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

Chronic Daily Headache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02090998
• Other study ID #: 2012002610
• Status: Terminated
• Phase: Phase 4
• Start date: May 2014
• Est. completion date: March 16, 2020

Study information

• Verified date: May 2023
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: March 16, 2020
• Est. primary completion date: March 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Daily Headache
• Headache
• Headache Disorders
• Migraine Disorders
• Transformed Migraine

Intervention

Procedure:
• SPG Block with 5% Lidocaine gel
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

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

Locations

Country	Name	City	State
United States	Rutgers, Robert Wood Johnson Medical School , Pain Center of NJ	New Brunswick	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Duration of Inactivity Associated With Headaches	The time after events that effects patient activity level	Study Day 1 thorugh Study Day 30
Primary	Number of Daily Headaches	The number of times per day that symptoms occur	Study Day 1 through Study Day 30