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Effect of Electro-Acupuncture on Blood Pressure

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ClinicalTrials.gov Identifier: NCT00932139
Recruitment Status : Recruiting
First Posted : July 3, 2009
Last Update Posted : March 19, 2018
Sponsor:
Information provided by (Responsible Party):
Stephanie Tjen-A-Looi, University of California, Irvine

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

Condition or disease Intervention/treatment Phase
Hypertension Arrhythmias Procedure: Electro-acupuncture control Procedure: Electro-acupuncture test Not Applicable

Detailed Description:

The purpose of this study is to prove: (1) Myocardial ischemia, cardiac arrhythmias and hypertensive response at rest and provoked by stress are decreased by EA; (2) The mechanism of the ischemic response is an imbalance between myocardial oxygen supply and demand originating as an increase in autonomic nervous system sympathetic activity causing increased oxygen demand. 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 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 precipitate coronary ischemia, arrhythmias and hypertension in exercise 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two different formulated sets of acupoints will be used as EA intervention in the treatment of hypertension.
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Masking Description: The care provider or acupuncturist does not know the outcome of the treatment. The investigator does not know the participants and the outcome of the study. The outcome assessor does not know the participants.
Primary Purpose: Treatment
Official Title: Neural Mechanism of the Effect of Acupuncture on Myocardial Ischemia
Study Start Date : February 2003
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture
U.S. FDA Resources

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
  • Arrhythmias
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.
Other Names:
  • Blood pressure
  • Hypertension
  • Arrhythmias
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
  • Arrhythmias
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.
Other Names:
  • Blood pressure
  • Hypertension
  • Arrhythmias



Primary Outcome Measures :
  1. blood pressure [ Time Frame: 8 weeks ]
    evaluation of systolic and diastolic blood pressures changes


Secondary Outcome Measures :
  1. Heart rate [ Time Frame: 8 weeks ]
    evaluation of heart rate change

  2. plasma catecholamine [ Time Frame: 8 weeks ]
    evaluation of plasma catecholamine (ng/ml) change

  3. plasma renin [ Time Frame: 8 weeks ]
    evaluation of plasma renin (ng/ml.hr) change



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with mild coronary disease, and no significant ECG change reflecting ischemia at rest

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00932139


Contacts
Contact: Stephanie Tjen-A-Looi, PhD stjenalo@uci.edu
Contact: Shaista Malik, MD, PhD, MPH smalik@uci.edu

Locations
United States, California
Susan Samueli Integrative Health Institute Recruiting
Costa Mesa, California, United States, 92626
Contact: Shaista Malik, MD, PhD, MPH       smalik@uci.edu   
Sub-Investigator: Stephanie Tjen-A-Looi, PhD         
Sub-Investigator: LiFang Xie, PhD, LAc         
Principal Investigator: Shaista Malik, MD, PhD, MPH         
Sponsors and Collaborators
University of California, Irvine
Investigators
Principal Investigator: Stephanie Tjen-A-Looi, PhD University of California, Irvine
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:
Responsible Party: Stephanie Tjen-A-Looi, Project Scientist, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00932139     History of Changes
Other Study ID Numbers: 1999-2222
First Posted: July 3, 2009    Key Record Dates
Last Update Posted: March 19, 2018
Last Verified: March 2018

Keywords provided by Stephanie Tjen-A-Looi, University of California, Irvine:
Hypertension
blood pressure
arrhythmias
mild to moderate hypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases