Transcutaneous Electrical Acupoint Stimulation on Blood Pressure

NCT ID: NCT06537167

Last Updated: 2025-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-31

Study Completion Date

2027-12-31

Brief Summary

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This study will be conducted in patients with high-normal blood pressure and grade 1 hypertension and will be divided into two phases.

In Phase One, a small group of patients will undergo transcutaneous electrical acupoint stimulation treatment for three consecutive days. Blood pressure changes will be observed before and after each stimulation session, as well as 1 hour, 3 hours, and 5 hours after stimulation, during the night of the treatment day, and the next morning.

Phase Two will be a single-center, single-blind, parallel randomized controlled trial. After screening, patients will be randomly assigned to either the "stimulation" experimental group or the "sham stimulation" control group. For three consecutive days, both groups will receive their respective interventions at the same time each day, and their blood pressure changes will be recorded.

Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
At the time of enrollment, each participant will be assigned a unique identification number (e.g., 001). The coded information will be stored in a secure database accessible only to designated members of the research team. A random number table will be generated using SPSS software, and participants will be allocated to either the "stimulation" experimental group or the "sham stimulation" control group according to the generated random numbers. Randomization information will be strictly confidential, ensuring that participants, outcome assessors, and statistical analysts are all blinded to the group assignments.

Study Groups

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"Stimulation" Experimental Group

Group Type EXPERIMENTAL

Transcutaneous electrical acupoint stimulation

Intervention Type DEVICE

Participants will receive proper transcutaneous electrical acupoint stimulation treatment for three consecutive days. Each day, the selected five target acupoints (Renying, Quchi, Taichong, Zusanli, and Hegu) will be stimulated in rotation. Each acupoint will be stimulated once a day for 10 minutes, with a 2-minute interval between each acupoint, totaling 60 minutes. Throughout the trial, the stimulation parameters for each participant will remain constant, and the treatment will begin between 8:00 and 10:00 AM each day.

"Sham Stimulation" Control Group

Group Type SHAM_COMPARATOR

Sham stimulation

Intervention Type DEVICE

Participants will receive sham stimulation treatment, where the left-side skin near the selected five target acupoints (avoiding other functional acupoints) will be stimulated in rotation. The stimulation time and method will be the same as in the experimental group. Throughout the trial, the stimulation parameters for each participant will remain constant, and the treatment will begin between 8:00 and 10:00 AM each day.

Interventions

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Transcutaneous electrical acupoint stimulation

Participants will receive proper transcutaneous electrical acupoint stimulation treatment for three consecutive days. Each day, the selected five target acupoints (Renying, Quchi, Taichong, Zusanli, and Hegu) will be stimulated in rotation. Each acupoint will be stimulated once a day for 10 minutes, with a 2-minute interval between each acupoint, totaling 60 minutes. Throughout the trial, the stimulation parameters for each participant will remain constant, and the treatment will begin between 8:00 and 10:00 AM each day.

Intervention Type DEVICE

Sham stimulation

Participants will receive sham stimulation treatment, where the left-side skin near the selected five target acupoints (avoiding other functional acupoints) will be stimulated in rotation. The stimulation time and method will be the same as in the experimental group. Throughout the trial, the stimulation parameters for each participant will remain constant, and the treatment will begin between 8:00 and 10:00 AM each day.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Office systolic blood pressure between 130-150 mmHg and/or diastolic blood pressure between 80-95 mmHg
* Age between 18 and 75 years
* Not currently receiving antihypertensive medication or having discontinued antihypertensive medication for more than two weeks
* Able to undergo and complete the transcutaneous electrical acupoint stimulation treatment
* Agree to participate and sign the informed consent form

Exclusion Criteria

* Pregnant or breastfeeding women
* Severe heart conditions, including coronary heart disease, myocardial infarction, arrhythmia, heart failure, or having an implanted cardiac pacemaker
* Skin conditions, including eczema, allergic dermatitis, or seborrheic dermatitis
* Neuromuscular diseases, mental disorders, epilepsy, or cognitive impairment
* Lower limb deep vein thrombosis or thrombophlebitis
* Wounds, surgical scars, or malignant tumors at the stimulation areas
* Inability to tolerate the transcutaneous electrical acupoint stimulation treatment or allergic to electrical stimulation
* Currently participating in other clinical trials
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Institute of Hypertension

OTHER

Sponsor Role collaborator

Shanghai Jiao Tong University School of Biomedical engineering

UNKNOWN

Sponsor Role collaborator

Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Ji-Guang Wang

Professor of the Shanghai Institute of Hypertension and the Department of Hypertension

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Jiguang Wang, MD, PhD

Role: CONTACT

021-64370045 ext. 610911

Other Identifiers

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TEAS-BP

Identifier Type: -

Identifier Source: org_study_id

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