Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06361381
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-11
First Post:
2024-03-25
Brief Title:
The Combined Effect of TENS and TaVNS on Pressure and Heat Pain Thresholds in Pain-Free Subjects
Sponsor:
University of Hartford
Organization:
University of Hartford
Study Overview
Official 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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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:
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
Pressure and Heat pain thresholds will be recorded at baseline 15 min 30 min and 45 min
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None