Effectiveness of Auricular Acupuncture for Migraine
ConditionMigraine
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversiti Tunku Abdul Rahman
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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);
Disqualifiers
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);
Trial design
Design model
Parallel
Treatments tested in this trial
Auricular acupuncture
Other interventionAuricular acupuncture
Acupuncture
Other interventionAcupuncture
Treatment groups
156 Participants
are divided into 2 treatment groupsGroup A: Auricular acupuncture and acupunctureExperimental treatment 2 interventions
Group B: Acupuncture and sham auricular acupuncturePlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
headache frequency
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.
Time frame
from baseline to 1 month post treatment.Secondary outcomes
1
pain severity
Pain severity is categorized as follows: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm). The score is determined by measuring the distance (in millimeters) on a 10 cm line between the "no pain" anchor and the patient's mark using a ruler, providing a score range of 0 to 100.
Time frame
from baseline to 1 month post treatment.2
migraine disability
The Migraine Disability Assessment (MIDAS) questionnaire consists of five questions, each addressing the number of days affected by migraines. The average pain intensity of headaches is rated on a scale from 0 to 10, where 0 indicates no pain and 10 represents the most severe pain.
Time frame
from baseline to 1 month post treatment3
Change of baseline in the mean quality of life as assessed by Migraine-Specific Quality of Life Questionnaire at 1 month
The Migraine-Specific Quality of Life Questionnaire (MSQ) comprises 3 domains: role function-restrictive (RR), role function-preventive (RP), and emotional function (EF). Each item is scored on a 1-6 scale. Raw dimension scores are computed as a sum of item responses and rescaled from a 0 to 100 scale such that higher scores indicate better quality of life.
Time frame
from baseline to 1 month post treatment4
physical (physical function, pain intensity)， mental (depression, anxiety, fatigue, sleep disturbance) and social (ability to participate in social roles and activities).
1. Patient-Reported Outcomes Measurement Information System (PROMIS) with 7 PROMIS domains including depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles and activities. The total score of each domain is converted to a standardized T score. 2. In this scale, each item has five response options, with each option scored from 1 to 5 points. For the Anxiety and Depression domains, scoring is reversed: higher scores reflect less severe symptoms. For all other domains, higher scores indicate more severe symptoms or greater impairment. Pain Intensity is rated directly on a 0-10 scale, where 0 represents no pain and 10 represents the worst possible pain.
Time frame
from baseline to 1 month post treatmentSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: