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

Condition(s) targeted: Transformed Migraine; Chronic Daily Headache

Intervention: SPG Block with 5% Lidocaine gel (Procedure); Amitriptyline (Drug)

Phase: Phase 4

Status: Enrolling by invitation

Sponsored by: Rutgers, The State University of New Jersey

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

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Number of Daily Headaches

Secondary outcome: Length of duration of headache

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Rutgers, Robert Wood Johnson Medical School , Pain Center of NJ, New Brunswick, New Jersey 08901, United States

Starting date: May 2014
Last updated: March 18, 2014