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

• ClinicalTrials.gov Identifier: NCT02090998
• Recruitment Status: Terminated
• First Posted: March 19, 2014
• Results First Posted: December 29, 2021
• Last Update Posted: December 29, 2021
• Sponsor: Rutgers, The State University of New Jersey
• Information provided by (Responsible Party): William Grubb, M.D., Rutgers, The State University of New Jersey

Study Description

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

Condition or disease	Intervention/treatment	Phase
Transformed Migraine; Chronic Daily Headache	Procedure: SPG Block with 5% Lidocaine gel; Drug: Amitriptyline	Phase 4

Detailed Description:

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

Arm two will receive Amitriptyline / Elavil daily for 30 Days

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: A Comparison of the Efficacy of 5% Lidocaine Anesthetic to Provide SPGB Vs. Elavil for the Treatment of Transformed Migraine
• Study Start Date: May 2014
• Actual Primary Completion Date: March 16, 2020
• Actual Study Completion Date: March 16, 2020

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 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	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; Other Name: Elavil
Active Comparator: 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	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; Other Name: Elavil

Outcome Measures

Primary Outcome Measures :

1. Number of Daily Headaches [ Time Frame: Study Day 1 through Study Day 30 ]
   The number of times per day that symptoms occur

Other Outcome Measures:

1. Duration of Inactivity Associated With Headaches [ Time Frame: Study Day 1 thorugh Study Day 30 ]
   The time after events that effects patient activity level

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, New Jersey

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

New Brunswick, New Jersey, United States, 08901

Sponsors and Collaborators

Rutgers, The State University of New Jersey

  Study Documents (Full-Text)

Documents provided by William Grubb, M.D., Rutgers, The State University of New Jersey:

Study Protocol and Statistical Analysis Plan  [PDF] August 3, 2021

Informed Consent Form  [PDF] August 3, 2021

More Information

• Responsible Party: William Grubb, M.D., Associate Prof., Rutgers, The State University of New Jersey
• ClinicalTrials.gov Identifier: NCT02090998
• Other Study ID Numbers: 2012002610
• First Posted: March 19, 2014
• Results First Posted: December 29, 2021
• Last Update Posted: December 29, 2021
• Last Verified: November 2021

Keywords provided by William Grubb, M.D., Rutgers, The State University of New Jersey:

Migraine Headache; Menstrual Migraine; Vascular Headache; Temporal Lobe Seizure

Additional relevant MeSH terms:

Migraine Disorders; Headache Disorders; Headache; Headache Disorders, Primary; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Lidocaine; Amitriptyline; Amitriptyline, perphenazine drug combination; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents; Anti-Arrhythmia Agents; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Antidepressive Agents, Tricyclic; Antidepressive Agents; Psychotropic Drugs; Analgesics, Non-Narcotic; Analgesics; Adrenergic Uptake Inhibitors; Neurotransmitter Uptake Inhibitors