Effectiveness of Auricular Acupuncture for Migraine

NCT07024511 | Not Yet Recruiting DMC

• 1 other identifier: 2024[K]122-01
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 2

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.

Conditions

Migraine

Keywords

Pain; Migraine

Outcome Measures

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.

  from baseline to 1 month post treatment.

Secondary Outcomes (7)

• pain severity

  from baseline to 1 month post treatment.

• migraine disability

  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

  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).

  from baseline to 1 month post treatment

• treatment success

  at immediate post treatment

Study Arms (2)

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.

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.

Other: Acupuncture

Interventions

Auricular acupuncture OTHER

Auricular acupuncture

Auricular acupuncture and acupuncture

Acupuncture OTHER

Acupuncture

Acupuncture and sham auricular acupuncture; Auricular acupuncture and acupuncture

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universiti Tunku Abdul Rahman: lead

Study Sites (2)

Hebei University of Engineering Affiliated Hospital

Handan, Hebei, 054000, China

Location

Yurangqiao Community Health Service Center, Xingdong New District, Xingtai City

Xingtai, Hebei, 054100, China

Location

MeSH Terms

Conditions

Migraine Disorders; Pain

Interventions

Acupuncture, Ear; Acupuncture Therapy

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Auriculotherapy

Central Study Contacts

Chai Nien Foo, PhD

CONTACT

+60123167252; foocn@utar.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 23, 2025
• First Posted: June 17, 2025
• Study Start: July 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)