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

Kaohsiung Medical University

Status: Enrolling

Conditions: Sympathetic Ganglia; Blood Flow; Transcutaneous Electrical Nerve Stimulation (TENS); Popliteal

Treatments: Device: Transcutaneous Electrical Nerve Stimulation，TENS

Study type: Interventional

Funder types: Other

Identifiers

NCT06882733

KMUHIRB-E(I)-20240357

Details and patient eligibility

About

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.

Enrollment: 43 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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43 participants in 4 patient groups

Sympathetic Ganglia with Low-Frequency Electrical Stimulation

Experimental group

Description:

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

Treatment:

Device: Transcutaneous Electrical Nerve Stimulation，TENS

Sympathetic Ganglia with High-Frequency Electrical Stimulation

Experimental group

Description:

Sympathetic Ganglia (T12.L1.L2) Low-Frequency Electrical Stimulation (80Hz) electrical stimulation:15-minute

Treatment:

Device: Transcutaneous Electrical Nerve Stimulation，TENS

gastrocnemius with Low-Frequency Electrical Stimulation

Experimental group

Description:

gastrocnemius with Low-Frequency Electrical Stimulation Low-Frequency (4Hz) electrical stimulation:15-minute

Treatment:

Device: Transcutaneous Electrical Nerve Stimulation，TENS

gastrocnemius with high-Frequency Electrical Stimulation

Experimental group

Description:

gastrocnemius with high-Frequency Electrical Stimulation high-Frequency(80Hz) electrical stimulation:15-minute

Treatment:

Device: Transcutaneous Electrical Nerve Stimulation，TENS