Trans Cutaneous Electrical Acupoint Stimulation Versus TENS On Blood Pressure And Quality Of Life In Patients With Primary Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Blood Pressure by using a digital sphygmomanometer
研究概览
简要总结
To compare between the effects of transcutaneous electrical acupoint stimulation and TENS on blood pressure and quality of life in patients with primary hypertension
BACKGROUND:
The current American College of Cardiology and the American Heart Association (ACC/AHA) 2017 guidelines define hypertension as systolic BP (SBP) of ≥130 mmHg or diastolic BP (DBP) of ≥80 mmHg. In adults, an increase of 20 mmHg in SBP or 10 mmHg in DBP is associated with more than a two-fold increase in mortality owing to stroke and other cardiovascular diseases. Hypertension accounts for 13% of premature deaths worldwide and is the third leading cause of disability-adjusted life years (Shah et al., 2022).
Transcutaneous electrical nerve stimulation of the Neiguan (P6) point with acupressure is possibly affecting the blood pressure by protecting the myocardial tissues and influencing the nervous system through regulating the autonomic nervous system function and reduction in sympathetic activity. (Hassanein et al., 2021).
HYPOTHESES There will be no a significant difference between the effects of transcutaneous electrical acupoint stimulation and TENS on blood pressure and quality of life in patients with primary hypertension
RESEARCH QUESTION:
Is there a significant difference between the effects of transcutaneous electrical acupoint stimulation and TENS on blood pressure and quality of life in patients with primary hypertension?
Evaluating equipment, pre-post intervension outcomes:
- BP by Digital Sphygmomanometer
- quality of life by The SF-12 health status questionnaire
- nitric oxide level in blood by nitric Oxide analysis.
- sleep quality. by Pittsburgh Sleep Quality Index (PSQI)
- exercise capacity and endurance by Thirty-Second Sit-To-Stand Test (30 STST)
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)
入排标准
- 年龄范围
- 50 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sixty patients from both sexes diagnosed with essential HT at least 6 months ago.
- •Their age will be ranged from 50 to 60 years old. 3) Their blood pressure will be ranged from (SBP is 140 -159 mmHg and/or DBP is 90-99 mmHg).
- •Their body mass index (BMI) ranged from will be ranged from 24.9 to 29.9 kg/m
- •All patients are medically stable and receive the same medical treatment 6) All patient nonsmoker or quitted smoking for at least 4-5 years 7) All patients will be similar in terms of status of functional activity, status of eating a salt-free diet and the presence of any chronic disease except HT
排除标准
- •Secondary hypertension 2) Patients with cardiac problems e.g. atrial fibrillation, left bundle-branch block, heart failure, recent myocardial infarction, coronary artery disease, or participation in cardiac rehabilitation following bypass surgery.
- •Patients with history, symptoms of, and/or laboratory reports suggestive of renal, neurologic, or hepatic complications.
- •Use of a cardiac pacemaker 5) Any metal implants at site of application of TENS 6) Dermatological abnormalities at the site of the application of TENS 7) Obesity with body mass index (BMI) > 30 kg/m2 8) Smoker, diabetes. 9) Soft tissue, nerve, and vascular diseases of upper or lower extremities which hinder the application of TEAS.
结局指标
主要结局
Blood Pressure by using a digital sphygmomanometer
时间窗: six weeks
Blood pressure was recorded by using a digital sphygmomanometer
Nitric oxide by nitric oxide sample analysis
时间窗: six weeks
by nitric oxide sample analysis
quality of life by Short Form twelve health status questionnaire
时间窗: six weeks
by Short Form twelve health status questionnaire Health-Related Quality of Life survey consisting of twelve questions that measure eight health domains to assess physical and mental health.The score ranges from 0 to 100, with a higher score indicating better physical and mental health functioning.
次要结局
- exercise capacity and endurance measured by Thirty-Second Sit-To-Stand Test (30 STST)(six weeks)
- sleep quality(six weeks)
研究者
Tawfik Tawfik Mahmoud Emara
Assistant Lecturer
Cairo University