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.
Do I have to stop taking my current medications for the trial?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 on a stable medication regimen for migraines, you can continue it, but you cannot change it.
Is the treatment Methylprednisolone, Nerve Blocks a promising treatment for migraines?Yes, Methylprednisolone, Nerve Blocks is a promising treatment for migraines. Studies show that occipital nerve blocks, which include Methylprednisolone, can effectively reduce migraine pain, frequency, and duration. Many patients experience significant pain relief after receiving this treatment, making it a valuable option for managing migraines.478910
What safety data is available for nerve blocks used in migraine treatment?The safety data for nerve blocks, including occipital nerve blocks, used in migraine treatment indicates that they are generally considered safe and well-tolerated. However, there are some reported adverse effects. A case report noted a transient facial nerve palsy following an occipital nerve block, which resolved within hours. Another study found that 9% of patients experienced adverse effects from lidocaine and Depo-medrol injections, with higher concentrations of lidocaine (5%) posing more risk, especially in elderly patients. Overall, while occipital nerve blocks are mostly safe, there are potential risks, particularly with higher anesthetic concentrations and bilateral injections.356711
What data supports the idea that Nerve Blocks for Migraines is an effective treatment?The available research shows limited support for the effectiveness of Nerve Blocks for Migraines. One study on occipital nerve block (ONB) for migraine prevention found no strong evidence from randomized, placebo-controlled trials to support its use. Another study on cluster headaches, which are similar to migraines, showed mixed results: some patients experienced reduced severity and frequency of headaches, while others did not respond at all. Overall, the data does not strongly support the effectiveness of Nerve Blocks for treating migraines compared to other treatments.12379
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 allergic or cannot take certain anesthetics or corticosteroids.
I don't have unstable diseases, recent major head surgeries, nerve stimulators, shunts, or infections at injection sites.
I have been diagnosed with a specific type of headache.
Treatment Details
The 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.
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
Research locations nearbySelect from list below to view details:
Mayo Clinic in RochesterRochester, MN
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Who is running the clinical trial?
Mayo ClinicLead Sponsor
References
Management of diskogenic pain using epidural and intrathecal steroids. [2019]The use of methylprednisolone acetate (Depo-Medrol) injected by the epidural or intrathecal route for the relief of diskogenic back pain with or without radiculopathy is an adjunct to conservative management useful when conservative measures fail and surgical treatment is under consideration. This is especially true when symptoms have been present for only a few months. Corticosteroids injected in the same manner seem to have little effect on patients with symptoms persisting for periods longer than 3 months or in patients treated previously by surgical methods.
The effects of Depo-Medrol preservative on the rabbit visual system. [2018]Periocular injections of corticosteroids play an important role in the management of various ophthalmologic diseases. The Depo-Medrol vehicle, injected into the vitreous, was shown to be toxic to the lens and to the retina when applied at double strength. The authors examined the effects of Depo-Medrol and one of the components of its vehicle, myristyl-gamma-picolinium chloride (MGP), on the functional integrity of the rabbit visual system. Visual function was assessed objectively from the electroretinogram (ERG) and the visual evoked potential (VEP). The experimental drugs were injected into the vitreous humor of one eye while saline was injected into the fellow eye for control. Depo-Medrol did not produce any measurable effects on the ERG or the VEP. When MGP solutions were injected in concentrations at least twice as large as that in the Depo-Medrol, significant reductions in the light- and dark-adapted ERG responses were seen. The effects of the drug on the ERG responses was seen as early as 3 days postinjection and developed to its maximal level within 1-2 weeks. No ERG recovery was seen over a period of more than 2 months. The VEP, elicited by applying light stimuli to the experimental eye, was characterized by low amplitude and delayed implicit time compared with the response obtained from the control eye.
[Treatment of vascular pain of the face by methylprednisolone injection into the area of the greater occipital nerve: 16 cases]. [2013]Sixteen patients suffering from cluster headache received an injection of 160 mg methylprednisolone into the region of the greater occipital nerve ipsilateral to the pain, when free of headache. In episodic cluster (n = 8), attacks ceased in 2 cases and decreased in severity and frequency in one other. Three patients failed to respond at all. Two became headache-free, but the injection had possibly been performed towards the time when the episode might have been expected to end spontaneously. In chronic cluster (n = 8), four patients failed to respond at all. Four others improved, but only partially and transiently. On the whole, the present results are not as favourable as those obtained by Anthony, who advocated this technique.
Blocking the greater occipital nerve: utility in headache management. [2021]Occipital nerve block has been part of headache medicine for more than half a century, with injection techniques and solutions varying greatly. Most studies have been case series and many show benefit for patients with migraine, cluster headache, and postconcussive headache. A double-blind, controlled trial of cluster headache has demonstrated that injectable steroids with local anesthetics benefit cluster headache patients. A double-blind, controlled trial of nerve blocks in occipital neuralgia, which may have actually been chronic migraine, was positive.
Adverse effect profile of lidocaine injections for occipital nerve block in occipital neuralgia. [2021]To determine whether there are differences in the adverse effect profile between 1, 2 and 5% Lidocaine when used for occipital nerve blocks (ONB) in patients with occipital neuralgia. Occipital neuralgia is an uncommon cause of headaches. Little is known regarding the safety of Lidocaine injections for treatment in larger series of patients. Retrospective chart analysis of all ONB was performed at our headache clinic during a 6-year period on occipital neuralgia patients. 89 consecutive patients with occipital neuralgia underwent a total of 315 ONB. All the patients fulfilled the IHS criteria for Occipital Neuralgia. Demographic data were collected including age, gender, and ethnicity. The average age of this cohort was 53.25 years, and the majority of patients were females 69 (78%). Ethnicity of patients was diverse, with Caucasian 48(54%), Hispanics 31(35%), and others 10 (11%). 69 patients had 1%, 18 patients had 2% and 29 patient were given 5% Lidocaine. All Lidocaine injections were given with 20 mg Depo-medrol and the same injection technique and location were used for all the procedures. Eight patients (9%)had adverse effects to the Lidocaine and Depo-medrol injections, of which 5 received 5% and 3 received 1% Lidocaine. Majority of patients who had adverse effects were female 7(87%), and had received bilateral blocks (75%). ONB is a safe procedure with 1% Lidocaine; however, caution should be exerted with 5% in elderly patients, 70 or older, especially when administering bilateral injections.
Transient facial nerve palsy after occipital nerve block: a case report. [2014]Occipital nerve blocks are commonly performed to treat a variety of headache syndromes and are generally believed to be safe and well tolerated. We report the case of an otherwise healthy 24-year-old woman with left side-locked occipital, parietal, and temporal pain who was diagnosed with probable occipital neuralgia. She developed complete left facial nerve palsy within minutes of blockade of the left greater and lesser occipital nerves with a solution of bupivicaine and triamcinolone. Magnetic resonance imaging of the brain with gadolinium contrast showed no abnormalities, and symptoms had completely resolved 4-5 hours later. Unintended spread of the anesthetic solution along tissue planes seems the most likely explanation for this adverse event. An aberrant course of the facial nerve or connections between the facial and occipital nerves also might have played a role, along with the patient's prone position and the use of a relatively large injection volume of a potent anesthetic. Clinicians should be aware that temporary facial nerve palsy is a possible complication of occipital nerve block.
Occipital nerve block for the short-term preventive treatment of migraine: A randomized, double-blinded, placebo-controlled study. [2017]Occipital nerve (ON) injections with corticosteroids and/or local anesthetics have been employed for the acute and preventive treatment of migraine for decades. However, to date there is no randomized, placebo-controlled evidence to support the use of occipital nerve block (ONB) for the prevention of migraine.
Use of occipital nerve block in emergency department treatment of status migrainosus. [2019]Migraine headaches make up a significant proportion of emergency department visits. There are multiple pharmacologic treatment modalities for migraine abortive therapy; however, these treatments are rarely targeted to the precise area of pain and thus elicit multiple systemic effects. It has been well established in the anesthesia pain literature that occipital nerve blocks can provide not only immediate pain relief from occipital migraines, but can also result in a long-term resolution of occipital migraines. In this case report, we present how an occipital nerve block in the emergency department resulted in immediate and long-lasting resolution of a patient's occipital migraine.
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]Greater occipital nerve block (GONB) is thought to be an effective treatment for acute migraine, though no randomized efficacy data have been published for this indication. We hypothesized that bilateral GONB with bupivacaine would provide greater rates of headache freedom than a sham injection among a population of emergency department (ED) patients who reported persistence of moderate or severe headache despite standard treatment with intravenous metoclopramide.
Evaluation of Occipital Nerve Blocks for Acute Pain Relief of Migraines. [2021]Migraines are a debilitating neurological disease affecting as many as 1 of 6 adults in the United States. Occipital nerve block, consisting of a local anesthetic and/or corticosteroid, has shown to be an effective treatment for the management of migraines. Occipital nerve block has been reported to reduce migraine pain scores, frequency, and duration. We aimed to evaluate the impact of occipital nerve block for acute pain relief in patients with migraines. This was a single-center retrospective observational study conducted at a 1162-bed academic medical center in Gainesville, Florida. Included patients were ≥18 years old, diagnosed with migraine with or without aura, and received at least 1 occipital nerve block. Excluded patients received nerve blocks not specific to the occipital region. The outcomes observed were migraine pain before and after administration within the same initial encounter of receiving an occipital nerve block using a numeric pain rating scale, injection direction, medications used, duration of effect and frequency of additional injections, and adverse reactions. A total of 190 patients met the inclusion criteria, with 63% rating their pain to be 6-8 of 10 prior to an occipital nerve block. After receiving an occipital nerve block, 27% of patients reported significant or immediate relief, and 42% experienced reduced pain scores of 0-2. The majority of injections were bilateral using lidocaine with dexamethasone. Only 3% of patients reported an adverse reaction. Occipital nerve block as adjunctive therapy has shown safety and efficacy in treating patients with migraines, measured by the reduction in pain.
Evaluating the Anatomic Spread of Selective Nerve Scalp Blocks Using Methylene Blue: A Cadaveric Analysis. [2023]The modern scalp block consists of local anesthesia injections that target the supraorbital, supratrochlear, zygomaticotemporal, auriculotemporal, and greater and lesser occipital nerves. Limited data exist on the local anesthetic spread that occurs with this technique. This study examines the extent of the spread of a scalp block using methylene blue in a cadaveric model.