Prevalence and Determinants of Migraine Among Headache Patients

Not yet recruiting

• Conditions: Headache (Migraine)

• Registration Number: NCT07038499
• Lead Sponsor: Universiti Tunku Abdul Rahman

Brief 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. 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 Timeline

• Study First Submitted: 2025-05-23
• Status Verified: 2025-06
• Study Start: 2025-06-23
• Study First Submitted QC: 2025-06-25
• Last Update Submitted: 2025-06-25
• Study First Posted: 2025-06-26
• Last Update Posted: 2025-06-26
• Primary Completion: 2025-10-31
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 158

Inclusion Criteria

• Patients diagnosed with headache according to the International Classification of Headache Disorders, 3rd Edition (ICHD-3).

Exclusion Criteria

• Patients with other major diseases or severe mental disorders;
• History of endocrine, immune, or nervous system diseases or other severe somatic diseases.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of migraine	Day 1	The overall number and proportion of people with migraine (according to the International Classification of Headache Disorders, 3rd edition (ICHD-3))

Secondary Outcome Measures

Name	Time	Method
Correlation with hypertension	Day 1	Hypertension will be assessed using self-reported hypertension status (Yes/ No)
Correlation with physical (physical function, pain intensity)， mental (depression, anxiety, fatigue, sleep disturbance) and social (ability to participate in social roles and activities)	Day 1	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.
Correlation with quality of life	Day 1	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.
Correlation with migraine disability	Day 1	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

Trial Locations

Locations (1)

Affiliated Hospital of Hebei University of Engineering, China; 🇨🇳 Hebei, China

Affiliated Hospital of Hebei University of Engineering, China

🇨🇳Hebei, China

Yuping Student

Contact

shiyuping0910@hotmail.com

Shi Yuping

Principal Investigator