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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 to 6 days
Awards & highlights
MigAcu Trial Summary
This trial will test if auricular acupuncture, a form of traditional Chinese medicine, is effective in treating migraines in children.
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.Check my eligibility
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.See study design
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.
MigAcu Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 to 6 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 to 6 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in baseline pain score by a numerical self-reported visual analog pain score (VAS)
Secondary outcome measures
Duration of pain relief using the VAS pain scale
MigAcu 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:
Ketorolac 0.5mg/kg, max 30mg
Metoclopramide 0.1 mg/kg, max 10mg
Diphenhydramine 1mg/kg, max 50mg
Normal saline fluid bolus 20mL/kg, max 1000mL
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Who is running the clinical trial?
University of LouisvilleLead Sponsor
338 Previous Clinical Trials
75,904 Total Patients Enrolled
Janice Sullivan, MDStudy DirectorUniversity of Louisville
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have taken migraine medication, including ibuprofen, before this study.My doctor thinks my neurological symptoms make me unsuitable for this study.My migraines may be caused by a brain condition like a tumor or bleeding.You are allergic to any of the medications used in our migraine treatment plan.You have been diagnosed with migraine headaches.
Awards:
This trial has 3 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How does Auricular Acupuncture compare to other treatments?
"Auricular Acupuncture is being trialled in 84 studies currently, 19 of which are in Phase 3. A majority of these Auricular Acupuncture clinical trials are based in Boston, yet there are 869 total locations running these medical trials."
Answered by AI
What benefits does Auricular Acupuncture have for patients?
"Auricular Acupuncture, which is commonly used to alleviate nausea, can also be applied to other areas such as the eyes, and can be used to help with pain and gastroparesis."
Answered by AI
Is this clinical trial only for people under 40 years old?
"According to the medical trial's inclusion criteria, participants must be aged 8 to 18 years old. Out of the 642 clinical trials searching for participants, 62 are for people under 18 and 242 are for seniors."
Answered by AI
Who else is applying?
What site did they apply to?
Norton Children's Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
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