- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04217616
Pain Perception of People Who Are Unable to Have Headache
Pain Perception, Headache Provocation and Multiomics of People Who Are Unable to Have Headache
Headaches are extremely common illnesses with a combined lifetime prevalence of 90-99% in Europe. Despite this high prevalence, there are persons who have never, in their whole life, encountered a headache.
The aim of the study is to identify factors that protect against headache by studying pain perception, muscle tenderness and pain tolerance in people who never have had a headache (headache resistant) versus non-resistant controls.
The investigators hope to contribute with novelty to the current understanding of headache pathophysiology and development of more efficient treatment of headache.
The investigator examining:
Quantitative sensory testing (cold pain threshold and heat pain threshold), Muscle tenderness (total tenderness score) and cold pressor test (time in the water and pain rating). All tests are performed the same day, by one investigator who are blinded to the grouping of the participants.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Region H
-
Glostrup, Region H, Denmark, 2600
- Danish Headache Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Headache resistant and non-resistant male participants from the Danish Blood Donor Study.
- Weight: 45 kg to 95 kg
Exclusion Criteria:
- Daily consumption of any medication.
- Consumption of any medication less than 12 hours prior to the study day.
- Headache on the study day or 48 hours prior to the study day.
- Amnestic or clinical signs of hypertension (systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg) or hypotension (systolic blood pressure <90 mmHg and/or diastolic blood pressure <50 mmHg).
- Any severe cardiovascular disease, including cerebrovascular illness.
- Amnestic or clinical signs of current mental illness.
- Amnestic or clinical signs of current substance or drug abuse.
- Amnestic or clinical signs of any illness the responsible doctor considers relevant for participation in the study.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Headache Resistant Participants
Male participants who have never had a headache.
|
Non-Resistant Participants
Male participants who have experienced headache.
Age matched.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quantitative Sensory Test: Cold Pain Threshold
Time Frame: 3 hours
|
Difference in Cold Pain Threshold (celcius) between cases and controls.
|
3 hours
|
Quantitative Sensory Test: Heat Pain Threshold
Time Frame: 3 hours.
|
Difference in Heat Pain Threshold (celcius) between cases and controls.
|
3 hours.
|
Pericranial Muscle Tenderness: Total Tenderness Scores
Time Frame: 3 hours
|
Difference in Total Tenderness Score between cases and controls.
8 pericranial muscles are palpated by the investigator and the tenderness is rated by the participant on a scale of 0-3 where 0 is no tenderness and 3 is severe tenderness.
|
3 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cold Pressor Test: Pain Tolerance
Time Frame: 3 hours
|
Difference in Cold Pressor Test Pain Tolerance (seconds) between cases and controls
|
3 hours
|
Cold Pressor Test: Pain Rating
Time Frame: 3 hours
|
Difference in Cold Pressor Test Pain Rating by Verbal Rating Scale (VRS) between cases and controls.
The pain is rated by the participant on the Verbal Rating Scale from 0 - 10 where 0 is no pain and 10 is the most severe pain imaginable.
|
3 hours
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HR001 Pain
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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