Sphenopalatine Ganglion Nerve Block vs. Elavil for Treatment of Transformed Migraines
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Migraine Headaches, Migraine Headaches |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/7/2018 |
| Start Date: | May 2014 |
| End Date: | July 2021 |
A Comparison of the Efficacy of 5% Lidocaine Anesthetic to Provide SPGB Vs. Elavil for the Treatment of Transformed Migraine
This study will compare a local anesthetic technique that has been used to treat subjects
suffering from transformed migraines (chronic migraines) versus medical management with
traditional antidepressant Amitriptyline / Elavil.
Subjects will be randomized into one of two treatment groups to compare the safety and
efficacy of the therapies. Subjects will recieve either sphenopalatine ganglion nerve block
with 5% lidocaine gel into the nasopharynx or medical management with traditional
antidepressants, Elavil, to produce a reduction in the frequency and severity of the
headache.
We propose that there will be a difference in the outcomes when comparing the two methods of
treating transformed migraines and that one research arm will result in more patient
satisfaction and greater efficacy in the treatment of subjects
suffering from transformed migraines (chronic migraines) versus medical management with
traditional antidepressant Amitriptyline / Elavil.
Subjects will be randomized into one of two treatment groups to compare the safety and
efficacy of the therapies. Subjects will recieve either sphenopalatine ganglion nerve block
with 5% lidocaine gel into the nasopharynx or medical management with traditional
antidepressants, Elavil, to produce a reduction in the frequency and severity of the
headache.
We propose that there will be a difference in the outcomes when comparing the two methods of
treating transformed migraines and that one research arm will result in more patient
satisfaction and greater efficacy in the treatment of subjects
Arm one will receive Sphenopalatine Ganglion Nerve Block weekly for 4 weeks
Arm two will receive Amitriptyline / Elavil daily for 30 Days
Arm two will receive Amitriptyline / Elavil daily for 30 Days
Inclusion Criteria:
1. Male and female age 18-90
2. Subject have formal medical diagnosis of migraine headache
3. Subjects currently require treatment for headache
4. Subjects who have received optimal medical management from migraines including
triptans (Imitrex, Amerge and Relpax)
5. Subjects who have recieved optimal medical management for migraines including
anticonvulsants (Depakote, Lamictal, klonopin
Exclusion Criteria:
1. Less than 18 years of age
2. Subjects will be excluded if they are already being treated with lidocaine (patch or
other vehicle) for chronic pain
3. Untreated Heart Failure
4. Pregnancy
5. Individuals unwilling to comply with study procedures and follow-up
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