Head Awareness in Chronic Migraine Patients

NCT06857383 | Completed

• 1 other identifier: 2024-GOKAEK2413_2024.11.20_191
• Study Type: observational
• Target: 180
• Locations: 2 countries
• Sites: 13

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

Keywords

migraine; awareness; headache

Outcome Measures

Primary Outcomes (5)

• Visual Analog Scale

  The visual analog scale consists of the pain level that the person currently experiences with a vertical line on a plane. The pain felt by the person is marked as "0: no pain at all", "10: I feel very severe pain". Scoring is based on the vertical marking the participant makes for the pain he/she marks on the plane with a ruler.

  In first enrollment, 1 minute

• Migraine Disability Assessment Questionnaire

  Disability of migraine patients will be assessed with the Migraine Disability Assessment Questionnaire (MEDA). MEDA assesses the last 3 months of disability and consists of a 5-item self-administered test covering disability-related activities at work/school, housework, family, and social or leisure. The total number of days missed in these activities is the total score and classifies disability as minimal disability (0-5 points), mild disability (6-10 points), moderate disability (11-20 points), or severe disability (≥21).

  In first enrollment, 3 minutes

• Headache Impact Test-6

  The impact of headache will be assessed with the Headache Impact Test-6 (HIT-6). HIT-6 is a quality of life questionnaire for headaches that assesses vitality, pain, psychological distress, sociability, role, and cognitive functioning. Each item is scored on a 5-point Likert scale (6=never, 8=rarely, 10=sometimes, 11=very often, 13=always). The total score is determined by summing the scores on the six items and ranges from 36 to 78 points. (≤49 = little/no impact, 50-55 = some impact, 56-59 = significant impact, and 60-78 = severe impact; higher scores indicate greater deterioration in quality of life).

  In first enrollment, 3 minutes

• Hospital Anxiety and Depression Scale

  Anxiety and depression will be assessed with the Hospital Anxiety and Depression Scale (HADS). 7 items of the 14-item scale assess anxiety and 7 items assess depression symptoms. It is scored between 0-3 points. By summing the subscale scores, 0-21 points can be obtained from each of the Depression and Anxiety subscales. It is stated that 0-7 points are the normal range for each subscale, 8-10 points suggest the presence of a mood disorder, and 11 and above points indicate a possible mood disorder. In addition, there are recommended cut-off scores for mild (8-10 points), moderate (11-15) and severe (16 and above) cases.

  In first enrollment, 3 minutes

• Pain Catastrophizing Scale

  A scale consisting of 13 items that evaluates negative thoughts and feelings about pain experienced. Each item is scored between "0-never and 4-always". The total score of the scale varies between 0-52 and an increase in score indicates a high level of pain catastrophizing. The scale consists of "Helplessness, Magnification, and Rumination" subscales.

  In first enrollment, 3 minutes

Interventions

Fremantle Headache Awareness Questionnaire OTHER

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.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bozok University: lead

Study Sites (13)

Elite Research and Surgical Hospital

Nicosia, Cyprus

Location

Bozok University

Yozgat, Merkez, 66100, Turkey (Türkiye)

Location

Gazi University

Ankara, Yenimahalle, 06560, Turkey (Türkiye)

Location

Mersin University

Mersin, Yenisehir, 33100, Turkey (Türkiye)

Location

Ankara Atatürk Sanatoryum Training and Research Hospital

Ankara, Turkey (Türkiye)

Location

Gazi University

Ankara, Turkey (Türkiye)

Location

Gaziantep City Hospital

Gaziantep, Turkey (Türkiye)

Location

İstanbul University

Istanbul, Turkey (Türkiye)

Location

Silivri State Hospital

Istanbul, Turkey (Türkiye)

Location

Kutahya Health Sciences University

Kütahya, Turkey (Türkiye)

Location

Headache and Cognition Clinic of Aynur Ozge

Mersin, Turkey (Türkiye)

Location

Tokay Gaziosmanpaşa University

Tokat Province, Turkey (Türkiye)

Location

Zonguldak Bülent Ecevit University

Zonguldak, Turkey (Türkiye)

Location

Related Publications (9)

• Karakas Ugurlu G, Ugurlu M, Erten S, Can SS, Ulusoy Kaymak S, Caykoylu A. Effect of familial Mediterranean fever on sexual and reproductive health in women. Turk J Med Sci. 2017 Apr 18;47(2):463-469. doi: 10.3906/sag-1602-88.

  PMID: 28425232 BACKGROUND

• Snaith RP. The Hospital Anxiety And Depression Scale. Health Qual Life Outcomes. 2003 Aug 1;1:29. doi: 10.1186/1477-7525-1-29.

  PMID: 12914662 BACKGROUND

• Aydemir Ö, Güvenir T, Küey L, Kültür S. Hastane Anksiyete ve Depresyon Ölçeğinin Türkçe formunun geçerlik ve güvenilirlik çalışması. Türk Psikiyatri Dergisi 1997;8(4):280-287

  BACKGROUND

• Dikmen PY, Bozdag M, Gunes M, Kosak S, Tasdelen B, Uluduz D, Ozge A. Reliability and Validity of Turkish Version of Headache Impact Test (HIT-6) in Patients with Migraine. Noro Psikiyatr Ars. 2020 Apr 24;58(4):300-307. doi: 10.29399/npa.24956. eCollection 2021.

  PMID: 34924791 BACKGROUND

• Ertas M, Siva A, Dalkara T, Uzuner N, Dora B, Inan L, Idiman F, Sarica Y, Selcuki D, Sirin H, Oguzhanoglu A, Irkec C, Ozmenoglu M, Ozbenli T, Ozturk M, Saip S, Neyal M, Zarifoglu M; Turkish MIDAS group. Validity and reliability of the Turkish Migraine Disability Assessment (MIDAS) questionnaire. Headache. 2004 Sep;44(8):786-93. doi: 10.1111/j.1526-4610.2004.04146.x.

  PMID: 15330825 BACKGROUND

• 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.

  PMID: 6226917 BACKGROUND

• 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.

  PMID: 32299230 BACKGROUND

• 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.

  PMID: 31425430 BACKGROUND

• 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.

  PMID: 27327235 BACKGROUND

MeSH Terms

Conditions

Migraine Disorders; Headache

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: March 4, 2025
• Study Start: January 2, 2025
• Primary Completion: May 28, 2025
• Study Completion: May 30, 2025
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CY (1); TU (12)