Skip to main content
OpenTrials
Completed

NCT Number: NCT06857383

Head Awareness in Chronic Migraine Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Elite Research and Surgical Hospital, Nicosia, Cyprus

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Visual Analog Scale

    Time frame: In first enrollment, 1 minute

    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.

  2. Migraine Disability Assessment Questionnaire

    Time frame: In first enrollment, 3 minutes

    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).

  3. Headache Impact Test-6

    Time frame: In first enrollment, 3 minutes

    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).

  4. Hospital Anxiety and Depression Scale

    Time frame: In first enrollment, 3 minutes

    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.

  5. Pain Catastrophizing Scale

    Time frame: In first enrollment, 3 minutes

    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.

Sponsors and collaborators

Lead sponsor

Bozok University

Other

Registry information

Official study title

Assessment of Head Awareness in Chronic Migraine Patients With the Fremantle Headache Awareness Questionnaire: Turkish Version, Validity and Reliability Study

Acronym: Awareness

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 4, 2025
Registry last updated
Jul 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.