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NCT Number: NCT06667895

Pain Perception and the Autonomic Nervous System

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.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Over 18 and below 40 years of age
  • Good general health
  • Able to give informed consent

Exclusion criteria

  • Any major medical or psychiatric condition (e.g. heart disease, diabetes, autoimmune disorders, infectious diseases, major depressive disorder), any chronic pain condition, any respiratory problems, any acute pain at time of study
  • Inability to follow study instructions, e.g. due to language problems
  • Pregnancy (female participants will be asked if pregnancy could be possible)
  • Increased alcohol (>2 (for women)/4 (for men) standard glasses per day or >5 (for women)/4 (for men) glasses at least once a month within a few hours) or caffeine consumption (≥ 400mg per day)
  • Consumption of alcohol, drugs, analgesics within the last 24 h
  • Consumption of more than 100 mg of caffeine within the last 8 h
  • Scar tissue or generally reduced sensitivity in the designated testing site areas
  • Shoe size < 38 (if experiment is conducted at the feet)
  • History of cardiovascular disease or carotid artery disease
  • Medication or Substances inferring with the autonomic nervous system or with pain sensitivity (e.g. Benzodiazepines, Nicotine)

Treatment and study plan

respiratory gated taVNS

Other

Electrical stimulation will be delivered in bursts during expiration

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

Primary outcomes

  1. Magnitude of the Nociceptive Withdrawl Reflex

    Time frame: Before, during, and/or immediately after the intervention

    Muscle responses of the biceps fermoris to an electrical stimulation of the sural nerve will be measured using an electromyogramm

Other outcomes

  1. Area of Secondary Hyperalgesia

    Time frame: Before and 20 min after the intervention

    Von Frey filaments will be used to assess the spatial extent of experimentally induced hyperalgesia

  2. Changes of Pressure Pain Threshold

    Time frame: Before, during, and/or immediately after the intervention

    Pressure will be applied over the thenar eminance of the hand until the participant reports a painful sensation

  3. Perceived Pain Intensity and Unpleasantness

    Time frame: Before, during, and/or immediately after the intervention

    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.

  4. Change in Autonomic Nervous System Activity

    Time frame: Before, during, and up to 2 min after the intervention.

    The activity of the autonomic nervous system will be measures using electrocardiogramm and galvanic skin response

Study contacts

Contact information is provided by the study sponsor or research team.

Madeleine Hau

CONTACT

[email protected]

+41 443865711

Petra Schweinhardt, PhD, M Chiro Med

CONTACT

[email protected]

+41 443865724

Sponsors and collaborators

Lead sponsor

Schweinhardt Petra

Other

Registry information

Official study title

Influences of the Autonomic Nervous System on Experimental Pain Sensitization

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 31, 2024
Registry last updated
Oct 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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