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In this study, we want to investigate how pain processing and sensation are related to a certain part of the nervous system, the so-called autonomic nervous system.
For this purpose, we apply heat and pressure stimuli to the skin and test pain processing by means of ratings scales and sensory tests. Breathing, heart rate and sweat response are also measured. To assess the spinal cord level, we measure muscle response (measured by electromyography, EMG) to electrical stimulation. Additionally, sensory nerves will be stimulated at the ear and participants will also be given various questionnaires to complete.
This study investigates the effects of autonomic regulation on pain perception and experimentally induced pain sensitivity. Participants come for one or two study visits, that will last approximately 3 hours. The study is divided into two phases: the pilot phase and the main experimental phase.
During the pilot phase, the perception of pressure and heat stimuli, as well as spinal excitability, will be assessed before and during different types of electrical stimulation of sensory nerves at the outer ear.
During the main experimental phase, skin sensitivity and spinal excitability will be assessed before and after repetitive heat stimulation and stimulation of sensory nerves at the outer ear.
In both study phases, the activity of the autonomic nervous system will be assessed throughout the experiment, and questionnaires will be completed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| taVNS | Experimental | Electrodes will be attached to the outer ear. Electrical stimulation pulses with a width of 250ms will be applied at a frequency of 25Hz. Stimulation intensity will be individually adjusted to be clearly perceived but not painful. |
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| Sham stimulation | Sham Comparator | Electrodes will be attached to the outer ear at a different position as for the taVNS. Electrical stimulation pulses with a width of 250ms will be applied at a frequency of 25Hz. Stimulation intensity will be individually adjusted to be clearly perceived but not painful. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| respiratory gated taVNS | Other | Electrical stimulation will be delivered in bursts during expiration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Magnitude of the Nociceptive Withdrawl Reflex | Muscle responses of the biceps fermoris to an electrical stimulation of the sural nerve will be measured using an electromyogramm | Before, during, and/or immediately after the intervention |
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| Measure | Description | Time Frame |
|---|---|---|
| Area of Secondary Hyperalgesia | Von Frey filaments will be used to assess the spatial extent of experimentally induced hyperalgesia | Before and 20 min after the intervention |
| Changes of Pressure Pain Threshold |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Petra Schweinhardt, PhD, M Chiro Med | Contact | +41 443865724 | petra.schweinhardt@balgrist.ch | |
| Madeleine Hau | Contact | +41 443865711 | madeleine.hau@balgrist.ch |
| Name | Affiliation | Role |
|---|---|---|
| Petra Schweinhardt, PhD, M Chiro Med | Balgrist University Hospital, University of Zurich, Zurich, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Balgrist University Hospital | Zurich | Canton of Zurich | 8008 | Switzerland |
Data of participants who gave informed consent for further use of their anonymized data will be made available upon request.
The PID, the study protocol and the analytical code will be available after publication for a maximum duration of 10 years
PID will be made available for research purposes only. Anonymized data of all outcome measures can be made available upon request to the sponsor-investigator.
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This study will be conducted in two phases, a pilot phase and a main experimental phase. The two phases involve different outcome measures. Both phases follow a double-blinded, randomized, within-subject design.
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| random burst stimulation | Other | Electrical stimulation will be delivered in bursts at random timepoints during the breathing cycle |
|
| continuous stimulation | Other | Electrical stimulation will be delivered continuously for 30sec followed by a 30sec break. |
|
| Sham stimulation | Other | Electrical stimulation will be identical to the taVNS, but the electrodes will be placed at a different position on the ear |
|
Pressure will be applied over the thenar eminance of the hand until the participant reports a painful sensation
| Before, during, and/or immediately after the intervention |
| Perceived Pain Intensity and Unpleasantness | Perceived intensity and unpleasantness of heat stimuli will be assessed using rating scales. The intensity rating scale ranges from 0, indicating no perception, to 100, indicating the pain threshold, and up to 200, indicating the most tolerable pain. The unpleasantness rating scale ranges from -100 for 'extremely unpleasant,' through 0 for 'neutral,' to 100 for 'extremely pleasant. | Before, during, and/or immediately after the intervention |
| Change in Autonomic Nervous System Activity | The activity of the autonomic nervous system will be measures using electrocardiogramm and galvanic skin response | Before, during, and up to 2 min after the intervention. |