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NCT06361381 · ClinicalTrials.gov registry record · NA
The Combined Effect of TENS and TaVNS on Pressure and Heat Pain Thresholds in Pain-Free Subjects
A NA study, sponsored by University of Hartford.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
NCT06361381 is a NA study that has completed, run by University of Hartford. The registered enrollment target is 30 participants.
The verdict
NCT06361381, a NA study, has completed, sponsored by University of Hartford.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
Study Summary
Transcutaneous electrical nerve stimulation (TENS) is a non-invasive modality that utilizes electrical currents to modulate pain in populations with acute and chronic pain. TENS has been demonstrated to produce hypoalgesic effects in postoperative pain, fibromyalgia, knee osteoarthritis, and healthy subjects. Transcutaneous auricular vagus nerve stimulation (TaVNS) is a non-invasive modality that modulates the vagus nerve by stimulating its auricular branches. The effects of the combination of TENS and TaVNS on producing an analgesic response have not been studied. Considering that TENS and TaVNS both stimulate similar analgesic pathways but through different means of activation, the investigators can hypothesize that a combination of both methods can produce a more pronounced analgesic response. Therefore, the objective of this study is to assess the hypoalgesic effect of a combination of TENS and TaVNS in pain-free subjects. The study will be a simple crossover design conducted at the University of Hartford. Subjects will be recruited from the University of Hartford population via oral communication, digital flyers, and posters on campus. Thirty participants will undergo two sessions in a crossover manner with one week in between. During one session, the participants will receive TENS with active TaVNS and the other session will be a placebo procedure (TENS with placebo TaVNS). The order of these sessions will be randomized. Importantly, the pressure pain threshold (PPT) and heat pain threshold (HPT) assessors will be blinded to the treatment category. For active TaVNS, a frequency of 25 Hz will be applied with a pulse duration of 200 µs. For placebo TaVNS, the intensity will be increased to a sensory level and then decreased to 0 mA. High frequency TENS of 100Hz will be applied in both sessions, with a pulse duration of 200 µsec, asymmetrical biphasic square waveform, and intensity of maximal tolerance without pain. TENS and TaVNS will be turned on for 30 minute
Interventions
- DEVICE Transcutaneous Electrical Nerve Stimulation
- DEVICE Active Transcutaneous Auricular Vagus Nerve Stimulation (TaVNS)
- DEVICE Placebo Transcutaneous Auricular Vagus Nerve Stimulation (TaVNS)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2024-04-01 |
| Est. Completion | 2024-10-20 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06361381
The ClinicalTrials.gov registry entry for NCT06361381 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Hartford, which has 14 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Transcutaneous Electrical Nerve Stimulation is the first listed.
NCT06361381 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06361381 about?
NCT06361381 is a clinical study titled "The Combined Effect of TENS and TaVNS on Pressure and Heat Pain Thresholds in Pain-Free Subjects". Transcutaneous electrical nerve stimulation (TENS) is a non-invasive modality that utilizes electrical currents to modulate pain in populations with acute and chronic pain. TENS has been demonstrated to produce hypoalgesic effects in postoperative pain, fibromyalgia, knee osteoarthritis, and healthy...
What is the current status of trial NCT06361381?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2024-04-01. Estimated completion is 2024-10-20.
What interventions are being tested in trial NCT06361381?
The interventions under investigation include: Transcutaneous Electrical Nerve Stimulation (DEVICE), Active Transcutaneous Auricular Vagus Nerve Stimulation (TaVNS) (DEVICE), Placebo Transcutaneous Auricular Vagus Nerve Stimulation (TaVNS) (DEVICE).
Who is sponsoring clinical trial NCT06361381?
This trial is sponsored by University of Hartford, which has 14 total clinical trials registered on ClinicalTrials.gov.
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