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临床试验/NCT07843745
NCT07843745尚未招募不适用

Assessment of Proprioceptive Head Awareness In Patients With Migraine Using The "Fremantle Headache Awareness" Questionnaire: Validity And Reliability Study Of The Greek Version

National and Kapodistrian University of Athens1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2026年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
90
试验地点
1
主要终点
Greek Version of the Fremantle Headache Awareness Questionnaire

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
观察性
观察模型
其他
时间视角
前瞻性

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • 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

排除标准

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

研究组 & 干预措施

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).

结局指标

主要结局

Greek Version of the Fremantle Headache Awareness Questionnaire

时间窗: Baseline and 1 week for test-retest reliability

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.

次要结局

  • Headache Intensity(Baseline)
  • Migraine-Related Disability(Baseline)
  • Headache Impact(Baseline)
  • Migraine-Specific Quality of Life(Baseline)

研究者

申办方类型
其他
责任方
主要研究者
主要研究者

Michalis Kodounis

PhD, Neurologist, Medical Doctor

National and Kapodistrian University of Athens

研究点 (1)

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标识符

NCT 编号
NCT07843745
其他研究编号
Approval Νο: 702, 3-6-2026

日期

首次提交
(9天前)
首次发布
(前天)
主要完成日期
(8个月后)
研究完成日期
(9个月后)
最近核实
(29天前)
最近更新
(前天)

监管与共享

FDA 监管药物
否
FDA 监管器械
否
个体参与者数据共享计划
否

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.

是否有结果
否

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