MedTrace Logo

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

NCT06401278 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-05-07

No results posted yet for this study

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)

Conditions

Interventions

DEVICE

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 nerve stimulation (group b):

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.

Sponsors & Collaborators

  • Tawfik Tawfik Mahmoud Emara

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-05
Primary Completion
2024-08-05
Completion
2024-08-10

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06401278 on ClinicalTrials.gov