Transcutaneous Electrical Acupoint Stimulation on Blood Pressure

Официальное название

The Antihypertensive Effects of Transcutaneous Electrical Acupoint Stimulation in Patients With High-normal Blood Pressure and Grade 1 Hypertension

Обзор

This study will be conducted in patients with high-normal blood pressure and grade 1 hypertension and will be divided into two phases. In Phase One, a small group of patients will undergo transcutaneous electrical acupoint stimulation treatment for three consecutive days. Blood pressure changes will be observed before and after each stimulation session, as well as 1 hour, 3 hours, and 5 hours after stimulation, during the night of the treatment day, and the next morning. Phase Two will be a single-center, single-blind, parallel randomized controlled trial. After screening, patients will be randomly assigned to either the "stimulation" experimental group or the "sham stimulation" control group. For three consecutive days, both groups will receive their respective interventions at the same time each day, and their blood pressure changes will be recorded.

Вмешательства

• Устройство Transcutaneous electrical acupoint stimulation
  Participants will receive proper transcutaneous electrical acupoint stimulation treatment for three consecutive days. Each day, the selected five target acupoints (Renying, Quchi, Taichong, Zusanli, and Hegu) will be stimulated in rotation. Each acupoint will be stimulated once a day for 10 minutes, with a 2-minute interval between each acupoint, totaling 60 minutes. Throughout the trial, the stimulation parameters for each participant will remain constant, and the treatment will begin between 8
• Устройство Sham stimulation
  Participants will receive sham stimulation treatment, where the left-side skin near the selected five target acupoints (avoiding other functional acupoints) will be stimulated in rotation. The stimulation time and method will be the same as in the experimental group. Throughout the trial, the stimulation parameters for each participant will remain constant, and the treatment will begin between 8:00 and 10:00 AM each day.

Первичные конечные точки

• Change in office systolic blood pressure between the third day after TEAS treatment and the baseline (before the start of treatment on the first day) [Срок оценки: At the third day after TEAS treatment and the baseline (before the start of treatment on the first day)]

Вторичные конечные точки (4)

• Changes in office systolic blood pressure at other time points before and after treatment [Срок оценки: At all other time points (excluding the third day after treatment) and the baseline (before the start of treatment on the first day)]
• Changes in office diastolic blood pressure at various time points before and after treatment [Срок оценки: At each time point before and after treatment and the baseline (before the start of treatment on the first day).]
• Changes in ambulatory blood pressure before and after treatment [Срок оценки: At the third day after the end of treatment and the baseline (before the start of treatment on the first day)]
• Changes in Hamilton Scale scores before and after treatment [Срок оценки: At the third day after the end of treatment and the baseline (before the start of treatment on the first day)]

Критерии участия

Критерии включения

• Office systolic blood pressure between 130-150 mmHg and/or diastolic blood pressure between 80-95 mmHg
• Age between 18 and 75 years
• Not currently receiving antihypertensive medication or having discontinued antihypertensive medication for more than two weeks
• Able to undergo and complete the transcutaneous electrical acupoint stimulation treatment
• Agree to participate and sign the informed consent form

Критерии исключения

• Pregnant or breastfeeding women
• Severe heart conditions, including coronary heart disease, myocardial infarction, arrhythmia, heart failure, or having an implanted cardiac pacemaker
• Skin conditions, including eczema, allergic dermatitis, or seborrheic dermatitis
• Neuromuscular diseases, mental disorders, epilepsy, or cognitive impairment
• Lower limb deep vein thrombosis or thrombophlebitis
• Wounds, surgical scars, or malignant tumors at the stimulation areas
• Inability to tolerate the transcutaneous electrical acupoint stimulation treatment or allergic to electrical stimulation
• Currently participating in other clinical trials

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06537167 · TEAS-BP

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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