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

NCT06882733 | Recruiting

• 1 other identifier: KMUHIRB-E(I)-20240357
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

transcutaneous electrical nerve stimulation (TENS); blood flow; sympathetic ganglia

Outcome Measures

Primary Outcomes (1)

• 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.

  45 minutes

Secondary Outcomes (1)

• heart rate

  45 minutes

Study Arms (4)

Sympathetic Ganglia with Low-Frequency Electrical Stimulation

EXPERIMENTAL

Sympathetic Ganglia (T12.L1.L2) Low-Frequency Electrical Stimulation (4Hz) electrical stimulation:15-minute

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

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

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

Device: Transcutaneous Electrical Nerve Stimulation，TENS

Interventions

Transcutaneous Electrical Nerve Stimulation，TENS DEVICE

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy people
• Age: 18 years and above (inclusive)
• Body mass index (BMI) between 18.5 and 24

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaohsiung Medical University: lead

Study Sites (1)

Kaohsiung Medical University

Kaohsiung City, Taiwan, 807378, Taiwan

RECRUITING

MeSH Terms

Interventions

Transcutaneous Electric Nerve Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Central Study Contacts

Mengjie Shen

CONTACT

+886935751158; mengjie910419@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: graduate student

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: March 18, 2025
• Study Start: December 3, 2024
• Primary Completion: March 30, 2025
• Study Completion: December 1, 2025
• Last Updated: July 18, 2025

Record last verified: 2025-07

Locations

TW (1)