160 Participants Needed

Electro-Acupuncture for High Blood Pressure

Recruiting at 2 trial locations
ST
SM
Overseen ByShaista Malik, MD, PhD, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of California, Irvine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Do I need to stop my current medications for this trial?

The trial does not specify if you need to stop taking your current medications. However, it mentions that patients with high blood pressure can participate with or without antihypertensive medication, suggesting you may not need to stop them.

Is electro-acupuncture generally safe for humans?

A systematic review of electro-acupuncture (EA) found that while adverse events (unwanted side effects) are reported, the safety of EA is less well documented compared to traditional acupuncture. Further studies are needed to better understand its safety profile.12345

How does the Electro-Acupuncture treatment for high blood pressure differ from other treatments?

Electro-Acupuncture (EA) is unique because it combines traditional acupuncture with electrical stimulation at specific points on the body, which may help lower blood pressure without the use of medication. This approach is different from standard drug treatments as it uses electrical currents to potentially achieve blood pressure reduction.13456

What data supports the effectiveness of the treatment Electro-Acupuncture for High Blood Pressure?

Research shows that electrical stimulation of specific acupuncture points can significantly reduce diastolic blood pressure in people with high blood pressure. Additionally, acupuncture combined with antihypertensive medications has been found to significantly lower blood pressure.13478

Who Is on the Research Team?

SM

Shaista Malik, MD, PhD, MPH

Principal Investigator

University of California, Irvine

LX

LiFang Xie, PhD, LAc

Principal Investigator

University of California, Irvine

LF

Liang-Wu Fu, MD, PhD

Principal Investigator

University of California, Irvine

Are You a Good Fit for This Trial?

This trial is for adults with high blood pressure, which can be with or without current medication. It's also open to those with mild heart disease but no serious ECG changes. However, it's not for pregnant women, individuals with severe heart issues like ongoing chest pain, peripheral vascular disease, certain ECG abnormalities, orthopedic conditions, skin sensitivities to tapes/dressings, very low blood pressure-related arrhythmias or uncontrolled diabetes and psychological conditions.

Inclusion Criteria

I have mild heart disease with no significant changes in my resting ECG.
I have high blood pressure, with or without medication.

Exclusion Criteria

You have a specific heart condition that shows up on an ECG test.
I have severe heart disease with constant chest pain.
I have heart rhythm problems with low blood pressure.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive electro-acupuncture treatment once a week for 8 weeks to evaluate its effect on blood pressure and other cardiovascular parameters.

8 weeks
8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Electro-acupuncture control
  • Electro-acupuncture test
Trial Overview The study is testing whether electro-acupuncture (EA) can help lower high blood pressure. Participants will receive either the test EA treatment or a control version of EA. The hypothesis is that EA could have beneficial effects on hypertension based on earlier research in animals and humans.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Electro-acupuncture testExperimental Treatment2 Interventions
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.
Group II: Electro-acupuncture controlExperimental Treatment2 Interventions
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.

Electro-acupuncture test is already approved in China, United States for the following indications:

🇨🇳
Approved in China as Electro-acupuncture for:
  • Hypertension
🇺🇸
Approved in United States as Electro-acupuncture for:
  • Hypertension (investigational)

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials
580
Recruited
4,943,000+

Published Research Related to This Trial

Hans electrical stimulation of acupuncture points significantly reduced systolic blood pressure in subjects over a 5-week treatment period, with systolic levels dropping from 117.8 mm Hg to 110.1 mm Hg (P < .05).
Diastolic blood pressure did not show significant changes, indicating that while the treatment may effectively lower systolic pressure, it does not have the same impact on diastolic pressure in this population.
Effects of electrical stimulation of acupuncture points on blood pressure.Zhang, J., Ng, D., Sau, A.[2022]
Acupuncture does not show significant improvement in systolic or diastolic blood pressure compared to sham acupuncture in patients not on antihypertensive medications, based on a review of 4 randomized controlled trials involving 386 participants.
However, acupuncture may significantly lower blood pressure in patients who are already taking antihypertensive medications, suggesting it could be a beneficial adjunct treatment for those individuals.
Acupuncture for essential hypertension: a meta-analysis of randomized sham-controlled clinical trials.Li, DZ., Zhou, Y., Yang, YN., et al.[2022]
This study will evaluate the effectiveness and safety of smartphone-based transcutaneous electrical acupoint stimulation (TEAS) as an adjunctive therapy for hypertension in a large cohort of 1600 patients over 52 weeks.
Patients in the TEAS group will receive non-invasive electrical stimulation at home for 30 minutes, four times a week for 12 weeks, with the primary outcome being the change in systolic blood pressure compared to usual care.
Smart phone-based transcutaneous electrical acupoint stimulation as adjunctive therapy for hypertension (STAT-H trial): protocol for a cluster randomised controlled trial.Tu, JF., Kang, SB., Wang, LQ., et al.[2022]

Citations

Effects of electrical stimulation of acupuncture points on blood pressure. [2022]
Acupuncture for essential hypertension: a meta-analysis of randomized sham-controlled clinical trials. [2022]
Smart phone-based transcutaneous electrical acupoint stimulation as adjunctive therapy for hypertension (STAT-H trial): protocol for a cluster randomised controlled trial. [2022]
Association between acupuncture and grade 1 hypertension: A systematic review and meta-analysis. [2022]
Effect of acupuncture-point stimulation on diastolic blood pressure in hypertensive subjects: a preliminary study. [2019]
Adverse events related to electroacupuncture: a systematic review of single case studies and case series. [2021]
Transcutaneous electrical acupoint stimulation for high-normal blood pressure: study protocol for a randomized controlled pilot trial. [2022]
Transcutaneous electrical acupoint stimulation for stage 1 hypertension: protocol for a randomized controlled pilot trial. [2021]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security