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The effect of transauricular electrical vagal nerve stimulation (taVNS) will be studied on temporal summation of heat pain (TSP) in 30 patients with chronic low-back pain and in 30 heathy volunteers. Participants will receive either taVNS or sham stimulation before and during TSP induction in a randomized crossover manner. The participants will be unaware regarding the type of intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Real taVNS intervention | Experimental | taVNS will be administered to cymba conchae of both ears using ECO2-TENS device |
|
| Sham | Sham Comparator | aVNS will be administered to lobes of both ears using ECO2-TENS device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transauricular electrical vagal nerve stimulation | Device | transauricular electrical vagal nerve stimulation will be applied to the cymba conchae of both ears using ECO2 TENS device (manufactured by Schwa-Medico GmbH/Germany) with currency intensity of max 10 mA and current frequency 2/100 Hz. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Continuously 5 minutes during the experimental heat pain stimulation |
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate | Heart rate (bpm) | 10 minutes (before, during and after stimulation of heat pain) |
| blood pressure | non-invasive measurement of systolic and diastolic blood pressure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Taras Usichenko, MD. PhD | Contact | +49 383486 | 5893 | taras@uni-greifswald.de |
| David Naegele | Contact | david.naegele@uni-greifswald.de |
| Name | Affiliation | Role |
|---|---|---|
| Taras Usichenko, MD, PhD | University Medicine of Greifswald | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medicine of Greifswald | Recruiting | Greifswald | 17475 | Germany |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Participants and outcome assessor will be unaware regarding the type (real or sham) taVNS intervention
|
| taVNS sham | Device | ECO2 TENS device (manufactured by Schwa-Medico GmbH/Germany) |
|
| 10 minutes (before, during and after stimulation of heat pain) |