Migraine is a primary headache disorder characterized by recurrent episodes of moderate to severe pain, frequently accompanied by nausea, photophobia, and phonophobia. It ranks as the third most prevalent medical condition globally and is recognized by the World Health Organization (WHO) as one of the top ten causes of disability worldwide. Migraine presents substantial public health concerns due to its considerable socioeconomic burden and its detrimental impact on individuals' quality of life. Although pharmacological treatments are widely available, their effectiveness is often limited, with many patients experiencing inadequate symptom relief or adverse side effects. Consequently, there has been growing interest in non-pharmacological approaches, particularly acupuncture and auricular therapy, due to their favorable safety profiles and reported efficacy in alleviating migraine symptoms. Auricular therapy, a microsystem of acupuncture applied to specific points on the external ear, has gained popularity for its simplicity, low risk, and therapeutic potential. Despite its increasing clinical use, robust scientific evidence supporting the effectiveness of auricular therapy for migraine remains insufficient, underscoring the need for well-designed clinical studies to validate its therapeutic value.
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria:
* Diagnosed as having migraine with aura and without aura according to the diagnostic criteria specified by the ICHD 3;
* Aged between 18 and 65 years old;
* Provided written informed consent;
* Headache lasting for 4 to 72 hours and occur at least 5 times (untreated or poorly treated);
* At least 2 out of 4 criteria must be met (unilateral, pulsatile, moderate to severe pain, headache aggravated by daily physical activity, or avoidance of daily activities such as walking or climbing stairs due to headache);
* At least one of the two criteria must be met (nausea and/or vomiting, photophobia, and fear of sound);
* At least one fully recoverable premonitory symptom (visual, sensory, speech and/or language, motor, brainstem, retina); Onset time more than 5 minutes; (8) No prophylaxis treatments with acupuncture or drugs in the past 3 months; (9) Written informed consent provided.
Exclusion Criteria:
* All other diagnoses of chronic, tension-type headache, cluster headache and/or secondary headaches;
* History of psychotic disorder(s).;
* Pregnancy or lactation;
* Severe somatic disorder(s);
* History of severe organic psychiatric disorder(s);
* History of other chronic pain condition(s) in the pass 3 months;
* History of addictive disorder(s);
* Visual Aura Rating Scale, VARS≥5 score;
* Taking long-term painkillers for more than 1 month within 3 months.
Primary outcome measure(s)
headache frequency — from baseline to 1 month post treatment. The frequency of headaches will be recorded in the form of a headache diary, and doctors will conduct electronic inquiries in WeChat groups every day.
Trial sites (2)
Facility
City
Region
Status
Hebei University of Engineering Affiliated Hospital
Handan
Hebei
Yurangqiao Community Health Service Center, Xingdong New District, Xingtai City
Xingtai
Hebei
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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