Trans Cutaneous Electrical Acupoint Stimulation Versus TENS On Blood Pressure In Primary Hypertension Patients

NCT06401278 | Recruiting DMC

• 1 other identifier: P.T.REC/012/004443
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Hypertension; Quality of Life

Outcome Measures

Primary Outcomes (3)

• Blood Pressure by using a digital sphygmomanometer

  Blood pressure was recorded by using a digital sphygmomanometer

  six weeks

• quality of life by Short Form twelve health status questionnaire

  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.

  six weeks

• Nitric oxide by nitric oxide sample analysis

  by nitric oxide sample analysis

  six weeks

Secondary Outcomes (2)

• exercise capacity and endurance measured by Thirty-Second Sit-To-Stand Test (30 STST)

  six weeks

• sleep quality

  six weeks

Study Arms (3)

Transcutaneous electrical acupoint stimulation (Group A):

EXPERIMENTAL

Transcutaneous electrical acupoint stimulation :It will be performed by using the TENS device on acupoint (TEAS) as the following: The patients will be placed in a relaxed comfortable sitting position with their back well supported. for 40 min three times weekly for a total of 6 weeks.The adhesive electrodes of the TENS device will be placed on the selected acupoint bilaterally Nei-Guan (PC6), Taichong (LR3), and Sanyinjiao (SP6)

Device: Transcutaneous electrical acupoint stimulation

Transcutaneous electrical nerve stimulation(Group b):

EXPERIMENTAL

TENS will be applied in the cervicothoracic ganglion region located between the C7 and T4 vertebral processes for 40 min three times weekly for a total of 6 weeks.

Device: Transcutaneous electrical nerve stimulation (group b):

Control

NO INTERVENTION

Routine medical treatment: (Group c): receive only routine medical treatment (antihypertensive medication, instructions and education to control blood pressure) * Nutrition Eat a diet that is high in fiber and potassium, and low in salt (sodium), added sugar, and fat. * Lifestyle Do not use any products that contain nicotine or tobacco, such as cigarettes, and chewing tobacco. * Identify your sources of stress and find ways to manage stress. This may include deep breathing or making time for fun activities. * Do not drink alcohol

Interventions

Transcutaneous electrical acupoint stimulation DEVICE

It will be performed by using the TENS device on acupoint (TEAS) as the following: The patients will be placed in a relaxed comfortable sitting position with their back well supported. for 40 min three times weekly for a total of 6 weeks.The adhesive electrodes of the TENS device will be placed on the selected acupoint bilaterally Nei-Guan (PC6), Taichong (LR3), and Sanyinjiao (SP6)

Transcutaneous electrical acupoint stimulation (Group A):

Transcutaneous electrical nerve stimulation (group b): DEVICE

TENS will be applied in the cervicothoracic ganglion region located between the C7 and T4 vertebral processes for 40 min three times weekly for a total of 6 weeks.

Transcutaneous electrical nerve stimulation(Group b):

Eligibility Criteria

• Age: 50 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \) 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/m2.
• \) 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

You may not qualify if:

• \) 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.

Sponsors & Collaborators

• Tawfik Tawfik Mahmoud Emara: lead

Study Sites (1)

Faculty of physical therapy- Cairo Uni.

Giza, 12611, Egypt

RECRUITING

MeSH Terms

Conditions

Hypertension

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: May 2, 2024
• First Posted: May 6, 2024
• Study Start: May 5, 2024
• Primary Completion: August 5, 2024
• Study Completion: August 10, 2024
• Last Updated: May 7, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)