HypertensionNCT06537167
Transcutaneous Electrical Acupoint Stimulation on Blood Pressure
A study testing Transcutaneous electrical acupoint stimulation in people with Hypertension, run by Shanghai Jiao Tong University School of Medicine.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Transcutaneous electrical acupoint stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Aug 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Antihypertensive Effects of Transcutaneous Electrical Acupoint Stimulation in Patients With High-normal Blood Pressure and Grade 1 Hypertension
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.
- Conditions
- Hypertension
- Being tested
- Transcutaneous electrical acupoint stimulation, Sham stimulation
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous electrical acupoint stimulationDevice
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 stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| "Stimulation" Experimental Group | Experimental | Not described Receives: Device: Transcutaneous electrical acupoint stimulation |
| "Sham Stimulation" Control Group | Sham comparator | Not described Receives: Device: Sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: At the third day after TEAS treatment and the baseline (before the start of treatment on the first day)
Secondary outcomes (4)
Changes in office systolic blood pressure at other time points before and after treatment
Measured: 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
Measured: 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
Measured: At the third day after the end of treatment and the baseline (before the start of treatment on the first day)
Changes in Hamilton Scale scores before and after treatment
Measured: At the third day after the end of treatment and the baseline (before the start of treatment on the first day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study startAug 2025 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Institute of Hypertension, Shanghai Jiao Tong University School of Biomedical engineering
- Responsible party
- Principal investigator, Ji-Guang Wang, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06537167
- Sponsor's protocol ID
- TEAS-BP
- Status last verified
- May 2025
- First submitted
- 31 Jul 2024
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Antihypertensive Effects of Transcutaneous Electrical Acupoint Stimulation in Patients With High-normal Blood Pressure and Grade 1 Hypertension
- ClinicalTrials.gov ID
- NCT06537167
- Acronym / sponsor ID
- TEAS-BP
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- Shanghai Institute of Hypertension, Shanghai Jiao Tong University School of Biomedical engineering
- Study start
- Aug 2025 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 5 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "Stimulation" Experimental Group | Experimental | Device: Transcutaneous electrical acupoint stimulation |
| "Sham Stimulation" Control Group | Sham comparator | Device: Sham stimulation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous electrical acupoint stimulationParticipants 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. | Device | "Stimulation" Experimental Group |
| Sham stimulationParticipants 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. | Device | "Sham Stimulation" Control Group |
Primary outcome
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)
4 secondary outcomes
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)
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).
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous electrical acupoint stimulation in people with Hypertension, run by Shanghai Jiao Tong University School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiguang Wang, MD, PhD (021-64370045 ext. 610911, jiguangwang@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: At the third day after TEAS treatment and the baseline (before the start of treatment on the first day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025.