New Clinical Study on Sphenopalatine Ganglion (SPG) Blocks to Prevent Migraine at UCSF

Sphenopalatine Ganglion Blocks have been utilized for over 100 years to treat a wide variety of chronic pain, headaches, Cluster Headaches, migraines, sinus headaches and many other conditions.
A new study is beginning at UCSF to study the effects of various nasal anesthetics for the prevention of migraines.  This is an enormous opportunity for patients in the San Francisco area who are interested in preventing migraines.
This study will focus on different anesthetics.  This author feels that the anesthetic is far less important than the frequency of the blocks.  In my practice I routinely teach self-administration of SPG Blocks with cotton-tipped nasal catheters giving patients full contol of when to utilize these blocks as preventive agent as well as for acute pain.
Sphenopalatine Ganglion Blocks or Pterygopalatine Ganglion Blocks were originally described by Greenfeld Sluder MD in 1908 to treat “Sluder’s Neuralgia” which is now thought to be either Cluster Headaches or TMJ Disorder headaches.
The Sphenopalatine Ganglion is the largest Parasympathetic Ganglion of the head and it contains Sympathetic fibers from the Superior Sympathetic Chain.  These sympathetic and parasympathetyic nerves travel along the fibers of all branches of the Trigeminal Nerve.  The Trigeminal Nerve is often referred to as “The Dentist’s Nerve” due to the expertise of dentists in dealing with the nerve that goes to the teeth, the dental pulp, the periodontal ligaments, the gums, the anterior 2/3 of the tongue, the mucosal  lining of the nose and sinuses and many other structures.  More importantly it also goes to the TMJoints, the joint capsules, the retrodiscal lamina which is richly innervated, the masitcatory muscles, the muscle spindles and golgi tendon organs, the muscles that open and close the eustacian tube and the tensor of the air drums.  It is the largest proprioceptive input to the brain and accounts for over 50% of all brain input after amplification in the Reticular Activating System.
The Trigeminal nerve is of  key importance to every type of headache.   Much of this is believed to be directly related to the autonomic nerves, both sympathetic and parasympathetic fibers  that travel on the trigeminal nerve branches.
TMJ disorders are often called “The Great Imposter” because they duplicate so many pain disorders.  In recent time there has been a classification of headache disorders that suffers greatly from misunderstanding the input to the brain from the trigeminal nervous system to the limbic system and the effects on the Hypothalamus, Pituitary and Adrenal glands.
When Sluder first studied this subject it was 30 years prior to Dr Costen’s articles on Costen’s Syndrome, now know as TMJ disorders or TMD.  The ULF-TENS utilized in Neuromuscular Dentistry acts as a neuromodulation device for the Sphenopalatine Ganglion as well as working directing on the trigeminally innervated muscles by a single synapse reflex.
ClinicalTrials.gov

Sphenopalatine Ganglion Blocks RCT (SPG Block)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03666663
Recruitment Status  : Not yet recruiting

First Posted  : September 12, 2018
Last Update Posted  : September 12, 2018
Sponsor:
Information provided by (Responsible Party):
Nina Riggins, MD, University of California, San Francisco
Study Description
Brief Summary:
RCT of Sphenopalatine Ganglion (SPG) Blocks using anesthetics vs. placebo for migraine.
Condition or disease  Intervention/treatment  Phase 
Migraine Drug: LidocaineDrug: Marcaine or RopivacaineDrug: Placebos Phase 2
Detailed Description:

Migraine is a disabling brain disorder with high prevalence. SPG blocks are widely used as an acute treatment of migraine; although the preventive effects have not been widely studied.

The sphenopalatine ganglion is located in the pterygopalatine ganglia close to the sphenopalatine foramen and is located below the maxillary nerve as it crosses the fossa. The sphenopalatine ganglion has multiple connections to facial, trigeminal, parasympathetic and sympathetic systems.

Due to the unique location it is possible to interrupt a pain signal by administering SPG blocks. As with many other preventive treatments, it appears to take up to 3-4 months to see long term headache benefit.

Study Design
Study Type  : Interventional  (Clinical Trial)
Estimated Enrollment  : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized placebo controlled study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double blind study
Primary Purpose: Prevention
Official Title: UCSF Sphenopalatine Ganglion Block Study- a Randomized Double Blind Placebo Controlled Trial to Compare Nasal Anesthetics for Migraine Prevention in Adults.
Estimated Study Start Date  : October 1, 2018
Estimated Primary Completion Date  : October 1, 2022
Estimated Study Completion Date  : October 1, 2023
Resource links provided by the National Library of Medicine

MedlinePlus related topics: HeadacheMigraine
Drug Information available for: Lidocaine
Arms and Interventions
Arm  Intervention/treatment 
Experimental: Lidocaine

Lidocaine anesthetic
Drug: Lidocaine

Lidocaine anesthetic
Experimental: Marcaine or Ropivacaine

Marcaine or Ropivacaine or comparable anesthetic available
Drug: Marcaine or Ropivacaine

Marcaine or Ropivacaine or comparable anesthetic available
Placebo Comparator: Placebo (saline)

Placebo (saline)
Drug: Placebos

Placebo Saline
Other Name: Placebo Saline
Outcome Measures
Primary Outcome Measures  :

  1. Reduction in headache days [ Time Frame: 16 weeks ]
    Reduction in headache days from baseline to month 3 of treatment
Eligibility Criteria
Information from the National Library of MedicineChoosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Inclusion Criteria:

  1. Current patients in the UCSF Headache Center who wish to receive SPG blocks for migraine and would otherwise receive treatment clinically
  2. Ability to provide consent for the research study
  3. Able to read and understand English

Exclusion Criteria:

  1. Patients who cannot read and understand English
  2. Deemed unsuitable for enrollment in study by the investigator
  3. Allergy to lidocaine, marcaine, ropivacaine, anesthetics, or saline
Contacts and Locations
Information from the National Library of MedicineTo learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03666663

Contacts
Contact: Nina Riggins, MD 415-885-7832 laura.dapkus@ucsf.edu
Locations
United States, California
UCSF Headache Center Not yet recruiting
San Francisco, California, United States, 94115
Contact: Nina Riggins, MD    415-885-7832    laura.dapkus@ucsf.edu
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Nina Riggins, MD UCSF Headache Center
More Information
Publications of Results:

Responsible Party: Nina Riggins, MD, Assistant Clinical Professor of Neurology, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03666663History of Changes
Other Study ID Numbers: 18-25736_SPG_2018.09
First Posted: September 12, 2018    Key Record Dates
Last Update Posted: September 12, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:

Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Lidocaine
Ropivacaine
Bupivacaine
Anesthetics
Anesthetics, Local
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

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