Pain Perception of People Who Are Unable to Have Headache

NCT04217616 | Completed

• 1 other identifier: HR001 Pain
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Headache; Pain, Head; Muscle Tenderness; Healthy

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Cold Pressor Test: Pain Tolerance

  3 hours

• Cold Pressor Test: Pain Rating

  3 hours

Study Arms (2)

Headache Resistant Participants

Male participants who have never had a headache.

Non-Resistant Participants

Male participants who have experienced headache. Age matched.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Danish Headache Center: lead

Study Sites (1)

Danish Headache Center

Glostrup Municipality, Region H, 2600, Denmark

Location

Related Publications (1)

• 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.

  PMID: 34749638 DERIVED

MeSH Terms

Conditions

Headache; Myalgia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain

Study Officials

• Jes Olesen, Professor

  Danish Headache Center

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, PhD student

Study Record Dates

• First Submitted: January 2, 2020
• First Posted: January 3, 2020
• Study Start: October 1, 2019
• Primary Completion: March 12, 2020
• Study Completion: March 12, 2020
• Last Updated: March 25, 2021

Record last verified: 2021-03

Locations

DK (1)