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Recruiting NCT06882733

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

No phase Interventional Transcutaneous Electrical Nerve Stimulation (TENS) Popliteal Blood Flow Sympathetic Ganglia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transcutaneous Electrical Nerve Stimulation,TENS.
Who it may be relevant to
Registry conditions: Transcutaneous Electrical Nerve Stimulation (TENS), Popliteal, Blood Flow, Sympathetic Ganglia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Doppler ultrasound measurement of changes in popliteal fossa blood flow [Time frame: 45 minutes]
Secondary outcome measures (1)
  • heart rate [Time frame: 45 minutes]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Taiwan · 1 center
  • Kaohsiung Medical University — Kaohsiung City

Identifiers

NCT: NCT06882733 · KMUHIRB-E(I)-20240357

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗