Transcutaneous electrical acupoint stimulation for high-normal blood pressure: study protocol for a randomized controlled pilot trial

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Abstract

Background

High-normal blood pressure (BP) is associated with increased all-cause, cardiovascular mortality and frequently progresses to hypertension. Transcutaneous electrical acupoint stimulation (TEAS) might be a non-pharmaceutical therapy option to control BP. This trial aims to determine the effectiveness and safety of TEAS combined with lifestyle modification for high-normal BP.

Methods/design

This prospective, randomized, and parallel clinical trial will be conducted in a community service center in China. Sixty participants with high-normal BP will be randomly allocated to receive TEAS plus lifestyle modification (intervention group) or lifestyle modification alone (control group) in a 1:1 ratio. In addition to lifestyle modification, the intervention group will receive TEAS at four acupoints for 30 min, 4 times weekly for 12 weeks for a total of 48 sessions at home. The control group will receive same lifestyle modification but no TEAS. The primary outcome will be the change in mean systolic blood pressure at 12 weeks from the baseline measurement. Secondary outcomes include the change of mean diastolic blood pressure, proportion of subjects with progression to hypertension, quality of life, body mass index, and waist circumference. Adverse events during the trial will be monitored.

Discussion

This trial will explore the feasibility and provide potential evidence for the effectiveness and safety of TEAS plus lifestyle modification for high-normal BP. Furthermore, this pilot trial is being undertaken to determine the feasibility of a full scale definitive randomized controlled trial. The results of this study will be published in a peer-reviewed journal.

Trial registration

Chinese Clinical Trial Registry, ChiCTR 1900024982. Registered on August 6, 2019.

Supplementary Information

The online version contains supplementary material available at 10.1186/s13063-021-05039-5.

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Most cited references 30

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Appropriate body-mass index for Asian populations and its implications for policy and intervention strategies.

(2004)

A WHO expert consultation addressed the debate about interpretation of recommended body-mass index (BMI) cut-off points for determining overweight and obesity in Asian populations, and considered whether population-specific cut-off points for BMI are necessary. They reviewed scientific evidence that suggests that Asian populations have different associations between BMI, percentage of body fat, and health risks than do European populations. The consultation concluded that the proportion of Asian people with a high risk of type 2 diabetes and cardiovascular disease is substantial at BMIs lower than the existing WHO cut-off point for overweight (> or =25 kg/m2). However, available data do not necessarily indicate a clear BMI cut-off point for all Asians for overweight or obesity. The cut-off point for observed risk varies from 22 kg/m2 to 25 kg/m2 in different Asian populations; for high risk it varies from 26 kg/m2 to 31 kg/m2. No attempt was made, therefore, to redefine cut-off points for each population separately. The consultation also agreed that the WHO BMI cut-off points should be retained as international classifications. The consultation identified further potential public health action points (23.0, 27.5, 32.5, and 37.5 kg/m2) along the continuum of BMI, and proposed methods by which countries could make decisions about the definitions of increased risk for their population.

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2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: Executive Summary

Paul K. Whelton, Robert Carey, Wilbert Aronow … (2018)

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Status of Hypertension in China

Zengwu Wang, Zuo Chen, Linfeng Zhang … (2018)

Although the prevalence of hypertension (HTN) continues to increase in developing countries, including China, recent data are lacking. A nationwide survey was conducted from October 2012 to December 2015 to assess the prevalence of HTN in China.

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Author and article information

Contributors

Yu Wang: wydeoo@163.com

Guang-Xia Shi: shiguangxia2008@126.com

Zhong-Xue Tian: 904618337@qq.com

Jun-Hong Liu: junhongliu120@sina.com

You-Sheng Qi: tyyysqb@126.com

Jian-Feng Tu: tujianfeng1@126.com

Jing-Wen Yang: yangjw0626@126.com

Li-Qiong Wang:

ORCID: http://orcid.org/0000-0002-0278-0405

wangliqiongwork@163.com

Cun-Zhi Liu: lcz623780@126.com

Journal

Journal ID (nlm-ta): Trials

Journal ID (iso-abbrev): Trials

Title: Trials

Publisher: BioMed Central (London )

ISSN (Electronic): 1745-6215

Publication date (Electronic): 15 February 2021

Publication date PMC-release: 15 February 2021

Publication date Collection: 2021

Volume: 22

Electronic Location Identifier: 140

Affiliations

[1 ]GRID grid.24695.3c, ISNI 0000 0001 1431 9176, International Acupuncture and Moxibustion Innovation Institute, School of Acupuncture-Moxibustion and Tuina, , Beijing University of Chinese Medicine, ; Chaoyang District, No. 11, Bei San Huan Dong Lu, Chaoyang District, Beijing, 100029 China

[2 ]Nanyuan Community Health Service Center, Fengtai District, Beijing, China

[3 ]GRID grid.459365.8, Department of Acupuncture and Moxibustion, , Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, ; Dongcheng District, Beijing, China

Author information

Li-Qiong Wang http://orcid.org/0000-0002-0278-0405

Article

Publisher ID: 5039

DOI: 10.1186/s13063-021-05039-5

PMC ID: 7885337

PubMed ID: 33588904

SO-VID: 65377680-50bd-4ed7-aa3f-87b12a2b6fb4

License:

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.

History

Date received : 7 February 2020

Date accepted : 9 January 2021

Funding

Funded by: FundRef http://dx.doi.org/10.13039/501100012226, Fundamental Research Funds for the Central Universities;

Award ID: 2019-JYB-XJSJJ-31

Award Recipient : Li-Qiong Wang

Custom metadata

ScienceOpen disciplines: Medicine

Keywords: transcutaneous electrical acupoint stimulation,high-normal blood pressure,lifestyle interventions,prehypertension

Data availability:

ScienceOpen disciplines: Medicine

Keywords: transcutaneous electrical acupoint stimulation, high-normal blood pressure, lifestyle interventions, prehypertension

Transcutaneous electrical acupoint stimulation for high-normal blood pressure: study protocol for a randomized controlled pilot trial

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Abstract

Background

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Trial registration

Supplementary Information

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Network Medicine

Most cited references 30

Appropriate body-mass index for Asian populations and its implications for policy and intervention strategies.

2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: Executive Summary

Status of Hypertension in China

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