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Recruiting NCT00932139

Effect of Electro-Acupuncture on Blood Pressure

No phase Interventional Hypertension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Electro-acupuncture control, Electro-acupuncture test.
Who it may be relevant to
Registry conditions: Hypertension. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Neural Mechanism of the Effect of Acupuncture on Hypertension

Overview

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • blood pressure [Time frame: 8 weeks]
Secondary outcome measures (3)
  • Heart rate [Time frame: 8 weeks]
  • plasma catecholamine [Time frame: 8 weeks]
  • plasma renin [Time frame: 8 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 2 centers
  • Susan Samueli Integrative Health Institute — Irvine
  • UCIMedical Center — Orange

Publications

  • 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. PMID 26392838

Identifiers

NCT: NCT00932139 · 1999-2222

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗