Pain Perception of People Who Are Unable to Have Headache
|ClinicalTrials.gov Identifier: NCT04217616|
Recruitment Status : Recruiting
First Posted : January 3, 2020
Last Update Posted : January 6, 2020
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.
|Condition or disease|
|Headache Pain, Head Muscle Tenderness Healthy|
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Pain Perception, Headache Provocation and Multiomics of People Who Are Unable to Have Headache|
|Actual Study Start Date :||October 1, 2019|
|Estimated Primary Completion Date :||May 1, 2020|
|Estimated Study Completion Date :||June 1, 2020|
Headache Resistant Participants
Male participants who have never had a headache.
Male participants who have experienced headache. Age matched.
- Quantitative Sensory Test: Cold Pain Threshold [ Time Frame: 3 hours ]Difference in Cold Pain Threshold (celcius) between cases and controls.
- Quantitative Sensory Test: Heat Pain Threshold [ Time Frame: 3 hours. ]Difference in Heat Pain Threshold (celcius) between cases and controls.
- 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.
- Cold Pressor Test: Pain Tolerance [ Time Frame: 3 hours ]Difference in Cold Pressor Test Pain Tolerance (seconds) between cases and controls
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04217616
|Contact: Isa A Olofsson, MD||0045 38 63 20 firstname.lastname@example.org|
|Danish Headache Center||Recruiting|
|Glostrup, Region H, Denmark, 2600|
|Contact: Isa A Olofsson, MD 0045 38 63 20 62 email@example.com|
|Principal Investigator: Isa A Olofsson, MD|
|Study Director:||Jes Olesen, Professor||Danish Headache Center|