MigraineNCT07116590
Cervical Stability and Body Awareness in Migraine
An observational study of Migraine, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Migraine
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2025to 26 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Adult
Study population: migraine patients and healthy subjects with inclusion criteria
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Cervical Spinal Stability, Proprioception, and Body Awareness in Individuals With Migraine
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.
Read the detailed description
After collecting demographic and disease-related data from individuals with migraine, and demographic data from healthy controls, the following assessments will be conducted: Migraine Disability Assessment Questionnaire (MIDAS), Bournemouth Neck Questionnaire, Fremantle Neck Awareness Questionnaire, Body Awareness Questionnaire, Body Awareness Rating Questionnaire, cervical spinal stability, and cervical proprioception.
- Conditions
- Migraine
- Keywords
- migraine, body awareness, cervical spinal stability, cervical proprioception
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start1 Jun 2025
- Primary completion26 Aug 2025
- Study completion26 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Collaborators
- Yuksek Ihtisas University
- Responsible party
- Principal investigator, Güngör Beyza ÖZVAR, Hacettepe University
- Investigators
- Esranur Özoğul, Principal investigator, Yuksek Ihtisas UniversityBüşra Kalkan Balak, Principal investigator, Yuksek Ihtisas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07116590
- Sponsor's protocol ID
- Migraine
- Status last verified
- Aug 2025
- First submitted
- 6 Aug 2025
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Cervical Spinal Stability, Proprioception, and Body Awareness in Individuals With Migraine
- ClinicalTrials.gov ID
- NCT07116590
- Acronym / sponsor ID
- Migraine
- Conditions
- Migraine
- Keywords
- migraine, body awareness, cervical spinal stability, cervical proprioception
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Collaborators
- Yuksek Ihtisas University
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 26 Aug 2025 (actual)
- Study completion
- 26 Aug 2025 (actual)
- First posted
- 11 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
After collecting demographic and disease-related data from individuals with migraine, and demographic data from healthy controls, the following assessments will be conducted: Migraine Disability Assessment Questionnaire (MIDAS), Bournemouth Neck Questionnaire, Fremantle Neck Awareness Questionnaire, Body Awareness Questionnaire, Body Awareness Rating Questionnaire, cervical spinal stability, and cervical proprioception.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Age groups
- Adult
- Study population
- migraine patients and healthy subjects with inclusion criteria
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Migraine Disability Assessment Questionnaire-MIDAS
Time frame: up to 3 months
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.
Bournemouth Neck Questionnaire:
Time frame: up to 3 months
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.
Fremantle Neck Awareness Questionnaire
Time frame: up to 3 months
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.
Body Awareness Questionnaire
Time frame: up to 3 months
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.
Body Awareness Rating Questionnaire
Time frame: up to 3 months
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
Cervical Spine Stability
Time frame: up to 3 months
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
Cervical Proprioception
Time frame: up to 3 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esranur Özoğul principal investigator
Yuksek Ihtisas University
Büşra Kalkan Balak principal investigator
Yuksek Ihtisas University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Migraine Disability Assessment Questionnaire-MIDAS (time frame: up to 3 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.