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Auricular Acupuncture vs SOC in Migraine HA (MigAcu)

Primary Purpose

Migraine Headache

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Auricular Acupuncture
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
Sponsored by
University of Louisville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine Headache focused on measuring migraine headache, acupuncture

Eligibility Criteria

8 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Norton Children's HospitalRecruiting
  • Norton Children's Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Auricular Acupuncture

Medication and Fluid

Arm Description

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 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

Outcomes

Primary Outcome Measures

Change in baseline pain score by a numerical self-reported visual analog pain score (VAS)
Pre-and post-intervention pain scores (0 to 10) by a numerical self-reported visual analog pain score (VAS)

Secondary Outcome Measures

Duration of pain relief using the VAS pain scale
Data to be collected on this phone follow-up include return of migraine/headache using the VAS pain scale; return to ED or PMD for migraine/headache symptoms; and medications taken for headache since discharge from the ED.

Full Information

First Posted
February 4, 2016
Last Updated
October 5, 2023
Sponsor
University of Louisville
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1. Study Identification

Unique Protocol Identification Number
NCT02681211
Brief Title
Auricular Acupuncture vs SOC in Migraine HA
Acronym
MigAcu
Official Title
A Randomized Trial Comparing Auricular Acupuncture and Intravenous Migraine Medications in the Treatment of Status Migrainosus in the Pediatric Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 2016 (Actual)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Louisville

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Headache
Keywords
migraine headache, acupuncture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Auricular Acupuncture
Arm Type
Experimental
Arm Description
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.
Arm Title
Medication and Fluid
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Auricular Acupuncture
Intervention Description
ASP (acupuncture semi-permanent) gold needles will be placed in the efficacious ear points with a maximum of 3 needles in each ear.
Intervention Type
Drug
Intervention Name(s)
Ketorolac 0.5mg/kg, max 30mg
Other Intervention Name(s)
Toradol
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Metoclopramide 0.1 mg/kg, max 10mg
Other Intervention Name(s)
Reglan
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Diphenhydramine 1mg/kg, max 50mg
Other Intervention Name(s)
Benadryl
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Normal saline fluid bolus 20mL/kg, max 1000mL
Other Intervention Name(s)
Normal Saline
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in baseline pain score by a numerical self-reported visual analog pain score (VAS)
Description
Pre-and post-intervention pain scores (0 to 10) by a numerical self-reported visual analog pain score (VAS)
Time Frame
Baseline and 15 minutes after completion of intervention
Secondary Outcome Measure Information:
Title
Duration of pain relief using the VAS pain scale
Description
Data to be collected on this phone follow-up include return of migraine/headache using the VAS pain scale; return to ED or PMD for migraine/headache symptoms; and medications taken for headache since discharge from the ED.
Time Frame
2 to 6 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Danielle Graff, MD
Phone
502-629-7212
Email
dmgraf02@louisville.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Mark J McDonald, MD
Phone
602-852-3720
Email
mjmcdo01@louisville.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janice Sullivan, MD
Organizational Affiliation
University of Louisville
Official's Role
Study Director
Facility Information:
Facility Name
Norton Children's Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Danielle M Graff, MD, MSc
First Name & Middle Initial & Last Name & Degree
Danielle M Graff, MD, MSc
First Name & Middle Initial & Last Name & Degree
Mark McDonald, MD
First Name & Middle Initial & Last Name & Degree
Beth Spurlin, MD
First Name & Middle Initial & Last Name & Degree
Amy Hanson, MD
First Name & Middle Initial & Last Name & Degree
Brit Anderson, MD
First Name & Middle Initial & Last Name & Degree
Fred Warkentine, MD
Facility Name
Norton Children's Medical Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Danielle Graff, MD, MSc
First Name & Middle Initial & Last Name & Degree
Danielle Graff, MD, MSc
First Name & Middle Initial & Last Name & Degree
Mark McDonald, MD
First Name & Middle Initial & Last Name & Degree
Fred Warkentine, MD
First Name & Middle Initial & Last Name & Degree
Amy Hanson, MD
First Name & Middle Initial & Last Name & Degree
Beth Spurlin, MD
First Name & Middle Initial & Last Name & Degree
Brit Anderson, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Auricular Acupuncture vs SOC in Migraine HA

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