The Effects of Pain and Pain Relief on Peripheral Nerve Excitability

Analgesia Clinical Trial

Official title:

The Effects of Pain and Pain Relief on Peripheral Nerve Excitability

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06356376
• Other study ID #: UAarhus_AGK_MNG_2
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Analgesia

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