Auricular Acupuncture vs SOC in Migraine HA (MigAcu)

October 5, 2023 updated by: Danielle Graff, University of Louisville

A Randomized Trial Comparing Auricular Acupuncture and Intravenous Migraine Medications in the Treatment of Status Migrainosus in the Pediatric Emergency Department

Patients with migraine headache will be offered the opportunity to participate in this randomized study evaluating auricular acupuncture versus standard treatment for migraine headaches for patients in the pediatric emergency department (ED).

Study Overview

Status

Recruiting

Conditions

Migraine Headache

Intervention / Treatment

Detailed Description

Potential subjects will be identified using the diagnosis of migraine headache classified by the modified ICHD-II (International Classification for Headache Disorders) criteria proposed by Hershey et. al. This diagnosis will be confirmed by the investigators prior to enrollment of the subject and will be documented in the study documents. Subjects will be recruited during the scheduled work or research hours of the investigators in the ED.

Eligible patients will be informed of the study including a discussion of the two possible interventions. After informed consent and assent are obtained, patients will be randomly assigned 1 of the 2 arms of the study. The target is 40 subjects in each arm. Subjects will be assigned to a study group using a computer generated randomization schema. This randomization will only be known to one unblinded collaborator that will not be enrolling subjects or be involved in the data analysis.

If assigned to receive intravenous migraine medications the subject will be treated with the standard of care medications which include ketorolac (0.5mg/kg, max 30mg), metoclopramide (0.1 mg/kg, max 10mg), diphenhydramine (1mg/kg, max 50mg) plus a normal saline fluid bolus (20mL/kg, max 1000mL).

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. If the subject does not improve with acupuncture, they will be assessed by the ED physician and at the MD discretion further emergency department treatment will be administered which may include intravenous migraine medications as this is the current standard of care in the Norton Children's Hospital/Norton Children's Medical Center (KCH/KCMC) ED.

All subjects will be contacted 2 to 6 days after discharge to determine their clinical status. If the darts are still in place at the follow-up call, the subjects will be contacted at 2 weeks and weekly thereafter until all darts have fallen out.

Study Type

Interventional

Enrollment (Estimated)

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Danielle Graff, MD
Phone Number: 502-629-7212
Email: dmgraf02@louisville.edu

Study Contact Backup

Name: Mark J McDonald, MD
Phone Number: 602-852-3720
Email: mjmcdo01@louisville.edu

Study Locations

United States
- Kentucky
  - Louisville, Kentucky, United States, 40202
    - Recruiting
    - Norton Children's Hospital
    - Contact:
      
      Danielle M Graff, MD, MSc
    - Principal Investigator:
      
      Danielle M Graff, MD, MSc
    - Sub-Investigator:
      
      Mark McDonald, MD
    - Sub-Investigator:
      
      Beth Spurlin, MD
    - Sub-Investigator:
      
      Amy Hanson, MD
    - Sub-Investigator:
      
      Brit Anderson, MD
    - Sub-Investigator:
      
      Fred Warkentine, MD
  - Louisville, Kentucky, United States, 40241
    - Recruiting
    - Norton Children's Medical Center
    - Sub-Investigator:
      
      Mark McDonald, MD
    - Sub-Investigator:
      
      Beth Spurlin, MD
    - Sub-Investigator:
      
      Amy Hanson, MD
    - Sub-Investigator:
      
      Brit Anderson, MD
    - Sub-Investigator:
      
      Fred Warkentine, MD
    - Contact:
      
      Danielle Graff, MD, MSc
    - Principal Investigator:
      
      Danielle Graff, MD, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Confirmation of the diagnosis of migraine headache

Exclusion Criteria:

Patients who received ED migraine medications (including ibuprofen or other NSAIDS) prior to study evaluation.
Allergy to any of the medications used in our migraine regimen protocol.
Patients exhibiting focal clinical neurological exam findings that the investigator deems makes the patient not a good candidate for this study.
Patients with underlying abnormal brain pathology (e.g. mass or bleed) as the potential cause of the migraine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Auricular Acupuncture 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.	Other: Auricular Acupuncture ASP (acupuncture semi-permanent) gold needles will be placed in the efficacious ear points with a maximum of 3 needles in each ear.
Active Comparator: Medication and Fluid 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	Drug: Ketorolac 0.5mg/kg, max 30mg 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 Other Names: Toradol Drug: Metoclopramide 0.1 mg/kg, max 10mg 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 Other Names: Reglan Drug: Diphenhydramine 1mg/kg, max 50mg 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 Other Names: Benadryl Drug: Normal saline fluid bolus 20mL/kg, max 1000mL 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 Other Names: Normal Saline

Participant Group / Arm

Intervention / Treatment

Experimental: Auricular Acupuncture

Other: Auricular Acupuncture

ASP (acupuncture semi-permanent) gold needles will be placed in the efficacious ear points with a maximum of 3 needles in each ear.

Active Comparator: Medication and Fluid