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CompletedNCT04217616Updated Mar 25, 2021

Pain Perception of People Who Are Unable to Have Headache

An observational study in Headache, Pain, Head and Muscle Tenderness, sponsored by Danish Headache Center. Completed at 1 site in Denmark. Open to male participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-03-25.

Sponsored by Danish Headache Center · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
100
Ages
18 Years to 70 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Headache
  • Pain, Head
  • Muscle Tenderness
  • Healthy

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Keywords

  • Headache
  • Healthy
  • Muscle Tenderness
  • quantitative sensory testing
  • cold pain threshold
  • heat pain threshold
  • Total Tenderness Score
  • Cold Pressor Test
  • Headache Resistant
03

In context

Myalgia

282 studies on the registry are indexed under Myalgia; 43 are open to participants now.

This study's enrollment of 100 is below the median of 154 across 35 observational studies indexed under Myalgia.

Browse Myalgia studies →

Lead sponsor

Danish Headache Center is the lead sponsor of 125 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  • Headache resistant and non-resistant male participants from the Danish Blood Donor Study.
  • Weight: 45 kg to 95 kg

Exclusion criteria

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.
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
100 participants (actual)
Patient registry
No

Groups and cohorts

  • Headache Resistant Participants

    Male participants who have never had a headache.

  • Non-Resistant Participants

    Male participants who have experienced headache. Age matched.

06

What researchers measure

Primary outcomes

  1. Quantitative Sensory Test: Cold Pain Threshold

    Difference in Cold Pain Threshold (celcius) between cases and controls.

    Time frame: 3 hours

  2. Quantitative Sensory Test: Heat Pain Threshold

    Difference in Heat Pain Threshold (celcius) between cases and controls.

    Time frame: 3 hours.

  3. 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.

    Time frame: 3 hours

Secondary outcomes

  1. Cold Pressor Test: Pain Tolerance

    Difference in Cold Pressor Test Pain Tolerance (seconds) between cases and controls

    Time frame: 3 hours

  2. 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.

    Time frame: 3 hours

07

Study locations

1 site
  • Danish Headache Center
    Glostrup, Region H 2600, Denmark
08

References and documents

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. PubMed 34749638 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 25, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04217616
Lead sponsor
Danish Headache Center
Responsible party
Isa Amalie Olofsson (Medical Doctor, PhD student, Danish Headache Center) — Principal investigator
First posted
Jan 3, 2020
Start date
Oct 1, 2019
Primary completion
Mar 12, 2020
Completion
Mar 12, 2020
Last update
Mar 25, 2021

Study contacts

Jes Olesen, Professor
study director · Danish Headache Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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