Auricular Acupuncture vs SOC in Migraine HA

NCT ID: NCT02681211

Last Updated: 2023-10-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2024-11-30

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.

Conditions

Migraine Headache

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Auricular Acupuncture

Intervention Type: OTHER

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

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:

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

Group Type: ACTIVE_COMPARATOR

Ketorolac 0.5mg/kg, max 30mg

Intervention Type: DRUG

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

Metoclopramide 0.1 mg/kg, max 10mg

Intervention Type: DRUG

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

Diphenhydramine 1mg/kg, max 50mg

Intervention Type: DRUG

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

Normal saline fluid bolus 20mL/kg, max 1000mL

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: OTHER

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:

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

Intervention Type: 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:

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

Intervention Type: 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:

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

Intervention Type: 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:

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

Intervention Type: DRUG

Other Intervention Names

Toradol; Reglan; Benadryl; Normal Saline

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Louisville

OTHER

Sponsor Role: lead

Responsible Party

Danielle Graff

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Janice Sullivan, MD

Role: STUDY_DIRECTOR

University of Louisville

Locations

Norton Children's Hospital

Louisville, Kentucky, United States

Site Status: RECRUITING

Norton Children's Medical Center

Louisville, Kentucky, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Danielle Graff, MD

Role: CONTACT

dmgraf02@louisville.edu

502-629-7212

Mark J McDonald, MD

Role: CONTACT

mjmcdo01@louisville.edu

602-852-3720

Facility Contacts

Danielle M Graff, MD, MSc

Role: primary

Danielle Graff, MD, MSc

Role: primary

Other Identifiers

15.0827

Identifier Type: -

Identifier Source: org_study_id