The Immediate Effect of Applying Transcutaneous Electrical Nerve Stimulation (TENS) on Sympathetic Ganglion and Gastrocnemius for Popliteal Blood Flow (TENS)

July 16, 2025 updated by: Mengjie Shen, Kaohsiung Medical University
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

43

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Kaohsiung City, Taiwan, 807378
        • Recruiting
        • Kaohsiung Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Healthy people
  2. Age: 18 years and above (inclusive)
  3. Body mass index (BMI) between 18.5 and 24

Exclusion Criteria:

  1. Unable to complete two interventions within a week
  2. Have contraindications to electrotherapy (for example: metal implants in the body, open wounds, pregnancy, sensory loss)
  3. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sympathetic Ganglia with Low-Frequency Electrical Stimulation
Sympathetic Ganglia (T12.L1.L2) Low-Frequency Electrical Stimulation (4Hz) electrical stimulation:15-minute
Device: Transcutaneous Electrical Nerve Stimulation，TENS
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
Experimental: Sympathetic Ganglia with High-Frequency Electrical Stimulation
Sympathetic Ganglia (T12.L1.L2) Low-Frequency Electrical Stimulation (80Hz) electrical stimulation:15-minute
Device: Transcutaneous Electrical Nerve Stimulation，TENS
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
Experimental: gastrocnemius with Low-Frequency Electrical Stimulation
gastrocnemius with Low-Frequency Electrical Stimulation Low-Frequency (4Hz) electrical stimulation:15-minute
Device: Transcutaneous Electrical Nerve Stimulation，TENS
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
Experimental: gastrocnemius with high-Frequency Electrical Stimulation
gastrocnemius with high-Frequency Electrical Stimulation high-Frequency(80Hz) electrical stimulation:15-minute
Device: Transcutaneous Electrical Nerve Stimulation，TENS
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
45 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
heart rate
Time Frame: 45 minutes
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.
45 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaohsiung Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 3, 2024

Primary Completion (Actual)

March 30, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

March 12, 2025

First Submitted That Met QC Criteria

March 17, 2025

First Posted (Actual)

March 18, 2025

Study Record Updates

Last Update Posted (Actual)

July 18, 2025

Last Update Submitted That Met QC Criteria

July 16, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KMUHIRB-E(I)-20240357

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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