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

NCT ID: NCT06882733

Last Updated: 2025-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-03

Study Completion Date

2025-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sympathetic Ganglia with Low-Frequency Electrical Stimulation

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

Group Type EXPERIMENTAL

Transcutaneous Electrical Nerve Stimulation,TENS

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

Group Type EXPERIMENTAL

Transcutaneous Electrical Nerve Stimulation,TENS

Intervention Type 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

gastrocnemius with Low-Frequency Electrical Stimulation

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

Group Type EXPERIMENTAL

Transcutaneous Electrical Nerve Stimulation,TENS

Intervention Type 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

gastrocnemius with high-Frequency Electrical Stimulation

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

Group Type EXPERIMENTAL

Transcutaneous Electrical Nerve Stimulation,TENS

Intervention Type 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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kaohsiung Medical University

OTHER

Sponsor Role lead

Responsible Party

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Mengjie Shen

graduate student

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kaohsiung Medical University

Kaohsiung City, Taiwan, Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Mengjie Shen

Role: CONTACT

+886935751158

Facility Contacts

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jie meng shen, graduate student

Role: primary

+886-935751158

Other Identifiers

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KMUHIRB-E(I)-20240357

Identifier Type: -

Identifier Source: org_study_id

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