Auricular Acupuncture vs SOC in Migraine HA

Migraine Headache Clinical Trial

— MigAcu  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02681211
• Other study ID #: 15.0827
• Status: Recruiting
• Phase: N/A
• Start date: February 2016
• Est. completion date: November 2024

Study information

• Verified date: October 2023
• Source: University of Louisville
• Contact: Danielle Graff, MD
• Phone: 502-629-7212
• Email: dmgraf02[@]louisville.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Headache
• Migraine Disorders
• Migraine Headache

Intervention

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.

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
• 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
• 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
• 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

Locations

Country	Name	City	State
United States	Norton Children's Hospital	Louisville	Kentucky
United States	Norton Children's Medical Center	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
University of Louisville

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Baseline and 15 minutes after completion of intervention
Secondary	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.	2 to 6 days