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 2026-09-28.
Sponsored by National and Kapodistrian University of Athens · Observational
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.
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 [1]. 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 [1,2].
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 [3,4].
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 [5]. 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 [6-10].
However, the literature contains insufficient studies examining body perception specifically in headache [11-13]. 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:
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.
Exclusion Criteria:
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).
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
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
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
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
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
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.
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National and Kapodistrian University of Athens