MigraineNCT07847528
Validity and Reliability of the Greek Pain Catastrophizing Scale
An observational study of Migraine, run by National and Kapodistrian University of Athens at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Migraine
- How many people
- 130 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: 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.
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.
Dimos Mitsikostas, Neurologist, PhD contact
Greece1 site
National Kapodistrian University of Athens, Aeginition Hospital, Headache Clinic
Athens, Attica, 11528
Michalis Kodounis, Neurologist, PhD, kodounis@gmail.com
About this study
Official title: Assessment of the Level of Pain Catastrophizing in Patients With Migraine Using the "Pain Catastrophizing Scale": Validity and Reliability Study of the Greek Version
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.
Read the detailed description
Migraine is a common and highly burdensome neurological disorder that significantly affects patients' quality of life, functioning, and psychosocial well-being [1]. In people with migraine, the overall burden of the disease is determined not only by pain intensity and frequency but also by cognitive and emotional factors related to the perception and management of pain [1,2]. Of particular interest is pain catastrophizing, a maladaptive cognitive state in which the individual perceives pain as excessively threatening, persistently focuses on it, and experiences feelings of helplessness or powerlessness in response to it [3].
The literature has shown that high levels of pain catastrophizing in patients with migraine are associated with greater pain intensity, increased migraine-related disability, and higher levels of anxiety and depression [2-4]. In addition, pain catastrophizing has been reported to play an important role in migraine chronicity and in the overall deterioration of patients' quality of life [5,6].
The Pain Catastrophizing Scale (PCS) is one of the most widely used instruments for assessing pain catastrophizing, and validity and reliability studies have been conducted in many different languages [7-9]. However, available data on the psychometric properties of the Greek version of the PCS in patients with migraine remain limited. A culturally adapted, valid, and reliable Greek version of the scale is particularly important because it may contribute substantially to improving clinical assessment, strengthening research activity, and implementing a comprehensive approach to migraine management.
Therefore, the aim of the present study is the cultural adaptation of the Greek version of the Pain Catastrophizing Scale in patients with migraine and the evaluation of its psychometric properties.
Aim of the study - Hypotheses to be tested The aim of the present study is to examine the validity and reliability of the Greek version of the Pain Catastrophizing Scale in Greek patients with migraine.
Hypotheses:
- H0: The Pain Catastrophizing Scale is not valid and reliable for patients with migraine in the Greek population.
- H1: The Pain Catastrophizing Scale is valid and reliable for patients with migraine in the Greek population.
- Conditions
- Migraine
- Keywords
- migraine, headache, pain catastrophizing, disability, quality of life, headache intensity
- 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 group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 7-14 days after baseline for test-retest reliability.
Secondary outcomes (4)
Migraine Disability Assessment
Migraine-related disability will be assessed using the MIDAS questionnaire. The total score is based on days of activity lost because of headache during the previous 3 months. Higher scores indicate greater migraine-related disability.
Measured: Baseline
Headache Impact
Headache-related impact 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
Migraine-Specific Quality of Life
Migraine-specific quality of life will be assessed using the 14-item 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
Headache Pain Intensity
Headache pain intensity will be assessed using the VAS, ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate 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.
- First posted29 Sep 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by National and Kapodistrian University of AthensThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michalis Kodounis, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07847528
- Sponsor's protocol ID
- Approval Νο: 701, 3-6-2026
- Status last verified
- Oct 2026
- First submitted
- 22 Sep 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The decision regarding the sharing of individual participant data (IPD) has not yet been finalized. Data sharing may be considered upon reasonable request following study completion, subject to participant confidentiality, ethical requirements, and applicable data protection regulations.
Publications
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.
PubMed 41693420Kim 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.
PubMed 33436778Alvarez-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.
PubMed 30857787Holroyd 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.
PubMed 17784854Barral 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.
PubMed 32242334Bond 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.
PubMed 26087348Terkawi 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.
PubMed 28616005Shen 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.
PubMed 29353539Harmancı, H. and B. Kul, Pain catastrophizing in migraine patients and associated factors. Journal of Health Sciences and Medicine, 2017. 4(6): p. 876-881.
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 29368949Price 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 6226917Oikonomidi 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 29464670Martin 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 15617953Giannouli 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 39007966Sullivan, M.J., S.R. Bishop, and J. Pivik, The pain catastrophizing scale: development and validation. Psychological assessment, 1995. 7(4): p. 524.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Level of Pain Catastrophizing in Patients With Migraine Using the "Pain Catastrophizing Scale": Validity and Reliability Study of the Greek Version
- ClinicalTrials.gov ID
- NCT07847528
- Acronym / sponsor ID
- Approval Νο: 701, 3-6-2026
- Conditions
- Migraine
- Keywords
- migraine, headache, pain catastrophizing, disability, quality of life, headache intensity
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 29 Sep 2026 (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.
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.
Detailed description
Migraine is a common and highly burdensome neurological disorder that significantly affects patients' quality of life, functioning, and psychosocial well-being [1]. In people with migraine, the overall burden of the disease is determined not only by pain intensity and frequency but also by cognitive and emotional factors related to the perception and management of pain [1,2]. Of particular interest is pain catastrophizing, a maladaptive cognitive state in which the individual perceives pain as excessively threatening, persistently focuses on it, and experiences feelings of helplessness or powerlessness in response to it [3].
The literature has shown that high levels of pain catastrophizing in patients with migraine are associated with greater pain intensity, increased migraine-related disability, and higher levels of anxiety and depression [2-4]. In addition, pain catastrophizing has been reported to play an important role in migraine chronicity and in the overall deterioration of patients' quality of life [5,6].
The Pain Catastrophizing Scale (PCS) is one of the most widely used instruments for assessing pain catastrophizing, and validity and reliability studies have been conducted in many different languages [7-9]. However, available data on the psychometric properties of the Greek version of the PCS in patients with migraine remain limited. A culturally adapted, valid, and reliable Greek version of the scale is particularly important because it may contribute substantially to improving clinical assessment, strengthening research activity, and implementing a comprehensive approach to migraine management.
Therefore, the aim of the present study is the cultural adaptation of the Greek version of the Pain Catastrophizing Scale in patients with migraine and the evaluation of its psychometric properties.
Aim of the study - Hypotheses to be tested The aim of the present study is to examine the validity and reliability of the Greek version of the Pain Catastrophizing Scale in Greek patients with migraine.
Hypotheses:
- H0: The Pain Catastrophizing Scale is not valid and reliable for patients with migraine in the Greek population.
- H1: The Pain Catastrophizing Scale is valid and reliable for patients with migraine in the Greek population.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Week
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Diagnosis of migraine
- Age 18-70 years
- Ability to understand, read, write, and speak the Greek language
Key exclusion criteria (2 listed)
- Presence of a headache disorder other than migraine
- History of systemic diseases (malignant, inflammatory, acute traumatic, infectious, surgical, neurological, psychiatric, or rheumatological conditions)
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
Pain Catastrophizing Scale
Time frame: Baseline and 7-14 days after baseline for test-retest reliability.
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.
4 secondary outcomes
Migraine Disability Assessment
Time frame: Baseline
Headache Impact
Time frame: Baseline
Migraine-Specific Quality of Life
Time frame: Baseline
Headache Pain Intensity
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Background: PubMed 41693420Tol 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.
- Background: PubMed 33436778Kim 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.
- Background: PubMed 30857787Alvarez-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.
- Background: PubMed 17784854Holroyd 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.
- Background: PubMed 32242334Barral 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.
- Background: PubMed 26087348Bond 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.
- Background: PubMed 28616005Terkawi 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.
- Background: PubMed 29353539Shen 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.
- BackgroundHarmancı, 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: PubMed 29368949Headache 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.
- Background: PubMed 6226917Price 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.
- Background: PubMed 29464670Oikonomidi 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.
- Individual participant dataSharing planned: Undecided. The decision regarding the sharing of individual participant data (IPD) has not yet been finalized. Data sharing may be considered upon reasonable request following study completion, subject to participant confidentiality, ethical requirements, and applicable data protection regulations.
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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.
Dimos Mitsikostas, Neurologist, PhD contact
1 site 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 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 7 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?
Pain Catastrophizing Scale (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 NCT07847528, which also lists 18 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 7 Oct 2026.