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NCT Number: NCT06361381

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 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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Key information

Conditions

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Hartford

West Hartford, Connecticut, 06117, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Absence of pain
  • Age 18-40
  • Men and women

Exclusion criteria

  • Neurological diseases
  • 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

Treatment and study plan

Active Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)

Device

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

Placebo Transcutaneous Auricular Vagus Nerve Stimulation (TaVNS)

Device

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

Transcutaneous electrical nerve stimulation

Device

TENS will be applied on subject's forearm at a strong but comfortable intensity

Other names: TENS

Primary outcomes

  1. Pressure Pain Threshold

    Time frame: 2 weeks

    A digital pressure algometer will measure the pain threshold to deep mechanical stimuli in kPa

Secondary outcomes

  1. Heat Pain Threshold

    Time frame: 2 weeks

    Superficial heat pain sensitivity, in degree Celsius, will be assessed using a handheld thermode.

  2. Heart rate

    Time frame: 2 weeks

    Heart rate (beats per minute) will be assessed using a fingertip pulse oximeter

  3. Oxygen saturation

    Time frame: 2 weeks

    Oxygen saturation in percentage will be assessed using a fingertip pulse oximeter

  4. Blood pressure

    Time frame: 2 weeks

    Systolic and Diastolic Blood pressure in millimeters of mercury will be assessed using a upper arm cuff, blood pressure monitor

Sponsors and collaborators

Lead sponsor

University of Hartford

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 11, 2024
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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