AnalgesiaNCT06356376
The Effects of Pain and Pain Relief on Peripheral Nerve Excitability
An observational study of Analgesia, run by University of Aarhus at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Analgesia
- What is being tested?
- Heat Stimulation
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 20 Dec 2023to 30 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy Subjects
Who may be able to join
- Healthy Participants able to give informed consent.
Who cannot join
- Chronic pain conditions
- Neurological or Psychiatric disease
- Other major diseases
- Pain medication within the last 24 hours
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Danish Pain Research Center
Aarhus N, 8200
Alexander G Kristensen, MD,PhD, +45 93 52 28 64, alexgramm@clin.au.dk
About this study
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.
- Conditions
- Analgesia
- Being tested
- Heat Stimulation
- Keywords
- Pain, Excitability, Microneurography, Autonomic nervous system
- Medical subject headings
- Agnosia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heat StimulationDevice
Heat stimulation at a painful, but to the subject tolerable level.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Participants | Not described Receives: Device: Heat Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 6 months
Secondary outcomes (5)
Action potential duration (ms)
Averaged analysis from repeated measures of a single nerve fiber signal.
Measured: Through study completion, an average of 6 months
Action potential amplitude (V)
Averaged analysis from repeated measures of a single nerve fiber signal.
Measured: Through study completion, an average of 6 months
Heart-rate variability (ms)
Comparison of heart-rate variability during experimental pain stimulation and during pain relief.
Measured: Through study completion, an average of 6 months
Blood pressure variability (mmHg)
Changes in continuous blood pressure measurement averages during experimental pain stimulation and during pain relief..
Measured: Through study completion, an average of 6 months
Sympathetic Skin Response (V)
Amplitude of Sympathetic skin response during pain stimulation and relief respectively.
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start20 Dec 2023
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Lundbeck Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06356376
- Sponsor's protocol ID
- UAarhus_AGK_MNG_2
- Status last verified
- Dec 2023
- First submitted
- 17 Dec 2023
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Pain and Pain Relief on Peripheral Nerve Excitability
- ClinicalTrials.gov ID
- NCT06356376
- Acronym / sponsor ID
- UAarhus_AGK_MNG_2
- Conditions
- Analgesia
- Keywords
- Pain, Excitability, Microneurography, Autonomic nervous system
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Lundbeck Foundation
- Study start
- 20 Dec 2023 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 10 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Participants | – | Device: Heat Stimulation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy Subjects
Key inclusion criteria (1 listed)
- Healthy Participants able to give informed consent.
Key exclusion criteria (4 listed)
- Chronic pain conditions
- Neurological or Psychiatric disease
- Other major diseases
- Pain medication within the last 24 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heat StimulationHeat stimulation at a painful, but to the subject tolerable level. | Device | Healthy Participants |
Primary outcome
C-fiber excitability
Time frame: 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.
5 secondary outcomes
Action potential duration (ms)
Time frame: Through study completion, an average of 6 months
Action potential amplitude (V)
Time frame: Through study completion, an average of 6 months
Heart-rate variability (ms)
Time frame: Through study completion, an average of 6 months
Blood pressure variability (mmHg)
Time frame: Through study completion, an average of 6 months
Sympathetic Skin Response (V)
Time frame: Through study completion, an average of 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Analgesia, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexander G Kristensen, MD, PhD (+45 93 52 28 64, alexgramm@clin.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
C-fiber excitability (time frame: Through study completion, an average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2024.