Acupuncture Therapy and Hypertension

Not Applicable

Recruiting

• Conditions: Mild to Moderate Hypertension
• Interventions: Other: electroacupuncture

• Registration Number: NCT05530512
• Lead Sponsor: University of California, Irvine

Brief Summary

Acupuncture therapy will be provided to reduce blood pressure in hypertensive patients. The mild to moderate hypertensive patients will be either on or off hypertensive medications. The course last for 8 weeks and the frequency is once a week.

Detailed Description

Improvement in BP control rates would lead to one of the largest impacts in improving life expectancy and the quality of life for over 100 million people in the United States and 1 billion people worldwide with immediate and measurable results. In the United States, 80% of patients with HTN are treated, but BP is controlled in only half of these individuals, with control worsening with increasing age. The reasons for inadequate treatment and BP control are complex, but one reason for this therapeutic misalignment may be an incomplete understanding of the mechanisms underlying the development and progression of HTN. The aging process leads to dysfunction of the ANS, resulting in neuroendocrine abnormalities and chronic low-grade inflammation.

The investigators have previously shown that electroacupuncture (EA) at four targeted acupoints, can decrease sympathetic activity \[sympathoinhibitory (SI)\], approaching levels close to those present prior to onset of HTN and may address this unmet need in HTN management. The investigators are now testing and have preliminary evidence that EA at two additional acupoints (SP6-7) increases parasympathetic activation, thereby decreasing circulating and tissue inflammatory biomarkers \[thus anti-inflammatory (AI)\] and when combined with SI-EA can improve measures of vascular health including endothelial function and arterial stiffness in preclinical model with overall greater reduction in BP. Together these combined six acupoints, when simultaneously activated by EA may restore optimal autonomic control of the immune system and target an important mechanistic pathway not addressed by BP-lowering pharmacotherapy alone. To date, 39 participants have been enrolled in the study.

Study Timeline

• Study First Submitted: 2022-08-27
• Study First Submitted QC: 2022-09-01
• Study First Posted: 2022-09-07
• Study Start: 2023-01-01
• Status Verified: 2024-12
• Last Update Submitted: 2025-04-10
• Last Update Posted: 2025-04-15
• Primary Completion: 2026-03-31
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Subjects from 45 to 75 years of age
2. Clinically diagnosed with mild to moderate hypertension and ON or OFF medication (Office SBP > 140 mmHg and < 160 mmHg Or ABPM average SBP > 130 mmHg and < 145 mmHg), and
3. No significant ECG change reflecting ischemia (i.e. ST elevation or depression) at rest will be recruited to participate in this study.

Exclusion Criteria

1. Subjects will be excluded if on anti-hypertensive medications.
2. Subjects will be excluded if pregnant or nursing.
3. Subjects will be excluded if they have coronary disease (by history or on ECG screening), 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 neuropathy or severe hypertension (BP >170 mmHg systolic or >110 mmHg diastolic), or any other physical or psychological illness.
4. Those with known sensitivity to any topical preparations or strong reactions to medical dressings and skin tapes also will be excluded.
5. Inability our or unwillingness of individual to give written informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Anti-inflammatory EA (AI-EA)	electroacupuncture	Anti-inflammatory electroacupuncture therapy
Sympathoinhibitory EA (SI-EA)	electroacupuncture	sympatho-inhibitory electroacupuncture therapy
Control EA (Sham-EA)	electroacupuncture	Sham electroacupuncture
Combined EA (cEA)	electroacupuncture	combination of SI-EA and AI-EA

Primary Outcome Measures

Name	Time	Method
Changes in sympathetic and parasympathetic nervous systems	through study completion, an average of 4.5 years	Heart rate variability and its component will be evaluated with EKG.

Secondary Outcome Measures

Name	Time	Method
Change in biomarkers like cytokines	through study completion, an average of 4.5 years	Plasma will be measured for inflammatory markers with ELISA kits.

Trial Locations

Locations (2)

Susan Samueli Integrative Health Institute; 🇺🇸 Irvine, California, United States

University of California, Irvine, Health Sciences Medical Center; 🇺🇸 Orange, California, United States