Effect of Electro-Acupuncture on Blood Pressure

April 10, 2025 updated by: Shaista Malik, University of California, Irvine

Neural Mechanism of the Effect of Acupuncture on Hypertension

Based on previous published research in animals and human, the investigators hypothesize that electroacupuncture (EA) will have a positive effect on hypertension.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to prove: (1) hypertensive response at rest and provoked by stress are decreased by EA; (2) The mechanisms of EA that reduces elevated blood pressure. EA inhibits the sympathetic nervous system, decreases blood pressure and reduces the oxygen demand. Our prior data in animals shows that improvements in cardiovascular function during myocardial ischemia, reflex hypertension and sustained hypertension are mediated by an EA-induced sensory neural reflex originating in somatic nerves to reduce sympathetic nerve activity. The specific aims of the present study will allow us to better understand and modulate the sympathetic nervous discharge activity that can cause hypertension during normal activity and stress in humans. The potential clinical application is the therapeutic value of EA in patients with hypertension.

Furthermore, the study will also investigate gender differences in the blood pressure lowering effect of EA. In particular in middle-aged hypertensive women and men.

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Stephanie Tjen-A-Looi, PhD
  • Phone Number: 9494005909
  • Email: stjenalo@uci.edu

Study Locations

  • United States
    • California
      • Irvine, California, United States, 92617
        • Recruiting
        • Susan Samueli Integrative Health Institute
        • Contact:
          • Mitchell Beasley, MD, PhD, MPH
          • Phone Number: 949-824-7000
          • Email: beasleym@uci.edu
        • Contact:
        • Contact:
          • LiFang Xie, PhD, LAc
        • Contact:
          • Shaista Malik, MD, PhD, MPH
        • Contact:
          • Stephanie Tjen-A-Looi, PhD
      • Orange, California, United States, 92868
        • Recruiting
        • UCIMedical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

39 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with mild coronary disease, and no significant ECG change reflecting ischemia at rest.
  • Patients with high blood pressure with or without antihypertensive medication.

Exclusion Criteria:

  • Pregnant or nursing women
  • Individuals with severe coronary disease (continuous angina)
  • Conduction abnormalities on ECG consistent with left bundle branch block
  • Cardiac arrhythmias associated with low blood pressure (90 mmHg)
  • Peripheral vascular disease
  • Orthopedic disease
  • Diabetic or psychological illness that could interfere with safe performance of exercise of psychophysiological stress testing
  • Those with known sensitivity to topical preparations or strong reactions to medical dressings and skin tapes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Electro-acupuncture control

Blood pressure will be recorded before and after each EA treatment for 8 weeks. The course is a once a week 8-week treatment.

Intervention is the Electro-acupuncture control treatment.
Procedure: Electro-acupuncture control
First visit, blood pressure monitoring for 60 minutes at rest, then monitoring for subsequent 24 hours to measure BP and heart rate. At next 6-8 visits, Electro-acupuncture (EA) treatment for 30 minutes will be administered. BP and heart rate measurements will be taken 30 minutes before and after EA.
Other Names:
  • Blood pressure
  • Hypertension
Procedure: Electro-acupuncture test
First visit, blood pressure monitoring for 60 minutes at rest, then monitoring for subsequent 24 hours to measure BP and heart rate. At next 6-8 visits, Electro-acupuncture (EA) treatment for 30 minutes will be administered. BP and heart rate measurements will be taken 30 minutes before and after EA. At end of 8-week treatment, 24 hours blood pressure and heart rate will be measured.
Other Names:
  • Blood pressure
  • Hypertension
Experimental: Electro-acupuncture test

Blood pressure will be recorded before and after each EA treatment for 8 weeks. The course is a once a week 8-week treatment.

Intervention is the active Electro-acupuncture treatment.
Procedure: Electro-acupuncture control
First visit, blood pressure monitoring for 60 minutes at rest, then monitoring for subsequent 24 hours to measure BP and heart rate. At next 6-8 visits, Electro-acupuncture (EA) treatment for 30 minutes will be administered. BP and heart rate measurements will be taken 30 minutes before and after EA.
Other Names:
  • Blood pressure
  • Hypertension
Procedure: Electro-acupuncture test
First visit, blood pressure monitoring for 60 minutes at rest, then monitoring for subsequent 24 hours to measure BP and heart rate. At next 6-8 visits, Electro-acupuncture (EA) treatment for 30 minutes will be administered. BP and heart rate measurements will be taken 30 minutes before and after EA. At end of 8-week treatment, 24 hours blood pressure and heart rate will be measured.
Other Names:
  • Blood pressure
  • Hypertension

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blood pressure
Time Frame: 8 weeks
evaluation of systolic and diastolic blood pressures changes
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate
Time Frame: 8 weeks
evaluation of heart rate change
8 weeks
plasma catecholamine
Time Frame: 8 weeks
evaluation of plasma catecholamine (ng/ml) change
8 weeks
plasma renin
Time Frame: 8 weeks
evaluation of plasma renin (ng/ml.hr) change
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Irvine

Investigators

  • Principal Investigator: Liang-Wu Fu, MD, PhD, University of California, Irvine
  • Principal Investigator: Shaista Malik, MD, PhD, MPH, University of California, Irvine
  • Principal Investigator: LiFang Xie, PhD, LAc, University of California, Irvine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2003

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

July 1, 2009

First Submitted That Met QC Criteria

July 2, 2009

First Posted (Estimated)

July 3, 2009

Study Record Updates

Last Update Posted (Actual)

April 15, 2025

Last Update Submitted That Met QC Criteria

April 10, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1999-2222

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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