Migraine HeadacheMigAcuNCT02681211
Auricular Acupuncture vs SOC in Migraine HA
A study testing Auricular Acupuncture, Ketorolac 0.5mg/kg, max 30mg and Metoclopramide 0.1 mg/kg, max 10mg in people with Migraine Headache, run by University of Louisville at 2 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Migraine Headache
- What is being tested?
- Auricular Acupuncture, Ketorolac 0.5mg/kg, max 30mg and Metoclopramide 0.1 mg/kg, max 10mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2016to Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Confirmation of the diagnosis of migraine headache
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Norton Children's Hospital
Louisville, Kentucky, 40202
Danielle M Graff, MD, MSc
Danielle M Graff, MD, MSc
- Recruiting
Norton Children's Medical Center
Louisville, Kentucky, 40241
Danielle Graff, MD, MSc
Danielle Graff, MD, MSc
About this study
Official title: 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).
Read the 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
- Being tested
- 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
- Keywords
- migraine headache, acupuncture
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular AcupunctureOther
ASP (acupuncture semi-permanent) gold needles will be placed in the efficacious ear points with a maximum of 3 needles in each ear.
Ketorolac 0.5mg/kg, max 30mgDrug
Also called Toradol
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 10mgDrug
Also called Reglan
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 50mgDrug
Also called Benadryl
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 1000mLDrug
Also called Normal Saline
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
| Study group | Role | What they receive |
|---|---|---|
| Auricular Acupuncture | Experimental | 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. Receives: Other: Auricular Acupuncture |
| Medication and Fluid | Active comparator | 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 Receives: Drug: Ketorolac 0.5mg/kg, max 30mg; Drug: Metoclopramide 0.1 mg/kg, max 10mg; Drug: Diphenhydramine 1mg/kg, max 50mg; Drug: Normal saline fluid bolus 20mL/kg, max 1000mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline and 15 minutes after completion of intervention
Secondary outcomes (1)
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.
Measured: 2 to 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionNov 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine HeadacheStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Danielle Graff, University of Louisville
- Investigators
- Janice Sullivan, MD, Study director, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02681211
- Sponsor's protocol ID
- 15.0827
- Acronym
- MigAcu
- Status last verified
- Oct 2023
- First submitted
- 4 Feb 2016
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial Comparing Auricular Acupuncture and Intravenous Migraine Medications in the Treatment of Status Migrainosus in the Pediatric Emergency Department
- ClinicalTrials.gov ID
- NCT02681211
- Acronym / sponsor ID
- MigAcu / 15.0827
- Conditions
- Migraine Headache
- Keywords
- migraine headache, acupuncture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 12 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Auricular Acupuncture | Experimental | Other: Auricular AcupunctureIf 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. |
| Medication and Fluid | Active comparator | Drug: Ketorolac 0.5mg/kg, max 30mg, Drug: Metoclopramide 0.1 mg/kg, max 10mg, Drug: Diphenhydramine 1mg/kg, max 50mg, Drug: Normal saline fluid bolus 20mL/kg, max 1000mLIf 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 |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Confirmation of the diagnosis of migraine headache
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auricular AcupunctureASP (acupuncture semi-permanent) gold needles will be placed in the efficacious ear points with a maximum of 3 needles in each ear. | Other | Auricular Acupuncture |
| Ketorolac 0.5mg/kg, max 30mgAlso: ToradolIf 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 | Drug | Medication and Fluid |
| Metoclopramide 0.1 mg/kg, max 10mgAlso: ReglanIf 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 | Drug | Medication and Fluid |
| Diphenhydramine 1mg/kg, max 50mgAlso: BenadrylIf 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 | Drug | Medication and Fluid |
| Normal saline fluid bolus 20mL/kg, max 1000mLAlso: Normal SalineIf 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 | Drug | Medication and Fluid |
Primary outcome
Change in baseline pain score by a numerical self-reported visual analog pain score (VAS)
Time frame: Baseline and 15 minutes after completion of intervention
Pre-and post-intervention pain scores (0 to 10) by a numerical self-reported visual analog pain score (VAS)
1 secondary outcome
Duration of pain relief using the VAS pain scale
Time frame: 2 to 6 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janice Sullivan, MD study director
University of Louisville
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auricular Acupuncture, Ketorolac 0.5mg/kg, max 30mg and Metoclopramide 0.1 mg/kg, max 10mg in people with Migraine Headache, run by University of Louisville at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Danielle Graff, MD (502-629-7212, dmgraf02@louisville.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in baseline pain score by a numerical self-reported visual analog pain score (VAS) (time frame: Baseline and 15 minutes after completion of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.