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Not yet recruitingNCT06537167Updated May 15, 2025

Transcutaneous Electrical Acupoint Stimulation on Blood Pressure

An interventional study of Transcutaneous electrical acupoint stimulation and Sham stimulation in Hypertension, sponsored by Shanghai Jiao Tong University School of Medicine. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-05-15.

Sponsored by Shanghai Jiao Tong University School of Medicine · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hypertension

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03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's planned enrollment of 120 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Shanghai Jiao Tong University School of Medicine is the lead sponsor of 358 studies on the registry; 104 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    "Stimulation" Experimental Group

    Device: Transcutaneous electrical acupoint stimulation

  • Sham comparator
    "Sham Stimulation" Control Group

    Device: Sham stimulation

Interventions

  • DeviceTranscutaneous 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.

  • DeviceSham 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.

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: At the third day after TEAS treatment and the baseline (before the start of treatment on the first day)

Secondary outcomes

  1. Changes in office systolic blood pressure at other time points before and after treatment

    Time frame: At all other time points (excluding the third day after treatment) and the baseline (before the start of treatment on the first day)

  2. Changes in office diastolic blood pressure at various time points before and after treatment

    Time frame: At each time point before and after treatment and the baseline (before the start of treatment on the first day).

  3. Changes in ambulatory blood pressure before and after treatment

    Time frame: At the third day after the end of treatment and the baseline (before the start of treatment on the first day)

  4. Changes in Hamilton Scale scores before and after treatment

    Time frame: At the third day after the end of treatment and the baseline (before the start of treatment on the first day)

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06537167
Lead sponsor
Shanghai Jiao Tong University School of Medicine
Collaborators
Shanghai Institute of Hypertension, Shanghai Jiao Tong University School of Biomedical engineering
Responsible party
Ji-Guang Wang (Professor of the Shanghai Institute of Hypertension and the Department of Hypertension, Shanghai Jiao Tong University School of Medicine) — Principal investigator
First posted
Aug 5, 2024
Start date
Aug 2025 (estimated)
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
May 15, 2025

Study contacts

Jiguang Wang, MD, PhD
Contact
jiguangwang@rjh.com.cn
021-64370045 ext. 610911

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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