Pain Perception of People Who Are Unable to Have Headache

NCT ID: NCT04217616

Last Updated: 2021-03-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2020-03-12

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.

Conditions

Headache; Pain, Head; Muscle Tenderness; Healthy

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Headache Resistant Participants

Male participants who have never had a headache.

No interventions assigned to this group

Non-Resistant Participants

Male participants who have experienced headache. Age matched.

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Danish Headache Center

OTHER

Sponsor Role: lead

Responsible Party

Isa Amalie Olofsson

Medical Doctor, PhD student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jes Olesen, Professor

Role: STUDY_DIRECTOR

Danish Headache Center

Locations

Danish Headache Center

Glostrup Municipality, Region H, Denmark

Countries

Denmark

References

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.

Reference Type: DERIVED

PMID: 34749638 (View on PubMed)

Other Identifiers

HR001 Pain

Identifier Type: -

Identifier Source: org_study_id