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: Completed
• Conditions: Healthy; Headache; Muscle Tenderness; Pain, Head

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Denmark
  • Region H
    • Glostrup, Region H, Denmark, 2600
      • Danish Headache Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

50 Headache resistant and 50 non-resistant male participants from the Danish Blood Donor Study.

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?

Number of groups / cohorts

2

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	Difference in Cold Pain Threshold (celcius) between cases and controls.	3 hours
Quantitative Sensory Test: Heat Pain Threshold	Difference in Heat Pain Threshold (celcius) between cases and controls.	3 hours.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cold Pressor Test: Pain Tolerance	Difference in Cold Pressor Test Pain Tolerance (seconds) between cases and controls	3 hours
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

Collaborators and Investigators

• Sponsor: Danish Headache Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2019
• Primary Completion (ACTUAL): March 12, 2020
• Study Completion (ACTUAL): March 12, 2020

Study Registration Dates

• First Submitted: January 2, 2020
• First Submitted That Met QC Criteria: January 2, 2020
• First Posted (ACTUAL): January 3, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 25, 2021
• Last Update Submitted That Met QC Criteria: March 24, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Headache; Healthy; quantitative sensory testing; Muscle Tenderness; cold pain threshold; heat pain threshold; Total Tenderness Score; Cold Pressor Test; Headache Resistant
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Musculoskeletal Pain; Myalgia; Headache
• Other Study ID Numbers: HR001 Pain

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No