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MigraineNCT07843745

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

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

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… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Migraine
How many people
90 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 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

Who cannot join

  • Presence of a headache disorder other than migraine
  • History of systemic diseases, including 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 Proprioceptive Head Awareness In Patients With Migraine Using The "Fremantle Headache Awareness" Questionnaire: Validity And Reliability Study Of The Greek Version

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.

Read more

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.
Conditions
Migraine
Keywords
migraine, headache, head awareness, 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 NCT07843745
Study groupRoleWhat they receive
Individuals With MigraineIndividuals 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).

What is being measured

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

  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.

    Measured: Baseline and 1 week for test-retest reliability

Secondary outcomes (4)
  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    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 posted28 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
90 participants (estimated)
Target duration
1 Week
IDs, dates and publications
ClinicalTrials.gov ID
NCT07843745
Sponsor's protocol ID
Approval Νο: 702, 3-6-2026
Status last verified
Oct 2026
First submitted
21 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

  • 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

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 Fremantle Headache Awareness Questionnaire (time frame: Baseline and 1 week 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 NCT07843745, which also lists 21 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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