The Combined Effect of TENS and TaVNS on Pressure and Heat Pain Thresholds in Pain-Free Subjects
NCT ID: NCT06361381
Last Updated: 2024-12-06
Study Results
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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COMPLETED
NA
30 participants
INTERVENTIONAL
2024-04-01
2024-10-20
Brief Summary
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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 minutes after a baseline measurement of outcomes. TENS and TaVNS will then be turned off, but the electrodes will remain on until completion of post-treatment assessment. Pressure pain threshold, heat pain threshold, blood pressure, oxygen saturation and heart rate will be tested 4 times: Once pre-intervention, once during intervention, once immediately after the intervention and once 15 minutes post-intervention.
Detailed Description
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Pressure and Heat pain thresholds will be recorded at baseline, 15 min, 30 min, and 45 min.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Active TaVNS
Active TaVNS: frequency of 25 Hz, pulse duration of 200 µs, at a strong but comfortable intensity.
Active Transcutaneous Auricular Vagus Nerve Stimulation (TaVNS)
Both concha will be swabbed with an alcohol wipe before applying a thin layer of conductive gel. An ear clip electrode will be placed in the concha of both ears.
A frequency of 25 Hz will be applied with a pulse duration of 200 µs. Every 5 minutes, the subject will be asked if the intensity can be increased, decreased or remain the same to maintain the same level of intensity. Participants will also receive active TENS, 100 Hz, 200 µsec on forearm.
Transcutaneous Electrical Nerve Stimulation
TENS will be applied on subject's forearm at a strong but comfortable intensity
Placebo TaVNS
Placebo TaVNS: the intensity will be increased to a sensory level and then decreased to 0 mA
Placebo Transcutaneous Auricular Vagus Nerve Stimulation (TaVNS)
For placebo TaVNS, the intensity will be increased to a sensory level and then decreased to 0 mA. Participants will also receive active TENS, 100 Hz, 200 µsec on forearm.
Transcutaneous Electrical Nerve Stimulation
TENS will be applied on subject's forearm at a strong but comfortable intensity
Interventions
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Active Transcutaneous Auricular Vagus Nerve Stimulation (TaVNS)
Both concha will be swabbed with an alcohol wipe before applying a thin layer of conductive gel. An ear clip electrode will be placed in the concha of both ears.
A frequency of 25 Hz will be applied with a pulse duration of 200 µs. Every 5 minutes, the subject will be asked if the intensity can be increased, decreased or remain the same to maintain the same level of intensity. Participants will also receive active TENS, 100 Hz, 200 µsec on forearm.
Placebo Transcutaneous Auricular Vagus Nerve Stimulation (TaVNS)
For placebo TaVNS, the intensity will be increased to a sensory level and then decreased to 0 mA. Participants will also receive active TENS, 100 Hz, 200 µsec on forearm.
Transcutaneous Electrical Nerve Stimulation
TENS will be applied on subject's forearm at a strong but comfortable intensity
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 18-40
* Men and women
Exclusion Criteria
* Severe cardiorespiratory disease
* Pregnancy
* Skin infection or lesions or change in sensation at the TENS or TaVNS application site
* Cancer
* Cardiac pacemaker
* Allergy to electrodes
* Chronic illness or pain
* Use of drugs that affect pain or vagal tone in the past 48 hours prior to data collection
18 Years
40 Years
ALL
Yes
Sponsors
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University of Hartford
OTHER
Responsible Party
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Richard Liebano
Associate Professor
Principal Investigators
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Richard E Liebano, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Hartford
Locations
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University of Hartford
West Hartford, Connecticut, United States
Countries
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References
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Liebano RE, Awad N, Bellino C, Bray K, Rosentrater H, Roy J, Tate C. The combined effect of transcutaneous electrical nerve stimulation and transcutaneous auricular vagus nerve stimulation on pressure and heat pain thresholds in pain-free subjects: a randomized cross-over trial. Trials. 2024 Jul 31;25(1):516. doi: 10.1186/s13063-024-08352-x.
Other Identifiers
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24-01-281
Identifier Type: -
Identifier Source: org_study_id