HeadacheNCT04217616
Pain Perception of People Who Are Unable to Have Headache
An observational study of Headache and Pain, Head, run by Danish Headache Center at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Headache, Pain, Head, Muscle Tenderness
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2019to 12 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: 50 Headache resistant and 50 non-resistant male participants from the Danish Blood Donor Study.
Who may be able to join
- Headache resistant and non-resistant male participants from the Danish Blood Donor Study.
- Weight: 45 kg to 95 kg
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Medical subject headings
- Headache, Myalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Headache Resistant Participants | Male participants who have never had a headache. | |
| Non-Resistant Participants | Male participants who have experienced headache. Age matched. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative Sensory Test: Cold Pain Threshold
Difference in Cold Pain Threshold (celcius) between cases and controls.
Measured: 3 hours
Quantitative Sensory Test: Heat Pain Threshold
Difference in Heat Pain Threshold (celcius) between cases and controls.
Measured: 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.
Measured: 3 hours
Secondary outcomes (2)
Cold Pressor Test: Pain Tolerance
Difference in Cold Pressor Test Pain Tolerance (seconds) between cases and controls
Measured: 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.
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2020
- Study start1 Oct 2019
- Primary completion12 Mar 2020
- Study completion12 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Headache Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isa Amalie Olofsson, Danish Headache Center
- Investigators
- Jes Olesen, Professor, Study director, Danish Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04217616
- Sponsor's protocol ID
- HR001 Pain
- Status last verified
- Mar 2021
- First submitted
- 2 Jan 2020
- Last updated
- 25 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Perception, Headache Provocation and Multiomics of People Who Are Unable to Have Headache
- ClinicalTrials.gov ID
- NCT04217616
- Acronym / sponsor ID
- HR001 Pain
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Danish Headache CenterUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 12 Mar 2020 (actual)
- Study completion
- 12 Mar 2020 (actual)
- First posted
- 3 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Headache Resistant Participants | – | –Male participants who have never had a headache. |
| Non-Resistant Participants | – | –Male participants who have experienced headache. Age matched. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 50 Headache resistant and 50 non-resistant male participants from the Danish Blood Donor Study.
Key inclusion criteria (2 listed)
- Headache resistant and non-resistant male participants from the Danish Blood Donor Study.
- Weight: 45 kg to 95 kg
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Cold Pressor Test: Pain Tolerance
Time frame: 3 hours
Cold Pressor Test: Pain Rating
Time frame: 3 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2021.
- Derived from this study: PubMed 34749638Olofsson 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jes Olesen, Professor study director
Danish Headache Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Headache and Pain, Head, run by Danish Headache Center at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative Sensory Test: Cold Pain Threshold (time frame: 3 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04217616, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2021.