The Effects of Pain and Pain Relief on Peripheral Nerve Excitability

Recruiting

• Conditions: Analgesia
• Interventions: Device: Heat Stimulation

• Registration Number: NCT06356376
• Lead Sponsor: University of Aarhus

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-12
• Study First Submitted: 2023-12-17
• Study Start: 2023-12-20
• Study First Submitted QC: 2024-04-09
• Last Update Submitted: 2024-04-09
• Study First Posted: 2024-04-10
• Last Update Posted: 2024-04-10
• Primary Completion: 2024-04-30
• Study Completion: 2024-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy Participants	Heat Stimulation	-

Primary Outcome Measures

Name	Time	Method
C-fiber excitability	Through study completion, an average of 6 months	Changes in C-fiber excitability measured in latency changes after electrical stimulation with a paired pulse protocol compared to an unpaired electrical stimulus.

Secondary Outcome Measures

Name	Time	Method
Action potential duration (ms)	Through study completion, an average of 6 months	Averaged analysis from repeated measures of a single nerve fiber signal.
Heart-rate variability (ms)	Through study completion, an average of 6 months	Comparison of heart-rate variability during experimental pain stimulation and during pain relief.
Blood pressure variability (mmHg)	Through study completion, an average of 6 months	Changes in continuous blood pressure measurement averages during experimental pain stimulation and during pain relief..
Action potential amplitude (V)	Through study completion, an average of 6 months	Averaged analysis from repeated measures of a single nerve fiber signal.
Sympathetic Skin Response (V)	Through study completion, an average of 6 months	Amplitude of Sympathetic skin response during pain stimulation and relief respectively.

Trial Locations

Locations (1)

Danish Pain Research Center; 🇩🇰 Aarhus N, Denmark