Clinical trial NCT07024511: Effectiveness of Auricular Acupuncture for Migraine
Official title: Effectiveness of Auricular Acupuncture for Migraine
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Migraine
Keywords: Pain
Migraine
Lead sponsor: Universiti Tunku Abdul Rahman
Sponsor class: OTHER
First posted: 2025-06-17
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: Migraine is a complex and dynamic neurological disorder characterized by fluctuations in attack frequency, duration, severity, and associated symptoms, necessitating timely prevention and effective management strategies. While pharmacological treatments remain the mainstay, their limitations have led to increasing interest in non-pharmacological interventions such as acupuncture. Acupuncture has gained global recognition for its efficacy, particularly in migraine, which is one of the conditions most responsive to this therapy. Supported by strong clinical evidence, acupuncture is considered safe and well-tolerated, with a low incidence of adverse effects. Guidelines for managing primary headache disorders now advocate a range of complementary approaches, including acupuncture, dietary changes, physical activity, and cognitive behavioral therapy which reflecting a paradigm shift towards integrative care. Clinical studies have demonstrated that acupuncture can significantly reduce migraine frequency, shorten attack duration, and alleviate symptom severity. Mechanistic research suggests acupuncture modulates migraine pathophysiology through neuroimmune and neurotransmitter regulation, although further studies are needed to elucidate its molecular effects, particularly beyond the trigeminovascular system. Within Traditional Chinese Medicine, auricular therapy based on stimulating specific points on the external ear aligned with internal organ systems via the "inverted fetus" model offers a simplified, non-invasive modality that activates neural signaling pathways to regulate bodily functions and relieve migraine symptoms. Despite its growing clinical use, further clinical evidence is needed to confirm the therapeutic efficacy and mechanisms of auricular acupuncture in migraine management.

Eligibility criteria: 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 outcomes:
measure: headache frequency
timeFrame: from baseline to 1 month post treatment.
Secondary outcomes:
measure: pain severity
timeFrame: from baseline to 1 month post treatment.
measure: migraine disability
timeFrame: from baseline to 1 month post treatment
measure: Change of baseline in the mean quality of life as assessed by Migraine-Specific Quality of Life Questionnaire at 1 month
timeFrame: from baseline to 1 month post treatment
measure: physical (physical function, pain intensity)， mental (depression, anxiety, fatigue, sleep disturbance) and social (ability to participate in social roles and activities).
timeFrame: from baseline to 1 month post treatment
measure: treatment success
timeFrame: at immediate post treatment
measure: red blood cell distribution width (RDW)
timeFrame: from baseline to immediate post treatment
measure: adverse side effects
timeFrame: up to 48 hours after each treatment
Other outcomes:
Locations:
city: Handan
country: China
facility: Hebei University of Engineering Affiliated Hospital
state: Hebei
city: Xingtai
country: China
facility: Yurangqiao Community Health Service Center, Xingdong New District, Xingtai City
state: Hebei
Study officials:
References: