Clinical trial NCT06537167: Transcutaneous Electrical Acupoint Stimulation on Blood Pressure
Official title: The Antihypertensive Effects of Transcutaneous Electrical Acupoint Stimulation in Patients With High-normal Blood Pressure and Grade 1 Hypertension
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hypertension
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: Shanghai Institute of Hypertension
name: Shanghai Jiao Tong University School of Biomedical engineering
First posted: 2024-08-05
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: At the third day after TEAS treatment and the baseline (before the start of treatment on the first day)
Secondary outcomes:
measure: Changes in office systolic blood pressure at other time points before and after treatment
timeFrame: At all other time points (excluding the third day after treatment) and the baseline (before the start of treatment on the first day)
measure: Changes in office diastolic blood pressure at various time points before and after treatment
timeFrame: At each time point before and after treatment and the baseline (before the start of treatment on the first day).
measure: Changes in ambulatory blood pressure before and after treatment
timeFrame: At the third day after the end of treatment and the baseline (before the start of treatment on the first day)
measure: Changes in Hamilton Scale scores before and after treatment
timeFrame: At the third day after the end of treatment and the baseline (before the start of treatment on the first day)
Other outcomes:
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