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

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...

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Autores principales: Du, Yu-zheng, Gao, Xin-xin, Wang, Cheng-Ting, Zheng, Hai-zhen, Lei, Yun, Wu, Meng-han, Shi, Xue-min, Ban, Hai-peng, Gu, Wen-long, Meng, Xiang-gang, Wei, Mao-ti, Hu, Chun-xiao
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5603044/
https://www.ncbi.nlm.nih.gov/pubmed/28915826
http://dx.doi.org/10.1186/s13063-017-2171-5
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author Du, Yu-zheng
Gao, Xin-xin
Wang, Cheng-Ting
Zheng, Hai-zhen
Lei, Yun
Wu, Meng-han
Shi, Xue-min
Ban, Hai-peng
Gu, Wen-long
Meng, Xiang-gang
Wei, Mao-ti
Hu, Chun-xiao
author_facet Du, Yu-zheng
Gao, Xin-xin
Wang, Cheng-Ting
Zheng, Hai-zhen
Lei, Yun
Wu, Meng-han
Shi, Xue-min
Ban, Hai-peng
Gu, Wen-long
Meng, Xiang-gang
Wei, Mao-ti
Hu, Chun-xiao
author_sort Du, Yu-zheng
collection PubMed
description 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. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-017-2171-5) contains supplementary material, which is available to authorized users.
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spelling pubmed-56030442017-09-20 Acupuncture lowering blood pressure for secondary prevention of stroke: a study protocol for a multicenter randomized controlled trial Du, Yu-zheng Gao, Xin-xin Wang, Cheng-Ting Zheng, Hai-zhen Lei, Yun Wu, Meng-han Shi, Xue-min Ban, Hai-peng Gu, Wen-long Meng, Xiang-gang Wei, Mao-ti Hu, Chun-xiao Trials Study Protocol 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. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-017-2171-5) contains supplementary material, which is available to authorized users. BioMed Central 2017-09-15 /pmc/articles/PMC5603044/ /pubmed/28915826 http://dx.doi.org/10.1186/s13063-017-2171-5 Text en © The Author(s). 2017 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Study Protocol
Du, Yu-zheng
Gao, Xin-xin
Wang, Cheng-Ting
Zheng, Hai-zhen
Lei, Yun
Wu, Meng-han
Shi, Xue-min
Ban, Hai-peng
Gu, Wen-long
Meng, Xiang-gang
Wei, Mao-ti
Hu, Chun-xiao
Acupuncture lowering blood pressure for secondary prevention of stroke: a study protocol for a multicenter randomized controlled trial
title Acupuncture lowering blood pressure for secondary prevention of stroke: a study protocol for a multicenter randomized controlled trial
title_full Acupuncture lowering blood pressure for secondary prevention of stroke: a study protocol for a multicenter randomized controlled trial
title_fullStr Acupuncture lowering blood pressure for secondary prevention of stroke: a study protocol for a multicenter randomized controlled trial
title_full_unstemmed Acupuncture lowering blood pressure for secondary prevention of stroke: a study protocol for a multicenter randomized controlled trial
title_short Acupuncture lowering blood pressure for secondary prevention of stroke: a study protocol for a multicenter randomized controlled trial
title_sort acupuncture lowering blood pressure for secondary prevention of stroke: a study protocol for a multicenter randomized controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5603044/
https://www.ncbi.nlm.nih.gov/pubmed/28915826
http://dx.doi.org/10.1186/s13063-017-2171-5
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