Headache (Migraine)NCT07038499
Prevalence and Determinants of Migraine Among Headache Patients
An observational study of Headache (Migraine), run by Universiti Tunku Abdul Rahman at 1 site in China.
Trial summary
Migraine is a prevalent and disabling neurological condition that often coexists with other health issues, such as hypertension and impaired physical, mental, and social functioning. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Headache (Migraine)
- How many people
- 158 participants
- Where
- 1 siteChina
- Study dates
- 23 Jun 2025to 31 Oct 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients attending at the Affiliated Hospital of Hebei University of Engineering, China.
Who may be able to join
- Patients diagnosed with headache according to the International Classification of Headache Disorders, 3rd Edition (ICHD-3).
Who cannot join
- Patients with other major diseases or severe mental disorders;
- History of endocrine, immune, or nervous system diseases or other severe somatic diseases.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chai Nien Associate Professor, PhD contact
China1 site
Affiliated Hospital of Hebei University of Engineering, China
Hebei
Yuping Student, shiyuping0910@hotmail.com
Shi Yuping
About this study
Migraine is a prevalent and disabling neurological condition that often coexists with other health issues, such as hypertension and impaired physical, mental, and social functioning. Understanding the prevalence of migraine and its associations with these health domains can provide valuable insights into the broader impact of migraine on overall well-being. By focusing on patients at the Affiliated Hospital of Hebei University of Engineering in China, this study can identify specific health burdens within this population, inform integrated clinical management strategies, and support the development of targeted interventions to improve patient outcomes and quality of life.
Read the detailed description
Migraine is a common and disabling neurological disorder that poses a significant public health burden worldwide. In China, the estimated prevalence of migraine is approximately 9.3%, with higher rates reported among women and individuals of working age. Despite being one of the most prevalent types of primary headache disorders, migraine remains underdiagnosed and undertreated in many regions of China, partly due to limited awareness and access to specialized care. Concurrently, hypertension is highly prevalent in the Chinese adult population, with nearly one in four adults affected, making it a leading contributor to cardiovascular morbidity. Emerging evidence suggests a potential bidirectional relationship between migraine and hypertension, possibly linked through shared pathophysiological mechanisms such as endothelial dysfunction, autonomic dysregulation, and inflammatory pathways.
Moreover, migraine is often associated with detrimental effects on physical, mental, and social health, including impaired physical function, increased pain intensity, depression, anxiety, fatigue, sleep disturbances, and reduced ability to participate in social roles and activities. However, studies exploring these multidimensional impacts in Chinese clinical populations remain limited.
Therefore, this study aims to investigate the prevalence of migraine and its association with hypertension as well as physical, mental, and social health domains among headache patients at the Affiliated Hospital of Hebei University of Engineering, China.
- Conditions
- Headache (Migraine)
- Keywords
- Pain, Headache, Migraine, Disability
- Medical subject headings
- Migraine Disorders, Pain, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
Participants are not assigned an intervention as part of the study.
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of migraine
The overall number and proportion of people with migraine (according to the International Classification of Headache Disorders, 3rd edition (ICHD-3))
Measured: Day 1
Secondary outcomes (4)
Correlation with hypertension
Hypertension will be assessed using self-reported hypertension status (Yes/ No)
Measured: Day 1
Correlation with physical (physical function, pain intensity)， mental (depression, anxiety, fatigue, sleep disturbance) and social (ability to participate in social roles and activities)
Patient-Reported Outcomes Measurement Information System (PROMIS) measures domains including physical (physical function, pain intensity)， mental (depression, anxiety, fatigue, sleep disturbance) and social (ability to participate in social roles and activities). The total score of each domain is converted to a standardized T score. High scores mean more of the domains being measured.
Measured: Day 1
Correlation with migraine disability
The MIDAS (Migraine Disability Assessment) is a validated questionnaire used to measure headache-related disability over the past three months. It consists of five questions, each addressing the number of days affected by migraines. Each answer is recorded as a number of days. The higher score indicating more severe migraine disability
Measured: Day 1
Correlation with quality of life
The Migraine-Specific Quality of Life Questionnaire (MSQ) is a validated tool used to assess the impact of migraine on a patient's quality of life. Raw scores are first calculated by summing item responses for each domain. Raw scores are then transformed into a 0-100 scale, where higher scores indicate better quality of life.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start23 Jun 2025 (estimated)
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Headache (Migraine)Studies of the same condition, open and under way.
- 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 158 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Universiti Tunku Abdul Rahman
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Foo Chai Nien, Universiti Tunku Abdul Rahman
- Investigators
- Chai Nien Associate Professor, PhD, Principal investigator, Universiti Tunku Abdul Rahman
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07038499
- Sponsor's protocol ID
- 2024[K]122
- Other IDs
- 2024[k]-122
- Status last verified
- Jun 2025
- First submitted
- 23 May 2025
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Determinants of Migraine Among Headache Patients
- ClinicalTrials.gov ID
- NCT07038499
- Acronym / sponsor ID
- 2024[K]122
- Conditions
- Headache (Migraine)
- Keywords
- Pain, Headache, Migraine, Disability
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- Universiti Tunku Abdul RahmanUniversity, hospital or other
- Study start
- 23 Jun 2025 (estimated)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 26 Jun 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.
Migraine is a prevalent and disabling neurological condition that often coexists with other health issues, such as hypertension and impaired physical, mental, and social functioning. Understanding the prevalence of migraine and its associations with these health domains can provide valuable insights into the broader impact of migraine on overall well-being. By focusing on patients at the Affiliated Hospital of Hebei University of Engineering in China, this study can identify specific health burdens within this population, inform integrated clinical management strategies, and support the development of targeted interventions to improve patient outcomes and quality of life.
Detailed description
Migraine is a common and disabling neurological disorder that poses a significant public health burden worldwide. In China, the estimated prevalence of migraine is approximately 9.3%, with higher rates reported among women and individuals of working age. Despite being one of the most prevalent types of primary headache disorders, migraine remains underdiagnosed and undertreated in many regions of China, partly due to limited awareness and access to specialized care. Concurrently, hypertension is highly prevalent in the Chinese adult population, with nearly one in four adults affected, making it a leading contributor to cardiovascular morbidity. Emerging evidence suggests a potential bidirectional relationship between migraine and hypertension, possibly linked through shared pathophysiological mechanisms such as endothelial dysfunction, autonomic dysregulation, and inflammatory pathways.
Moreover, migraine is often associated with detrimental effects on physical, mental, and social health, including impaired physical function, increased pain intensity, depression, anxiety, fatigue, sleep disturbances, and reduced ability to participate in social roles and activities. However, studies exploring these multidimensional impacts in Chinese clinical populations remain limited.
Therefore, this study aims to investigate the prevalence of migraine and its association with hypertension as well as physical, mental, and social health domains among headache patients at the Affiliated Hospital of Hebei University of Engineering, China.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients attending at the Affiliated Hospital of Hebei University of Engineering, China.
Key inclusion criteria (1 listed)
- Patients diagnosed with headache according to the International Classification of Headache Disorders, 3rd Edition (ICHD-3).
Key exclusion criteria (2 listed)
- Patients with other major diseases or severe mental disorders;
- History of endocrine, immune, or nervous system diseases or other severe somatic diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Participants are not assigned an intervention as part of the study. | Other | – |
Primary outcome
Prevalence of migraine
Time frame: Day 1
The overall number and proportion of people with migraine (according to the International Classification of Headache Disorders, 3rd edition (ICHD-3))
4 secondary outcomes
Correlation with hypertension
Time frame: Day 1
Correlation with physical (physical function, pain intensity)， mental (depression, anxiety, fatigue, sleep disturbance) and social (ability to participate in social roles and activities)
Time frame: Day 1
Correlation with migraine disability
Time frame: Day 1
Correlation with quality of life
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for Headache (Migraine)
RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
Migraine Disorders
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
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.
Chai Nien Associate Professor, PhD contact
Chai Nien Associate Professor, PhD principal investigator
Universiti Tunku Abdul Rahman
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 Headache (Migraine), run by Universiti Tunku Abdul Rahman at 1 site in China.
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 1 inclusion and 2 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: opening soon, as of the sponsor's last update on 26 Jun 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chai Nien Associate Professor, PhD (+60123167252, foocn@utar.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of migraine (time frame: Day 1). 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 26 Jun 2025.