Pain Perception of People Who Are Unable to Have Headache

Healthy Clinical Trial

Official title:

Pain Perception, Headache Provocation and Multiomics of People Who Are Unable to Have Headache

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04217616
• Other study ID #: HR001 Pain
• Status: Completed
• Start date: October 1, 2019
• Est. completion date: March 12, 2020

Study information

• Verified date: March 2021
• Source: Danish Headache Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 12, 2020
• Est. primary completion date: March 12, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Headache
• Healthy
• Muscle Tenderness
• Myalgia
• Pain, Head

Locations

Country	Name	City	State
Denmark	Danish Headache Center	Glostrup	Region H

Sponsors (1)

Lead Sponsor	Collaborator
Danish Headache Center

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantitative Sensory Test: Cold Pain Threshold	Difference in Cold Pain Threshold (celcius) between cases and controls.	3 hours
Primary	Quantitative Sensory Test: Heat Pain Threshold	Difference in Heat Pain Threshold (celcius) between cases and controls.	3 hours.
Primary	Pericranial Muscle Tenderness: Total Tenderness Scores	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	Cold Pressor Test: Pain Tolerance	Difference in Cold Pressor Test Pain Tolerance (seconds) between cases and controls	3 hours
Secondary	Cold Pressor Test: Pain Rating	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