Transcutaneous Electrical Acupoint Stimulation on Blood Pressure
NCT ID: NCT06537167
Last Updated: 2025-05-15
Study Results
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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NOT_YET_RECRUITING
NA
120 participants
INTERVENTIONAL
2025-08-31
2027-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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"Stimulation" Experimental Group
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.
"Sham Stimulation" Control Group
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Shanghai Institute of Hypertension
OTHER
Shanghai Jiao Tong University School of Biomedical engineering
UNKNOWN
Shanghai Jiao Tong University School of Medicine
OTHER
Responsible Party
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Ji-Guang Wang
Professor of the Shanghai Institute of Hypertension and the Department of Hypertension
Central Contacts
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Other Identifiers
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TEAS-BP
Identifier Type: -
Identifier Source: org_study_id
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