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

Phase 4TerminatedNCT02090998

Rutgers, The State University of New Jersey10 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Transformed Migraine Chronic Daily Headache

SPG Block with 5% Lidocaine gelPROCEDURE

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

AmitriptylineDRUG

The intervention will be Amitriptyline daily (starting with 10 mg) PO for 30 Days

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes