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Not yet recruitingNCT07847554Updated Sep 29, 2026

Validity and Reliability of the Greek WPAI:Migraine

An observational study in Migraine, sponsored by National and Kapodistrian University of Athens. Not yet recruiting at 1 site in Greece. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-29.

Sponsored by National and Kapodistrian University of Athens · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
60
Ages
18 Years to 70 Years
Sex
All
01

Study 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 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 [1,2]. 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 [3]. 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 [4].

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 [1,5]. International Headache Society (IHS) guidelines for preventive treatment trials in episodic and chronic migraine recommend the use of the WPAI [6,7]. Therefore, it is important to evaluate the impact of migraine not only through clinical parameters but also in terms of productivity and functioning [6,7].

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 [8,9].

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.
02

Conditions studied

  • Migraine

Keywords

  • migraine
  • headache
  • work productivity
  • absenteeism
  • presenteeism
  • disability
  • quality of life
03

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Presence of a headache disorder other than migraine
  • History of systemic diseases (malignant, inflammatory, acute traumatic, infectious, surgical, neurological, psychiatric, or rheumatological conditions)
04

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
60 participants (estimated)
Target follow-up
1 Week
Patient registry
Yes

Groups and cohorts

  • Patients with Migraine
05

What researchers measure

Primary outcomes

  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.

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

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: Baseline

06

Study locations

1 site
  • National Kapodistrian University of Athens, Aeginition Hospital, Headache Clinic
    Athens, Attica 11528, Greece
07

References and documents

Publications

  • 18. Portney LG. Foundations of Clinical Research: Applications to Evidencebased Practice. Philadelphia, PA: FA Davis; 2020
  • Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3186-91. doi: 10.1097/00007632-200012150-00014. No abstract available. PubMed 11124735 ↗
  • 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 ↗
  • 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 ↗
  • 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 ↗
  • 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 ↗
  • 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 ↗
  • 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 ↗
  • 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 ↗
  • 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 ↗
  • 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 ↗
  • 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 ↗
  • 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 ↗
  • 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 ↗
  • 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 ↗
  • 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 ↗
  • 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 ↗

Related links

Individual participant data

Plan to share: 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.

08

Registry details

Key details

Study ID
NCT07847554
Lead sponsor
National and Kapodistrian University of Athens
Responsible party
Michalis Kodounis (PhD, Neurologist, Medical Doctor, National and Kapodistrian University of Athens) — Principal investigator
First posted
Sep 29, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Jun 1, 2027 (estimated)
Completion
Jul 1, 2027 (estimated)
Last update
Sep 29, 2026

Study contacts

Michalis Kodounis, Neurologist, PhD
Contact
kodounis@gmail.com
+30 697 3600069
Dimos Mitsikostas, Neurologist, PhD
Contact
dimosmitsikostas@me.com

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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