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Effect of Electro-Acupuncture on Blood Pressure

Primary Purpose

Hypertension

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Electro-acupuncture control
Electro-acupuncture test
Sponsored by
University of California, Irvine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Hypertension, blood pressure, mild to moderate hypertension

Eligibility Criteria

39 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Susan Samueli Integrative Health InstituteRecruiting
  • UCIMedical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Electro-acupuncture control

Electro-acupuncture test

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

blood pressure
evaluation of systolic and diastolic blood pressures changes

Secondary Outcome Measures

Heart rate
evaluation of heart rate change
plasma catecholamine
evaluation of plasma catecholamine (ng/ml) change
plasma renin
evaluation of plasma renin (ng/ml.hr) change

Full Information

First Posted
July 1, 2009
Last Updated
June 15, 2023
Sponsor
University of California, Irvine
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1. Study Identification

Unique Protocol Identification Number
NCT00932139
Brief Title
Effect of Electro-Acupuncture on Blood Pressure
Official Title
Neural Mechanism of the Effect of Acupuncture on Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 2003 (undefined)
Primary Completion Date
September 2027 (Anticipated)
Study Completion Date
December 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Irvine

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Hypertension, blood pressure, mild to moderate hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two different formulated sets of acupoints will be used as EA intervention in the treatment of hypertension.
Masking
Care ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Electro-acupuncture control
Arm Type
Experimental
Arm Description
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.
Arm Title
Electro-acupuncture test
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Electro-acupuncture control
Other Intervention Name(s)
Blood pressure, Hypertension
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Electro-acupuncture test
Other Intervention Name(s)
Blood pressure, Hypertension
Intervention Description
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.
Primary Outcome Measure Information:
Title
blood pressure
Description
evaluation of systolic and diastolic blood pressures changes
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Heart rate
Description
evaluation of heart rate change
Time Frame
8 weeks
Title
plasma catecholamine
Description
evaluation of plasma catecholamine (ng/ml) change
Time Frame
8 weeks
Title
plasma renin
Description
evaluation of plasma renin (ng/ml.hr) change
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
39 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephanie Tjen-A-Looi, PhD
Email
stjenalo@uci.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Shaista Malik, MD, PhD, MPH
Email
smalik@uci.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie Tjen-A-Looi, PhD
Organizational Affiliation
University of California, Irvine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Liang-Wu Fu, MD, PhD
Organizational Affiliation
University of California, Irvine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shaista Malik, MD, PhD, MPH
Organizational Affiliation
University of California, Irvine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
LiFang Xie, PhD, LAc
Organizational Affiliation
University of California, Irvine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Susan Samueli Integrative Health Institute
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shaista Malik, MD, PhD, MPH
Email
smalik@uci.edu
First Name & Middle Initial & Last Name & Degree
Stephanie Tjen-A-Looi, PhD
Email
stjenalo@uci.edu
First Name & Middle Initial & Last Name & Degree
Stephanie Tjen-A-Looi, PhD
First Name & Middle Initial & Last Name & Degree
LiFang Xie, PhD, LAc
First Name & Middle Initial & Last Name & Degree
Shaista Malik, MD, PhD, MPH
Facility Name
UCIMedical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shaista Malik, MD, PhD, MPH
Email
smalik@uci.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26392838
Citation
Li P, Tjen-A-Looi SC, Cheng L, Liu D, Painovich J, Vinjamury S, Longhurst JC. Long-Lasting Reduction of Blood Pressure by Electroacupuncture in Patients with Hypertension: Randomized Controlled Trial. Med Acupunct. 2015 Aug 1;27(4):253-266. doi: 10.1089/acu.2015.1106.
Results Reference
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Effect of Electro-Acupuncture on Blood Pressure

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