60 Participants Needed

Nerve Blocks for Migraines

FM
Overseen ByFamily Medicine Research Study Coordinators
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

The purpose of this study is to see how well blocking two to ten of the scalp nerves (that give feeling to the scalp and are painful during migraine headaches) with bupivacaine anesthetic (numbing medication) and low dose methylprednisolone (cortisone-like medicine or steroid) work for treating and preventing migraines. Our hypothesis is that the pain of most episodic migraine headaches can be eliminated and prevented for months by blocking the nerves that give pain sensation during a migraine.

Will I have to stop taking my current medications?

The trial requires that you do not start or stop any new medication to treat or prevent migraines during the six months of the trial. If you are currently using opiate medications for pain or have started a new migraine-preventive medication in the last two months, you may not be eligible to participate.

What data supports the effectiveness of the treatment for migraines?

There is some evidence that injections near the occipital nerve with corticosteroids like methylprednisolone can help reduce the frequency and severity of cluster headaches, which are similar to migraines. However, there is no strong evidence from randomized studies to support the use of occipital nerve blocks specifically for preventing migraines.12345

Is the occipital nerve block generally safe for humans?

Occipital nerve blocks are generally considered safe, but there can be temporary side effects like facial nerve palsy, which is a temporary weakness or paralysis of the facial muscles. This side effect is rare and usually resolves within a few hours. Caution is advised when using higher concentrations of anesthetics, especially in older patients.12678

How is the treatment of nerve blocks with Methylprednisolone unique for migraines?

This treatment is unique because it involves injecting a combination of a corticosteroid (Methylprednisolone) and a local anesthetic directly into the occipital nerve area, which can provide immediate and long-lasting relief from migraine pain by targeting the precise area of pain, unlike many other treatments that have systemic effects.19101112

Research Team

SM

Stephen Merry, MD, MPH

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for individuals who experience episodic migraines at least four times a month but less than fifteen, with pain levels of 5/10 or higher. Participants should not start or stop any migraine medications during the six-month study and must fit the specific criteria for migraine headaches. Pregnant women, those allergic to anesthetics or steroids, on certain medications like blood thinners, Botox for migraines, opiates, or have a history of substance abuse are excluded.

Inclusion Criteria

I agree not to change my migraine medications for six months.
I have a history of migraines lasting 4-72 hours with specific symptoms.
I experience migraines 4-14 times a month with severe pain.

Exclusion Criteria

I am not pregnant, breastfeeding, or planning to become pregnant without using contraception.
I am allergic or cannot take certain anesthetics or corticosteroids.
You have had issues with using drugs or alcohol in the past two years.
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (virtual or in-person)

Run-in

Participants maintain a headache diary for baseline data collection

4 weeks
Weekly electronic diary submissions

Treatment

Participants receive either GONBs or MPNBs for acute migraine treatment

1 day
1 visit (in-person)

Follow-up

Participants are monitored for headache frequency and severity, and absenteeism

12 weeks
Weekly electronic diary submissions

Treatment Details

Interventions

  • Methylprednisolone
  • Nerve Blocks
Trial OverviewThe study tests if nerve blocks using bupivacaine (a numbing agent) and low-dose methylprednisolone (a steroid) can treat and prevent episodic migraines by targeting scalp nerves linked to migraine pain. The hypothesis suggests that this treatment could relieve pain and prevent future episodes for months.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Multiple Peripheral Nerve block groupExperimental Treatment2 Interventions
Subjects will receive 10 nerve blocks to include bilateral greater occipital, lesser occipital, auriculotemporal, supraorbital and supratrochlear nerves.
Group II: Greater Occipital Nerve block groupExperimental Treatment2 Interventions
Subjects will receive bilateral greater occipital nerve blocks for a total of 2 blocks

Methylprednisolone is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Medrol for:
  • Allergic reactions
  • Blood disorders
  • Cancer
  • Eye diseases
  • Immune system disorders
  • Inflammatory diseases
  • Respiratory diseases
  • Skin diseases
🇪🇺
Approved in European Union as Depo-Medrol for:
  • Allergic reactions
  • Blood disorders
  • Cancer
  • Eye diseases
  • Immune system disorders
  • Inflammatory diseases
  • Respiratory diseases
  • Skin diseases
🇨🇦
Approved in Canada as Solu-Medrol for:
  • Allergic reactions
  • Blood disorders
  • Cancer
  • Eye diseases
  • Immune system disorders
  • Inflammatory diseases
  • Respiratory diseases
  • Skin diseases

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

Findings from Research

Occipital nerve block (ONB) with a combination of local anesthetic and corticosteroid did not show a significant reduction in the frequency of moderate to severe migraine days compared to a placebo, with both groups having a 30% response rate.
The study involved 69 patients with episodic or chronic migraines, and the results suggest that ONB may not be an effective preventive treatment for migraines, as there was no substantial difference in outcomes between the active and placebo groups.
Occipital nerve block for the short-term preventive treatment of migraine: A randomized, double-blinded, placebo-controlled study.Dilli, E., Halker, R., Vargas, B., et al.[2017]
In a study of 16 patients with cluster headaches, an injection of 160 mg methylprednisolone into the greater occipital nerve showed mixed results, with some patients experiencing cessation or reduction in headache severity, while others did not respond at all.
Overall, the efficacy of this treatment was not as favorable as previously reported, indicating that while some patients may benefit, the response can be variable and not guaranteed.
[Treatment of vascular pain of the face by methylprednisolone injection into the area of the greater occipital nerve: 16 cases].Bigo, A., Delrieu, F., Bousser, MG.[2013]
Methylprednisolone acetate (Depo-Medrol) injections via epidural or intrathecal routes can effectively relieve diskogenic back pain and radiculopathy when conservative treatments have failed, particularly if symptoms have lasted less than three months.
Corticosteroid injections are less effective for patients with chronic symptoms lasting over three months or those who have previously undergone surgery, suggesting a limited window for optimal use.
Management of diskogenic pain using epidural and intrathecal steroids.Brown, FW.[2019]

References

Occipital nerve block for the short-term preventive treatment of migraine: A randomized, double-blinded, placebo-controlled study. [2017]
[Treatment of vascular pain of the face by methylprednisolone injection into the area of the greater occipital nerve: 16 cases]. [2013]
Management of diskogenic pain using epidural and intrathecal steroids. [2019]
The effects of Depo-Medrol preservative on the rabbit visual system. [2018]
A Randomized, Sham-Controlled Trial of Bilateral Greater Occipital Nerve Blocks With Bupivacaine for Acute Migraine Patients Refractory to Standard Emergency Department Treatment With Metoclopramide. [2019]
Transient facial nerve palsy after occipital nerve block: a case report. [2014]
Evaluating the Anatomic Spread of Selective Nerve Scalp Blocks Using Methylene Blue: A Cadaveric Analysis. [2023]
Adverse effect profile of lidocaine injections for occipital nerve block in occipital neuralgia. [2021]
Evaluation of Occipital Nerve Blocks for Acute Pain Relief of Migraines. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Blocking the greater occipital nerve: utility in headache management. [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
Use of occipital nerve block in emergency department treatment of status migrainosus. [2019]
Comparison of greater occipital nerve and supra orbital nerve blocks methods in the treatment of acute migraine attack: A randomized double-blind controlled trial. [2022]