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MigraineNCT07847554

Validity and Reliability of the Greek WPAI:Migraine

An observational study of Migraine, run by National and Kapodistrian University of Athens at 1 site in Greece.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Migraine is a common neurological disorder that can substantially impair work productivity and daily functioning through both absenteeism and presenteeism. The Work Productivity and Activity Impairment Questionnaire for Migraine (WPAI:Migraine) is a brief patient-reported measure designed to assess migraine-related… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Migraine
How many people
60 participants
Where
1 siteGreece
Study dates
1 Nov 2026to 1 Jul 2027
How long will I take part?
1 Week
Phase
Observational
Are there results?
Not yet: the study is under way

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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adults aged 18-70 years with a diagnosis of episodic or chronic migraine according to the International Classification of Headache Disorders, 3rd edition (ICHD-3), confirmed by a specialist neurologist. Participants will be recruited from the Specialized Headache Clinic of Aeginition Hospital in Greece.

Who may be able to join

  • Diagnosis of migraine
  • Age 18-70 years
  • Ability to understand, read, write, and speak the Greek language

Who cannot join

  • Presence of a headache disorder other than migraine
  • History of systemic diseases (malignant, inflammatory, acute traumatic, infectious, surgical, neurological, psychiatric, or rheumatological conditions)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Michalis Kodounis, Neurologist, PhD contact

+30 697 3600069

kodounis@gmail.com

Dimos Mitsikostas, Neurologist, PhD contact

dimosmitsikostas@me.com

Greece1 site
  • National Kapodistrian University of Athens, Aeginition Hospital, Headache Clinic

    Athens, Attica, 11528

    Michalis Kodounis, Neurologist, PhD, +30 697 3600069, kodounis@gmail.com

Other trials in Greece

About this study

Official title: Assessment of Work Productivity and Activities in Patients With Migraine Using the "WPAI (Work Productivity and Activity Impairment)" Questionnaire: Validity and Reliability Study of the Greek Version

Migraine is a common neurological disorder that can substantially impair work productivity and daily functioning through both absenteeism and presenteeism. The Work Productivity and Activity Impairment Questionnaire for Migraine (WPAI:Migraine) is a brief patient-reported measure designed to assess migraine-related impairment in work and daily activities. Although the questionnaire has demonstrated validity and reliability in other populations, a validated Greek version is currently unavailable. This study aims to evaluate the validity and reliability of the Greek version of the WPAI:Migraine in individuals with episodic or chronic migraine, thereby providing an appropriate tool for assessing migraine-related work productivity and functional impairment in the Greek population.

Read the detailed description

Migraine is one of the most common neurological disorders among working-age individuals worldwide and a major cause of lost work productivity. Migraine attacks not only cause pain and associated symptoms but also lead to work absenteeism, reduced productivity, and limitations in daily activities. A study including 31 countries showed that 52% of individuals with at least 4 migraine days per month experienced an overall reduction in work performance due to migraine, and that this was attributable more to presenteeism than absenteeism. The American Migraine Prevalence and Prevention Study reported that the cost of presenteeism was nearly three times that of absenteeism in patients with episodic migraine.

The Work Productivity and Activity Impairment Questionnaire (WPAI) is a brief and widely used patient-reported outcome measure that assesses the impact of chronic diseases on work performance. WPAI:Migraine, a migraine-specific version, has been found to be valid and reliable in American and Arabic populations of patients with episodic and chronic migraine. International Headache Society (IHS) guidelines for preventive treatment trials in episodic and chronic migraine recommend the use of the WPAI. Therefore, it is important to evaluate the impact of migraine not only through clinical parameters but also in terms of productivity and functioning.

In Greece, migraine studies have been conducted at the population level using pharmacological treatments and assessments. However, with regard to daily life and work productivity, there is currently no validated Greek WPAI:Migraine questionnaire available to assess migraine-related productivity loss. Availability of such a scale for the Greek migraine population is important for clinical applications, health-economics research, and evaluation of treatment outcomes.

Aim of the study - Hypotheses to be tested The aim of the present study is to investigate the validity and reliability of the Greek version of the WPAI:Migraine questionnaire in individuals with migraine and to determine whether it can be used as a valid and reliable tool for assessing work productivity and functioning in the Greek population.

Hypotheses:

Hypotheses:

  • H0: The Greek version of the WPAI:Migraine is not valid and reliable for patients with migraine in the Greek population.
  • H1: The Greek version of the WPAI:Migraine is valid and reliable for patients with migraine in the Greek population.
Conditions
Migraine
Keywords
migraine, headache, work productivity, absenteeism, presenteeism, disability, quality of life
Medical subject headings
Migraine Disorders, Headache

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07847554
Study groupRoleWhat they receive
Patients with MigraineNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Greek Version of the Work Productivity and Activity Impairment Questionnaire for Migraine (WPAI:Migraine)

    The validity and reliability of the Greek version of the WPAI:Migraine will be evaluated in patients with migraine. The questionnaire assesses work productivity and activity impairment over the previous 7 days, including absenteeism, presenteeism, overall work impairment, and activity impairment. Higher percentage scores indicate greater impairment.

    Measured: Baseline and 7-14 days after baseline for test-retest reliability.

Secondary outcomes (4)
  1. Migraine-Related Disability

    igraine-related disability will be assessed using the MIDAS questionnaire, which evaluates disability over the previous 3 months. The total score is calculated from five items, with higher scores indicating greater migraine-related disability.

    Measured: Baseline

  2. Headache Impact

    The impact of headache on daily functioning and quality of life will be assessed using the HIT-6. Total scores range from 36 to 78, with higher scores indicating greater headache impact.

    Measured: Baseline

  3. Migraine-Specific Quality of Life

    Migraine-specific quality of life over the previous 4 weeks will be assessed using the MSQv2.1, which includes Role Function-Restrictive, Role Function-Preventive, and Emotional Function domains. Scores are transformed to a 0-100 scale, with higher scores indicating better migraine-specific quality of life.

    Measured: Baseline

  4. Headache Pain Intensity

    Headache pain intensity will be assessed using the Visual Analog Scale, ranging from 0 (no pain) to 10 (worst imaginable pain), with higher scores indicating greater pain intensity.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2026
  2. Study start1 Nov 2026 (estimated)
  3. Primary completion1 Jun 2027 (estimated)
  4. Study completion1 Jul 2027 (estimated)

Resources

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
Other
Time perspective
Prospective
Enrolment
60 participants (estimated)
Target duration
1 Week
IDs, dates and publications
ClinicalTrials.gov ID
NCT07847554
Sponsor's protocol ID
Approval Νο: 703, 3-6-2026
Status last verified
Oct 2026
First submitted
22 Sep 2026
Last updated
8 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) are not planned to be made publicly available. Data may be considered for sharing upon reasonable request and subject to applicable ethical and institutional requirements.

Publications

  • Ford JH, Ye W, Ayer DW, Mi X, Bhandari S, Buse DC, Lipton RB. Validation and meaningful within-patient change in work productivity and activity impairment questionnaire (WPAI) for episodic or chronic migraine. J Patient Rep Outcomes. 2023 Apr 4;7(1):34. doi: 10.1186/s41687-023-00552-4.

    PubMed 37016181
  • Ishii R, Sakai F, Sano H, Nakai M, Koga N, Matsukawa M. Quality of life and work productivity and activity impairment among online survey respondents with migraine across a range of headache frequency. Front Neurol. 2024 Jul 9;15:1440733. doi: 10.3389/fneur.2024.1440733. eCollection 2024.

    PubMed 39045427
  • Martelletti P, Schwedt TJ, Lanteri-Minet M, Quintana R, Carboni V, Diener HC, Ruiz de la Torre E, Craven A, Rasmussen AV, Evans S, Laflamme AK, Fink R, Walsh D, Dumas P, Vo P. My Migraine Voice survey: a global study of disease burden among individuals with migraine for whom preventive treatments have failed. J Headache Pain. 2018 Nov 27;19(1):115. doi: 10.1186/s10194-018-0946-z.

    PubMed 30482181
  • Munakata J, Hazard E, Serrano D, Klingman D, Rupnow MF, Tierce J, Reed M, Lipton RB. Economic burden of transformed migraine: results from the American Migraine Prevalence and Prevention (AMPP) Study. Headache. 2009 Apr;49(4):498-508. doi: 10.1111/j.1526-4610.2009.01369.x. Epub 2009 Feb 25.

    PubMed 19245386
  • Albilali A, Almutawa RA, Almusahel EA, Almutawa RA, Almutawa NA, Almutawa FM, AlAujan S, AlMalag HM. Psychometric Validation of the Arabic Version of the WPAI:Migraine Questionnaire in Patients with Migraine. Neurol Int. 2025 Dec 12;17(12):202. doi: 10.3390/neurolint17120202.

    PubMed 41441221
  • Tassorelli C, Diener HC, Dodick DW, Silberstein SD, Lipton RB, Ashina M, Becker WJ, Ferrari MD, Goadsby PJ, Pozo-Rosich P, Wang SJ; International Headache Society Clinical Trials Standing Committee. Guidelines of the International Headache Society for controlled trials of preventive treatment of chronic migraine in adults. Cephalalgia. 2018 Apr;38(5):815-832. doi: 10.1177/0333102418758283. Epub 2018 Mar 4.

    PubMed 29504482
  • Diener HC, Tassorelli C, Dodick DW, Silberstein SD, Lipton RB, Ashina M, Becker WJ, Ferrari MD, Goadsby PJ, Pozo-Rosich P, Wang SJ, Houle TT, Hoek TCVD, Martinelli D, Terwindt GM; International Headache Society Clinical Trials Committee. Guidelines of the International Headache Society for controlled trials of preventive treatment of migraine attacks in episodic migraine in adults. Cephalalgia. 2020 Sep;40(10):1026-1044. doi: 10.1177/0333102420941839. Epub 2020 Jul 28.

    PubMed 32722936
  • Axiotidou M, Karapanayiotides T, Papakonstantinou D. Exploring the professional and personal impact of migraine: a cross-sectional study in Greece. J Oral Facial Pain Headache. 2025 Jun;39(2):124-136. doi: 10.22514/jofph.2025.031. Epub 2025 Jun 12.

    PubMed 41070540
  • Vikelis M, Kourlaba G, Barba L, Bilias K, Barbalia E, Solakidi A, Trafalis D, Lioliou K, Zyga S, Karapanayiotides T, Mitsikostas DD. The unmet needs in management, the treatment gap and the burden of migraine in Greece: a Delphi consensus and focus group study from patients' perspective. Front Neurol. 2025 Feb 24;16:1558014. doi: 10.3389/fneur.2025.1558014. eCollection 2025.

    PubMed 40066304
  • 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 29368949
  • Price DD, McGrath PA, Rafii A, Buckingham B. The validation of visual analogue scales as ratio scale measures for chronic and experimental pain. Pain. 1983 Sep;17(1):45-56. doi: 10.1016/0304-3959(83)90126-4.

    PubMed 6226917
  • Oikonomidi T, Vikelis M, Artemiadis A, Chrousos GP, Darviri C. Reliability and Validity of the Greek Migraine Disability Assessment (MIDAS) Questionnaire. Pharmacoecon Open. 2018 Mar;2(1):77-85. doi: 10.1007/s41669-017-0034-3.

    PubMed 29464670
  • Martin M, Blaisdell B, Kwong JW, Bjorner JB. The Short-Form Headache Impact Test (HIT-6) was psychometrically equivalent in nine languages. J Clin Epidemiol. 2004 Dec;57(12):1271-8. doi: 10.1016/j.jclinepi.2004.05.004.

    PubMed 15617953
  • Giannouli E, Giannouli E, Alexoudi A, Arvaniti C, Fakas N, Constantinidis TS, Kouremenos E, Mitsikostas DD; Hellenic Headache Society. Validity and reliability of the Greek Migraine-Specific Quality of Life Questionnaire (MSQ Version 2.1-GR). J Patient Rep Outcomes. 2024 Jul 15;8(1):72. doi: 10.1186/s41687-024-00762-4.

    PubMed 39007966
  • Reilly MC, Zbrozek AS, Dukes EM. The validity and reproducibility of a work productivity and activity impairment instrument. Pharmacoeconomics. 1993 Nov;4(5):353-65. doi: 10.2165/00019053-199304050-00006.

    PubMed 10146874

Questions about this trial

What is this clinical trial studying?

An observational study of Migraine, run by National and Kapodistrian University of Athens at 1 site in Greece.

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 3 inclusion and 2 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: opening soon, as of the sponsor's last update on 8 Oct 2026. 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 Greece. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Michalis Kodounis, Neurologist, PhD (+30 697 3600069, kodounis@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Greek Version of the Work Productivity and Activity Impairment Questionnaire for Migraine (WPAI:Migraine) (time frame: Baseline and 7-14 days after baseline for test-retest reliability.). 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 NCT07847554, which also lists 17 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 8 Oct 2026.

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