Transcutaneous Electrical Nerve Stimulation (TENS)TENSNCT06882733
The Immediate Effect of Applying Transcutaneous Electrical Nerve Stimulation (TENS) on Sympathetic Ganglion and Gastrocnemius for Popliteal Blood Flow
A study testing Transcutaneous Electrical Nerve Stimulation，TENS in people with Transcutaneous Electrical Nerve Stimulation (TENS) and Popliteal, run by Kaohsiung Medical University at 1 site in Taiwan.
Trial summary
This study aims to evaluate the immediate hemodynamic effects of transcutaneous electrical nerve stimulation (TENS) on the popliteal artery and vein. Vascular issues like PAOD and DVT are common in patients with diabetes, obesity, or immobility due to increased resistance and reduced blood flow. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Transcutaneous Electrical Nerve Stimulation (TENS), Popliteal, Blood Flow
- What is being tested?
- Transcutaneous Electrical Nerve Stimulation，TENS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteTaiwan
- Study dates
- 3 Dec 2024to 1 Dec 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy people
- Age: 18 years and above (inclusive)
- Body mass index (BMI) between 18.5 and 24
Who cannot join
- Unable to complete two interventions within a week
- Have contraindications to electrotherapy (for example: metal implants in the body, open wounds, pregnancy, sensory loss)
- Obvious varicose veins 4. Unable to lie down for about 1 to 2 hours 5. Taking drugs or nutritional supplements that affect autonomic nervous activity or vasodilation (for example: Ginkgo biloba) 6. Smoking 7. Ankle and Ankle Index (ABI) less than 0.9 or greater than 1.3
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Medical University
Kaohsiung City, Taiwan, 807378
jie meng shen, graduate student, +886-935751158, mengjie910419@gmail.com
About this study
This study aims to evaluate the immediate hemodynamic effects of transcutaneous electrical nerve stimulation (TENS) on the popliteal artery and vein. Vascular issues like PAOD and DVT are common in patients with diabetes, obesity, or immobility due to increased resistance and reduced blood flow. Traditional treatments (medication or surgery) are not always feasible, prompting interest in TENS as an alternative. Although primarily used for pain relief, TENS may enhance blood flow. This research compares different stimulation frequencies (80 Hz vs. 4 Hz) and sites (gastrocnemius muscle vs. thoracolumbar sympathetic ganglia) to identify the most effective configuration.
- Conditions
- Transcutaneous Electrical Nerve Stimulation (TENS), Popliteal, Blood Flow, Sympathetic Ganglia
- Being tested
- Transcutaneous Electrical Nerve Stimulation，TENS
- Keywords
- transcutaneous electrical nerve stimulation (TENS), blood flow, sympathetic ganglia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Electrical Nerve Stimulation，TENSDevice
low frequency (4Hz) and sympathetic ganglion(T12.L1.L2) low frequency (4Hz) and gastrocnemius high frequency (80Hz) and sympathetic ganglion(T12.L1.L2) high frequency (80Hz) and gastrocnemius
| Study group | Role | What they receive |
|---|---|---|
| Sympathetic Ganglia with Low-Frequency Electrical Stimulation | Experimental | Sympathetic Ganglia (T12.L1.L2) Low-Frequency Electrical Stimulation (4Hz) electrical stimulation:15-minute Receives: Device: Transcutaneous Electrical Nerve Stimulation，TENS |
| Sympathetic Ganglia with High-Frequency Electrical Stimulation | Experimental | Sympathetic Ganglia (T12.L1.L2) Low-Frequency Electrical Stimulation (80Hz) electrical stimulation:15-minute Receives: Device: Transcutaneous Electrical Nerve Stimulation，TENS |
| gastrocnemius with Low-Frequency Electrical Stimulation | Experimental | gastrocnemius with Low-Frequency Electrical Stimulation Low-Frequency (4Hz) electrical stimulation:15-minute Receives: Device: Transcutaneous Electrical Nerve Stimulation，TENS |
| gastrocnemius with high-Frequency Electrical Stimulation | Experimental | gastrocnemius with high-Frequency Electrical Stimulation high-Frequency(80Hz) electrical stimulation:15-minute Receives: Device: Transcutaneous Electrical Nerve Stimulation，TENS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Doppler ultrasound measurement of changes in popliteal fossa blood flow
Using Doppler ultrasound to measure blood flow before, during, immediately after, and 15 minutes after electrical stimulation to observe the effects of electrical stimulation on blood flow.
Measured: 45 minutes
Secondary outcomes (1)
heart rate
oximeter to measure heart rate before, during, immediately after, and 15 minutes after electrical stimulation to observe the effects of electrical stimulation on heart rate.
Measured: 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start3 Dec 2024
- Primary completion30 Mar 2025
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcutaneous Electrical Nerve Stimulation (TENS)Studies of the same condition, open and under way.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mengjie Shen, Kaohsiung Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06882733
- Sponsor's protocol ID
- KMUHIRB-E(I)-20240357
- Acronym
- TENS
- Status last verified
- Jul 2025
- First submitted
- 12 Mar 2025
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Immediate Effect of Applying Transcutaneous Electrical Nerve Stimulation (TENS) on Sympathetic Ganglion and Gastrocnemius for Popliteal Blood Flow
- ClinicalTrials.gov ID
- NCT06882733
- Acronym / sponsor ID
- TENS / KMUHIRB-E(I)-20240357
- Conditions
- Transcutaneous Electrical Nerve Stimulation (TENS), Popliteal, Blood Flow, Sympathetic Ganglia
- Keywords
- transcutaneous electrical nerve stimulation (TENS), blood flow, sympathetic ganglia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Kaohsiung Medical UniversityUniversity, hospital or other
- Study start
- 3 Dec 2024 (actual)
- Primary completion
- 30 Mar 2025 (actual)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 18 Mar 2025 (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 aims to evaluate the immediate hemodynamic effects of transcutaneous electrical nerve stimulation (TENS) on the popliteal artery and vein. Vascular issues like PAOD and DVT are common in patients with diabetes, obesity, or immobility due to increased resistance and reduced blood flow. Traditional treatments (medication or surgery) are not always feasible, prompting interest in TENS as an alternative. Although primarily used for pain relief, TENS may enhance blood flow. This research compares different stimulation frequencies (80 Hz vs. 4 Hz) and sites (gastrocnemius muscle vs. thoracolumbar sympathetic ganglia) to identify the most effective configuration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sympathetic Ganglia with Low-Frequency Electrical Stimulation | Experimental | Device: Transcutaneous Electrical Nerve Stimulation，TENSSympathetic Ganglia (T12.L1.L2) Low-Frequency Electrical Stimulation (4Hz) electrical stimulation:15-minute |
| Sympathetic Ganglia with High-Frequency Electrical Stimulation | Experimental | Device: Transcutaneous Electrical Nerve Stimulation，TENSSympathetic Ganglia (T12.L1.L2) Low-Frequency Electrical Stimulation (80Hz) electrical stimulation:15-minute |
| gastrocnemius with Low-Frequency Electrical Stimulation | Experimental | Device: Transcutaneous Electrical Nerve Stimulation，TENSgastrocnemius with Low-Frequency Electrical Stimulation Low-Frequency (4Hz) electrical stimulation:15-minute |
| gastrocnemius with high-Frequency Electrical Stimulation | Experimental | Device: Transcutaneous Electrical Nerve Stimulation，TENSgastrocnemius with high-Frequency Electrical Stimulation high-Frequency(80Hz) electrical stimulation:15-minute |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy people
- Age: 18 years and above (inclusive)
- Body mass index (BMI) between 18.5 and 24
Key exclusion criteria (3 listed)
- Unable to complete two interventions within a week
- Have contraindications to electrotherapy (for example: metal implants in the body, open wounds, pregnancy, sensory loss)
- Obvious varicose veins 4. Unable to lie down for about 1 to 2 hours 5. Taking drugs or nutritional supplements that affect autonomic nervous activity or vasodilation (for example: Ginkgo biloba) 6. Smoking 7. Ankle and Ankle Index (ABI) less than 0.9 or greater than 1.3
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 Nerve Stimulation，TENSlow frequency (4Hz) and sympathetic ganglion(T12.L1.L2) low frequency (4Hz) and gastrocnemius high frequency (80Hz) and sympathetic ganglion(T12.L1.L2) high frequency (80Hz) and gastrocnemius | Device | Sympathetic Ganglia with High-Frequency Electrical Stimulation, Sympathetic Ganglia with Low-Frequency Electrical Stimulation, gastrocnemius with Low-Frequency Electrical Stimulation, gastrocnemius with high-Frequency Electrical Stimulation |
Primary outcome
Doppler ultrasound measurement of changes in popliteal fossa blood flow
Time frame: 45 minutes
Using Doppler ultrasound to measure blood flow before, during, immediately after, and 15 minutes after electrical stimulation to observe the effects of electrical stimulation on blood flow.
1 secondary outcome
heart rate
Time frame: 45 minutes
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 18 Jul 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Electrical Nerve Stimulation，TENS in people with Transcutaneous Electrical Nerve Stimulation (TENS) and Popliteal, run by Kaohsiung Medical University at 1 site in Taiwan.
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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 Mengjie Shen (+886935751158, mengjie910419@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Doppler ultrasound measurement of changes in popliteal fossa blood flow (time frame: 45 minutes). 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 18 Jul 2025.