NCT07847528

Brief Summary

Migraine is a common neurological disorder that can significantly affect daily activities, quality of life, and emotional well-being. How individuals think and feel about pain may also influence their experience of migraine. Pain catastrophizing refers to an exaggerated negative response to pain, including persistent worry about pain and feelings of helplessness. The Pain Catastrophizing Scale (PCS) is a commonly used questionnaire for assessing pain catastrophizing. However, the psychometric properties of the Greek version of the PCS have not been adequately evaluated in people with migraine. This study aims to evaluate the validity and reliability of the Greek version of the Pain Catastrophizing Scale in patients with migraine. The study will determine whether the Greek PCS can be used as an appropriate tool for assessing pain catastrophizing in the Greek migraine population.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
9mo left

Started Sep 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress11%
Sep 2026Jul 2027

Study Start

First participant enrolled

September 1, 2026

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

September 22, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 29, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

September 29, 2026

Status Verified

September 1, 2026

Enrollment Period

9 months

First QC Date

September 22, 2026

Last Update Submit

September 22, 2026

Conditions

Keywords

migraineheadachepain catastrophizingdisabilityquality of lifeheadache intensity

Outcome Measures

Primary Outcomes (1)

  • Pain Catastrophizing Scale

    The psychometric properties of the Greek version of the Pain Catastrophizing Scale (PCS) will be evaluated in patients with migraine. The PCS consists of 13 items scored from 0 (never) to 4 (always), with a total score ranging from 0 to 52. Higher scores indicate greater pain catastrophizing. Reliability will be assessed using internal consistency and test-retest reliability.

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

Secondary Outcomes (4)

  • Migraine Disability Assessment

    Baseline

  • Headache Impact

    Baseline

  • Migraine-Specific Quality of Life

    Baseline

  • Headache Pain Intensity

    Baseline

Study Arms (1)

Patients with Migraine

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), who are able to understand, read, write, and speak Greek. Participants will complete the Greek version of the Pain Catastrophizing Scale (PCS) and other study questionnaires for psychometric evaluation. No intervention will be administered.

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will consist of adults aged 18-70 years with episodic or chronic migraine diagnosed by a neurologist according to the International Classification of Headache Disorders, 3rd edition (ICHD-3). Participants will be recruited from the Headache Outpatient Clinic of Aeginition Hospital, National and Kapodistrian University of Athens, Greece. Eligible participants must be able to understand, read, write, and speak Greek.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Kapodistrian University of Athens, Aeginition Hospital, Headache Clinic

Athens, Attica, 11528, Greece

Location

Related Publications (18)

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    PMID: 41777502BACKGROUND
  • 17. Portney, L.G., Foundations of clinical research: applications to evidence-based practice. 2020: FA Davis.

    BACKGROUND
  • 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.

    PMID: 11124735BACKGROUND
  • 15. Sullivan, M.J., S.R. Bishop, and J. Pivik, The pain catastrophizing scale: development and validation. Psychological assessment, 1995. 7(4): p. 524.

    BACKGROUND
  • 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.

    PMID: 39007966BACKGROUND
  • 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.

    PMID: 15617953BACKGROUND
  • 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.

    PMID: 29464670BACKGROUND
  • 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.

    PMID: 6226917BACKGROUND
  • 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.

    PMID: 29368949BACKGROUND
  • 9. Harmancı, H. and B. Kul, Pain catastrophizing in migraine patients and associated factors. Journal of Health Sciences and Medicine, 2017. 4(6): p. 876-881.

    BACKGROUND
  • Shen B, Wu B, Abdullah TB, Zhan G, Lian Q, Vania Apkarian A, Huang L. Translation and validation of Simplified Chinese version of the Pain Catastrophizing Scale in chronic pain patients: Education may matter. Mol Pain. 2018 Jan-Dec;14:1744806918755283. doi: 10.1177/1744806918755283. Epub 2018 Jan 21.

    PMID: 29353539BACKGROUND
  • Terkawi AS, Sullivan M, Abolkhair A, Al-Zhahrani T, Terkawi RS, Alasfar EM, Khait SSA, Elkabbani A, Kabbani N, Altirkawi KA, Tsang S. Development and validation of Arabic version of the pain catastrophizing scale. Saudi J Anaesth. 2017 May;11(Suppl 1):S63-S70. doi: 10.4103/sja.SJA_130_17.

    PMID: 28616005BACKGROUND
  • Bond DS, Buse DC, Lipton RB, Thomas JG, Rathier L, Roth J, Pavlovic JM, Evans EW, Wing RR. Clinical Pain Catastrophizing in Women With Migraine and Obesity. Headache. 2015 Jul-Aug;55(7):923-33. doi: 10.1111/head.12597. Epub 2015 Jun 18.

    PMID: 26087348BACKGROUND
  • Barral E, Buonanotte F. [Pain catastrophizing and medication overuse in patients with chronic migraine]. Rev Neurol. 2020 Apr 16;70(8):282-286. doi: 10.33588/rn.7008.2020034. Spanish.

    PMID: 32242334BACKGROUND
  • Holroyd KA, Drew JB, Cottrell CK, Romanek KM, Heh V. Impaired functioning and quality of life in severe migraine: the role of catastrophizing and associated symptoms. Cephalalgia. 2007 Oct;27(10):1156-65. doi: 10.1111/j.1468-2982.2007.01420.x. Epub 2007 Sep 4.

    PMID: 17784854BACKGROUND
  • Alvarez-Astorga A, Garcia-Azorin D, Hernandez M, de la Red H, Sotelo E, Uribe F, Guerrero AL. Pain catastrophising in a population of patients with migraine. Neurologia (Engl Ed). 2021 Jan-Feb;36(1):24-28. doi: 10.1016/j.nrl.2018.10.005. Epub 2019 Mar 8. English, Spanish.

    PMID: 30857787BACKGROUND
  • Kim S, Bae DW, Park SG, Park JW. The impact of Pain-related emotions on migraine. Sci Rep. 2021 Jan 12;11(1):577. doi: 10.1038/s41598-020-80094-7.

    PMID: 33436778BACKGROUND
  • Tol CHM, van der Meer HA, van der Wal AC, Su N, Visscher CM. Association between psychological factors and headache burden in patients with migraine and tension-type headache: a systematic review and meta-analysis. Disabil Rehabil. 2026 Aug;48(16):5117-5149. doi: 10.1080/09638288.2026.2621641. Epub 2026 Feb 16.

    PMID: 41693420BACKGROUND

MeSH Terms

Conditions

Migraine DisordersHeadache

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Michalis Kodounis, Neurologist, PhD

CONTACT

Dimos Mitsikostas, Neurologist, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
1 Week
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Neurologist, Medical Doctor

Study Record Dates

First Submitted

September 22, 2026

First Posted

September 29, 2026

Study Start

September 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

September 29, 2026

Record last verified: 2026-09

Locations