Transcutaneous Electrical Acupoint Stimulation on Blood Pressure

Not Applicable

Not yet recruiting

• Conditions: Hypertension
• Interventions: Device: Transcutaneous electrical acupoint stimulation; Device: Sham stimulation

• Registration Number: NCT06537167
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2024-07-31
• Study First Submitted QC: 2024-08-02
• Study First Posted: 2024-08-05
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-15
• Study Start: 2025-08
• Primary Completion: 2027-12
• Study Completion: 2027-12

Recruitment & Eligibility

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
"Stimulation" Experimental Group	Transcutaneous electrical acupoint stimulation	-
"Sham Stimulation" Control Group	Sham stimulation	-

Primary Outcome Measures

Name	Time	Method
Change in office systolic blood pressure between the third day after TEAS treatment and the baseline (before the start of treatment on the first day)	At the third day after TEAS treatment and the baseline (before the start of treatment on the first day)

Secondary Outcome Measures

Name	Time	Method
Changes in Hamilton Scale scores before and after treatment	At the third day after the end of treatment and the baseline (before the start of treatment on the first day)
Changes in office systolic blood pressure at other time points before and after treatment	At all other time points (excluding the third day after treatment) and the baseline (before the start of treatment on the first day)
Changes in office diastolic blood pressure at various time points before and after treatment	At each time point before and after treatment and the baseline (before the start of treatment on the first day).
Changes in ambulatory blood pressure before and after treatment	At the third day after the end of treatment and the baseline (before the start of treatment on the first day)