MigraineNCT07024511
Effectiveness of Auricular Acupuncture for Migraine
A study testing Auricular acupuncture and Acupuncture in people with Migraine, run by Universiti Tunku Abdul Rahman at 2 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine
- What is being tested?
- Auricular acupuncture and Acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 156 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jul 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 9Show fewer
- History of addictive disorder(s);
- Visual Aura Rating Scale, VARS≥5 score;
- Taking long-term painkillers for more than 1 month within 3 months.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Hebei University of Engineering Affiliated Hospital
Handan, Hebei, 054000
玉萍 Yuping SHI, +8615231937026, shiyuping0910@hotmail.com
Yurangqiao Community Health Service Center, Xingdong New District, Xingtai City
Xingtai, Hebei, 054100
Yuping SHI Yuping, +8615231937026, shiyuping0910@hotmail.com
About this study
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.
Read the 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.
- Conditions
- Migraine
- Being tested
- Auricular acupuncture, Acupuncture
- Keywords
- Pain, Migraine
- Medical subject headings
- Migraine Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular acupunctureOther
Auricular acupuncture
AcupunctureOther
Acupuncture
| Study group | Role | What they receive |
|---|---|---|
| Auricular acupuncture and acupuncture | Experimental | A total of eight treatment sessions will be administered over a period of three weeks, with sessions scheduled approximately every two to three days. Receives: Other: Auricular acupuncture; Other: Acupuncture |
| Acupuncture and sham auricular acupuncture | Placebo comparator | A total of eight treatment sessions will be administered over a period of three weeks, with sessions scheduled approximately every two to three days. Receives: Other: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from baseline to 1 month post treatment.
Secondary outcomes (7)
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.
Measured: from baseline to 1 month post treatment.
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.
Measured: from baseline to 1 month post treatment
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.
Measured: from baseline to 1 month post treatment
physical (physical function, pain intensity)， mental (depression, anxiety, fatigue, sleep disturbance) and social (ability to participate in social roles and activities).
- 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.
- 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.
Measured: from baseline to 1 month post treatment
treatment success
Patients Global Impression of Improvement (PGI-I) is a transition scale that is a single question asking the patient to rate their condition, as compared with how it is prior to before beginning treatment on a scale. This is measured by success , where it is defined as "very much improved" or "much improved".
Measured: at immediate post treatment
red blood cell distribution width (RDW)
RDW testing is a part of blood routine and usually does not require special preparation. Patients do not need to be on an empty stomach. To ensure that blood indicators are not affected by time, all patients will have their blood drawn at 10am on the day after the end of treatment
Measured: from baseline to immediate post treatment
adverse side effects
including bleeding, subcutaneous hemorrhage, hematoma, fainting, serious pain, and local infection
Measured: up to 48 hours after each treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start1 Jul 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Tunku Abdul Rahman
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Foo Chai Nien, Universiti Tunku Abdul Rahman
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07024511
- Sponsor's protocol ID
- 2024[K]122-01
- Status last verified
- Jun 2025
- First submitted
- 23 May 2025
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Auricular Acupuncture for Migraine
- ClinicalTrials.gov ID
- NCT07024511
- Acronym / sponsor ID
- 2024[K]122-01
- Conditions
- Migraine
- Keywords
- Pain, Migraine
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Universiti Tunku Abdul RahmanUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 17 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Auricular acupuncture and acupuncture | Experimental | Other: Auricular acupuncture, Other: AcupunctureA total of eight treatment sessions will be administered over a period of three weeks, with sessions scheduled approximately every two to three days. |
| Acupuncture and sham auricular acupuncture | Placebo comparator | Other: AcupunctureA total of eight treatment sessions will be administered over a period of three weeks, with sessions scheduled approximately every two to three days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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);
Key exclusion criteria (9 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auricular acupunctureAuricular acupuncture | Other | Auricular acupuncture and acupuncture |
| AcupunctureAcupuncture | Other | Acupuncture and sham auricular acupuncture, Auricular acupuncture and acupuncture |
Primary outcome
headache frequency
Time frame: 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.
7 secondary outcomes
pain severity
Time frame: from baseline to 1 month post treatment.
migraine disability
Time frame: from baseline to 1 month post treatment
Change of baseline in the mean quality of life as assessed by Migraine-Specific Quality of Life Questionnaire at 1 month
Time frame: from baseline to 1 month post treatment
physical (physical function, pain intensity)， mental (depression, anxiety, fatigue, sleep disturbance) and social (ability to participate in social roles and activities).
Time frame: from baseline to 1 month post treatment
treatment success
Time frame: at immediate post treatment
red blood cell distribution width (RDW)
Time frame: from baseline to immediate post treatment
adverse side effects
Time frame: up to 48 hours after each treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for Migraine
RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
Migraine Disorders
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auricular acupuncture and Acupuncture in people with Migraine, run by Universiti Tunku Abdul Rahman at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chai Nien Foo, PhD (+60123167252, foocn@utar.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
headache frequency (time frame: from baseline to 1 month post treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2025.