wei²  Xin-xin Gao³  Chun-xiao Hu⁴  Meng-han Wu⁴  Yun Lei⁴ 

[1] Acupuncture and Moxibustion Department, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine;Department of Epidemiology, Logistics College of Chinese People’s Armed Police Forces;Emergency Department, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine;Tianjin University of Traditional Chinese Medicine;

关键词: Acupuncture;    Hypertension;    Secondary prevention of stroke;    RCT;    Study protocol;   

DOI  :  10.1186/s13063-017-2171-5

来源: DOAJ

【 摘 要 】

Abstract 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.

【 授权许可】

Unknown