The Combined Effect of TENS and TaVNS on Pressure and Heat Pain Thresholds in Pain-Free Subjects

NCT06361381 | Completed FDA Device

• 1 other identifier: 24-01-281
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Healthy Volunteers

Keywords

Transcutaneous Electric Nerve Stimulation; Transcutaneous Auricular Vagus Nerve Stimulation; Randomized cross-over trial; Pain Measurement; Pain Threshold

Outcome Measures

Primary Outcomes (1)

• Pressure Pain Threshold

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

  2 weeks

Secondary Outcomes (4)

• Heat Pain Threshold

  2 weeks

• Heart rate

  2 weeks

• Oxygen saturation

  2 weeks

• Blood pressure

  2 weeks

Study Arms (2)

Active TaVNS

EXPERIMENTAL

Active TaVNS: frequency of 25 Hz, pulse duration of 200 µs, at a strong but comfortable intensity.

Device: Active Transcutaneous Auricular Vagus Nerve Stimulation (TaVNS); Device: Transcutaneous Electrical Nerve Stimulation

Placebo TaVNS

PLACEBO COMPARATOR

Placebo TaVNS: the intensity will be increased to a sensory level and then decreased to 0 mA

Device: Placebo Transcutaneous Auricular Vagus Nerve Stimulation (TaVNS); Device: Transcutaneous Electrical Nerve Stimulation

Interventions

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.

Also known as: TaVNS

Active 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.

Also known as: Placebo TaVNS

Placebo TaVNS

Transcutaneous Electrical Nerve Stimulation DEVICE

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

Also known as: TENS

Active TaVNS; Placebo TaVNS

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Hartford: lead

Study Sites (1)

University of Hartford

West Hartford, Connecticut, 06117, United States

Location

Related Publications (1)

• 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.

  PMID: 39085951 DERIVED

MeSH Terms

Interventions

Transcutaneous Electric Nerve Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Richard E Liebano, PhD

  University of Hartford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 11, 2024
• Study Start: April 1, 2024
• Primary Completion: July 20, 2024
• Study Completion: October 20, 2024
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)