University of Hartford
West Hartford, Connecticut, 06117, United States
NCT Number: NCT06361381
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 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.
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Notify Me18 year–40 year
All sexes
Interventional
Not applicable
West Hartford, Connecticut, 06117, United States
The study will be a simple crossover design with the following two treatments: (1) active TaVNS and (2) placebo TaVNS. Each subject will receive both interventions in random order.
Pressure and Heat pain thresholds will be recorded at baseline, 15 min, 30 min, and 45 min.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: 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.
Other names: Placebo TaVNS
TENS will be applied on subject's forearm at a strong but comfortable intensity
Other names: TENS
Time frame: 2 weeks
A digital pressure algometer will measure the pain threshold to deep mechanical stimuli in kPa
Time frame: 2 weeks
Superficial heat pain sensitivity, in degree Celsius, will be assessed using a handheld thermode.
Time frame: 2 weeks
Heart rate (beats per minute) will be assessed using a fingertip pulse oximeter
Time frame: 2 weeks
Oxygen saturation in percentage will be assessed using a fingertip pulse oximeter
Time frame: 2 weeks
Systolic and Diastolic Blood pressure in millimeters of mercury will be assessed using a upper arm cuff, blood pressure monitor
University of Hartford
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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