The Effects of Pain and Pain Relief on Peripheral Nerve Excitability
1 other identifier
observational
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Dec 2023
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 17, 2023
CompletedStudy Start
First participant enrolled
December 20, 2023
CompletedFirst Posted
Study publicly available on registry
April 10, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2024
CompletedApril 10, 2024
December 1, 2023
4 months
December 17, 2023
April 9, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Action potential duration (ms)
Through study completion, an average of 6 months
Action potential amplitude (V)
Through study completion, an average of 6 months
Heart-rate variability (ms)
Through study completion, an average of 6 months
Blood pressure variability (mmHg)
Through study completion, an average of 6 months
Sympathetic Skin Response (V)
Through study completion, an average of 6 months
Study Arms (1)
Healthy Participants
Interventions
Heat stimulation at a painful, but to the subject tolerable level.
Eligibility Criteria
Healthy Subjects
You may qualify if:
- Healthy Participants able to give informed consent.
You may not qualify if:
- Chronic pain conditions
- Neurological or Psychiatric disease
- Other major diseases
- Pain medication within the last 24 hours
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Aarhuslead
- Lundbeck Foundationcollaborator
Study Sites (1)
Danish Pain Research Center
Aarhus N, 8200, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 17, 2023
First Posted
April 10, 2024
Study Start
December 20, 2023
Primary Completion
April 30, 2024
Study Completion
April 30, 2024
Last Updated
April 10, 2024
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share