An observational study in Nummular Headache, Migraine and Headache Disorders, Primary, sponsored by Hospital Clínico Universitario de Valladolid. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-22.
Sponsored by Hospital Clínico Universitario de Valladolid · Observational
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.
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:
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.
1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.
This study's enrollment of 19 is below the median of 137 across 331 observational studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Hospital Clínico Universitario de Valladolid is the lead sponsor of 21 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with definite diagnosis of nummular headache that visit the headache outpatient clinic of Valladolid University Hospital.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Through study completion, an average of 1 month
Presence of prodromes
To assess the presence of typical migraine prodromes before the headache episodes.
Time frame: Through study completion, an average of 1 month
Presence of postdromes
To assess the presence of typical migraine postdromes after the headache episode.
Time frame: 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.
Time frame: Through study completion, an average of 1 month
Response to acute treatment
To describe response to prior acute medications.
Time frame: Through study completion, an average of 1 month
Response to prophylactic treatment
To assess response to prior prophylactic treatments.
Time frame: Through study completion, an average of 1 month
Plan to share: Undecided — To be decided if anonymous data-sheets are available for other researchers upon reasonable request.
Ran from Apr 2020 to primary completion in Mar 2023, 35 months.
Of 132 non-industry observational studies under Migraine Disorders, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 72. This study's 35 months is above that.
Counting every sponsor, half of 160 studies reached it within 27 months; a quarter within 13 and three quarters within 63.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Hospital Clínico Universitario de Valladolid