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RecruitingPhase 2

Efficacy of Nerve Blocks for Episodic Migraine

A Randomized Trial of Bilateral Greater Occipital Nerve Blocks Versus Ten Peripheral Nerve Blocks for Acute Relief and Prophylaxis of Episodic Migraine

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Phone or video check-ins, Questionnaires, Injections

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Study coordinators will then schedule a screening phone visit to explain the study and validate inclusion/exclusion criteria and obtain written consent either digitally, in person or eConsent and enroll the subject in the study."
  • "A brief interval history will be obtained by the investigator at the time of the appointment to confirm the details on an interval history questionnaire filled out by the patient earlier that day."
  • "Randomization codes generated by the statistician and kept in sealed opaque envelopes in the Procedure Clinic in a sequential order numbered #1 - #60 will be opened by the physician investigator performing the injection at the time of the visit."
  • "Any residual headache pain present 10 minutes after injections are completed will be identified and recorded by scalp location (central back of head, lateral back of head, temples, forehead, central forehead above the nose) and sidedness (left or right or both) and anesthesia in those nerve distributions assessed."
  • "Time to complete the GONBs or MPNBs will be recorded along with any need for repeat injection(s) specifying where they were repeated in the procedure note."
  • "Since both GONBs and MPNBs are presently standard of care for different consultants in different departments at our institution, safety monitoring will be through assessment of post-injection anesthesia and compliance with injection and anesthesia assessment technique and assuring repeat injection to the point of anesthesia to ensure both safety and data validity."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether numbing 2 to 10 scalp nerves can treat migraines and prevent them for months. It uses bupivacaine, a numbing drug, and low-dose methylprednisolone, a steroid. It is for people with migraines 4 to 14 times a month and pain rated at least 5 out of 10.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have migraines 4 to 14 times a month, with pain of at least 5 out of 10. Migraines may come with or without aura, such as vision changes.
  • Agree not to start or stop migraine treatment or prevention medicines during the 6-month study.
  • Have headaches lasting 4 to 72 hours with at least two features: one-sided pain, throbbing pain, moderate to severe pain, or pain that gets worse with or makes you avoid everyday physical activity.
  • During headaches, have at least one of these: nausea or vomiting, discomfort from light, or discomfort from sound.

Who can't join

  • Have headache pain in the cheeks as well as the scalp; certain other headache types caused by medicine overuse, neck problems, or injury; or cluster headaches or their symptoms.
  • Are pregnant or breastfeeding, or could become pregnant and will not use reliable birth control during treatment.
  • Have an allergy or another medical reason you cannot use the listed numbing drugs or steroids, or have had a nerve block before.
  • Take blood thinners or opioid pain medicines, or get Botox to prevent migraines.
  • Started a migraine-prevention medicine in the past 2 months, or plan to start any new medicine during the study.
  • Have a history of drug or alcohol abuse in the past 2 years, or an unstable illness or surgical condition that could keep you from taking part.
  • Have had surgery that opened or drilled holes in the skull, skull fractures, or an opening in the skull; or have an implanted nerve stimulator or shunt, a tube that drains fluid.
  • Have a strong fear of needles, or a skin or tissue infection where the shots would be given.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Suffering from episodic migraines with and without aura occurring at least four times a month but less than 15 times a month at a severity of 5/10 pain level or greater. * Willing to not start or stop any new medication to treat or prevent migraines during the six months of the trial. * History fits the definition of migraine: * Have a history of episodic headache lasting 4-72 hours with at least 2 of the 4 following: unilateral location, pulsating/throbbing quality, moderate-severe intensity, aggravation by/causing avoidance of routine physical activity, and * Have a history of at least one of the following: nausea and/or vomiting, photophobia (seek out a dark room during a headache because that feels better), phonophobia (seek out a quiet environment during a headache because that feels better) Exclusion Criteria: * Headache in cheeks (infraorbital nerve distribution) in addition to scalp distribution. * Women who report being currently pregnant or lactating or are of child-bearing potential or are likely to become pregnant during the medication phase and are unwilling to use a reliable form of contraception. Acceptable forms include: * Hormonal methods, such as birth control pills, patches, injections, vaginal ring, or implants * Barrier methods (such as a condom or diaphragm) used with a spermicide (a foam, cream, or gel that kills sperm) * Intrauterine device (IUD) * Total hysterectomy or tubal ligation * Abstinence (no sex) * Allergy or documented contraindication to amide anesthetics (bupivacaine, lidocaine, ropivacaine, prilocaine, mepivacaine, etidocaine or levobupivacaine) or corticosteroids * Previously received peripheral nerve blocks (PNBs) * Currently anticoagulated * Currently receiving Botox for migraine prophylaxis * Started on new medication in the prior two months with known migraine-preventive efficacy or planning to start any new medication during the study * Currently using opiate medications for pain * History of drug or alcohol abuse within the prior two years * Have unstable medical or surgical diseases that could impair participation in this study * History of craniotomies, burr holes, skull fractures and/or have open skull defects * Patients with implanted nerve stimulators or shunts * Phobia of needles * Active skin or soft tissue infection overlying injection sites * Diagnosis of medication overuse, cervicogenic, post-traumatic, or cluster headaches or history on pre-enrollment questionnaire of cluster headache symptoms.

Study sites (1)

MN