Nummular HeadacheNCT04299958
Observational Prospective Study on the Presence of Typical Migraine Features in Nummular Headache Patients: The Numamig Study
An observational study of Nummular Headache and Migraine, run by Hospital Clínico Universitario de Valladolid at 1 site in Spain.
Trial summary
Observational analytic study with prospective cohort design that aim to describe the presence of typical features of migraine in a cohort of nummular headache patients. The aim of the study is to analyze family history, epidemiology, clinical description, presence of prodromes, postdromes and response to treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nummular Headache, Migraine, Headache Disorders, Primary
- What is being tested?
- Patient diary
- How many people
- 19 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2020to 25 Apr 2023
- How long will I take part?
- 1 Month
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with definite diagnosis of nummular headache that visit the headache outpatient clinic of Valladolid University Hospital.
Who may be able to join
- Diagnosis of Nummular Headache (NH) according to the International Classification of Headache Disorders, 3rd version (ICHD-3).
- More than 3 months of NH evolution.
- No better accounted for by another ICHD-3 diagnosis.
- Older than 18 years.
- Capable of prospectively register headache characteristics in a diary.
- Ability to provide informed consent form.
Who cannot join
- Other primary or secondary headache, except for infrequent tension-type headache or medication overuse headache.
- Major psychiatric disorders.
- Alcoholism or drug use.
Trial locations and contacts
1 site in 1 country.
About this study
Observational analytic study with prospective cohort design that aim to describe the presence of typical features of migraine in a cohort of nummular headache patients. The aim of the study is to analyze family history, epidemiology, clinical description, presence of prodromes, postdromes and response to treatment.
Read the detailed description
Background:
Nummular headache (NH) is a primary headache included in the International Classification of Headache Disorders (ICHD) characterized by a well delimited superficial pain, with sharp border, felt in a rounded or elliptical 1-6 centimeters area. Pain might be continuous or intermittent. The key feature of nummular headache is the fixed superficial topography.
The real nature of this condition is still a matter of controversial. Some authors defend it as a specific condition with a particular pathophysiology; whereas others consider that it might be a localized form of migraine with a shared phenotype and pathophysiology.
Among the arguments that defend its existence as a differentiated entity we include: the older age of onset, the fixed and localized pain without pain in other territories, presence of trophic changes, the localized abnormality in pressure pain threshold determination, the description of secondary cases, the description of posttraumatic cases or the specific therapeutic response.
On the other hand, in some cases hypersensitivity to stimuli has been described, other typical migrainous symptoms such as nausea or vomiting might be present, and some patients respond to triptans or other migraine prophylactics.
Information is scarce about the presence of prodromes, postdromes or family history of migraine. Moreover, little is known about NH pathophysiology, some studies suggest an impairment in superficial sensory fibers because a localized alteration of pressure-pain threshold. No imaging or laboratory studies have been done so far.
This is a proof of concept study. The aim is to analyze if patients with a definite NH diagnosis according to ICHD present any shared epidemiological, clinical or therapeutical features with migraine.
Hypothesis:
Nummular headache might be a specific condition or it might share migraine biologic features. The detailed description of it might help to clarify whether if NH is a single entity or a focal presentation form of migraine.
Objective:
To describe the presence of typical features of migraine in a cohort of NH patients, including family history, epidemiology, clinical description, presence of prodromes or postdromes and response to treatment.
Methods:
The study has an observational analytic design following the Strengthening the Reporting of Observational in Epidemiology (STROBE) guidelines. Patients with definite nummular headache diagnosis according to The International Classification of Headache Disorders1 will be invited to participate. The study will be conducted in the Headache Unit of Hospital Clinico Universitario de Valladolid, a third level hospital sited in Valladolid, with a reference population of 280.000 people.
Intervention:
The study will be divided into different sections:
- Family history of headache and in particular, migraine.
- Epidemiology of NH patients.
- Clinical phenotype and pattern of the headache.
- Associated symptoms, presence of prodromes and postdromes.
- Physical examination.
- Prior treatment use, tolerability and response.
Selection of participants:
Recruitment will be recruited by a non-probabilistic sampling method by convenience and by formal invitation if they are included in the clinical registry of the Headache Unit of the Hospital Clinico Universitario de Valladolid.
In the first visit participants will be examined by a neurologist with experience in headache disorders and NH diagnosis will be reviewed. Patients will be invited to participate into the study and they will provide and sign informed consent form. They will be instructed and trained to complete the prospective headache diary during 14 days. A follow up visit will be done within 15 to 30 days to review the data and analyze possible sources of bias.
- Conditions
- Nummular Headache, Migraine, Headache Disorders, Primary
- Being tested
- Patient diary
- Keywords
- Nummular headache
- Medical subject headings
- Migraine Disorders, Headache Disorders, Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient diaryOther
In the first visit they will be examined by a neurologist with experience in headache disorders and NH diagnosis will be reviewed. Patients will be invited to participate into the study and they will provide and sign informed consent form. They will be instructed and trained to complete the prospective headache diary during 14 days. A follow up visit will be done within 15 to 30 days to review the data and analyze possible sources of bias.
What is being measured
The primary outcome is the main question the study is designed to answer.
Family history of migraine
To assess family history of migraine headache in nummular patients. We will build family tree up to 3 generations and we will ask patients to complete it by questioning their relatives.
Measured: Through study completion, an average of 1 month
Epidemiological pattern
To determine age of onset, age when they were diagnosed, temporal pattern and frequency of headache.
Measured: Through study completion, an average of 1 month
Clinical phenotype
To assess the clinical characteristics of nummular headache, analyzing the presence of typical features of migraine. Patients will complete a prospective headache diary for 15 days.
Measured: Through study completion, an average of 1 month
Presence of associated symptoms
To assess the presence of symptoms such as nausea, vomiting, dizziness during the headache episodes.
Measured: Through study completion, an average of 1 month
Presence of prodromes
To assess the presence of typical migraine prodromes before the headache episodes.
Measured: Through study completion, an average of 1 month
Presence of postdromes
To assess the presence of typical migraine postdromes after the headache episode.
Measured: Through study completion, an average of 1 month
Presence of sensory disturbances
To evaluate the presence of sensory changes such as hypoesthesia, hyperalgesia or allodinia upon examination.
Measured: Through study completion, an average of 1 month
Response to acute treatment
To describe response to prior acute medications.
Measured: Through study completion, an average of 1 month
Response to prophylactic treatment
To assess response to prior prophylactic treatments.
Measured: Through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2020
- Study start1 Apr 2020
- Primary completion25 Mar 2023
- Study completion25 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Nummular 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Hospital Clínico Universitario de Valladolid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David García Azorín, Hospital Clínico Universitario de Valladolid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04299958
- Sponsor's protocol ID
- PI 20-1638
- Status last verified
- Sep 2023
- First submitted
- 5 Mar 2020
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: To be decided if anonymous data-sheets are available for other researchers upon reasonable request.
Publications
Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211. doi: 10.1177/0333102417738202. No abstract available.
PubMed 29368949Pareja JA, Caminero AB, Serra J, Barriga FJ, Baron M, Dobato JL, Vela L, Sanchez del Rio M. Numular headache: a coin-shaped cephalgia. Neurology. 2002 Jun 11;58(11):1678-9. doi: 10.1212/wnl.58.11.1678.
PubMed 12058099Trigo J, Garcia-Azorin D, Martinez Pias E, Sierra A, Chavarria A, Guerrero AL. Clinical characteristics of nummular headache and differentiation between spontaneous and posttraumatic variant: an observational study. J Headache Pain. 2019 Apr 8;20(1):34. doi: 10.1186/s10194-019-0981-4.
PubMed 30961529Garcia-Azorin D, Trigo-Lopez J, Sierra A, Blanco-Garcia L, Martinez-Pias E, Martinez B, Talavera B, Guerrero AL. Observational, open-label, non-randomized study on the efficacy of onabotulinumtoxinA in the treatment of nummular headache: The pre-numabot study. Cephalalgia. 2019 Dec;39(14):1818-1826. doi: 10.1177/0333102419863023. Epub 2019 Jul 4.
PubMed 31272194Cuadrado ML, Lopez-Ruiz P, Guerrero AL. Nummular headache: an update and future prospects. Expert Rev Neurother. 2018 Jan;18(1):9-19. doi: 10.1080/14737175.2018.1401925. Epub 2017 Nov 9.
PubMed 29103335
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Prospective Study on the Presence of Typical Migraine Features in Nummular Headache Patients: The Numamig Study
- ClinicalTrials.gov ID
- NCT04299958
- Acronym / sponsor ID
- PI 20-1638
- Conditions
- Nummular Headache, Migraine, Headache Disorders, Primary
- Keywords
- Nummular headache
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Hospital Clínico Universitario de ValladolidUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 25 Mar 2023 (actual)
- Study completion
- 25 Apr 2023 (actual)
- First posted
- 9 Mar 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.
Observational analytic study with prospective cohort design that aim to describe the presence of typical features of migraine in a cohort of nummular headache patients. The aim of the study is to analyze family history, epidemiology, clinical description, presence of prodromes, postdromes and response to treatment.
Detailed description
Background:
Nummular headache (NH) is a primary headache included in the International Classification of Headache Disorders (ICHD) characterized by a well delimited superficial pain, with sharp border, felt in a rounded or elliptical 1-6 centimeters area. Pain might be continuous or intermittent. The key feature of nummular headache is the fixed superficial topography.
The real nature of this condition is still a matter of controversial. Some authors defend it as a specific condition with a particular pathophysiology; whereas others consider that it might be a localized form of migraine with a shared phenotype and pathophysiology.
Among the arguments that defend its existence as a differentiated entity we include: the older age of onset, the fixed and localized pain without pain in other territories, presence of trophic changes, the localized abnormality in pressure pain threshold determination, the description of secondary cases, the description of posttraumatic cases or the specific therapeutic response.
On the other hand, in some cases hypersensitivity to stimuli has been described, other typical migrainous symptoms such as nausea or vomiting might be present, and some patients respond to triptans or other migraine prophylactics.
Information is scarce about the presence of prodromes, postdromes or family history of migraine. Moreover, little is known about NH pathophysiology, some studies suggest an impairment in superficial sensory fibers because a localized alteration of pressure-pain threshold. No imaging or laboratory studies have been done so far.
This is a proof of concept study. The aim is to analyze if patients with a definite NH diagnosis according to ICHD present any shared epidemiological, clinical or therapeutical features with migraine.
Hypothesis:
Nummular headache might be a specific condition or it might share migraine biologic features. The detailed description of it might help to clarify whether if NH is a single entity or a focal presentation form of migraine.
Objective:
To describe the presence of typical features of migraine in a cohort of NH patients, including family history, epidemiology, clinical description, presence of prodromes or postdromes and response to treatment.
Methods:
The study has an observational analytic design following the Strengthening the Reporting of Observational in Epidemiology (STROBE) guidelines. Patients with definite nummular headache diagnosis according to The International Classification of Headache Disorders1 will be invited to participate. The study will be conducted in the Headache Unit of Hospital Clinico Universitario de Valladolid, a third level hospital sited in Valladolid, with a reference population of 280.000 people.
Intervention:
The study will be divided into different sections:
- Family history of headache and in particular, migraine.
- Epidemiology of NH patients.
- Clinical phenotype and pattern of the headache.
- Associated symptoms, presence of prodromes and postdromes.
- Physical examination.
- Prior treatment use, tolerability and response.
Selection of participants:
Recruitment will be recruited by a non-probabilistic sampling method by convenience and by formal invitation if they are included in the clinical registry of the Headache Unit of the Hospital Clinico Universitario de Valladolid.
In the first visit participants will be examined by a neurologist with experience in headache disorders and NH diagnosis will be reviewed. Patients will be invited to participate into the study and they will provide and sign informed consent form. They will be instructed and trained to complete the prospective headache diary during 14 days. A follow up visit will be done within 15 to 30 days to review the data and analyze possible sources of bias.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with definite diagnosis of nummular headache that visit the headache outpatient clinic of Valladolid University Hospital.
Key inclusion criteria (6 listed)
- Diagnosis of Nummular Headache (NH) according to the International Classification of Headache Disorders, 3rd version (ICHD-3).
- More than 3 months of NH evolution.
- No better accounted for by another ICHD-3 diagnosis.
- Older than 18 years.
- Capable of prospectively register headache characteristics in a diary.
Key exclusion criteria (3 listed)
- Other primary or secondary headache, except for infrequent tension-type headache or medication overuse headache.
- Major psychiatric disorders.
- Alcoholism or drug use.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient diaryIn the first visit they will be examined by a neurologist with experience in headache disorders and NH diagnosis will be reviewed. Patients will be invited to participate into the study and they will provide and sign informed consent form. They will be instructed and trained to complete the prospective headache diary during 14 days. A follow up visit will be done within 15 to 30 days to review the data and analyze possible sources of bias. | Other | – |
Primary outcome
Family history of migraine
Time frame: Through study completion, an average of 1 month
To assess family history of migraine headache in nummular patients. We will build family tree up to 3 generations and we will ask patients to complete it by questioning their relatives.
Epidemiological pattern
Time frame: Through study completion, an average of 1 month
To determine age of onset, age when they were diagnosed, temporal pattern and frequency of headache.
Clinical phenotype
Time frame: Through study completion, an average of 1 month
To assess the clinical characteristics of nummular headache, analyzing the presence of typical features of migraine. Patients will complete a prospective headache diary for 15 days.
Presence of associated symptoms
Time frame: Through study completion, an average of 1 month
To assess the presence of symptoms such as nausea, vomiting, dizziness during the headache episodes.
Presence of prodromes
Time frame: Through study completion, an average of 1 month
To assess the presence of typical migraine prodromes before the headache episodes.
Presence of postdromes
Time frame: Through study completion, an average of 1 month
To assess the presence of typical migraine postdromes after the headache episode.
Presence of sensory disturbances
Time frame: Through study completion, an average of 1 month
To evaluate the presence of sensory changes such as hypoesthesia, hyperalgesia or allodinia upon examination.
Response to acute treatment
Time frame: Through study completion, an average of 1 month
To describe response to prior acute medications.
Response to prophylactic treatment
Time frame: Through study completion, an average of 1 month
To assess response to prior prophylactic treatments.
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 22 Sep 2023.
- Background: PubMed 29368949Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211. doi: 10.1177/0333102417738202. No abstract available.
- Background: PubMed 12058099Pareja JA, Caminero AB, Serra J, Barriga FJ, Baron M, Dobato JL, Vela L, Sanchez del Rio M. Numular headache: a coin-shaped cephalgia. Neurology. 2002 Jun 11;58(11):1678-9. doi: 10.1212/wnl.58.11.1678.
- Background: PubMed 30961529Trigo J, Garcia-Azorin D, Martinez Pias E, Sierra A, Chavarria A, Guerrero AL. Clinical characteristics of nummular headache and differentiation between spontaneous and posttraumatic variant: an observational study. J Headache Pain. 2019 Apr 8;20(1):34. doi: 10.1186/s10194-019-0981-4.
- Background: PubMed 31272194Garcia-Azorin D, Trigo-Lopez J, Sierra A, Blanco-Garcia L, Martinez-Pias E, Martinez B, Talavera B, Guerrero AL. Observational, open-label, non-randomized study on the efficacy of onabotulinumtoxinA in the treatment of nummular headache: The pre-numabot study. Cephalalgia. 2019 Dec;39(14):1818-1826. doi: 10.1177/0333102419863023. Epub 2019 Jul 4.
- Background: PubMed 29103335Cuadrado ML, Lopez-Ruiz P, Guerrero AL. Nummular headache: an update and future prospects. Expert Rev Neurother. 2018 Jan;18(1):9-19. doi: 10.1080/14737175.2018.1401925. Epub 2017 Nov 9.
- Individual participant dataSharing planned: Undecided. To be decided if anonymous data-sheets are available for other researchers upon reasonable request.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Nummular Headache and Migraine, run by Hospital Clínico Universitario de Valladolid at 1 site in Spain.
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 6 inclusion and 3 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 22 Sep 2023. 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 Spain. 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?
Family history of migraine (time frame: Through study completion, an average of 1 month). The study lists 9 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 NCT04299958, which also lists 5 linked publications.
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 22 Sep 2023.