Transcutaneous Electrical Acupoint Stimulation on Blood Pressure

Shanghai Jiao Tong University School of Medicine

Status

Not yet enrolling

Conditions

Hypertension

Treatments

Device: Transcutaneous electrical acupoint stimulation

Device: Sham stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT06537167

TEAS-BP

Details and patient eligibility

About

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.

Enrollment

120 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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