Cervical Stability and Body Awareness in Migraine

NCT07116590 | Completed

• 1 other identifier: Migraine
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare cervical spinal stability, cervical proprioception, and body awareness in individuals with migraine and healthy controls, and to examine the relationship between these parameters. Hypotheses of the Study: H1: Cervical spinal stability differs between individuals with migraine and healthy individuals. H2: Cervical proprioception differs between individuals with migraine and healthy individuals. H3: Body awareness differs between individuals with migraine and healthy individuals. H4: There is a relationship between cervical spinal stability, cervical proprioception, and body awareness in individuals with migraine.

Conditions

Migraine

Keywords

migraine; body awareness; cervical spinal stability; cervical proprioception

Outcome Measures

Primary Outcomes (7)

• Migraine Disability Assessment Questionnaire-MIDAS

  It is a questionnaire consisting of five questions related to disability over the past three months. Individuals score the number of days lost due to headache in three domains: schoolwork, paid work, and household activities. Additionally, they report the number of extra days with significant activity limitations (defined as at least a 50% reduction in productivity) in paid and household work. The MIDAS score is calculated by summing the scores of these five items.

  up to 3 months

• Bournemouth Neck Questionnaire:

  This questionnaire consists of seven items, each scored on a scale from 0 to 10. It evaluates the impact of pain on daily activities, pain severity, levels of anxiety and depression, kinesiophobia, and the ability to cope with pain.

  up to 3 months

• Fremantle Neck Awareness Questionnaire

  This questionnaire consists of nine items, each scored on a scale from 0 to 4. It assesses awareness of the cervical region. Higher scores indicate poorer body awareness.

  up to 3 months

• Body Awareness Questionnaire

  This questionnaire consists of 18 items, each scored on a scale from 1 to 7, and is used to assess body awareness. Higher scores indicate better body awareness.

  up to 3 months

• Body Awareness Rating Questionnaire

  This questionnaire consists of 24 items divided into four domains: function, mood, sensation/emotion, and awareness. Each item scores a 7-point Likert type scale. Each factor's scores range between 6 to 42 and higher scores indicates higher body awareness

  up to 3 months

• Cervical Spine Stability

  The craniocervical flexion test will be performed using a pressure biofeedback unit (Stabilizer, Chattanooga, Australia). The test consists of five stages. During the test, participants will lie in a supine position with the head and neck in neutral alignment, and the device will be placed under the suboccipital region. In the initial stage, the pressure will be set at 20 mmHg, and participants will be instructed to perform a craniocervical flexion movement. Subsequently, the test will proceed through five incremental stages, increasing the pressure in 2 mmHg increments from the initial 20 mmHg up to a maximum of 30 mmHg. At each pressure level, participants will be asked to maintain the movement for 10 repetitions of 10 seconds each. Based on these stages, the Activation Score and Performance Index will be calculated

  up to 3 months

• Cervical Proprioception

  Joint position error test will be conducted using a laser pointer attached to the participant's head. While sitting on a chair with back support, participants will face a wall where a target will be placed 90 cm away. Participants will first be asked to sense the starting position (the center of the target). Then, with their eyes closed, they will be instructed to return their head to the starting position from various directions (flexion, extension, and rotation). The deviation from the target center will be measured in centimeters, and the test will be repeated three times. The average of the three trials will be used as the final score.

  up to 3 months

Study Arms (2)

Migraine

Patients diagnosed with migraine without aura according to the International Classification of Headache Disorders (ICHD-III) criteria, currently in the interictal period, aged between 18 and 55 years, and who agree to participate in the study will be included.

Healthy subjects

Individuals matched with the migraine group in terms of age and sex distribution.

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

migraine patients and healthy subjects with inclusion criteria

You may qualify if:

• Have been diagnosed with migraine without aura according to the International Classification of Headache Disorders (ICHD-III) criteria,
• Are in the interictal period,
• Are between 18 and 55 years of age, and
• Agree to participate in the study
• Age- and sex-matched healthy individuals

You may not qualify if:

• Individuals with other types of headache,
• Those with a history of neck or head trauma,
• Individuals with cervical disc herniation or cervical arthrosis,
• Those with any other systemic or neurological medical condition (e.g., chronic pain syndrome, rheumatoid arthritis, systemic lupus erythematosus, stroke, trigeminal neuralgia, etc.),
• Pregnant individuals,
• Patients who have received anesthetic blockade within the past 6 months.

Sponsors & Collaborators

• Hacettepe University: lead
• Yuksek Ihtisas University: collaborator

Study Sites (1)

Yuksek Ihtisas University

Ankara, Balgat, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Esranur Özoğul

  Yuksek Ihtisas University

  PRINCIPAL INVESTIGATOR

• Büşra Kalkan Balak

  Yuksek Ihtisas University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: August 11, 2025
• Study Start: June 1, 2025
• Primary Completion: August 26, 2025
• Study Completion: August 26, 2025
• Last Updated: September 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)