This study is a prospective, observational cohort study. The plan of this study is to consecutively enroll 2,000 primary headache patients who meet the inclusion criteria from the neurology outpatient department and inpatient department of Sun Yat-sen Memorial Hospital, Sun Yat-sen University. Basic clinical data registration, various scale evaluations, cranial imaging examinations, and collection of blood and fecal biological samples will be completed. During the 10-year follow-up plan, systematic clinical evaluations of the disease severity, diagnosis and treatment, living ability and health status of patients will be carried out regularly every 6 - 12 months. Imaging and other functional evaluations will be conducted when necessary. Data collection includes:
Demographic data (including age, gender, education, ethnicity, marital status, occupation, etc.); General clinical data (past medical history, medication history, personal history, menstrual and childbearing history, family history, etc.); Clinical data of primary headache: headache frequency, duration, severity (Numeric Rating Scale for pain, NRS), headache-related medication use, drug efficacy and side effects; Scale evaluations: MIDAS, HIT-6, BPI, MSQ, ADL, CDR, PGIC, CGIC, PHQ-4, mTOQ-4, ASC-12, MIBS-4, HARDSHIP, WHO-QOL BREF, HAMD, HAMA, TNQ; Records of neurological imaging examinations, blood sample and fecal sample collection.
Age is less than 65 years old.
Meets the diagnostic criteria for relevant primary headaches (such as tension-type headache, migraine, cluster headache, trigeminal autonomic cephalalgia, etc.) in the third edition of the International Classification of Headache Disorders (ICHD - 3).
Is willing and able to participate throughout the entire study period and sign the informed consent form.
Has the ability to complete the "Headache Diary" independently or with the help of a guardian.
Secondary headache
High - risk populations, such as those with severe heart disease, impaired liver and kidney function, malignant tumors, etc.
Patients with mental illness, cognitive impairment, or those who are unable to cooperate with the research requirements
History of intracranial lesions or other nervous system diseases (including stroke, epilepsy, etc.)
Primary headache is a common neurological disease worldwide, with a prevalence rate of approximately 10% - 20%. Its occurrence is not related to brain structural damage, infection, metabolic abnormalities, or other diseases, but is directly caused by the abnormal function of the central or peripheral nervous system. According to the ICHD-3, primary headache mainly includes migraine, tension - type headache, and cluster headache etc. The attack frequency, duration, and severity of primary headache show a high degree of heterogeneity. Primary headache is highly comorbid with anxiety, depression, and sleep disorders. The quality of life of patients with chronic primary headache significantly declines, and the work absenteeism rate and economic burden increase. Analgesic drugs are mainly used in the acute phase. Preventive treatment is applicable to patients with frequent or chronic attacks, and non-pharmacological interventions are also effective strategies.
Cohort
Prospective
Disease education, pharmacological treatment, Non-pharmacological treatment
Combination productDisease education: Provide patients with education on knowledge related to primary headache, including the causes, pathogenesis, symptoms, treatment methods, and preventive measures of headache, etc., to help patients better understand their own diseases and improve their self-management ability. Non-pharmacological treatment: Although specific non-pharmacological treatment methods are not elaborated in detail in the research protocol, they may include psychotherapy, physical therapy, etc. For example, biofeedback therapy, relaxation training, transcranial magnetic stimulation, etc. These can all be recorded as possible intervention measures. Pharmacological treatment: Record the medications used for the treatment of acute episodes and preventive treatment by patients during the research process, including the types of medications, dosages, frequency of use, etc. For instance, non-steroidal anti-inflammatory drugs and triptan drugs used during acute episodes, and β-blockers.
The number of headache days per month.
The number of headache days per month: This indicator is used to count the actual number of days each research subject experiences headache symptoms within each month. Through the recording and analysis of the number of headache days per month, it can directly reflect the frequency of headache attacks, helping researchers understand the duration of the interference of primary headache with the daily life of patients, and further evaluate the severity and development trend of the disease.
Changes in scores of headache assessment scales: NRS.
NRS (The Numerical Rating Scale for Pain) is a commonly used simple pain measurement tool. Patients select a value within the numerical range from 0 (representing no pain) to 10 (representing the most severe pain) according to the degree of pain they feel, to quantify the intensity of pain.
Changes in scores of headache assessment scales: HIT-6.
The HIT - 6 scale (the Headache Impact Test - 6) is mainly used to evaluate the impact of headache on various aspects of patients' lives, such as daily activities, social interaction, work, etc.
The number of days of emergency medication use per month.
The types of preventive medications and the number of days of use per month.
Changes in scale scores at MIDAS.
Changes in scale scores at Migraine Disability Assessment Scale (MIDAS)
Changes in scale scores at BPI.
Changes in scale scores at Brief Pain Inventory (BPI).
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
