Clinical trial NCT04217616: Pain Perception of People Who Are Unable to Have Headache
Official title: Pain Perception, Headache Provocation and Multiomics of People Who Are Unable to Have Headache
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Headache
Pain, Head
Muscle Tenderness
Healthy
Keywords: Headache
Healthy
Muscle Tenderness
quantitative sensory testing
cold pain threshold
heat pain threshold
Total Tenderness Score
Cold Pressor Test
Headache Resistant
Lead sponsor: Danish Headache Center
Sponsor class: OTHER
First posted: 2020-01-03
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 50 Headache resistant and 50 non-resistant male participants from the Danish Blood Donor Study.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Quantitative Sensory Test: Cold Pain Threshold
timeFrame: 3 hours
measure: Quantitative Sensory Test: Heat Pain Threshold
timeFrame: 3 hours.
measure: Pericranial Muscle Tenderness: Total Tenderness Scores
timeFrame: 3 hours
Secondary outcomes:
measure: Cold Pressor Test: Pain Tolerance
timeFrame: 3 hours
measure: Cold Pressor Test: Pain Rating
timeFrame: 3 hours
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Danish Headache Center
state: Region H
Study officials:
affiliation: Danish Headache Center
name: Jes Olesen, Professor
role: STUDY_DIRECTOR
References:
citation: Olofsson IA, Hvedstrup J, Falkenberg K, Chalmer MA, Schytz HW, Pedersen MB, Ullum H, Pedersen OB, Olesen J, Hansen TF. Pain sensitivity in men who have never experienced a headache: an observer blinded case control study. J Headache Pain. 2021 Nov 8;22(1):134. doi: 10.1186/s10194-021-01345-0.