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

NCT ID: NCT02090998

Last Updated: 2024-07-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2020-03-16

Brief 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

Detailed Description

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

Arm two will receive Amitriptyline / Elavil daily for 30 Days

Conditions

Transformed Migraine; Chronic Daily Headache

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

SPG Nerve Block with Lidocaine 5% gel

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

Group Type: ACTIVE_COMPARATOR

SPG Block with 5% Lidocaine gel

Intervention Type: PROCEDURE

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

Amitriptyline

Intervention Type: DRUG

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

Amitriptyline / Elavil

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

Group Type: ACTIVE_COMPARATOR

SPG Block with 5% Lidocaine gel

Intervention Type: PROCEDURE

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

Amitriptyline

Intervention Type: DRUG

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

Interventions

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

Intervention Type: PROCEDURE

Amitriptyline

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

Intervention Type: DRUG

Other Intervention Names

Elavil

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rutgers, The State University of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

William Grubb, M.D.

Associate Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Rutgers, Robert Wood Johnson Medical School , Pain Center of NJ

New Brunswick, New Jersey, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2012002610

Identifier Type: -

Identifier Source: org_study_id