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Not yet recruitingNCT07843745Updated Oct 8, 2026

Assessment of Head Awareness in Patients With Migraine in the Greek Population

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 2026-10-08.

Sponsored by National and Kapodistrian University of Athens · Observational

Updated Oct 8, 2026Start date movedNewly registeredGo to Updates ↓

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Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
90
Ages
18 Years to 70 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 13 studies in Migraine Disorders with a site in Greece — 3 open to participants now, 3 under way, none of them phase 3. Migraine Disorders · Greece.

Started
2026
with 2 others
Observational
6 of 13
3 open now
Registered
11th of 13
by date
Lead sponsor
5 of 13
National and Kapodistrian University of Athens

Among the 13 studies in Migraine Disorders with a site in Greece, this one is one of 3 that started in 2026, is one of 6 observational ones, and was the 11th registered.

Migraine Disorders

1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.

Browse Migraine Disorders studies →

Open to participants now

3 of the 13 studies in Migraine Disorders with a site in Greece are open now. Recruiting first, the newest first:

All 3 open studies →

A study can be open while its sites in Greece have not opened yet or have stopped. Only those recruiting at a site in Greece →

Who these studies take

Of the 217 Migraine Disorders studies recruiting now, 66 (30%) set no upper age limit and 136 (63%) stop at 75 or younger; 44 take children under 18; 37 take healthy volunteers.

This study: 18 Years to 70 Years · all sexes · no healthy volunteers.

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02

Study summary

Body perception and awareness may be altered in individuals with chronic pain and may be associated with pain intensity, disability, and pain-related psychological factors. Although alterations in pain processing and cortical organization have been reported in individuals with migraine, head-related perceptual awareness has received limited attention, and practical tools for its assessment are lacking.

The Fremantle Headache Awareness Questionnaire (FreHAQ) was developed to assess altered perception and awareness of the head in individuals with headache. A valid and reliable Greek version of this questionnaire could provide clinicians and researchers with a simple and practical tool for evaluating head awareness in individuals with migraine.

The primary aim of this study is to translate and culturally adapt the Fremantle Headache Awareness Questionnaire into Greek and to evaluate the validity and reliability of the Greek version in individuals with migraine. The study will examine the psychometric properties of the questionnaire, including its reliability and validity. Associations between head awareness and relevant clinical and pain-related characteristics will also be investigated.

This study is expected to determine whether the Greek version of the Fremantle Headache Awareness Questionnaire is an appropriate tool for assessing head awareness in the Greek migraine population.

Read the detailed description

Body perception is a multidimensional concept that encompasses the management and experience of the body, expressing the relationship between body and mind, and is defined differently across medical fields. At the psychomotor level, body perception is related to the level of awareness associated with mental, emotional, and physical activity, whereas from a neurophysiological perspective it is linked to proprioception and the perception of internal bodily signals. The brain perceives stimuli from both the internal and external environments of the body, which over time are transformed into experiential and learned information. Initially, this information develops at a conscious level through the pyramidal system; however, with repetition and consolidation, it becomes an automated, unconscious function through the extrapyramidal system. Therefore, body perception includes body awareness, body management, and bodily experience, enabling the individual to perceive the body and its environment through internal and external stimuli.

Wand and colleagues proposed a theoretical model for low back pain according to which cognitive and behavioral factors are associated with structural and functional changes in the central nervous system. This model suggests that pain and its future consequences may be attributable to maladaptive neuroplastic changes. Changes in the central nervous system increase pain perception by influencing conscious attention and enhancing the perception of pain, ultimately leading to disability. As a result, an unconscious form of perception develops while conscious perception becomes disturbed. Since pain functions as a protective signal of the organism, its conscious recognition is a fundamental component in the development of body perception.

In chronic pain conditions, painful body regions have been shown to be associated with disturbances in body perception, which in turn contribute to the maintenance and amplification of pain. For example, in cervical or lumbar disorders, disruption of sensorimotor information and a shift in activation from deep to superficial muscles lead to impaired motor control. These conditions may cause altered perception of the size, position, and movement of the affected body part because of asymmetry and increased muscle tension. Assessment and restoration of internal and external body perception, together with enhancement of conscious body awareness, are key therapeutic targets.

However, the literature contains insufficient studies examining body perception specifically in headache. Although imaging studies have confirmed the presence of cortical changes in patients with chronic migraine, methods based on patients' verbal and psychological assessment remain limited. Moreover, the use of imaging techniques in clinical practice is often not feasible because of cost and time constraints. Therefore, the development of a rapid and practical assessment method could be particularly useful for clinicians.

The existing literature does not include studies evaluating the perceptual dimension and nociceptive awareness in chronic migraine. Based on the Fremantle Back Awareness Questionnaire, the "Fremantle Headache Awareness Questionnaire" was developed, and its adaptation and validation in the Greek population may provide a reliable and practical assessment tool. This questionnaire could contribute to the objective evaluation of the effectiveness of therapeutic interventions and support the design of programs aimed at enhancing awareness of the head and headache. Within the scope of the study, the psychometric properties of the questionnaire and possible associations among body perception, nociceptive sensitivity, and beliefs regarding headache will be investigated.

Aim of the study - Hypotheses to be tested Studies have shown that different beliefs regarding the nature of lumbar problems and their future consequences can guide behaviors that may lead to neuroplastic changes. Through regulation of the processing and perception of painful stimuli, the central nervous system may contribute to the resolution of persistent pain. For this reason, the Fremantle Back Awareness Questionnaire was developed to assess perceptual awareness of the lumbar region.

In individuals with chronic pain, changes in body perception are attributed to cortical reorganization. Similarly, patients with chronic migraine have been reported to show reduced cortical thickness in brain regions related to pain processing compared with healthy individuals. However, these structural changes have been reported to be potentially reversible, because appropriate treatment of headache and accompanying symptoms may lead to improvement. Nevertheless, individuals with chronic pain continue their daily lives with disturbed body perception.

Reduced perception has been extensively studied in populations with neck, low back, and knee pain using Fremantle Awareness questionnaires in various countries. These studies found that individuals with pain have lower levels of perception, which are associated with pain intensity, catastrophizing, degree of disability, quality of life, anxiety, depression, and kinesiophobia. In addition, therapeutic intervention has been shown to improve body perception.

Although reversible cortical changes in migraine have been studied using imaging methods, their use in routine clinical practice is limited by cost and time requirements. Therefore, a rapid, practical, and easy-to-use assessment tool could be particularly useful. The literature indicates that there are no studies evaluating proprioceptive awareness of the head in migraine.

Based on the "Fremantle Back Awareness Questionnaire", the "Fremantle Headache Awareness Questionnaire" was developed, and studying its validity and reliability in the Greek population is expected to provide a practical tool for objectively evaluating the effectiveness of therapeutic interventions in clinical practice.

Hypotheses:

  • H0: The Fremantle Headache Awareness Questionnaire is not valid and reliable for patients with migraine in the Greek population.
  • H1: The Fremantle Headache Awareness Questionnaire is valid and reliable for patients with migraine in the Greek population.
03

Conditions studied

  • Migraine

Keywords

  • migraine
  • headache
  • head awareness
  • disability
  • quality of life
04

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diagnosis of episodic or chronic migraine according to the International Classification of Headache Disorders, 3rd edition (ICHD-3), confirmed by a specialist neurologist
  • Age between 18 and 70 years
  • Ability to understand, read, write, and speak Greek

Exclusion criteria

Exclusion Criteria:

  • Presence of a headache disorder other than migraine
  • History of systemic diseases, including malignant, inflammatory, acute traumatic, infectious, surgical, neurological, psychiatric, or rheumatological conditions
05

Study design

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

Groups and cohorts

  • Individuals With Migraine

    Individuals diagnosed with migraine who will participate in the cross-cultural adaptation and psychometric evaluation of the Greek version of the Fremantle Headache Awareness Questionnaire (FreHAQ-GR).

06

What researchers measure

Primary outcomes

  1. Greek Version of the Fremantle Headache Awareness Questionnaire

    The psychometric properties of the Greek version of the Fremantle Headache Awareness Questionnaire (FreHAQ-GR) will be evaluated in individuals with migraine. Reliability will be assessed using internal consistency and test-retest reliability. Validity will be evaluated through appropriate construct validity analyses and associations with related clinical measures. Higher FreHAQ scores indicate greater disturbance in head awareness.

    Time frame: Baseline and 1 week for test-retest reliability

Secondary outcomes

  1. Headache Intensity

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

    Time frame: Baseline

  2. Migraine-Related Disability

    Migraine-related disability will be assessed using the Migraine Disability Assessment (MIDAS), which evaluates days of lost or reduced activity due to migraine during the previous 3 months. Higher scores indicate greater migraine-related disability.

    Time frame: Baseline

  3. Headache Impact

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

    Time frame: Baseline

  4. Migraine-Specific Quality of Life

    Migraine-specific quality of life will be assessed using the 14-item Migraine-Specific Quality of Life Questionnaire Version 2.1 (MSQv2.1), covering Role Function-Restrictive, Role Function-Preventive, and Emotional Function domains. Scores are transformed to a 0-100 scale, with higher scores indicating better migraine-related quality of life.

    Time frame: Baseline

07

Study locations

1 site
08

References and documents

Publications

  • Dragesund T, Elisabeth Ljunggren A, Kvåle A, Inger L. Body Awareness Rating Questionnaire - Development of a self-administered questionnaire for patients with long-lasting musculoskeletal and psychosomatic disorders. 2010. 87-94 p.
  • Roxendal G. Body awareness therapy and the body awareness scale: treatment and evaluation in psychiatric physiotherapy1985.
  • Wand BM, Catley MJ, Rabey MI, O'Sullivan PB, O'Connell NE, Smith AJ. Disrupted Self-Perception in People With Chronic Low Back Pain. Further Evaluation of the Fremantle Back Awareness Questionnaire. J Pain. 2016 Sep;17(9):1001-12. doi: 10.1016/j.jpain.2016.06.003. Epub 2016 Jun 18. PubMed 27327235 ↗
  • Wand BM, Parkitny L, O'Connell NE, Luomajoki H, McAuley JH, Thacker M, Moseley GL. Cortical changes in chronic low back pain: current state of the art and implications for clinical practice. Man Ther. 2011 Feb;16(1):15-20. doi: 10.1016/j.math.2010.06.008. Epub 2010 Jul 23. PubMed 20655796 ↗
  • Treleaven J. Sensorimotor disturbances in neck disorders affecting postural stability, head and eye movement control. Man Ther. 2008 Feb;13(1):2-11. doi: 10.1016/j.math.2007.06.003. Epub 2007 Aug 16. PubMed 17702636 ↗
  • Kulkarni V, Chandy MJ, Babu KS. Quantitative study of muscle spindles in suboccipital muscles of human foetuses. Neurol India. 2001 Dec;49(4):355-9. PubMed 11799407 ↗
  • Moreira C, Bassi AR, Brandão MP, Silva AG. Do patients with chronic neck pain have distorted body image and tactile dysfunction? European Journal of Physiotherapy. 2017:1-7.
  • Onan D, Gokmen D, Ulger O. The Fremantle Neck Awareness Questionnaire in Chronic Neck Pain Patients: Turkish Version, Validity and Reliability Study. Spine (Phila Pa 1976). 2020 Feb 1;45(3):E163-E169. doi: 10.1097/BRS.0000000000003207. PubMed 31425430 ↗
  • Erol E, Yildiz A, Yildiz R, Apaydin U, Gokmen D, Elbasan B. Reliability and Validity of the Turkish Version of the Fremantle Back Awareness Questionnaire. Spine (Phila Pa 1976). 2019 May 1;44(9):E549-E554. doi: 10.1097/BRS.0000000000002909. PubMed 30325886 ↗
  • Hedayati R, Amjadian F, Ebadi A, Ehsani F. Cross-cultural adaptation, validity and reliability of the Persian version of Fremantle Knee Awareness Questionnaire. J Bodyw Mov Ther. 2022 Jan;29:257-263. doi: 10.1016/j.jbmt.2021.10.009. Epub 2021 Oct 21. PubMed 35248279 ↗
  • Lai KL, Niddam DM, Fuh JL, Chen WT, Wu JC, Wang SJ. Cortical morphological changes in chronic migraine in a Taiwanese cohort: Surface- and voxel-based analyses. Cephalalgia. 2020 May;40(6):575-585. doi: 10.1177/0333102420920005. Epub 2020 Apr 16. PubMed 32299230 ↗
  • Newman-Norlund RD, Rorden C, Maleki N, Patel M, Cheng B, Androulakis XM. Cortical and subcortical changes following sphenopalatine ganglion blocks in chronic migraine with medication overuse headache: a preliminary longitudinal study. Womens Midlife Health. 2020 Aug 5;6:7. doi: 10.1186/s40695-020-00055-y. eCollection 2020. PubMed 32774872 ↗
  • Mahmut AN, Gizem G, Nevin P. Changes in the hippocampal volume in chronic migraine, episodic migraine, and medication overuse headache patients. Ideggyogy Sz. 2023 Nov 30;76(11-12):373-378. doi: 10.18071/isz.76.0373. PubMed 38051692 ↗
  • 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 ↗
  • Onan D, Arikan H, Vuralli D, Akgor MC, Pala AB, Yanik E, Can AI, Ulutas C, Yesildas PY, Yildirim I, Gelener P, Demirel EA, Ekizoglu E, Ozge A. Assessment of Head Awareness in Patients with Chronic Migraine Using the Fremantle Headache Awareness Questionnaire: Turkish Version, Validity, and Reliability Study. Noro Psikiyatr Ars. 2025 Sep 19;63:308-315. doi: 10.29399/npa.29190. eCollection 2026. PubMed 41777502 ↗
  • 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 ↗
  • Portney LG. Foundations of Clinical Research: Applications to Evidencebased Practice. Philadelphia, PA: FA Davis; 2020

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.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Jun 2027, 7 months later.

Of 132 non-industry observational studies under Migraine Disorders, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 72. This study's planned 7 months is below that.

Counting every sponsor, half of 160 studies reached it within 27 months; a quarter within 13 and three quarters within 63.

Start moved once since we started tracking on Sep 25, 2026: Sep 2026 → Nov 2026, on Oct 8, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Sep 21, 2026
First posted
Sep 28, 2026
StartEst.
Nov 1, 2026was Sep 2026
Primary completionEst.
Jun 1, 2027
CompletionEst.
Jul 1, 2027
Last update
Oct 8, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Start date
Sep 1, 2026→Nov 1, 2026
Oct 8, 2026
Registered
First appeared on the registry
Sep 28, 2026
Show all 2 updates
  1. Oct 8, 2026
    Start date Sep 1, 2026→Nov 1, 2026
    + 4 other changes: verification date, responsible party, description and references
  2. Sep 28, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07843745
Responsible party
Michalis Kodounis (Principal Investigator, National and Kapodistrian University of Athens) — Principal investigator
First posted
Sep 28, 2026
Start date
Nov 1, 2026 (estimated)
Primary completion
Jun 1, 2027 (estimated)
Completion
Jul 1, 2027 (estimated)
Last update
Oct 8, 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 ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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