Head Awareness in Chronic Migraine Patients

NCT ID: NCT06857383

Last Updated: 2025-07-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 180 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-02
• Study Completion Date: 2025-05-30

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.

Conditions

Migraine

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

Fremantle Headache Awareness Questionnaire

It is a simple Likert-type questionnaire that evaluates individual-specific altered perception (0 = Never/Never feel like this, 1 = Rarely feel like this, 2 = Sometimes or sometimes feel like this, 3 = Often feel like this, 4 = Always or most of the time feel like this). The questionnaire asks individuals 9 questions about how they perceive their heads and headaches in relation to their bodies. The questionnaire was developed by Wand et al. in its first version as "The Fremantle Back Awareness Questionnaire". With permission from the author, the questionnaire was created by adapting the questions of the Fremantle Back Awareness Questionnaire to headache.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bozok University

OTHER

Sponsor Role: lead

Responsible Party

Dilara Onan

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Elite Research and Surgical Hospital

Nicosia, , Cyprus

Bozok University

Yozgat, Merkez, Turkey (Türkiye)

Gazi University

Ankara, Yenimahalle, Turkey (Türkiye)

Mersin University

Mersin, Yenisehir, Turkey (Türkiye)

Ankara Atatürk Sanatoryum Training and Research Hospital

Ankara, , Turkey (Türkiye)

Gazi University

Ankara, , Turkey (Türkiye)

Gaziantep City Hospital

Gaziantep, , Turkey (Türkiye)

İstanbul University

Istanbul, , Turkey (Türkiye)

Silivri State Hospital

Istanbul, , Turkey (Türkiye)

Kutahya Health Sciences University

Kütahya, , Turkey (Türkiye)

Headache and Cognition Clinic of Aynur Ozge

Mersin, , Turkey (Türkiye)

Tokay Gaziosmanpaşa University

Tokat Province, , Turkey (Türkiye)

Zonguldak Bülent Ecevit University

Zonguldak, , Turkey (Türkiye)

Countries

Cyprus; Turkey (Türkiye)

References

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Other Identifiers

2024-GOKAEK2413_2024.11.20_191

Identifier Type: -

Identifier Source: org_study_id