Sphenopalatine Ganglion Nerve Block vs. Elavil for Treatment of Transformed Migraines

Study Overview
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Brief Summary
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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

Detailed Description
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Arm one will receive Sphenopalatine Ganglion Nerve Block weekly for 4 weeks Arm two will receive Amitriptyline / Elavil daily for 30 Days

Official Title
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A Comparison of the Efficacy of 5% Lidocaine Anesthetic to Provide SPGB Vs. Elavil for the Treatment of Transformed Migraine

Conditions
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Transformed Migraine, Chronic Daily Headache

Intervention / Treatment
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* Procedure: SPG Block with 5% Lidocaine gel
* Drug: Amitriptyline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female age 18-90 Subject have formal medical diagnosis of migraine headache Subjects currently require treatment for headache Subjects who have received optimal medical management from migraines including triptans (Imitrex, Amerge and Relpax) Subjects who have recieved optimal medical management for migraines including anticonvulsants (Depakote, Lamictal, klonopin Exclusion Criteria: Less than 18 years of age Subjects will be excluded if they are already being treated with lidocaine (patch or other vehicle) for chronic pain Untreated Heart Failure Pregnancy Individuals unwilling to comply with study procedures and follow-up

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SPG Nerve Block with Lidocaine 5% gel<br>Sphenopalatine Ganglion Nerve Block (SPG Nerve Block) will be administed weekly for 4 weeks using 5% Lidocaine gel This intervention (a nerve block) will treat the headache for the time period investigated | Procedure: SPG Block with 5% Lidocaine gel<br>* cotten tipped applicators are with 5% lidocaine gel and placed in the nares to lye in the skin over the sphenopalitine ganglion. The applcator is use to saturate the spenopalitine ganglion with 5ml of 1% lidocaine local anesthesia<br>Drug: Amitriptyline<br>* The intervention will be Amitriptyline daily (starting with 10 mg) PO for 30 Days<br>* Other names: Elavil;|
| Active Comparator: Amitriptyline / Elavil<br>Amitriptyline / Elavil 10 mg once a day for one week then Amitriotyline 20 mg once a day for three weeks This intervention will treat the headache for the time period investigated | Procedure: SPG Block with 5% Lidocaine gel<br>* cotten tipped applicators are with 5% lidocaine gel and placed in the nares to lye in the skin over the sphenopalitine ganglion. The applcator is use to saturate the spenopalitine ganglion with 5ml of 1% lidocaine local anesthesia<br>Drug: Amitriptyline<br>* The intervention will be Amitriptyline daily (starting with 10 mg) PO for 30 Days<br>* Other names: Elavil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Daily Headaches | The number of times per day that symptoms occur | Study Day 1 through Study Day 30 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Migraine Headache, Menstrual Migraine, Vascular Headache, Temporal Lobe Seizure