Clinical trial NCT06857383: Head Awareness in Chronic Migraine Patients
Official title: Assessment of Head Awareness in Chronic Migraine Patients with the Fremantle Headache Awareness Questionnaire: Turkish Version, Validity and Reliability Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Migraine
Keywords: migraine
awareness
headache
Lead sponsor: Bozok University
Sponsor class: OTHER
First posted: 2025-03-04
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients between the ages of 18 and 70 who applied to the Department of Neurology of Mersin University Faculty of Medicine and the Department of Neurology of Gazi University Faculty of Medicine and who were diagnosed with chronic migraine, according to the International Classification of Headache Disorders, 3rd Edition, by a neurologist who is an expert in the field of headache were included in the study.

Brief summary: Research indicates that different beliefs about the nature of back problems and their future consequences direct behaviors that may cause falsely stimulated neuroplastic changes. The central nervous system can help relieve ongoing pain by regulating nociceptive activity. For this purpose, "The Fremantle Back Awareness Questionnaire" was developed to evaluate the perceptual awareness status of the back. In individuals with chronic pain, changes in body perception can be explained by the cortical reorganization that occurs in these individuals. Compared to healthy individuals, cortical thickness is reduced in the brain regions that process pain in chronic migraine patients. On the other hand, it is stated that these cortical structural changes can be reversed and recovery can be achieved by treating headache and related symptoms in chronic migraine patients. Individuals try to continue their daily lives with impaired body awareness due to pain. Decreased awareness has been studied in many neck, back and knee pain studies in the literature with Fremantle Awareness Questionnaires in different societies. In these studies, the awareness of individuals experiencing pain was found to be low and it was found that neck, waist or knee awareness was related to pain intensity, pain catastrophizing, disability, quality of life, anxiety, depression and kinesiophobia. It was even determined that awareness increased with treatments. Although reversible structural changes in the cortical regions of chronic migraine patients have been investigated with radiological imaging methods and are still being investigated, not every patient can be evaluated with radiological imaging in clinics due to cost and time problems. Therefore, a fast, practical and understandable questionnaire evaluation can benefit clinicians. When the literature is examined, there is no study evaluating the perceptual level and nociceptive awareness in chronic migraine headache. Conducting a validity and reliability study of the "Fremantle Headache Awareness Questionnaire" developed from The Fremantle Back Awareness Questionnaire in Turkish society can provide objective results in evaluating the effectiveness of treatment as a practical evaluation method in clinics. Hypotheses:

H0: The Fremantle Headache Awareness Questionnaire is not valid and reliable for the Turkish population in chronic migraine patients.

H1: The Fremantle Headache Awareness Questionnaire is valid and reliable for the Turkish population in chronic migraine patients.


Eligibility criteria: Inclusion Criteria:

* Being diagnosed with chronic migraine
* Being between the ages of 18-70,
* Being able to read, speak, understand and write Turkish in order to understand the items/questions of the surveys and scales and to give correct answers.

Exclusion Criteria:

* Having any headache diagnosis other than chronic migraine,
* Having a history of any systemic disease such as malignant, inflammatory, acute fracture/infection, surgery, neurological, psychological, rheumatological.
* Having neck or back pain

Primary outcomes:
measure: Visual Analog Scale
timeFrame: In first enrollment, 1 minute
measure: Migraine Disability Assessment Questionnaire
timeFrame: In first enrollment, 3 minutes
measure: Headache Impact Test-6
timeFrame: In first enrollment, 3 minutes
measure: Hospital Anxiety and Depression Scale
timeFrame: In first enrollment, 3 minutes
measure: Pain Catastrophizing Scale
timeFrame: In first enrollment, 3 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Yozgat
country: Turkey
facility: Bozok University
state: Merkez
city: Ankara
country: Turkey
facility: Gazi University
state: Yenimahalle
city: Mersin
country: Turkey
facility: Mersin University
state: Yenisehir
Study officials:
References:
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