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Completed

NCT Number: NCT04217616

Pain Perception 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.

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Key information

Conditions

Headache Healthy Muscle Tenderness Muscular Diseases Musculoskeletal Diseases Musculoskeletal Pain Myalgia Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pain, Head Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

Male

Study type

Observational

Primary location

Danish Headache Center

Glostrup Municipality, Region H, 2600, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Quantitative Sensory Test: Cold Pain Threshold

    Time frame: 3 hours

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

  2. Quantitative Sensory Test: Heat Pain Threshold

    Time frame: 3 hours.

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

  3. 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.

Secondary outcomes

  1. Cold Pressor Test: Pain Tolerance

    Time frame: 3 hours

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

  2. 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.

Sponsors and collaborators

Lead sponsor

Danish Headache Center

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 3, 2020
Registry last updated
Mar 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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