An interventional study of TENS eco 2 Transauricular vagal nerve stimulation and Sham TENS eco 2 in Pain, Acute, sponsored by University Medicine Greifswald. Status unknown at 1 site in Germany. Open to participants aged 19 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-26.
Sponsored by University Medicine Greifswald · Not applicable, Interventional, and Basic science
This investigation is going to study whether electrical tVNS applied at the cymba of auricular conchae reduces central sensitization of experimentally induced pain in comparison with electrical sham stimulation applied at the earlobes and whether the hypoalgesic effects of tVNS disappear after pharmacological block of muscarinic receptors. Also, this investigation will examine whether tVNS is associated with activation in brain areas, involved in processing of thermal pain stimuli and emotional and vegetative modulation of thermal pain in subjects who will respond with antinociceptive reaction to tVNS.
876 studies on the registry are indexed under Acute Pain; 154 are open to participants now.
This study's planned enrollment of 66 is below the median of 90 across 732 interventional studies indexed under Acute Pain.
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Exclusion Criteria:
Stimulation will be applied using TENS device eco 2 (Schwa-Medico, Pierenkemper GmbH, Ehringshausen, Germany) bilaterally at the cymba conchae of the auricles for 20 minutes. Current intensity (1-max. 10 mA) will be individually adjusted for each ear separately until the maximal tVNS intensity, which is not uncomfortable or painful, will be achieved.
Device: TENS eco 2 Transauricular vagal nerve stimulation
Same stimulation will be applied using TENS device eco 2 (Schwa-Medico, Pierenkemper GmbH, Ehringshausen, Germany) to bilaterally to the earlobes for 20 minutes. Current intensity (1-max. 10 mA) will be individually adjusted for each ear separately until the maximal tVNS intensity, which is not uncomfortable or painful, will be achieved.
Device: Sham TENS eco 2
Auricular electrical stimulation will be applied bilaterally using Transcutaneous Electrical Nerve Stimulation device TENS eco 2 (Schwa-Medico, Pierenkemper GmbH, Ehringshausen, Germany). tVNS will be applied bilaterally using electrical square impulses delivered in blocks of 9 impulses with a frequency of 100 Hz and a pulse width of 200 μs emitted twice per second resulting in mixed frequency pattern of 100 Hz/2 Hz with the current intensity, that will be individually adjusted for each ear separately until the maximal tVNS intensity, which is not uncomfortable or painful, will be achieved.
Sham
Unpleasantness of pain
perceived unpleasantness of pain, which participants will rate continuously during the repetitive heat stimulation using a computerized visual analogue scale (CoVAS, Medoc Advanced Medical Systems, Ramat Yishai, Israel) ranging from 0 (= not unpleasant at all) to 100 (= intolerable pain).
Time frame: Continuously 5 minutes during the experimental heat pain stimulation
Heart rate
Heart rate (bpm)
Time frame: Continuously 5 minutes during the experimental heat pain stimulation
Blood pressure
Systolic and diastolic blood pressure
Time frame: 4 times during 5 minutes of the experimental heat pain stimulation
Plan to share: Undecided — Data will be available of request
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This study is status unknown, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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University Medicine Greifswald