What side effects are associated with this type of intervention?

Common treatments for migraines include pharmacological options like NSAIDs, triptans, and antiemetics, which can cause gastrointestinal issues, dizziness, and fatigue. Non-pharmacological treatments such as acupuncture, including auricular acupuncture, are generally safe but may cause minor side effects like localized pain, bruising, or infection at the needle site.

What prior FDA approvals exist?

FDA-approved treatments for migraines include a variety of pharmacologic and non-pharmacologic options. Pharmacologic treatments include triptans (e.g., sumatriptan), CGRP inhibitors (e.g., erenumab), and NSAIDs (e.g., ibuprofen). Non-pharmacologic treatments that are somewhat similar to auricular acupuncture in their approach to modulating pain pathways include neuromodulation devices such as transcutaneous electrical nerve stimulation (TENS) and transcranial magnetic stimulation (TMS). These devices aim to alleviate migraine symptoms by stimulating specific nerves or brain regions, akin to the proposed mechanism of auricular acupuncture.

What other types of research exist?

Promising novel alternatives to auricular acupuncture for migraine patients include non-invasive vagus nerve stimulation (nVNS), transcutaneous electrical nerve stimulation (TENS), and mindfulness-based practices such as meditation and relaxation therapy. These approaches have shown potential in modulating pain pathways and reducing migraine symptoms.

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Auricular Acupuncture for Migraines (MigAcu Trial)

N/A

Recruiting

Research Sponsored by University of Louisville

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Must not have

Patients who received ED migraine medications (including ibuprofen or other NSAIDS) prior to study evaluation

Patients with underlying abnormal brain pathology (e.g. mass or bleed) as the potential cause of the migraine

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 to 6 days

Awards & highlights

No Placebo-Only Group

All Individual Drugs Already Approved

Approved for 5 Other Conditions

Summary

This trial compares ear acupuncture and standard IV medications for treating migraines in children in the emergency room. Ear acupuncture uses needles in the ear to change nerve signals and reduce pain, while standard treatments use drugs to relieve symptoms.

Who is the study for?

This trial is for pediatric patients with confirmed migraine headaches who haven't taken any ED migraine medications like ibuprofen before the study. It's not for those allergic to the meds used in this trial, showing specific neurological symptoms, or with brain conditions like a mass or bleed causing their migraines.

What is being tested?

The study compares auricular acupuncture against standard treatments (including Ketorolac, Metoclopramide, Diphenhydramine, and saline fluid) for migraines in children at the emergency department. Patients are randomly chosen to receive either acupuncture or standard care.

What are the potential side effects?

Possible side effects include pain or discomfort from acupuncture; reactions to medications such as stomach upset from Ketorolac; drowsiness from Diphenhydramine; and restlessness or fatigue from Metoclopramide.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have taken migraine medication, including ibuprofen, before this study.

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My migraines may be caused by a brain condition like a tumor or bleeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 to 6 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 to 6 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 to 6 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in baseline pain score by a numerical self-reported visual analog pain score (VAS)

Secondary study objectives

Duration of pain relief using the VAS pain scale

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Auricular AcupunctureExperimental Treatment1 Intervention

If assigned to the auricular acupuncture arm, efficacious ear points will be located by a needle contact test and/or an electrical point finder which emits an acoustic alarm when a change in electrical resistance is detected signifying a potential active auricular acupoint.

Group II: Medication and FluidActive Control4 Interventions

If assigned to receive intravenous medications and fluid the subject will be treated with the ED standard of care medications which include: 1. Ketorolac 0.5mg/kg, max 30mg 2. Metoclopramide 0.1 mg/kg, max 10mg 3. Diphenhydramine 1mg/kg, max 50mg 4. Normal saline fluid bolus 20mL/kg, max 1000mL

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for migraines include acupuncture, transcranial magnetic stimulation (TMS), and noninvasive vagus nerve stimulation (nVNS). Acupuncture, including auricular acupuncture, is believed to modulate pain pathways by stimulating specific points, potentially altering local purinergic signaling and inflammatory pathways. TMS uses magnetic pulses to influence brain activity, providing pain relief by targeting specific brain regions involved in migraine. nVNS stimulates the vagus nerve to modulate pain and reduce migraine symptoms. Understanding these mechanisms helps patients and clinicians choose appropriate treatments based on how they interact with the body's pain pathways, potentially leading to more effective and personalized migraine management.

Migraine-Associated Otalgia: An Underappreciated Entity.Acupuncture for migraine prophylaxis.[Evaluation of therapeutic effects of synthetic auricular point therapy for treatment of common migraine at the attack stage].