Efficacy of Nerve Blocks for Episodic Migraine
ConditionEpisodic Migraine
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
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)
Disqualifiers
Headache in cheeks (infraorbital nerve distribution) in addition to scalp distribution.
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Bupivacaine HCl 0.5% Injectable Solution
DrugWill receive 0.5 ml (supratrochlear) to 1.0 ml (supraorbital, auriculotemporal) to 1.25 ml (greater and lesser occipital) for each nerve block. Will receive 0.25 ml or 10 mg methylprednisolone to each greater and lesser occipital nerve in the MPNB arm and 0.5 ml or 20 mg methylprednisolone to both greater occipital nerves in the GONB arm.
Methylprednisolone 40 MG Injection
DrugWill receive 10 mg (0.25 ml) mixed with 1.25 ml Bupivacaine 0.5% for each greater and lesser occipital nerve block if MPNB group or 20 mg (0.5 ml) methylprednisolone in each GON if GONB group.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Greater Occipital Nerve block groupExperimental treatment 2 interventions
Group B: Multiple Peripheral Nerve block groupExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Elimination of acute headache
Number of subjects to experience an elimination of acute headache (pain freedom) defined as pain 0/10
Time frame
20 minutes after the last nerve intended for blockSecondary outcomes
1
Days of work/school/life event absenteeism
Number of days subjects miss work, school or life events due to headaches following peripheral nerve block
Time frame
3 months after peripheral nerve block2
Headache Pain Reduction
Headache pain NRS 0-1/10 severity
Time frame
Measured at 20 minutes after confirmation of all nerves blocked3
Sustained pain freedom
Patient report of any headache pain (yes/no) on electronic questionnaire the day after the PNBs
Time frame
History of headache pain for the prior 24 hours the day after PNB intervention.4
Time to pain freedom
Time between PNBs and when headache reaches 0/10 NRS
Time frame
measurement of pain every 5 minutes during PNBs to measure rapidity of headache resolutionOther outcomes
1
Average headache days
Number of days subjects experience headaches after peripheral nerve block
Time frame
3 months after peripheral nerve blockSponsors and contacts
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Source ClinicalTrials.gov