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

Overview of attention for article published in Trials, February 2021
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Title
Transcutaneous electrical acupoint stimulation for high-normal blood pressure: study protocol for a randomized controlled pilot trial
Published in
Trials, February 2021
DOI 10.1186/s13063-021-05039-5
Pubmed ID
Authors

Yu Wang, Guang-Xia Shi, Zhong-Xue Tian, Jun-Hong Liu, You-Sheng Qi, Jian-Feng Tu, Jing-Wen Yang, Li-Qiong Wang, Cun-Zhi Liu

Abstract

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

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Geographical breakdown

Country Count As %
Unknown 28 100%

Demographic breakdown

Readers by professional status Count As %
Researcher 4 14%
Student > Postgraduate 3 11%
Student > Ph. D. Student 2 7%
Lecturer 1 4%
Student > Doctoral Student 1 4%
Other 2 7%
Unknown 15 54%
Readers by discipline Count As %
Medicine and Dentistry 8 29%
Pharmacology, Toxicology and Pharmaceutical Science 1 4%
Biochemistry, Genetics and Molecular Biology 1 4%
Sports and Recreations 1 4%
Nursing and Health Professions 1 4%
Other 2 7%
Unknown 14 50%