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Transcutaneous electrical acupoint stimulation for stage 1 hypertension: protocol for a randomized controlled pilot trial

BACKGROUND: Hypertension is a major pathogenic factor of cardiovascular diseases. Insufficient blood pressure control rate and sub-optimal medication adherence remain challenges for effective management of hypertension. Transcutaneous electrical acupoint stimulation (TEAS) has been used to treat var...

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Autores principales: Tian, Zhong-Xue, Liu, Cun-Zhi, Qi, You-Sheng, Tu, Jian-Feng, Lin, Ying, Wang, Yu, Yang, Jing-Wen, Shi, Guang-Xia, Liu, Jun-Hong, Wang, Li-Qiong
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7310085/
https://www.ncbi.nlm.nih.gov/pubmed/32571411
http://dx.doi.org/10.1186/s13063-020-04493-x
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author Tian, Zhong-Xue
Liu, Cun-Zhi
Qi, You-Sheng
Tu, Jian-Feng
Lin, Ying
Wang, Yu
Yang, Jing-Wen
Shi, Guang-Xia
Liu, Jun-Hong
Wang, Li-Qiong
author_facet Tian, Zhong-Xue
Liu, Cun-Zhi
Qi, You-Sheng
Tu, Jian-Feng
Lin, Ying
Wang, Yu
Yang, Jing-Wen
Shi, Guang-Xia
Liu, Jun-Hong
Wang, Li-Qiong
author_sort Tian, Zhong-Xue
collection PubMed
description BACKGROUND: Hypertension is a major pathogenic factor of cardiovascular diseases. Insufficient blood pressure control rate and sub-optimal medication adherence remain challenges for effective management of hypertension. Transcutaneous electrical acupoint stimulation (TEAS) has been used to treat various diseases, including hypertension, but the scientific evidence for its benefit remains insufficient. Therefore, we will perform a randomized, controlled clinical trial in patients with stage 1 hypertension to evaluate the effect of TEAS. METHODS/DESIGN: The study will be a two-arm parallel, randomized controlled trial. Sixty patients with stage 1 hypertension will be randomly assigned to the TEAS group and the control group in a 1:1 ratio. The participants in the TEAS group will receive non-invasive acupoint electrical stimulation for 30 min at four acupoints in the upper and lower extremities at home, 4 times weekly for 12 weeks for a total of 48 sessions. Participants in the control group will not receive any form of acupoint stimulation. All participants in both groups will receive lifestyle education on how to control high blood pressure, including diet, weight control, and exercise. The primary outcome measure will be the change of the mean systolic blood pressure from baseline to 12 weeks. Secondary outcomes include the change of mean diastolic blood pressure, quality of life, body mass index, and physical activity level. DISCUSSION: This pilot, randomized, controlled trial will explore the feasibility of TEAS. It will also provide potential clinical evidence for the efficacy and safety of TEAS in the treatment of patients with stage 1 hypertension. The results of this study will be published in peer-reviewed journals. Furthermore, this pilot trial as the precursor of a large scale randomized controlled trial will inform the sample size of the subsequent trial. TRIAL REGISTRATION: Chinese clinical trial registry, ChiCTR1900025042, Registered on 8 August 2019 (http://www.chictr.org.cn/showproj.aspx?proj=41496).
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spelling pubmed-73100852020-06-23 Transcutaneous electrical acupoint stimulation for stage 1 hypertension: protocol for a randomized controlled pilot trial Tian, Zhong-Xue Liu, Cun-Zhi Qi, You-Sheng Tu, Jian-Feng Lin, Ying Wang, Yu Yang, Jing-Wen Shi, Guang-Xia Liu, Jun-Hong Wang, Li-Qiong Trials Study Protocol BACKGROUND: Hypertension is a major pathogenic factor of cardiovascular diseases. Insufficient blood pressure control rate and sub-optimal medication adherence remain challenges for effective management of hypertension. Transcutaneous electrical acupoint stimulation (TEAS) has been used to treat various diseases, including hypertension, but the scientific evidence for its benefit remains insufficient. Therefore, we will perform a randomized, controlled clinical trial in patients with stage 1 hypertension to evaluate the effect of TEAS. METHODS/DESIGN: The study will be a two-arm parallel, randomized controlled trial. Sixty patients with stage 1 hypertension will be randomly assigned to the TEAS group and the control group in a 1:1 ratio. The participants in the TEAS group will receive non-invasive acupoint electrical stimulation for 30 min at four acupoints in the upper and lower extremities at home, 4 times weekly for 12 weeks for a total of 48 sessions. Participants in the control group will not receive any form of acupoint stimulation. All participants in both groups will receive lifestyle education on how to control high blood pressure, including diet, weight control, and exercise. The primary outcome measure will be the change of the mean systolic blood pressure from baseline to 12 weeks. Secondary outcomes include the change of mean diastolic blood pressure, quality of life, body mass index, and physical activity level. DISCUSSION: This pilot, randomized, controlled trial will explore the feasibility of TEAS. It will also provide potential clinical evidence for the efficacy and safety of TEAS in the treatment of patients with stage 1 hypertension. The results of this study will be published in peer-reviewed journals. Furthermore, this pilot trial as the precursor of a large scale randomized controlled trial will inform the sample size of the subsequent trial. TRIAL REGISTRATION: Chinese clinical trial registry, ChiCTR1900025042, Registered on 8 August 2019 (http://www.chictr.org.cn/showproj.aspx?proj=41496). BioMed Central 2020-06-22 /pmc/articles/PMC7310085/ /pubmed/32571411 http://dx.doi.org/10.1186/s13063-020-04493-x Text en © The Author(s) 2020 Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. 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 in a credit line to the data.
spellingShingle Study Protocol
Tian, Zhong-Xue
Liu, Cun-Zhi
Qi, You-Sheng
Tu, Jian-Feng
Lin, Ying
Wang, Yu
Yang, Jing-Wen
Shi, Guang-Xia
Liu, Jun-Hong
Wang, Li-Qiong
Transcutaneous electrical acupoint stimulation for stage 1 hypertension: protocol for a randomized controlled pilot trial
title Transcutaneous electrical acupoint stimulation for stage 1 hypertension: protocol for a randomized controlled pilot trial
title_full Transcutaneous electrical acupoint stimulation for stage 1 hypertension: protocol for a randomized controlled pilot trial
title_fullStr Transcutaneous electrical acupoint stimulation for stage 1 hypertension: protocol for a randomized controlled pilot trial
title_full_unstemmed Transcutaneous electrical acupoint stimulation for stage 1 hypertension: protocol for a randomized controlled pilot trial
title_short Transcutaneous electrical acupoint stimulation for stage 1 hypertension: protocol for a randomized controlled pilot trial
title_sort transcutaneous electrical acupoint stimulation for stage 1 hypertension: protocol for a randomized controlled pilot trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7310085/
https://www.ncbi.nlm.nih.gov/pubmed/32571411
http://dx.doi.org/10.1186/s13063-020-04493-x
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