The trigeminal cardiac reflex (TCR) is a unique, powerful, and well-established neurocardiogenic reflex that is a result of stimulation along the path of the fifth cranial nerve (trigeminal nerve). It can produce adverse cardiorespiratory changes including hypotension, bradycardia, and asystole, as well as gastric consequences such as hypermotility. This reflex has been reported to occur in various surgical conditions, as well as in neurosurgical interventions.
Sleep bruxism, thought to be a more intense form of rhythmic masticatory muscle activity, has a prevalence of about 8%1 and has been explicitly linked to the TCR.2We report a case of a young woman with severe bruxism who incited her TCR, which subsequently produced profound nocturnal pauses that ultimately required dual-chamber pacemaker implantation.
A 27-year-old woman presented with palpitations and syncope. Three years prior to presentation she developed nocturnal and early morning nausea and vomiting that would often wake her from sleep. She was noted to have a long-standing history of severe bruxism with physical signs on examination of significant attrition. This had persisted despite the use of a retainer and bite block. Evaluation with Holter monitoring revealed sinus bradycardia, intermittent second-degree type II atrioventricular (AV) block, and a pause of 8.6 seconds (Figure 1). Interestingly, the rhythm strips showed simultaneous effects on both the sinus and AV node, suggesting an autonomic etiology. Of note, these rhythm disturbances were principally nocturnal in nature. While she was wearing the Holter, the husband was awake and corroborated that she was having severe episodes of bruxism. Further cardiac evaluation was unrevealing, including a normal echocardiogram, cardiac magnetic resonance imaging, sleep study, and thorough autonomic testing. With her constellation of symptoms—severe bruxism, AV nodal block with cardiac pauses (that were predominantly nocturnal), and gastrointestinal symptoms—we diagnosed her with hypervagotonia from stimulation of the powerful TCR from severe bruxism (Figure 2). Out of concern for risk of cardiac death from these pauses without a stable ventricular escape, we elected to place a dual-chamber pacemaker for bradycardic prevention.
This case highlights the intricate and noteworthy relationship between the autonomic nervous system and the heart. Our patient developed high-grade AV block and syncope owing to significant and profound hypervagotonia. Based upon her evaluation and corroboration of these events by her husband, we deemed that her intense vagal stimulation was a consequence of her severe bruxism, which was eliciting the TCR.
The TCR (Figure 2) is a powerful brain stem reflex that can be associated with a sudden onset of parasympathetic dysrhythmia, sympathetic hypotension, or gastric hypermotility. The proposed mechanism of this reflex is stimulation of the sensory nerve endings of the trigeminal nerve (Figure 2, cranial nerve V), which sends signals via the Gasserian ganglion (Figure 2, indicated by asterisk) to the sensory nucleus of the trigeminal nerve (Figure 2 inset). The afferent pathway then continues along the short internuncial nerve fibers in the reticular formation to connect with the efferent pathway, the motor nucleus of the vagus nerve (Figure 2, cranial nerve X). The last part of the reflex is formed by cardioinhibitory efferent fibers, which connect the motor nucleus of the vagus nerve to the myocardium.3
Bruxism is a common occurrence in the population (8%) and has been associated with alterations in the autonomic nervous system and stimulation of the TCR.2, 4, 5, 6 The mechanism behind the TCR stimulation is felt to be 2-fold. Firstly, masticatory movements (rhythmic masticatory muscle activity) and secondly, teeth contact can stimulate mechanoreceptors in the periodontal tissue.7 The link between bruxism, TCR, and alteration in the autonomic nervous system is important to highlight as it is well established that the autonomic nervous system plays a critical role in the pathogenesis of various cardiac arrhythmias, particularly atrial fibrillation. Although not specifically related to our patient, the fact that bruxism is so common raises the potential role it could be contributing to autonomic drivers of atrial fibrillation, and this is something that requires further research examination.
2. Schames S.E., Schames J., Schames M., Chagall-Gungur S.S. Sleep bruxism, an autonomic self-regulating response by triggering the trigeminal cardiac reflex. J Calif Dent Assoc. 2012;40:670–671. 674–676. [PubMed]
3. Arasho B., Sandu N., Spiriev T., Prabhakar H., Schaller B. Management of the trigeminocardiac reflex: facts and own experience. Neurol India. 2009;57:375–380. [PubMed]
4. Gastaldo E., Quatrale R., Graziani A., Eleopra R., Tugnoli V., Tola M.R., Granieri E. The excitability of the trigeminal motor system in sleep bruxism: a transcranial magnetic stimulation and brainstem reflex study. J Orofac Pain. 2006;20:145–155. [PubMed]
5. Chowdhury T., Bindu B., Singh G.P., Schaller B. Sleep disorders: is the trigemino-cardiac reflex a missing link? Front Neurol. 2017;8:63. [PubMed]
6. Sjoholm T.T., Piha S.J., Lehtinen I. Cardiovascular autonomic control is disturbed in nocturnal teethgrinders. Clin Physiol. 1995;15:349–354. [PubMed]
7. Okada Y., Kamijo Y., Okazaki K., Masuki S., Goto M., Nose H. Pressor responses to isometric biting are evoked by somatosensory receptors in periodontal tissue in humans. J Appl Physiol. 2009;107:531–539. [PubMed]
DNA and RNA Appliance are used to Treat a wide variety of issues including TMJ disorders, Headaches, Migraines, Snoring and Sleep Apnea. Postural disorders to impaired breathing can be related to chronic head and neck pain and spread postural issues throughout the body.
It is vitally important for dentistry and medicine to address the development of airway issues that last a lifetime. I primarily work with older children, adolescents and adults in my practice. Children, even very young children receive the biggest benefit from expansion of airways. The DNA/RNA Appliance gives an important second chance to patients who did not properly develop as children. Adults can now be treated without orthognathic surgery, tongue reduction and other invasive procedures.
The DNA Appliances are changing the field or dental orthodontics from cosmetic shifting of teeth in available bone into the field of Epigenetic Orthopedics correcting problems that conventional orthodontics never addressed.
Orthodontics utilizing braces and brackets or plastic aligners as used by Invisalign, Smile Direct and other systems is about moving the teeth in the available bone to create a prettier smile and straighter teeth. Phased orthodontics in children has to a small extent embraced expansion of bone to create more space to straighten the teeth. Airway has only been minimally addressed by most of orthodontics.
There are many orthodontists who still practice “Contraction Orthodontics” also known as “Four on the Floor” or Bicuspid Extraction cases. The thought process is the you “Amputate” the teeth to make room in the mouth for all of the remaining teeth. This Contraction Orthodontics” makes the teeeth fit but crowds the tongue and impairs breathing.
Unfortunately, until recently the question of airway and ideal development of the jaws has not been addressed. There have been major changes in the last few hundred years to patterns of orofacial and cranial bone growth. These are negative epigenetic changes due to environmental issues including pollution, changes in how babies are fed and nurtured as new borns ant throughout their early lives. This has led to a massive problem of underdeveloped maxillas, mandiibles and airways.
I became involved in the early 1980’s in managing airway in adults by treating sleep apnea and snoring. I saw my son Billy had issues but when he was ready to start Kindergarten he was evaluated and I was told he had ADD, ADHD, could not start Kindergarten and needed to be on
Ritalin for life. You worry about your child’s when they cannot start kindergarten and I refused the diagnosis and took Billy to Rush Medical School for a sleep study. He had severe sleep apnea and we proceeded to have tonsils and adenoids removed and at 5 orthopedic expansion of hist maxilla. He had a tongue and lip tie corrected as well. He became a straight “A” student, went from 50% growth curve to 90% growth curve, slept well and mood was vastly improved. He graduated college double major, double minor Magna Cum Laude, His drug of choice was Oxygen not Ritalin. I became a Visiting Assistant Professor at Rush Medical School Sleep Center in 1985 and did research into similarities in jaw position in sleep apnea patients and TMJ patients.
Breast feeding is a major factor in the development of proper facial form. “Form follows function” is a truth in medicine and the changes in how babies are fed and nurtured has changed, which changes their development. These changes in growth and development affect airway and sleep, intelligence and learning and most importantly brain development and function and can lead to learning and behavioral disorders including ADD, ADHD and ODD. Many of these disorders are related to sleep disordered breathing including snoring, increased upper airway resistance syndrome (UARS), Respiratory effort related arousals (RERA) Hypopnea, Sleep Apnea.
The underdevelopment of the nasal oropharyngeal airway is the single biggest culprit and creates problems not just in infants, children and adolescents but also problems that last a lifetime. Sleep Apnea can cause issues with insulin resistance, memory loss and dementia, they cause a 300-600% increase in heart attacks and strokes as well as motor vehicle accidents, are implicated in hypertension, metabolic syndrome and obesity. Ideally a narrow airway is corrected before 8 years of age and it was thought expansion was limited if not impossible in adolescents and adults. The DNA Appliance has changed all that and expansion is possible throughout your life.
The DNA Appliance is an FDA approved orthodontic device that can often correct all of these issues. The RNA version of the
DNA Appliance is an FDA approved Sleep Apnea Appliance. Both the DNA and RNA Appliance utilize Epigenetic Orthopedics to grow larger airways and offer the possibility of curing sleep disordered breathing in all forms. The process of growing a larger airway has been called Pneumopedics by Dr David Singh who invented the DNA Appliance.
I will present several video testimonials of patients who have utilized the DNA/RNA Appliances. The first one is a patient experiencing major improvement in nasal breathing after just a few months of treatment. When the maxilla is expanded the roof of the mouth widens and high palates correct themselves flattening out. The hard palate is the roof of the mouth but that same bone is also the floor of the nose. With epigenetic expansion the cross section of the nose dramatically increases in both height and width. The expansion of the mouth makes more room for the tongue.
Nasal breathing increase the amount of Nitric Oxide the body produces which is the single most powerful antioxidant known. A Nobel prize has been given for work on Nitric oxide.
Sleep Apnea is a serious medical issue for millions of Americans. There are many treatments available to treat Sleep Apnea, the best known treatment is CPAP or Continuous Positive Airway Pressure which uses a compressor to deliver pressurized air through the nose and/or mouth through a mask. CPAP is extremely effective when it is used by patients but only about one in four patients prescribed CPAP actually use it on a regular basis. The 25% of patients who utilize CPAP is dwarfed in number by the 60% of patients who reject or fail CPAP completely. Approximately 15% try to manage CPAP but do poorly. Success is not the norm with CPAP in spite of the fact that it is extremely effective when used and is considered the “Gold Standard” of treatment.
The primary reason patients don’t use CPAP is that they “Hate CPAP”. Oral Appliances are also extremely successful at treating Sleep Apnea and are considered a first line approach for mild to moderate sleep apnea and an alternative to CPAP for severe sleep apnea. They are under prescribed primarily due ignorance in the medical community about effectiveness. CPAP is a billion dollar industry that has tremendous monetary power and thee makers of CPAP machines also make much of the diagnostic instrumentation for sleep.
The website https://www.IHATECPAP.com is an excellent resource to learn more about Sleep Apnea diagnosis and treatment. The name of the website is from patients who when asked why the wanted an oral appliance would commonly reply “I HATE CPAP!”
The following is a video of a physician describing his experience with an oral appliance to treat sleep apnea. Many physicians choose not to utilize CPAP but rather a comfortable oral appliance. Oral Appliances are excellent for managing Sleep Apnea but the DNA/RNA Appliances offer a “CURE”! Patients with sleep apnea must have their sleep apnea treated but it can be managed for a lifetime without negative consequences.
The following video is a physician whose life was affected by her sleep apnea and who chose to seek a cure for her apnea rather than just a treatment. She has not completed treatment at the time this video was made. Prior to treatment she was living in a state of exhaustion. The RNA Appliance is acting as both a sleep appliance and is growing her airway orthopedically. When the DNA/RNA Appliance is used to cure sleep apnea it actually results in a 24/7 improvement in airway not just a correction during sleep. This patient discusses oral Myofunctional Therapy which can aid in expansion and ideally should be utilized in every single orthodontic treatment. More important pediatric dentists and physicians should learn to be aware of these developmental issues and address them as soon as possible to prevent future issues. In retrospect, my son would have been far better off having his airway issues treated far earlier. Brain development is changed by sleep apnea even in infants and very young children.
TMJ Disorders, Chronic Headaches and Migraines and other types of Orofacial pain are often associated with airway issues. The National Heart Lung and Blood Institute published a report “The cardiovascular and sleep related consequences of TMJ disorders” The NHLBI of the NIH considers Sleep Apnea to be a TMJ disorder. The DNA Appliance is often utilized as a second phase of treatment for patients with TMD. The following is a patient who has lived her entire life with an underdeveloped maxilla and is using the DNA/RNA appliance to pneumopedically grow a larger airway and orthopedically grow her maxilla in order to treat her TMJ disorder. While she is still early in treatment she feels that her TMJ disorder has been cured. Her lower jaw (mandible) was locked in a posterior position and maxillary expansion has given it freedom to move forward and relieve abnormal pressure in the TM Joints
The next video is a patient who has lived with chronic head and neck pain for many years and initially was treated with a neuromuscular dental orthotic and is now utilizing the DNA Appliance to complete her treatment (Phase 2 ). She describes a wide variety of improvements after wearing the DNA Appliance for a couple of months. When you breathe better and correct airway issues it has positive effects throughout the entire body.
The next video is a patient who has had a lifetime of sinus issues and TMJ issues. While here TMJ issues were dealt with her small airway would create a less stable result and relapse. The DNA Appliance is being utilized to increase her airway and led to dramatic improvements in he sinus issues. Listen as she discusses how improved breathing is improving all aspects of her life.
Shimshak et al published a paper in Cranio Journal in 1998 looking at medical expenses in patients with TMJ disorders and found that there was a 300% increase in medical expenses in every single field of medicine. We now know that sleep and airway are very closely related and that the increase in medical expenses has many causes but treatment with the DNA Appliance addresses a wide spectrum of these issues. I wrote an article for Cranio Journal in 2013. The full ediitorial can be found at https://www.tandfonline.com/doi/pdf/10.1179/crn.2013.001?needAccess=true. I was asked to write this editorial by Riley Lunn tthe editor of
Cranio Journal because I had been treating sleep and airway issues since 1982 long before most of medicine or dentistry ever looked at airway and sleep apnea.
TMJ Alias, The Great Imposter, Has a Co-Conspirator: Poor Sleep
The next patient is much younger and his parents who are both Chiropractors brought him in to address airway issues that were leading to forward head posture and was affecting his posture in his entire body. Chiropractors are very aware of how head and jaw position affect the entire body.
The DNA Appliance is giving three dimensional expansion and there is a cascade of positive outcomes that occur as airway improves.
The next video is of Lewis who is now utilizing his RNA Appliance instead of CPAP while he is growing a larger airway. He appreciates being able to go camping with his appliance, something he could not do with CPAP.His teeeth have straightened out and he has a bigger better lower jaw.
The DNA and RNA Appliance utilize Epigenetic Orthodontics which is the single most exciting advancement in dentistry today. While it is called epigenetic orthodontics a more accurate name would be epigenetic orthopedics because it actually grows and reshapes and idealizes the bone rather than just move the teeth. This is far different than typical orthodontics.
This technological advances of the Vivos System allows us to comfortably create (grow) big wide healthy looking smiles even in patients with narrow arches. Patients with weak chins and poor profiles can see improvements often even early in treatment. In an ideal world every patient would naturally have developed big wide healthy arches with resultant large airways and enough room for their lower jaw to grow ideally.
One very special aspect of utilizing the DNA Appliance and Epigenetic Orthodontics is that the appliances are only worn for 14-16 hours per day. This is very different that standard orthodontics with brackets and wire or Invisalign®. Most of the wear can be done in your sleep, watching TV or commuting. During the day at work or with friends you can be free of the appliance. This is one of the special features patients love about the DNA Appliance, the convenient fit into your lifestyle.
The time when the appliances are out the teeth move to ideal position as nature and/or genes intended.
Typical orthodontics is a four-step process designed to move teeth through the bone. The first step is FORCE that creates PRESSURE (1) that compresses the periodontal ligament and puts pressure on the bone. The second step is INFLAMATION (2) which is associated with pain and discomfort. The third step which is RESORBTION (3) which is breaking down the bone by osteoclasts to create space. The fourth step is CONSOLIDATION (4) where new bone is formed. The process is then repeated after every orthodontic visit when braces are tightened or with each new Invisalign® tray.
Epigenetic Orthodontics is very different because it is a two step process. The forces are very light and movement is limited to 250 microns approximately every four days. The light forces are applied and growth and movement occur without inflammation which makes the entire process practically pain free. If there is any discomfort the adjustments are spaced out further.
Relapse is frequently a problem with orthodontics after orthodontists have used fixed braces to straighten crooked teeth. Relapse is the teeth moving back to their original position and relapse is why orthodontists make retainers. The reason for relapse is complex and not well understood. The hours when the appliance is out let the teeth follow natural eruption processes with far lower risks of relapse.
According to Dr. Dave Singh the Founder of the field of pneumopedics and craniofacial epigenetics which includes epigenetic orthodontics “there is a natural way for the body to remodel the upper airway, reshape bone and move teeth into their correct positions painlessly without the use of surgery, drugs or injections.”
Professor G. Dave Singh DDSc, PhD, BDS states on his website: “However, the entire human genome has now been sequenced, and we now know that certain genes are involved in moving teeth. Teeth are naturally-designed to move, for example, tooth eruption in a normally-growing child. In addition, the teeth in some people erupt in a specific arrangement, producing a beautiful smile. Dr Singh believes that the specific arrangement of teeth is due to certain genes. In fact, a natural process called ‘temporo-spatial patterning’ is at work. This process is the blueprint or body plan that is encoded by genes. In other words, the right and left sides of the body, the top and bottom of the body as well as the front and back of the entire body is under the control of a genetic body plan, including the teeth. Sometimes, however, the plan gets disturbed, producing crooked teeth and improper orthopedics.”:
Getting Older or Getting Better™. THE CHOICE IS YOURS! Come in and find out what is possible.
The Vivos DNA Appliance allows us to grow and develop a more ideal facial structure and a healthier airway.
Dr. Shapira has long had a special interest in developmental processes because of his work with sleep apnea in children and adults. Dr Shapira also has over 38 years experience in treating difficult TMJ Disorders, Migraines, headaches and other Chronic Pain. When these processes go are disturbed it changes how people breathe and swallow. Young children are frequently put in expanders to expand their maxilla or upper jaw. This is needed because of negative epigenetic changes caused by environmental allergies, food allergies or disturbed growth from insufficient breast feeding and bottle feeding.
Dr. Shapira, has taught classes to hundreds of dentists and their teams on how to treat sleep apnea with oral appliance therapy. It is one of Dr. Shapira’s students Dr .Martha Cortes who first introduced him to Dr Singh and to this exciting new field.
Dr Shapira has studied this field extensively and in 2014 gave a lecture in Buenos Aires, Argentina on the “Common Developmental Pathways of TMJ Disorders and Sleep Apnea.” These pathways are an example of negative environmental effects on development that can be reversed in adults who were not expanded as children. Prior to the DNA Appliance only extensive orthognathic surgery was available to widen or move bone.
Faces are different and each and every one of us is unique. Our appearance and physiology is determined by our DNA or genes. Genes determine our physiology and everything else about us. This is a description of Genetics
What many people are not aware of is that the environment and other factors can change how our genes express themselves. These types of changes are called Epigenetic changes.
Each person has a unique Genotype, these are the genes we inherited from our parents that when combined created a unique and special person. Identical twins actually share a identical DNA .
The Phenotype is how are Genes are expressed, the effects of the environment on us. These are the epigenetic changes that can be positive or negative in nature. This can be the difference between a big wide smile that shows all the teeth
What makes the DNA Appliance special is that it uses the patient’s own genes to modify and change not just the position of the teeth but the size, shape and position of the bone that holds the teeth as well as Pneumopedically change the size and shape of the airway. This 3-D spatial reconfiguring of the teeth and bone can make amazing changes not just in the teeth but in the face as well. The changes the DNA Appliance stimulates mimic the natural developmental process that occur in an ideal world. Biomimetic is the term used to describe what the DNA Appliance accomplishes, it mimics through biologic means what an ideal environment would have developed.
Oral appliances are frequently worn as a comfortable alternative to CPAP to manage snoring and obstructive sleep apnea. These appliances often protrude the lower jaw and are needed for life. Pneumopedics® is a term coined by Dr Singh to describe non-surgical upper airway remodeling is a different approach because instead of merely repositioning the lower jaw during sleep it gently allows allows the body to gently and gradually orthopedically increase the size of the upper jaw and increase the nasal airway. This has been shown in some clinical cases to create a cure for sleep apnea and snoring. The FDA-registered Daytime-Nighttime Appliance® system (or DNA appliance®) is worn during the evening and night for a total of 14-16 hours/day
Patients who are CPAP intolerant can utilize the FDA-cleared, patented mandibular Repositioning-Nighttime Appliance® (or mRNA appliance®) which works to maintain an open airway in the fashion of sleep apnea oral while gently re-developing the upper airway and moving the mandible or lower jaw and the teeth into a more natural position.
The DNA appliance® and mRNA appliance® protocols can effectively address TMD issues and headaches in both adults and children. Dr Shapira is a leader in the use of the DNA Appliance to finish phase two treatment in TMD patients.
TMJ disorders have been called “The Great Imposter” because they can masquerade as many different types of problems and are usually misdiagnosed multiple times before being identified.. Most physicians other than ENT’s know very little about TMJ Disorders (TMD) .
Chronic Sinus Headache and other Sinus Pains are closely related to TMJ Disorders. The connections between these problems is multifacted.
The Trigeminal Nerve also called the Dentist’s Nerve is the underlying common source of all of these problems.
Dentists are the experts on the Trigeminal Nerrve Disorders and in particular neuromuscular dentists who optimize eliminating noxious input to the trigeminal system. The term “TMJ: The Great Imposter” was coinded because patients with TMJ disorders frequently report symptoms not specifically related to the joints.
Dentists who practice TMD and Neuromuscular Dentistry are well versed in Myofascial Pain and Dysfunction or MPD as it relates to upper body, head neck and facial pain referred from active myofascial trigger points.
The Sphenopalatine Ganglion (SPG), the largest parasympathetic ganglion in the head is on the maxillary division of the trigeminal nerve. I have taught hundreds of neuromuscular dentists both from the USA and from across the world how to utilize SPG Blocks as part of Neuromuscular Treatment.
The Sphenopalatine Ganglion also contains Sympathetic fibers of superior cervical change responsible for “Fight or Flight” reflex and when not controlled create a wide variety of stress, pain and emotional issues.
The Myomonitor utilized by Neuromuscular Dentistry effectively neuromodulates the sympathetic and parasympathetic autonnomic input from the Trigeminal Nervous System.
The majority of sinus pain and sinus headache are NOT primary issues or infections within the sinuses. Antibiotics may actually create new sinus issues related to fungal infections.
Sinus pain and Headaches can be relieved with SPG Blocks very quickly.
Long term sinus improvements are related to function and structure. The following is a video of a patient who has experienced a cure of her lifetime sinus issues with DNA Appliance. Neuromuscular Dentistry treated her TMJ disorders and the DNA is used for long term stabilization and to increase the size of her airway.
There are over 150 additional videos on treatment of TMJ Disorders, Headaches, Migraines, MPD, Fibromyalgia, Sinus pain, Sleep Apnea and snoring mat this link: https://www.youtube.com/channel/UCk9Bfz6pklC7_UluWFHzLrg/videos
This new article in Cranio (abstract below) discusses use of SPG Blocks in treating Facial Pain of Nasal Origin. I teach patients to self administer these block for many types of headache and facial pain.
This specific case was due to a nasal contact headache where the nasal turbinate is touching the septum.
Another approach is to grow the underdeveloped maxilla to open up airway, decrease sinus pain and infections while improving breathing.
This video is a patient who has used SPG Blocks in the past but is now making permanent changes in her nasal airway to improve health including TMJ disorder with the DNA Appliance and Epigenetic orthopedics/ orthodontics.
Cranio. 2018 Jun 8:1-3. doi: 10.1080/08869634.2018.1475859. [Epub ahead of print]
Efficacy of sphenopalatine ganglion block in nasal mucosal headache presenting as facial pain.
Lee SH1, Kim Y1, Lim TY1.
Background When intranasal contact points are the cause of headache and facial pain, opinions regarding whether to remove intranasal contact points when they are believed to be the cause of headache and facial pain are divided. Clinical Presentation A 46-year-old woman visited the authors’ pain clinic with complaints of right nasal pain accompanied by frontotemporal headache. She first met an Otorhinolaryngologist and a neurologist. Based on nasal endoscopy and pain pattern, they presumed that her pain was a nasal mucosal headache rather than migraine. A mild septal deviation to the right side with bony spur near the inferior turbinate was observed. The use of medication provided very insufficient relief. However, the sphenopalatine ganglion (SPG) block provided excellent pain relief, and the effect lasted for six months. Conclusion Considering the mechanism of pain in intranasal contact point headache, (SPG) block is a potentially effective therapeutic tool.
A new article published in 208 discusses utilization of Sphenopalatine Ganglion Blocks for treatment of Severe Migraine. Because it is published byty.the US National Library of Medicine of the National Institute of Health I can reprint it here.
I will make my personal comments in ALL CAPITAL LETTERS. I ALSO FIND THAT SPG BLOCKS CAN TREAT MANY OTHER DISORDERS INCLUDING FIBROMYALGIA, NECK, BACK, TMJ DISORDERS, TMD AND SHOULDER PAINS.
SELF-ADMINISTRATION OF SPG BLOCKS SHOULD BE CONSIDERED BY ALL PATIENTS WITH CHRONIC HEAD AND NECK PAIN, CLUSTER HEADACHES, ACUTE MIGRAINES, SINUS PAIN, SINUS HEADACHE AND EYE PAIN. THIS DOES NOT MEAN THAT NEW PAIN SHOULD NOT BE EVALUATED BY APPROPRIATE PHYSICIANS AND SPECIALISTS.
INTRESTING NEW STUDIES HAVE SHOWN SPG BLOCKS ELIMINATING ESSENTIAL HYPERTENSION IN ONE THIRD OF PATIENTS.
Transnasal sphenopalatine ganglion (THE SPHENOPALATINE GANGLION IS ALSO KNOWN AS THE PTERYGOPALATINE GANGLION, MECKEL’S GANGLIO, THE NASAL GANGLION AND SLUDER’S GANGLION) block is emerging as is an attractive and effective treatment modality for acute migraine headaches, cluster headache, trigeminal neuralgia, and several other conditions. We assessed the efficacy and safety of this treatment using the Sphenocath® device. 55 patients with acute migraine headaches underwent this procedure, receiving 2 ml of 2% lidocaine in each nostril. (2% LIDOCAINE HAS ANTIINFLAMATORY PROPERTIES AND HAS VERY FAVORABLE SAFETY PROFILE) Pain numeric rating scale (baseline, 15 minutes, 2 hours, and 24 hours) and patient global impression of change (2 hours and 24 hours after treatment) were recorded. The majority of patients became headache-free at 15 minutes, 2 hours, and 24 hours after procedure (70.9%, 78.2%, and 70.4%, resp.). The rate of headache relief (50% or more reduction in headache intensity) was 27.3% at 15 minutes, 20% at 2 hours, and 22.2% at 24 hours. The mean pain numeric rating scale decreased significantly at 15 minutes, 2 hours, and 24 hours, respectively. Most patients rated the results as very good or good. The procedure was well-tolerated with few adverse events. This treatment is emerging as an effective and safe option for management of acute migraine attacks. THE EXCELLENT AND RAPID RESPONSE IS EXTREMELY FAVORABLE HOWEVER PATIENTS MUST GO TO THE EMERGENCY DE3PARTMENT OR PHYSICIANS OFFICE TO BE TREATED. A BETTER APPROACH IS TO TREAT THE PATIENTS TO SELF ADMINISTER THE BLOCKS TO STOP THE MIGRAINE EARLY OR PREVENT IT COMPLETELY IF THE BLOCK IS DONE DURING PRODROME.
THE SPHENOPALATINE GANGLION BLOCK WAS ORIGINALLY DESCRIBED BY SLUDER IN 1908. DR GREENFELD SLUDER WROTE A TEXTBOOK NASAL NEUROLOGY AND BECAME CHAIR OF OTOLARYNGOLOGY AT WASHINGTON UNIVERSITY MEDICAL SCHOOL IN ST LOUIS.A A 930 ARTICLE IN THE ANNALS OF INTERNAL MEDICINE BY HIRAM BYRD MD REPORTED ON 10,000 BLOCKS ON 2000 SEPERATE PATIENTS WITH VIRTUALLY NO ADVERSE EFFECTS. UNFORTUNATELY, THE SPHENOPALATINE GANGLION BLOCK BECAME A VICTIM OF FORGOTTEN MEDICINE WHEN DRUG COMPANIES CREATED A STORM OF PHARMACEUTICALS. THE SAFETY PROFILE OF THESE DRUGS DO NOT APPROACH THAT OF SPG BLOCKS WITH 2% LIDOCAINE. A 1986 BOOK ‘MIRACLES ON PARK AVENUE” WAS PROBABLY RESPONSIBLE FOR THE GRADUAL RESURGENCE OF THIS EXCELLENT TECHNIQUE. THE BOOK DESCRIBED THE NYC PAIN PRACTICE OF DR MILTON REDER AND ENT WHO UTILIZED ONLY SPG BLOCKS TO TREAT A WIDE VARIETY OF PAINFUL CONDITIONS REGARDLESS OF UNDERLYING DIAGNOSIS.
Migraine is a common primary headache disorder, causing significant disability and personal, societal, and financial burden (SELF ADMINISTRATION OF SPG BLOCKS CAN SIGNIFICANTLY REDUCE COSTS IN TERMS OF EXPENSES, LOST WORK AND SUFFERING) . It is a highly prevalent condition, affecting 11% of adult population worldwide, including people of all ages, races, geographical areas, and income levels . Although there are currently many options for acute migraine treatment, such as acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDS), triptans, combinations analgesics, and antiemetics , these treatment options are often (MORE OFTEN THAN NOT) suboptimal, with inadequate efficacy and significant side effects [4, 5]. In addition, several studies [6–8] have shown that migraine patients with poor response to acute treatment are at increased risk for transformation to chronic migraine (CM) (SPG BLOCKS ARE ALSO EFFECTIVE AT TREATING CHRONIC MIGRAINE BUT EARLY INTERVENTION IS STILL THE BEST ROUTE) , with roughly 2.5-3.5-fold greater odds of developing CM ; patients with a moderate or better acute treatment efficacy did not have a significant increased risk. Therefore, there is a continuous need for new treatment modalities to address the therapeutic needs of migraine sufferers, especially those with frequent and disabling attacks .
Sphenopalatine ganglion (SPG) block has gained interest as an effective treatment modality for migraine and other headache and facial pain syndromes . SPG, also known as the pterygopalatine ganglion (PPG), is a large extracranial parasympathetic ganglion (THE SPG IS THE LARGEST PARASYMPATHETIC GANGLION OF THE HEAD)with multiple neural connections (Figure 1), including autonomic, motor, and sensory [11, 12]. This complex neural structure is located deeply in the pterygopalatine fossa (PPF) posterior to the middle turbinate and maxillary sinus , on each side of the face. The parasympathetic preganglionic cell bodies originate in the superior salivatory nucleus in the pons, and the parasympathetic fibers run in the nervus intermedius (a branch from the facial nerve) through the geniculate ganglion, forming the greater petrosal nerve (GPN). The sympathetic fibers originate in the superior cervical ganglion (THE SYMPATHETIC FIBERS OF THE SUPERIOR CERVICAL SYMPATHETIC CHAIN ARE VERY IMPORTANT IN THE ABILITY OF THESE BLOCKS TO TURN OFF THE “FIGHT OR FLIGHT” REFLEX) around the internal carotid artery and give rise to the deep petrosal nerve, which joins the GPN to form the Vidian nerve, which enters the SPG. The sensory input to the SPG is via branches from the maxillary nerve, carrying sensations from the palate, buccal cavity, gingival, and tonsils .
Saggital view of the nasopharynx, showing the sphenopalatine ganglion and its neural connections. Reproduced with permission from Robbins et al. (2016) [under the Creative Commons Attribution License number 4318850197898 (Wiley).
The parasympathetic fibers synapse in the SPG and second-order neurons provide secretomotor function to the mucous membranes of nose, mouth, pharynx, and lacrimal glands, as well as branches to the meningeal and cerebral blood vessels [10, 12, 13]. The sympathetic fibers pass through the SPG without synapsing and provide innervations to the palate, nasal cavity, and pharynx.
As acute migraine attacks, as well as other primary headache disorders like cluster headache, are often associated with signs of parasympathetic activation, including lacrimation, nasal congestion, and conjunctival injection, blocking the SPG, which is the major parasympathetic outflow to the cranial and facial structures, is a reasonable target to help relief pain and autonomic features seen in these disorders . It is proposed that various migraine triggers activate brain areas related to superior salivatory nucleus, leading to stimulation of the trigemino-autonomic reflex. This results in increased parasympathetic outflow from the SPG, causing vasodilatation of cranial blood vessels that happens during migraine [10, 14], with the release of inflammatory mediators from blood vessels and activation of meningeal nociceptors, causing migraine pain [11, 14]. Another possible effect of SPG block is modulation of sensory processes in the trigeminal nucleus caudalis via the afferent sensory fibers, which may change pain processing center and reduce central sensitization to pain that is commonly seen in migraine [9, 10].
SPG blocks have been used for the treatment of headache since a long time . In 1908, Sluder described the use of transnasal SPG block using a long needle to inject cocaine, treating what was called Sluder’s neuralgia . The technique was further developed by Simon Ruskin , and in 1925 he used it to treat trigeminal neuralgia. Since then, the indications for SPG block have expanded to include cluster headache, migraine, trigeminal neuralgia, and many more [10, 17–19].
SPG blocks have been achieved with various techniques, including the use of lidocaine-soaked cotton tip applicator through the nose, transorally, transnasal endoscopic, infratemporal approach, and more recently using various noninvasive transnasal devices to inject anesthetics into the SPG .
The objective of this study is to assess the efficacy of SPG block, using the Sphenocath device, for the treatment of acute migraine headaches in the outpatient setting. We also report the safety of this novel technique for migraine treatment.
We conducted an open, uncontrolled, retrospective study in the neurology clinic at a university medical center. The patients were treated between March 2017 and September 2017. The study was approved by the institutional review board of University Medical Center at King Abdullah Medical City.
2.2. Study Population
The patients were recruited to the study if they were between 18 and 60 years of age, have been diagnosed with migraine headache according to International Classification of Headache Disorders-3 Beta  since at least one year, and present with moderate to severe headache lasting between 4 and 72 hours not responding to abortive medications. Patients with medication overuse headache, bleeding disorders, abnormal neurological examination, and history of allergy to local anesthetics were not included in the study. All patients gave an informed written consent.
2.3. Methods of Measurement
Pain was assessed using numeric rating scale (NRS), where 0 is no pain and 10 is worst pain imaginable; this was recorded at baseline, 15 minutes, 2 hours, and 24 hours after the procedure. We also recorded patient global impression of change (PGIC; very poor, poor, no change, good, and very good) at 2 hours and 24 hours after procedure.
2.4. Outcome Measures
The primary efficacy measure was the percentage of patients free of headache at 15 minutes, 2 hours, and 24 hours after the procedure. Secondary endpoints were
headache relief rate, defined as percentage of patients with 50% or more reduction in headache intensity at 15 minutes, 2 hours, and 24 hours;
change in NRS from baseline to 15 minutes, 2 hours, and 24 hours after treatment;
PGIC (effects on headache and its associated symptoms and tolerability) at 2 hours and 24 hours;
all adverse events up to 24 hours after procedure.
Statistical analysis was done using SPSS Statistics Version 23.
Prior to procedure, the nose was inspected for any obstruction, and xylometazoline 0.05% nasal drops( AFRIN NASAL SPRAY, OXYMETAZOLINE SPRAY IS EXTREMELY EFFECTIVE IN SHRINKING NASAL MUCOSAL TISSUES) ) (one drop in each nostril) were used to help open the nasal passages. Face temperature was recorded using temperature sensor skin probes put on both cheeks. A small amount of 2% lidocaine jelly was installed in each nostril for patients’ comfort, using a needless syringe. (AN ALTERNATIVE IS TO USE 2% LIDOCAINE IN A SPRAY FORM ONE MINUTE BEFORE PLACEMENT) Each patient received a single treatment of transnasal SPG block with 2 cc of 2% lidocaine in each nostril in the supine position with head extension, delivered using the Sphenocath device. (I UTILIZE PRIMARILY A COTTON-TIPPED NASAL CATHETER THAT ALLOWS CONTINUAL CAPILLARY FEED OF LIDOCAINE FOR MOST PATIENTS. I ALSO UTILIZE THE SPHENOCATH AND THE TX360 DEVICES IN MY OFFICE. THE ALLEVIO DEVICE IS SIMILAR TO THE SPHENOCATH DEVICE) This is a small flexible sheath with a curved tip (Figure 2). It is inserted through the anterior nasal passage parallel to nasal septum and above the middle turbinate. Once in place, the inner catheter is advanced to administer 2 cc of 2% lidocaine. It is then removed and the procedure is repeated on the other side. Typically after the block, there is an increase in face temperature by 1 to 2 degrees Celsius and/or tearing . The patient is instructed to remain in the same position for 10 minutes. GENERALLY THERE IS LESS DISCOMFORT WITH THE COTTON TIPPED CATHETER BUT IN SOME PATIENTS WITH DIFFICULT ACCESS I UTILIZE DEVICE DELIVERY.
55 patients received treatment with bilateral transnasal SPG blocks. 72.7% were females. The age range of patients was 19 to 58 years, with a mean age of 37.9 years. The baseline NRS range was 4 to 10, with a mean of 6.8. For the primary end point (headache freedom at 15 minutes, 2 hours, and 24 hours), the percentages were 70.9%, 78.2%, and 70.4%, respectively (Figure 3). Among the secondary efficacy measures, 27.3%, 20%, and 22.2% of patients reported headache relief at 15 minutes, 2 hours, and 24 hours after the procedure, respectively (Figure 3). THE RAPID RELIEF IS TYPICAL OF PATIENTS RECEIVING SPG BLOCKS REGARDLESS OF THE METHOD OF DELIVERY. THE COSTS OF THE DEVICES ARE HIGH APPROXIMATELY $75.00. I PREFER THE COTTON-TIPPED NASAL CATHETERS WHICH COST LESS THAN $1.00 PER BILATERAL APPLICATION. MORE IMPORTANT THEY ARE VERY EASY FOR MOST PATIENTS TO UTILIZE FOR SELF ADMINISTRATION AT HOME.
The percentage of patients reaching headache freedom (pain numeric rating scale 0) and patients with headache relief (50% or more reduction in headache intensity), at 15 minutes, 2 hours, and 24 hours.
The mean NRS scores decreased significantly from a baseline of 6.8 to 0.9, 0.6, and 0.8 at 15 minutes, 2 hours, and 24 hours after procedure, respectively (Figure 4).
The mean pain numeric rating scale at baseline and 15 minutes, 2 hours, and 24 hours after treatment, showing significant and sustained reduction in pain intensity.
Regarding PGIC, the majority of patients (98.1% at 2 hours, 98.1% at 24 hours) reported feeling very good or good (Figure 5). Only one patient reported “no change” in PGIC scale at 2 hours, but “very good” at 24 hours, and another patient rated her PGIC as “good” at 2 hours and “poor” at 24 hours due to return of headache which was slightly worse than before.
Patient global impression of change after the procedure at 2 hours and 24 hours. The majority of patients rated the treatment result as very good or good. PATIENTS SIMILARLY RATE RELIEF FROM TRANS-NASAL COTTON-TIPPED CATHETERS VERY HIGH.
Overall, the procedure was well-tolerated. Adverse events reported by the study population were mild (Figure 6), including transient throat numbness (100%), nausea (10.9%), dizziness (10.9%), vomiting (1.8%), nasal discomfort (18.2%), and worsening of preexisting headache (1.8%). These adverse events were transient and lasted less than 24 hours. I RARELY SEE ADVERSE REACTIONS THOUGH THERE IS LIMITED COMPLAINTS ABOUT TASTE AND THROAT NUMBNESS BUT BECAUSE OF THE SLOWER DELIVERY THIS IS LESS OF A PROBLEM. CHIEF COMPLAINT IS NASAL DISCOMFORT THAT CAN USUALLY BE ELIMINATED WITH AFRIN NASAL SPRAY AND LIDOCAINE SPRAY. THOSE SPRAYS.
This retrospective case series demonstrated that transnasal SPG block with 2% lidocaine, using the Sphenocath device, is an effective and safe treatment for acute migraine headaches. There was a rapid relief of headaches observed at 15 minutes and 2 hours, and treatment effect was sustained at 24 hours after procedure in most patients. 70.9%, 78.2%, and 70.9% of patients were completely headache-free at 15 minutes, 2 hours, and 24 hours, respectively, while further 27%, 20%, and 27% achieved 50% or more headache relief at 15 minutes, 2 hours, and 24 hours, respectively. The majority of study population reported either very good or good response on PGIC at 2 hours and 24 hours.
A number of studies were published over the years regarding SPG blockade in acute migraine, with variable results . Kudrow et al.  conducted a noncontrolled study in migraine patients using 4% intranasal lidocaine and showed that 12 out of 23 patients achieved complete headache relief, and the effect was sustained at 24 hours. Maizels and Geiger  evaluated the efficacy of 4% intranasal lidocaine as a treatment for acute migraine attacks, which was administered by the patient at home, in a double-blind, randomized controlled study. There was a significant reduction in headache severity at 15 minutes compared to placebo, but there was headache recurrence in 21% of patients receiving lidocaine.
Another placebo-controlled study compared outcomes for acute treatment of chronic migraine patients with intranasal 0.5% bupivacaine (n = 26) or saline (n = 12) using the Tx 360® device to block the SPG . The injection was given twice a week for 6 weeks. The trial revealed significant reduction in pain numeric rating scores in the bupivacaine group at 15 minutes, 30 minutes, and 24 hours after each treatment. A randomized, double-blind, placebo-controlled study using intranasal bupivacaine or saline injections in patients presenting to the emergency department with acute frontal-based headache [specific classification was not required] demonstrated no significant difference in the proportion of patients achieving 50% or more headache relief at 15 minutes .
Other studies used different agents for SPG blockade. For example, Bratbak et al. used onabotulinum toxin A injections into the SPG in 10 patients with intractable chronic migraine in an open, uncontrolled study . This was done through a percutaneous infrazygomatic approach with a novel injection device. A statistically significant reduction of moderate and severe headaches was observed at 2 months after treatment; there were a total of 25 adverse events, mostly local discomfort, but none were classified as severe.
The SPG unique position in the PPF, as well as its multiple neural connections to sensory and autonomic systems involved in pain generation and propagation and the associated autonomic manifestations seen in many primary headache and facial pain syndromes, makes it a promising target for the treatment of these conditions. Inhibition of parasympathetic outflow from the SPG causes reduced activation of perivascular pain receptors in the cranial and meningeal blood vessels, with resultant reduction in the release of neuroinflammatory mediators (acetylcholine, nitric oxide, vasoactive intestinal peptide, substance P, and calcitonin gene-related peptide) from sensory fibers supplying the cranial and meningeal vasculature. This, in turn, reduces pain intensity and intracranial hypersensitivity observed in migraine .
In our study, SPG blockade produced a rapid relief of headache at 15 minutes, with a significant treatment effect observed at 24 hours and high patient satisfaction. In general, the treatment was well-tolerated. We recorded few adverse events, which were mild and transient, similar to those seen in previous studies .
The main limitation of our study included the lack of a placebo group, as subjective pain response might have a significant placebo component . However, the high treatment response and satisfaction rates in this study were both encouraging and clinically meaningful for our patients. We did not assess the use of analgesics after two hours of receiving the SPG block, which might have influenced the headache relief percentage at 24 hours. However, this is allowed in acute headache trials guidelines .
Transnasal SPG blockade is emerging as an effective and safe option for the treatment of several disabling headache and facial pain conditions such as migraine, cluster headache, and trigeminal neuralgia. Its ease of administration using noninvasive devices, safety profile, and quick pain relief makes it an attractive treatment option for these conditions. More well-designed studies are needed to further explore the efficacy of this treatment modality and its use as part of a comprehensive headache management program.
1. Marmura M. J., Silberstein S. D., Schwedt T. J. The Acute Treatment of Migraine in Adults: The American Headache Society Evidence Assessment of Migraine Pharmacotherapies. 2015;55(1):3–20. doi: 10.1111/head.12499.[PubMed][Cross Ref]
3. Becker W. J. Acute migraine treatment in adults. 2015;55(6):778–793.[PubMed]
4. Magis D., Jensen R., Schoenen J. Neurostimulation therapies for primary headache disorders. 2012;25(3):269–276. doi: 10.1097/WCO.0b013e3283532023.[PubMed][Cross Ref]
5. Lipton R. B., Munjal S., Buse D. C., Fanning K. M., Bennett A., Reed M. L. Predicting Inadequate Response to Acute Migraine Medication: Results From the American Migraine Prevalence and Prevention (AMPP) Study. 2016;56(10):1635–1648. doi: 10.1111/head.12941. [PubMed][Cross Ref]
6. Lipton R. B., Fanning K. M., Serrano D., Reed M. L., Cady R., Buse D. C. Ineffective acute treatment of episodic migraine is associated with new-onset chronic migraine. 2015;84(7):688–695. doi: 10.1212/WNL.0000000000001256.[PMC free article][PubMed][Cross Ref]
7. Lipton R. B., Silberstein S. D. Episodic and Chronic Migraine Headache: Breaking Down Barriers to Optimal Treatment and Prevention. 2015;55:103–122. doi: 10.1111/head.12505_2. [PubMed][Cross Ref]
8. Rizzoli P. B. Acute and preventive treatment of migraine. 2012;18(4):764–782. doi: 10.1212/01.CON.0000418641.45522.3b. [PubMed][Cross Ref]
9. Khan S., Schoenen J., Ashina M. Sphenopalatine ganglion neuromodulation in migraine: What is the rationale? 2014;34(5):382–391. doi: 10.1177/0333102413512032. [PubMed][Cross Ref]
10. Robbins M. S., Robertson C. E., Kaplan E., et al. The Sphenopalatine Ganglion: Anatomy, Pathophysiology, and Therapeutic Targeting in Headache. 2016;56(2):240–258. doi: 10.1111/head.12729. [PubMed][Cross Ref]
11. Piagkou M. N., Demesticha T., Troupis T., et al. The Pterygopalatine Ganglion and its Role in Various Pain Syndromes: From Anatomy to Clinical Practice. 2012;12(5):399–412. doi: 10.1111/j.1533-2500.2011.00507.x. [PubMed][Cross Ref]
12. Láinez M. J. A., Puche M., Garcia A., Gascón F. Sphenopalatine ganglion stimulation for the treatment of cluster headache. 2014;7(3):162–168. doi: 10.1177/1756285613510961. [PMC free article][PubMed][Cross Ref]
13. Suzuki N., Hardebo J. E. The cerebrovascular parasympathetic innervation. 1993;5(1):33–46. [PubMed]
14. Yarnitsky D., Goor-Aryeh I., Bajwa Z. H., et al. 2003 Wolff award: possible parasympathetic contributions to peripheral and central sensitization during migraine. 2003;43(7):704–714. doi: 10.1046/j.1526-4610.2003.03127.x. [PubMed][Cross Ref]
15. Sluder G. The role of the sphenopalatine ganglion in nasal headaches. 1908;27:8–13.
16. Waldman S. D. Sphenopalatine ganglion block-80 years later. 1993;18(5):274–276. [PubMed]
17. Coven I., Dayısoylu E. H. Evaluation of sphenopalatine ganglion blockade via intra oral route for the management of atypical trigeminal neuralgia. 2016;5(1, article no. 906):1–5. doi: 10.1186/s40064-016-2612-8. [PMC free article][PubMed][Cross Ref]
18. Miller S., Matharu M. Trigeminal autonomic cephalalgias: Beyond the conventional treatments. 2014;18(8, article no. 438) doi: 10.1007/s11916-014-0438-z. [PMC free article][PubMed][Cross Ref]
19. Candido K. D., Massey S. T., Sauer R., Darabad R. R., Knezevic N. N. A novel revision to the classical transnasal topical sphenopalatine ganglion block for the treatment of headache and facial pain. 2013;16(6):E769–E778. [PubMed]
20. Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders. 2013;33(9):629–808. doi: 10.1177/0333102413485658. 3rd edition. [PubMed][Cross Ref]
21. Wasserman RA., Schack T., Moser SE., Brummett CM., Cooper W. Facial temperature changes following intranasal sphenopalatine ganglion nerve block. 2017;3(5):p. e354.
22. Kudrow L., Kudrow D. B., Sandweiss J. H. Rapid and Sustained Relief of Migraine Attacks With Intranasal Lidocaine: Preliminary Findings. 1995;35(2):79–82. doi: 10.1111/j.1526-4610.1995.hed3502079.x. [PubMed][Cross Ref]
23. Maizels M., Geiger A. M. Intranasal lidocaine for migraine: A randomized trial and open-label follow-up. 1999;39(8):543–551. doi: 10.1046/j.1526-4610.1999.3908543.x. [PubMed][Cross Ref]
24. Cady R., Saper J., Dexter K., Manley H. R. A double-blind, placebo-controlled study of repetitive transnasal sphenopalatine ganglion blockade with Tx360® as acute treatment for chronic migraine. 2015;55(1):101–116. doi: 10.1111/head.12458. [PMC free article][PubMed][Cross Ref]
25. Schaffer J. T., Hunter B. R., Ball K. M., Weaver C. S. Noninvasive Sphenopalatine Ganglion Block for Acute Headache in the Emergency Department: A Randomized Placebo-Controlled Trial. 2015;65(5):503–510. doi: 10.1016/j.annemergmed.2014.12.012. [PubMed][Cross Ref]
26. Bratbak D. F., Nordgård S., Stovner L. J., et al. Pilot study of sphenopalatine injection of onabotulinumtoxinA for the treatment of intractable chronic cluster headache. 2015;36(6):503–509. doi: 10.1177/0333102415597891.[PMC free article][PubMed][Cross Ref]
27. Diener H. C., Schorn C. F., Bingel U., Dodick D. W. The importance of placebo in headache research. 2008;28(10):1003–1011. doi: 10.1111/j.1468-2982.2008.01660.x. [PubMed][Cross Ref]
28. Tfelt-Hansen P., Pascual J., Ramadan N., et al. Guidelines for controlled trials of drugs in migraine: Third edition. A guide for investigators. 2011;32(1):6–38. doi: 10.1177/0333102411417901. [PubMed][Cross Ref]
I am pleased to announce that I am now a new Diplomate of the American Board of Sleep and Breathing. I am a long term Diplomate of the American Board of Dental Sleep Medicine, Credentialed by the Sleep Disorder Dental Society (SDDS) and a Founding member of both the SDDS (Now AADSM) and Dosa , the Dental Organization for Sleep Apnea.
I did research into jaw position and sleep apnea as a visiting Assistant Professor at Rush Medical School from 1985 until 1991 and returned as an Assistant Professor from 1998 until 2001. I had the pleasure of working with Dr Rosalind Cartwright who was responsible for the growth of Dental Sleep Medicine.
I am currently in day two of my Harvard Medical School course on Advanced Pain Management. I am spending all of this week in Boston to improve on my skills in pain management.
The program is on Advanced Pain Management continuing Education with Academy of Integrative Pain Management and Harvard Medical School’s Top Pain Doctors.
Updates and Practice Recommendations to
Optimize the Assessment and Treatment of Pain
Headache, Fibromyalgia, Neuropathic, Myofascial, Cancer, Abdominal, Pelvic, Musculoskeletal, Spinal Pain.
OXYGEN, SPG BLOCKS, NEUROMODULATION AND NEUROMUSCULAR ORTHOTICS GIVE RELIEF!
Cluster Headaches are frequently called the suicide headache.
Many patients respond quickly to 100% oxygen but it is not always available and there are patients who only have partial relief.
Sphenopalatine Ganglion (SPG) Blocks not only offer almost immediate relief of Cluster Headache pain but repeated use can eliminate cluster headaches.
The Sphenopalatine Ganglion is accessible through the nose and non-invasive delivery of lidocaine and other anesthetics can give almost immediate relief.
Repeated SPG Blocks can prevent future cluster headaches. Self-Administration of SPG Blocks put patients in control of their relief making it available 24/7 without needing an oxygen tank.
The best method of Self-Administration is with cotton-tipped nasal catheters that I teach patients. Most patients can easily learn the technique and Self-Administration becomes routine, easier they taking medication and for most patients almost immediate relief.
There are three nasal catheters used by physicians to deliver Sphenopalatine Ganglion Blocks for Cluster Headaches and Migraines. The Sphenocath is the first one commercially available. The TX360 is a novel design and has been reported on in multiple studies and is used with the MiRx protocol. The Allevio is similar to the Sphenocath. All three are specialized “Squirt Guns” designed to deliver anesthetic to the mucosa over the SPG.
I find the cotton-tipped easier for most patients as well as more effective due to the continual capillary feed of anesthetic in any position.
The Myomonitor is an Ultra Low Frequency device designed to relax muscles innervated by the fifth and seventh cranial nerves (trigeminal and facial nerves) and is used in neuromuscular dentistry to create neuromuscular orthotics. These orthotics can eliminate future episodes of cluster headaches, migraines and other painful conditions. The Myomonitor has beenin use for over 50 years and also serves as a non-invasive sphenopalatine ganglion neuromuscular device.
Neuromuscular orthotics act as a reset mechanism for posture and for the trigeminal nervous system. Sphenopalatine ganglion blocks serve as a reset mechanism for the autonomic nervous system.
Treatment of Orofacial Pain can be complex and there are many issues that are both medical and dental in nature.
There is hope and this paper gives one clear example of what is wrong with many of the concepts of the Orofacial Pain Group that tends to discount valuable treatments with good scientific evidence.
One important concept in Orofacial Pain is the concept of MMI or Maximum Medical Improvement ie, this is the best results possible. This is an escape clause for doctors who do not have the expertise or knowledge to move their patients to a better quality of life or further reduction of symptoms. Very often the best treatment for a patient may never be offered. An example of this problem can be found in the conclusions of this paper from J Orofac Pain. 2010
“Systematic review and meta-analysis of randomized controlled trials evaluating intraoral orthopedic appliances for temporomandibular disorders.” By Fricton et al. which concluded that; “Hard stabilization appliances, when adjusted properly, have good evidence of modest efficacy in the treatment of TMJD pain compared to non-occluding appliances and no treatment. Other types of appliances, including soft stabilization appliances, anterior positioning appliances, and anterior bite appliances, have some RCT evidence of efficacy in reducing TMJD pain. However, the potential for adverse events with these appliances is higher and suggests the need for close monitoring in their use.”
Dr Fricton found that hard stabilization splints had “modest efficiency “compared to non-occluding appliances and no treatment” He also states that “Other types of appliances, including soft stabilization appliances, anterior positioning appliances, and anterior bite appliances, have some RCT evidence of efficacy in reducing TMJD pain.” One would assume when dealing with patients in pain that success alleviation of pain would be paramount but Dr Fricton actually finishes the conclusion stating “However, the potential for adverse events with these appliances is higher and suggests the need for close monitoring in their use.” This does not mean don’t use them but that use carries some risk. A patient in pain has the right to decide if that is a risk he or she wants to take. The problem is due to the politics of the AAOP patients are actually losing their right to the most efficacuos treatments.
This video is of a patient treated at Mayo Clinic who was told there was “NO HOPE” and was condemned by a neurologist at to a lifetime of pain. I utilized an appliance that “carried some risk of adverse consequences” but worked out very well for this patient. https://www.youtube.com/watch?v=IOJTPQEGr1w
Had we followed the satndard protocol of Orofacial Pain this patient was condemned to a “Lifetime of Pain and No Hope!”
Instead, she took advantage of a more efficacous and now lives pain free.
Yes, there are randomized Controlled Studies showing efficacy but even if there were only testimonials and clinical histories she has a right to chose her own fate.
We know that the third leading cause of death in this country is medical mistakes according to a study by Johns Hopkins.
Is the leading cause of pain in TMJ patients due to mistakes of non-treatment rather than overtreatment? …
Patrick : What are the surgical options for treating my severe cluster headaches?
Reprint from http://chicago-headaches.blogspot.com/2013/09/
Dr Shapira response: Dear Patrick,
am not a big advocate of surgery for cluster headaches. Treatment of the Trigeminal Nerve ” microvascular decompression of the trigeminal nerve with section of the nervus intermedius compares very favorably to other destructive techniques without the accompanying neurologic deficits” (see below) is probably the best surgical treatment but do not expect success. There is a significant risk of very negative outcomes. As there is unquestionably a Trigeminal Nerve basis in cluster headaches I would first attempt a diagnostic neuromuscular orthotic (ie Neuromuscular Dentistry ) and/or sphenopalatine ganglion (SPG) block as prophylactic method. Patients can learn to self administer the intranasal SPG block quickly and easily at home with special hollow tube cotton applicators. Surgery of the Sphenopalatine Ganglion has been attempted but is not recommended.
There is a new study out of South Africa that showed good results on 4 out of 5 patients (short term study) but the surgery is relatively atraumatic. (see below) There is also a study on implantable neurostimulation of the Spenopalatine Ganglon (SPG) but I would certainly try the intranasal approach first.
Neuromuscular Dentistry also offers relief to Cluster Headache Patients. The Myomonitor that relaxes trigeminal and facial muscles also has a 50 year safety record as a Sphenopalatine Ganglion Stimulator.
Many Cluster headaches respond rapidly to 100% oxygen as an emergency treatment.
What have you previously attempted to treat your cluster headachers?
I have included three excerpts from PubMed abstracts but all conclude surgery is not a first line approach and the newest article concludes ” We do not recommend trigeminal nerve radiosurgery for treatment of cluster headache.”
It has been said that: “There is no disease or disorder known to man that cannot be made worse by sticking a knife in it.” This does not mean surgery is bad but you should approach it with caution and be aware of possible negative outcomes.
Ira L Shapira DDS, D,ABDSM, D,AAPM, FICCMO
SEE ABSTRACTS BELOW FOR MORE INFORMATION
Headache. 1998 Sep;38(8):590-4.
The surgical management of chronic cluster headache.
Chronic cluster headache remains a debilitating and poorly controlled syndrome. Although various surgical treatments have had limited success, microvascular decompression of the trigeminal nerve with section of the nervus intermedius compares very favorably to other destructive techniques without the accompanying neurologic deficits. It is, therefore, our recommendation as the first-line operative treatment of chronic cluster headache.
Curr Pain Headache Rep. 2002 Feb;6(1):57-64.
Interventional treatment for cluster headache: a review of the options.
Cleveland Clinic Headache Center, 9500 Euclid Avenue, Cleveland, OH 44195, USA. RozenT@ccf.org
There is no more severe pain than that sustained by a cluster headache sufferer. Surgical treatment of cluster headache should only be considered after a patient has exhausted all medical options or when a patient’s medical history precludes the use of typical cluster abortive and preventive medications. Once a cluster patient is deemed a medical failure only those who have strictly side-fixed headaches should be considered for surgery. Other criteria for cluster surgery include pain localizing to the ophthalmic division of the trigeminal nerve, a psychologically stable individual, and absence of addictive personality traits. To understand the rationale behind the surgical treatment strategies for cluster, one must have a general understanding of the anatomy of cluster pathogenesis. The most frequently used surgical techniques for cluster are directed toward the sensory trigeminal nerve and the cranial parasympathetic system.
Cephalalgia. 2012 Jun;32(8):635-40. doi: 10.1177/0333102412445219. Epub 2012 Apr 23.
Predilection to deafferentation pain syndrome after radiosurgery in cluster headache.
Donnet A, Carron R, Régis J.
Department of Neurology, Timone Hospital, Marseille, France. firstname.lastname@example.org
Cluster-tic syndrome is a rare, disabling disorder. We report the first case of cluster-tic syndrome with a successful response to stereotactic radiosurgery. After failing optimal medical treatment, a 58-year-old woman suffering from cluster-tic syndrome was treated with gamma knife radiosurgery. The trigeminal nerve and sphenopalatine ganglion were targeted with a maximum dose of 85 and 90 Gy respectively. The patient experienced a complete resolution of the initial pain, but developed, as previously described after radiosurgical treatment for cluster headache, a trigeminal nerve dysfunction. This suggests that trigeminal nerve sensitivity to radiosurgery can be extremely different depending on the underlying pathological condition, and that there is an abnormal sensitivity of the trigeminal nerve in cluster headache patients. We do not recommend trigeminal nerve radiosurgery for treatment of cluster headache.
Other relevant articles show short term relief:
Neurosurgery. 2006 Dec;59(6):1258-62; discussion 1262-3.
Long-term results of radiosurgery for refractory cluster headache.
McClelland S 3rd, Tendulkar RD, Barnett GH, Neyman G, Suh JH.
Department of Neurosurgery, University of Minnesota Medical School, Minneapolis, Minnesota, USA.
Medically refractory cluster headache (CH) is a debilitating condition for which few surgical modalities have proven effective. Previous reports involving short-term follow-up of CH patients have reported modest degrees of pain relief after radiosurgery of the trigeminal nerve ipsilateral to symptom onset. With the recent success of deep brain stimulation as a surgical modality for these patients, it becomes imperative for the long-term risks and benefits of radiosurgery to be more extensively delineated. To address this issue, we present our findings from the largest retrospective series of patients undergoing radiosurgery for CH with extended follow-up periods.
Between 1997 and 2001, 10 patients with CH underwent gamma knife radiosurgery at our institution. All patients fulfilled clinical criteria for treatment, including complete resistance to pharmacotherapy (usually methysergide, verapamil, and lithium), pain primarily localized to the ophthalmic division of the trigeminal nerve, and psychological stability. The mean age at radiosurgery was 40.3 years (range, 26-62 yr), and the average CH duration was 11.3 years (range, 2-21 yr). Patients received 75 Gy to the 100% isodose line delivered to the most proximal part of the trigeminal nerve where the 50% isodose line was outside the brainstem (4-mm collimator), with a mean follow-up period of 39.7 months (range, 5-88 mo). Pain relief was defined as excellent (free of CH with minimal or no medications), good (50% reduction of CH severity and frequency with medications), fair (25% reduction of CH severity and frequency with medications), or poor (less than 25% reduction of CH severity and frequency with medications).
After radiosurgery, pain relief was poor in nine patients and fair in one patient. Six patients with poor to fair relief initially experienced excellent to good relief (range, 2 wk-2 yr after treatment) before regressing. Five patients (50%) experienced trigeminal nerve dysfunction, manifesting predominantly as facial numbness after treatment.
Although some patients may experience short-term pain relief, none had relief sustainable for longer than 2 years. The results from this series indicate that radiosurgery of the trigeminal nerve does not provide long-term pain relief for medically refractory CH.
PMID: 17277688 [PubMed – indexed for MEDLINE]
This article consider the treatment worse than the disease:
J Neurol Neurosurg Psychiatry. 2005 February; 76(2): 218–221.
Gamma knife treatment for refractory cluster headache: prospective open trial
A Donnet, D Valade, and J Regis
Background: Since the initial report of Ford et al in 1998 no further study has evaluated radiosurgery of the trigeminal nerve in chronic cluster headache (CCH).
Methods: We carried out a prospective open trial of neurosurgery and enrolled 10 patients (nine men, one woman; mean age 49.8 years, range 32–77) presenting with severe and drug resistant CCH (mean duration 9 years, range 2–33). The cisternal segment of the nerve was targeted with a single 4 mm collimator (80–85 Gy max).
Results: The mean follow up was 13.2 months. No improvement was observed in two patients and three patients had no further attacks. Three patients showed dramatic improvement with a few attacks per month or very few attacks over the last six months. Two patients were pain free for only one and two weeks and their headaches recurred with the same severity as before. Three patients developed paraesthesia with no hypoaesthesia, one developed hypoaesthesia, and one developed deafferentation pain.
Conclusions: The rate and severity of trigeminal nerve injury appeared to be significantly higher than in trigeminal neuralgia, and this study does not support the positive results of the study of Ford et al. We consider the morbidity to be significant for the low rate of pain cessation, making this procedure less attractive even for the more severely affected subgroup of patients.
THIS ARTICLE CONSIDERS CLUSTER HEADACHES TO BE INTERNALLY GENERATED WITHIN THE BRAIN THEREFORE NOT AMENABLE TO SURGERY BUT IT DID REPORT GOOD RESULTS IN ONE CASE WITH SUMATRIPTAN
Brain. 2002 May;125(Pt 5):976-84.
Persistence of attacks of cluster headache after trigeminal nerve root section.
Matharu MS, Goadsby PJ.
Headache Group, Institute of Neurology, University College London, UK.
Cluster headache is a strictly unilateral headache that occurs in association with cranial autonomic features. We report a patient with a trigeminal nerve section who continued to have attacks. A 59-year-old man described a 14-year history of left-sided episodes of excruciating pain centred on the retro-orbital and orbital regions. These episodes lasted 1-4 h, recurring 2-3 times daily. The attacks were associated with ipsilateral ptosis, conjunctival injection, lacrimation, rhinorrhoea and facial flushing. From 1986 to 1988, he had trials of medications without any benefit. In February 1988, he had complete surgical section of the left trigeminal sensory root that shortened the attacks in length for 1 month without change in their frequency or character. In April 1988, he had further surgical exploration and the root was found to be completely excised; post-operatively, there was no change in the symptoms. From 1988 to 1999, he had a number of medications, including verapamil and indomethacin, all of which were ineffective. Prednisolone 30 mg orally daily rendered the patient completely pain free. Sumatriptan 100 mg orally and 6 mg subcutaneously aborted the attack after approximately 45 and 15 min, respectively. He was completely anaesthetic over the entire left trigeminal distribution. Left corneal reflex was absent. Motor function of the left trigeminal nerve was preserved. Neurological and physical examination was otherwise normal. MRI scan showed a marked reduction in the calibre of the left trigeminal nerve from the nerve root exit zone in the pons to Meckel’s cave. An ECG-gated three-dimensional multislab MRI inflow angiogram was performed. No dilatation was observed in the left internal carotid artery during the cluster attack. Blink reflexes were elicited with a standard electrode and stimulus. Stimulation of the left supraorbital nerve produced neither ipsilateral nor contralateral blink reflex response. Stimulation of the right supraorbital nerve produced an ipsilateral response with a mean R2 onset latency of 36 ms and a contralateral response with a mean R2 onset latency of 32 ms. Lack of ipsilateral vessel dilatation makes the role of vascular factors in the initiation of cluster attacks questionable. With complete section of the left trigeminal sensory root the brain would perceive neither vasodilatation nor a peripheral neural inflammatory process; however, the patient continued to have an excellent response to sumatriptan. The case illustrates that cluster headache may be generated primarily from within the brain, and that triptans may have anti-headache effects through an entirely central mechanism.
A more positive result was shown in this study from Mayo but does not discuss length of relief only short term results.
Mayo Clin Proc. 1986 Jul;61(7):537-44.
Surgical treatment of chronic cluster headache.
Onofrio BM, Campbell JK.
Chronic cluster headache, also known as chronic migrainous neuralgia, is frequently unresponsive to medical management. Although neuronal factors may be involved in the pathogenesis of this form of recurrent hemicranial pain, vasodilatation within the distribution of the trigeminal nerve is believed to be important. Attempts to provide relief by surgical means have primarily involved interruption of the vasodilator pathways of the greater superficial petrosal nerve and the sphenopalatine ganglion. A more direct approach of interrupting the pain pathways of the trigeminal nerve has been attempted sporadically for more than 50 years. Recent interest in the role of substance P in the production of pain in cluster headache suggests that trigeminal ablative procedures might have a dual role in the relief of medically intractable cases. Among 26 patients who underwent posterior fossa trigeminal sensory rhizotomy or percutaneous radio-frequency trigeminal gangliorhizolysis at our institution, relief of pain was excellent in 14 (54%), fair to good in 4 (15%), and poor in 8 (31%)
The next article (a case study) discusses brain stimulation of the hypothalamus as a treatment alternative:
Cephalalgia. 2011 Jan;31(1):112-5. doi: 10.1177/0333102410373157. Epub 2010 May 17.
Mere surgery will not cure cluster headache–implications for neurostimulation.
Hidding U, May A.
Department of Systems Neuroscience, University Medical Centre Hamburg-Eppendorf (UKE), Martinistrasse 52, Hamburg, Germany.
This case study concerns a patient with primary chronic cluster headache, who was unresponsive to all treatments and consecutively underwent hypothalamic deep brain stimulation (DBS). DBS had no effect on the cluster attacks, but cured an existing polydipsia as well as restlessness. However, hypothalamic DBS produced a constant, dull headache without concomitant symptoms and a high-frequent tremor. All of these effects were repeated when the stimulation was stopped and than started again. DBS had no effect on a pathological weight gain from 70 kg to 150 kg due to bulimia at night, usually during headache attacks. This case illustrates that cluster headache is, in some patients, only one symptom of a complex hypothalamic syndrome. This case also underlines that the stimulation parameters and anatomical target area for hypothalamic DBS may be too unspecific to do justice to the clinical variety of patients and concomitant symptoms. Hypothalamic DBS is an exquisite and potentially life-saving treatment method in otherwise intractable patients, but needs to be better characterised and should only be considered when other stimulation methods, such as stimulation of the greater occipital nerve, are unsuccessful.
J Oral Maxillofac Surg. 2013 Apr;71(4):677-81. doi: 10.1016/j.joms.2012.12.001.
A new minimally invasive technique for cauterizing the maxillary artery and its application in the treatment ofcluster headache.
The Headache Clinic, Johannesburg, South Africa. email@example.com
To describe a new, relatively atraumatic method of cauterizing the maxillary artery and its effectiveness in treating cluster headache.
MATERIALS AND METHODS:
Five patients with cluster headache were treated with arterial ligation of certain terminal branches of the external carotid artery. A new, atraumatic method of cauterizing the maxillary artery is described.
The success rate and postoperative morbidity are presented. In four out of five patients the cluster attacks ceased immediately following surgery.
A new intraoral technique for maxillary artery cauterization and the effectiveness of cauterization of the terminal branches of the external carotid artery in the treatment of cluster headache are described. Although the sample is small, the results are encouraging, and may offer permanent relief of cluster headache pain.
Cephalalgia. 2013 Jul;33(10):816-30. doi: 10.1177/0333102412473667. Epub 2013 Jan 11.
Stimulation of the sphenopalatine ganglion (SPG) for cluster headache treatment. Pathway CH-1: A randomized, sham-controlled study.
Schoenen J, Jensen RH, Lantéri-Minet M, Láinez MJ, Gaul C, Goodman AM, Caparso A, May A.
Headache Research Unit, Department of Neurology, CHR Citadelle, Liège University, B-4000 Liège, Belgium. firstname.lastname@example.org
The pain and autonomic symptoms of cluster headache (CH) result from activation of the trigeminal parasympathetic reflex, mediated through the sphenopalatine ganglion (SPG). We investigated the safety and efficacy of on-demand SPG stimulation for chronic CH (CCH).
A multicenter, multiple CH attack study of an implantable on-demand SPG neurostimulator was conducted in patients suffering from refractory CCH. Each CH attack was randomly treated with full, sub-perception, or sham stimulation. Pain relief at 15 minutes following SPG stimulation and device- or procedure-related serious adverse events (SAEs) were evaluated.
Thirty-two patients were enrolled and 28 completed the randomized experimental period. Pain relief was achieved in 67.1% of full stimulation-treated attacks compared to 7.4% of sham-treated and 7.3% of sub-perception-treated attacks ( P < 0.0001). Nineteen of 28 (68%) patients experienced a clinically significant improvement: seven (25%) achieved pain relief in ≥50% of treated attacks, 10 (36%), a ≥50% reduction in attack frequency, and two (7%), both. Five SAEs occurred and most patients (81%) experienced transient, mild/moderate loss of sensation within distinct maxillary nerve regions; 65% of events resolved within three months.
On-demand SPG stimulation using the ATI Neurostimulation System is an effective novel therapy for CCH sufferers, with dual beneficial effects, acute pain relief and observed attack prevention, and has an acceptable safety profile compared to similar surgical procedures.