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

Rutgers The State University of New Jersey

Status and phase: Terminated; Phase 4

Conditions: Transformed Migraine; Chronic Daily Headache

Treatments: Drug: Amitriptyline; Procedure: SPG Block with 5% Lidocaine gel

Study type: Interventional

Funder types: Other

Identifiers

NCT02090998

2012002610

Details and patient eligibility

About

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

Full description

Arm one will receive Sphenopalatine Ganglion Nerve Block weekly for 4 weeks

Arm two will receive Amitriptyline / Elavil daily for 30 Days

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

SPG Nerve Block with Lidocaine 5% gel

Active Comparator group

Description:

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

Treatment:

Procedure: SPG Block with 5% Lidocaine gel

Drug: Amitriptyline

Amitriptyline / Elavil

Active Comparator group

Description:

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

Treatment:

Procedure: SPG Block with 5% Lidocaine gel

Drug: Amitriptyline