Efficacy of Nerve Blocks for Episodic Migraine

Overview

About this study

The purpose of this study is to compare whether anesthetizing multiple peripheral nerves of the scalp in the distribution of acute migraine headache pain (also known as multiple peripheral nerve block (MPNB)) provides more acute headache pain relief than greater occipital nerve block (GONB) alone. Also, to compare whether patients that received MPNB for acute migraine treatment have improved longer-term headache prophylaxis than patients that received GONB.

Additionally to determine whether there are fewer missed work/school/life activity days in the 12 weeks following nerve block for patients that received MPNB compared to patients that received GONB, and compare whether there are fewer Emergency Room/Clinic visits for headache in the 12 week follow up for patients that received MPNB compared to patients that received GONB.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

- Suffering from episodic migraines with and without aura occurring at least four times a month but less than 15 headache days 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.

Eligibility last updated 7/24/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Stephen Merry, M.D.

Open for enrollment

Contact information:

Lucas Timmons M.H.A.

(507) 266-0141

Timmons.Lucas@mayo.edu

More information

Publications

Publications are currently not available