Clinical trial NCT06401278: Trans Cutaneous Electrical Acupoint Stimulation Versus TENS On Blood Pressure In Primary Hypertension Patients
Official title: Trans Cutaneous Electrical Acupoint Stimulation Versus TENS On Blood Pressure And Quality Of Life In Patients With Primary Hypertension
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Quality of Life
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-05-06
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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:

1. BP by Digital Sphygmomanometer
2. quality of life by The SF-12 health status questionnaire
3. nitric oxide level in blood by nitric Oxide analysis.
4. sleep quality. by Pittsburgh Sleep Quality Index (PSQI)
5. exercise capacity and endurance by Thirty-Second Sit-To-Stand Test (30 STST)


Eligibility criteria: Inclusion Criteria:

* 1) Sixty patients from both sexes diagnosed with essential HT at least 6 months ago.

  2) 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).

  4) Their body mass index (BMI) ranged from will be ranged from 24.9 to 29.9 kg/m2.

  5) 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

Exclusion Criteria:

* 1) 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.

  3) Patients with history, symptoms of, and/or laboratory reports suggestive of renal, neurologic, or hepatic complications.

  4) 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.

Primary outcomes:
measure: Blood Pressure by using a digital sphygmomanometer
timeFrame: six weeks
measure: quality of life by Short Form twelve health status questionnaire
timeFrame: six weeks
measure: Nitric oxide by nitric oxide sample analysis
timeFrame: six weeks
Secondary outcomes:
measure: exercise capacity and endurance measured by Thirty-Second Sit-To-Stand Test (30 STST)
timeFrame: six weeks
measure: sleep quality
timeFrame: six weeks
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of physical therapy- Cairo Uni.
Study officials:
References: