The Antihypertensive Effects of Transcutaneous Electrical Acupoint Stimulation in Patients With High-normal Blood Pressure and Grade 1 Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 主要终点
- 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)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
At the time of enrollment, each participant will be assigned a unique identification number (e.g., 001). The coded information will be stored in a secure database accessible only to designated members of the research team. A random number table will be generated using SPSS software, and participants will be allocated to either the "stimulation" experimental group or the "sham stimulation" control group according to the generated random numbers. Randomization information will be strictly confidential, ensuring that participants, outcome assessors, and statistical analysts are all blinded to the group assignments.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
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)
时间窗: At the third day after TEAS treatment and the baseline (before the start of treatment on the first day)
次要结局
- Changes in Hamilton Scale scores before and after treatment(At the third day after the end of treatment and the baseline (before the start of treatment on the first day))
- Changes in office systolic blood pressure at other time points before and after treatment(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(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(At the third day after the end of treatment and the baseline (before the start of treatment on the first day))
研究者
Ji-Guang Wang
Professor of the Shanghai Institute of Hypertension and the Department of Hypertension
Shanghai Jiao Tong University School of Medicine