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A Study on the Efficacy and Safety of Acupuncture Intervention During the Prodromal Phase of Migraine Attacks Based on Professor Wang Linpeng's Theory of Expelling Pathogenic Factors

Acupuncture as the intervention of migraine attacks during the prodrome Based on Professor Linpeng Wang 's Theory of Dispelling Pathogens: a randomised, crossover trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002579
Enrollment
Unknown
Registered
2025-12-29
Start date
2026-01-21
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine

Interventions

Group A:During the study period encompassing two migraine episodes, the first acupuncture session was conducted during the migraine prodrome phase, with the episode details recorded in the headache di
Group B:During the study period of two consecutive migraine episodes, sham acupuncture was administered during the prodrome of the first migraine, and the episode was recorded in the headache diary. A

Sponsors

Beijing Massage Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Patients who meet the diagnostic criteria for "migraine" in the *International Classification of Headache Disorders (ICHD-III)*, including "migraine without aura" and "migraine with aura." The specific diagnostic criteria are as follows: (1.1) Migraine without aura: A. Headaches that meet criteria B-D occur at least 5 times. B. Headache episodes last 4-72 hours (untreated or ineffectively treated). C. At least 2 of the following 4 characteristics: 1) Unilateral (one-sided) location; 2) Pulsating quality; 3) Moderate or severe intensity; 4) Aggravation by or inability to perform routine physical activity (e.g., walking or climbing stairs). D. During the attack, at least 1 of the following 2: 1) Nausea and/or vomiting; 2) Photophobia and phonophobia. E. Cannot be better explained by another ICHD-III diagnosis. (1.2) Migraine with aura: A. At least 2 attacks meet criteria B and C. B. At least 1 fully reversible aura symptom, which may be: 1) Visual; 2) Sensory; 3) Speech and/or language; 4) Motor; 5) Brainstem; 6) Retinal. C. At least 3 of the following 6 characteristics: 1) At least 1 aura symptom lasts more than 5 minutes; 2) Two or more symptoms occur in succession; 3) Each individual aura symptom lasts 5-60 minutes; 4) At least 1 aura symptom is unilateral; 5) At least 1 aura symptom is positive (e.g., flashes of light); 6) Headache occurs during the aura or within 60 minutes of its onset. D. Cannot be better explained by another ICHD-III diagnosis. (2) Patients who meet the diagnostic criteria for both migraine without aura and migraine with aura, and have a history of multiple attacks of migraine with a prodrome. Prodromal symptoms may include but are not limited to: A. Gastrointestinal symptoms: nausea, vomiting, bloating, hunger, etc. B. Sensory symptoms: dizziness, photophobia, phonophobia, etc. C. Neurological and psychological symptoms: difficulty concentrating, excitability, irritability, etc. D. General symptoms: fatigue, frequent yawning, neck stiffness, etc. (3) Patients aged 18-75 years, of any gender, with a BMI <40 kg/m², who voluntarily participate in this study and sign the "Informed Consent Form." (4) Patients with good compliance and excellent communication skills. (5) Patients with a history of migraine lasting more than 3 months, with at least 2 episodes per month. (6) Patients whose migraine treatment regimen has been stable for 1 month with no significant changes. (7) Patients who can distinguish prodromal symptoms associated with migraine from similar symptoms unrelated to migraine.

Exclusion criteria

Exclusion criteria: (1) Patients with severe cardiovascular, cerebrovascular, kidney, liver, gastrointestinal, endocrine, or nervous system diseases; (2) Patients with a history of hemiplegia or migraines; (3) Patients with cognitive impairments or mental illnesses who are unable to cooperate with treatment or medical history collection; (4) Patients who are pregnant, breastfeeding, or planning to conceive; (5) Patients with tension-type headaches lasting more than 10 days per month; (6) Patients with a history of allergies or adverse reactions to related Chinese herbal medicines; (7) Patients who have participated in other drug clinical studies in the past six months.

Design outcomes

Primary

MeasureTime frame
Frequency of migraine attacks;

Secondary

MeasureTime frame
Headache Duration;Numerical Pain Rating Scale;Headache Impact Test;Migraine Disability Assessment Questionnaire;Traditional Chinese Medicine (TCM) Syndrome Efficacy;

Countries

China

Contacts

Public ContactZhang Chen

Beijing Massage Hospital

episode123150@hotmail.com15652609425

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026