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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06356376
Other study ID # UAarhus_AGK_MNG_2
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 20, 2023
Est. completion date April 30, 2024

Study information

Verified date December 2023
Source University of Aarhus
Contact Alexander G Kristensen, MD, PhD
Phone +45 93 52 28 64
Email alexgramm@clin.au.dk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study will assess changes in nerve excitability of C-fibers, and changes in sympathetic or parasympathetic tone, when the subject experiences pain and pain relief. The investigators will continuously measure blood pressure, heart rate, respiration rate, gastric motility, sympathetic skin response and C-fiber excitability while using thermal stimuli before and after an analgesic.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date April 30, 2024
Est. primary completion date April 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Healthy Participants able to give informed consent. Exclusion Criteria: - Chronic pain conditions - Neurological or Psychiatric disease - Other major diseases - Pain medication within the last 24 hours

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Heat Stimulation
Heat stimulation at a painful, but to the subject tolerable level.

Locations

Country Name City State
Denmark Danish Pain Research Center Aarhus N

Sponsors (2)

Lead Sponsor Collaborator
University of Aarhus Lundbeck Foundation

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary C-fiber excitability Changes in C-fiber excitability measured in latency changes after electrical stimulation with a paired pulse protocol compared to an unpaired electrical stimulus. Through study completion, an average of 6 months
Secondary Action potential duration (ms) Averaged analysis from repeated measures of a single nerve fiber signal. Through study completion, an average of 6 months
Secondary Action potential amplitude (V) Averaged analysis from repeated measures of a single nerve fiber signal. Through study completion, an average of 6 months
Secondary Heart-rate variability (ms) Comparison of heart-rate variability during experimental pain stimulation and during pain relief. Through study completion, an average of 6 months
Secondary Blood pressure variability (mmHg) Changes in continuous blood pressure measurement averages during experimental pain stimulation and during pain relief.. Through study completion, an average of 6 months
Secondary Sympathetic Skin Response (V) Amplitude of Sympathetic skin response during pain stimulation and relief respectively. Through study completion, an average of 6 months
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