MigraineMIGinPOL2021NCT05087420
Migraine in Poland - a Web-based Cross-sectional Survey
An observational study of Migraine, run by Swiat Zdrowia at 2 sites in Poland.
Trial summary
A survey of Polish respondents will aim to define migraine characteristics in Polish subjects. To achieve this, a structured questionnaire based mainly on American Migraine Prevalence and Prevention Study has been prepared to serve as a tool for data extraction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine
- How many people
- 2,800 participants
- Where
- 2 sitesPoland
- Study dates
- 1 Sep 2021to 30 Apr 2022
- 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
- Adult, Older adult
Study population: Participant will be recruited from miscellaneous sources including: specialist headache practices, primary care clinics, patients associations. An invitation would be also extended via social and traditional media and employers.
Who may be able to join
- consent to participate in the study
Who cannot join
- responses missing in questionnaire
Trial locations and contacts
2 sites in 1 country.
Poland2 sites
Marcin Straburzyński
Dźwierzuty, Warmian-Masurian Voivodeship, 12-120
Department of Neurology, Wrocław Medical University
Wroclaw
About this study
A survey of Polish respondents will aim to define migraine characteristics in Polish subjects. To achieve this, a structured questionnaire based mainly on American Migraine Prevalence and Prevention Study has been prepared to serve as a tool for data extraction. The obtained data should allow for defining disease parameters, burden and received treatments. Additionally questions regarding patients rhinological symptoms and COVID-19-related history were included.
- Conditions
- Migraine
- Keywords
- migraine, headache, rhinosinusitis, COVID-19
- Medical subject headings
- Migraine Disorders, Headache, Rhinosinusitis, COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache phenotype
Classification of reported headache according to International Classification of Headache Disorders
Measured: in the preceding year
Migraine burden
Consequences of the disease measured by the Migraine Disability Assessment Test
Measured: in the preceding year
Secondary outcomes (25)
Monthly headache days
Number of days per month
Measured: in the preceding month
Monthly headache days
Number of days per year
Measured: in the preceding year
Time from last headache professional consultation
Number of months
Measured: in the preceding 10 years
Migraine diagnosed by headache professional
yes/no
Measured: in the preceding 10 years
Age at diagnosis
years
Measured: from the onset of headache (time frame up to 99 years)
Comoribidities
Disease according to International Classsification of Disease 10
Measured: in the preceding year
Type of previous headache professional consultation
Name of headache profession/speciality
Measured: in the preceding 10 years
Number of consultations in the last year
Number 0-100
Measured: in the last 12 months
Number of consultations in the last year because of headaches
Number 0-100
Measured: in the last 12 months
Number of days spent in hospital in the last year because of headaches
Number 0-100
Measured: in the last 12 months
Acute treatment used
Name of abortive medication
Measured: in the preceding 10 years
Preventive treatment used
Name of abortive medication
Measured: in the preceding 10 years
Acute treatment frequency
Number of days per month
Measured: in the last 3 months
Preventive treatment frequency
Number of months form the last dose
Measured: in the last 12 months
Preventive treatment effectiveness
Likert scale
Measured: in the last 12 months
Employment
Type of employment
Measured: in the last 12 months
Time spent at work
Number of hours per week
Measured: in the last 12 months
Work absence due to headache
Number of days per month
Measured: in the last month
Presenteeism
Number of days per month
Measured: in the last month
PHQ-9 Patient Health Questionnaire
Number
Measured: in the last 2 weeks
Sinus headache
Number of days
Measured: in the last 3 months
Sinonasal symptoms accompanying headache
Type of symptoms
Measured: in the last 12 months
Sinonasal symptoms not associated with headache
Type of symptom
Measured: in the last 12 months
COVID-19 association with headache
Likert scale
Measured: in the last 2 years
COVID-19 vaccine association with headache
Likert scale
Measured: in the last year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start1 Sep 2021
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
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 MigraineStudies 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
- Cross-sectional
- Enrolment
- 2,800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiat Zdrowia
- Sponsor type
- University, hospital or other
- Collaborators
- Wroclaw Medical University
- Responsible party
- Principal investigator, Marcin Straburzynski, Swiat Zdrowia
- Investigators
- Marta Waliszewska-Prosół, MD, PhD, Study chair, Departament of Neurolog, Wrocław Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05087420
- Sponsor's protocol ID
- MIGinPOL2021
- Acronym
- MIGinPOL2021
- Status last verified
- May 2022
- First submitted
- 19 Sep 2021
- Last updated
- 4 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Straburzynski M, Waliszewska-Prosol M, Nowaczewska M, Czapinska-Ciepiela EK, Gryglas-Dworak A, Budrewicz S. Prevalence of cranial autonomic symptoms in frequent episodic tension-type headache: A post hoc analysis of the cross-sectional Migraine in Poland study. Dent Med Probl. 2024 Jul-Aug;61(4):489-493. doi: 10.17219/dmp/175611.
PubMed 38652923
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Migraine in Poland - a Web-based Cross-sectional Survey
- ClinicalTrials.gov ID
- NCT05087420
- Acronym / sponsor ID
- MIGinPOL2021 / MIGinPOL2021
- Conditions
- Migraine
- Keywords
- migraine, headache, rhinosinusitis, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,800 participants (actual)
- Lead sponsor
- Swiat ZdrowiaUniversity, hospital or other
- Collaborators
- Wroclaw Medical University
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 21 Oct 2021 (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.
A survey of Polish respondents will aim to define migraine characteristics in Polish subjects. To achieve this, a structured questionnaire based mainly on American Migraine Prevalence and Prevention Study has been prepared to serve as a tool for data extraction. The obtained data should allow for defining disease parameters, burden and received treatments. Additionally questions regarding patients rhinological symptoms and COVID-19-related history were included.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Participant will be recruited from miscellaneous sources including: specialist headache practices, primary care clinics, patients associations. An invitation would be also extended via social and traditional media and employers.
Key inclusion criteria (1 listed)
- consent to participate in the study
Key exclusion criteria (1 listed)
- responses missing in questionnaire
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
Headache phenotype
Time frame: in the preceding year
Classification of reported headache according to International Classification of Headache Disorders
Migraine burden
Time frame: in the preceding year
Consequences of the disease measured by the Migraine Disability Assessment Test
25 secondary outcomes
Monthly headache days
Time frame: in the preceding month
Monthly headache days
Time frame: in the preceding year
Time from last headache professional consultation
Time frame: in the preceding 10 years
Migraine diagnosed by headache professional
Time frame: in the preceding 10 years
Age at diagnosis
Time frame: from the onset of headache (time frame up to 99 years)
Comoribidities
Time frame: in the preceding year
Type of previous headache professional consultation
Time frame: in the preceding 10 years
Number of consultations in the last year
Time frame: in the last 12 months
Number of consultations in the last year because of headaches
Time frame: in the last 12 months
Number of days spent in hospital in the last year because of headaches
Time frame: in the last 12 months
Acute treatment used
Time frame: in the preceding 10 years
Preventive treatment used
Time frame: in the preceding 10 years
Acute treatment frequency
Time frame: in the last 3 months
Preventive treatment frequency
Time frame: in the last 12 months
Preventive treatment effectiveness
Time frame: in the last 12 months
Employment
Time frame: in the last 12 months
Time spent at work
Time frame: in the last 12 months
Work absence due to headache
Time frame: in the last month
Presenteeism
Time frame: in the last month
PHQ-9 Patient Health Questionnaire
Time frame: in the last 2 weeks
Sinus headache
Time frame: in the last 3 months
Sinonasal symptoms accompanying headache
Time frame: in the last 12 months
Sinonasal symptoms not associated with headache
Time frame: in the last 12 months
COVID-19 association with headache
Time frame: in the last 2 years
COVID-19 vaccine association with headache
Time frame: in the last year
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 4 May 2022.
- Derived from this study: PubMed 38652923Straburzynski M, Waliszewska-Prosol M, Nowaczewska M, Czapinska-Ciepiela EK, Gryglas-Dworak A, Budrewicz S. Prevalence of cranial autonomic symptoms in frequent episodic tension-type headache: A post hoc analysis of the cross-sectional Migraine in Poland study. Dent Med Probl. 2024 Jul-Aug;61(4):489-493. doi: 10.17219/dmp/175611.
- Individual participant dataSharing planned: No
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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.
Marta Waliszewska-Prosół, MD, PhD study chair
Departament of Neurolog, Wrocław Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine, run by Swiat Zdrowia at 2 sites in Poland.
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 1 inclusion and 1 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 4 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. 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?
Headache phenotype (time frame: in the preceding year). The study lists 2 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 NCT05087420, 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 4 May 2022.