At Briarcliff Center for Esthetic Dentistry, we have non-invasive treatments for migraine and tension headaches, developed by the late Dr. Mark Friedman, that in many cases work better, faster, and more safely than any of the standard headache/pain medications. One of these treatments has recently received FDA approval for migraine treatment.
THE STORY . THE SCIENCE
The heart of our Migraine headache treatment is the amazingly simple, yet devastatingly effective device known as the "Cryotron." Developed by the late Dr. Mark Friedman, he found that migraine Headaches were actually caused by inflammation and swelling of a plexus, or small area, at the base of the maxillary nerve before it branches out to the rest of the head. This swelling put pressure on the nerve, causing Migraine Headaches. In his search for a cure, he consulted sports medicine MD's. asking how to treat swelling & inflammation & was told with cold, to, in effect, chill the area.
He then proceeded to not just invent the Cryotron, get it patented, and perform years of extensive study at a major NY medical center, but even got the research published in major medical journals, culminating in it finally winning FDA approval. Shortly before his death, he was developing plans to produce and sell the Cryotron, so people all over the world could benefit from it.
After his untimely death, the directors -including Dr. Teitelbaum - of the Westchester Academy of Restorative Dentistry (for whom he had lectured many times) stepped in, temporarily running his practice. As a gift for this help, his widow gave one of the 3 protoypes in existence to Dr. Teitelbaum and asked him to please carry on Dr. Friedman's legacy and care for Migraine sufferers.
In a study conducted at Westchester Medical Center, one of our methods was used on patients with severe enough migraine or tension headaches (average duration of 30 hours) to require an Emergency room visit. In 80% of patients, including three pregnant women, the headaches were virtually eliminated in less than one hour. No side effects were reported and the patients remained comfortable the following day, with no rebound headaches. (Friedman MH, Nehrbauer NJ, Larsen EA. An alternative approach to acute headache treatment: an emergency department pilot study. Headache Quarterly, 1999; 10:131-134)
In a placebo controlled study conducted at the New York Medical College Department of Medicine, the same technique proved more effective than Imitrex, the most widely prescribed migraine medication. Again, our technique caused no rebound headaches or side effects.(Friedman MH, Peterson SJ, Behar CF, Zaida Z. Intraoral chilling vs. oral sumatriptan for acute migraine. Heart Dis 2001;3(6):357-361)
Our treatments are based on our discovery that headache patients have an inflamed tender area above the upper molar teeth, even in the headache-free state. The inflammation is also present in patients with facial pain and neck muscle spasm. This inflammation causes a swelling which puts pressure on the adjacent maxillary nerve which is what causes the headache. This is contrary to current theories that describe its origin in the outer covering of the brain. We demonstrated this link in a multi-centered study by measuring the temperature and tenderness of the area above the upper molars. In patients with unilateral migraine or tension-type headaches, the temperature and tenderness of the area on the same side as the headache was consistently higher than on the identical area on the opposite side, as well as directly proportional to symptom severity. Tenderness and elevated temperature are signs of inflammation. (Friedman MH, Luque FA, Larsen EA: Ipsilateral intra-oral tenderness and elevated temperature during unilateral migraine and tension-type headache. Headache Q 1997;8(4):341-344)
In the Department of Medicine and Emergency Department studies, a device was used to chill the inflamed area to reduce the swelling which takes pressure off the nerve to eliminate the headache.
In addition to chilling this area to treat acute headaches, we also have patients use a topical anti-inflammatory cream at home applied to the same area for headache prevention. In a new home application study, the treatment was far more effective than any available preventive headache medication, not only for migraine, but also for tension and post-traumatic headaches. In the study, we measured a value called Headache Burden, which equals total monthly headache hours multiplied by average headache intensity (0-10 scale). While using the cream, patients experienced an 81% reduction in Headache Burden as well as a significant reduction in the use of headache pain medications. (Friedman MH, Peterson SJ, Frishman WH, Behar, CF. Intaoral Topical Non-Steroidal Anti-Inflammatory Drug Application for Headache Prevention. Heart Dis. In Press)
Our headache treatments have been profiled by ABC, NBC, CBS, CNN, FOX, Reuters, The New York Times, and The USA Today. However, because the treatment is still investigational, under FDA guidelines, the cream is only available through our office following a diagnostic exam.
In a multi-center study (Our Lady of Mercy Hospital, NY Medical College Dept. of Neurology, Westchester Medical Center Emergency Department, Westchester Head and Neck Pain Center,) we studied 40 patients during one-sided migraine or tension headaches. The upper third molar areas (even if the teeth were missing) were palpated on both sides for tenderness, and their local temperatures were recorded. Consistent correlations were found between laterality (side) of symptoms to both tenderness and increased local temperature1.
Tenderness and increased temperature are classic signs of inflammation. In addition to heat, redness, and tenderness, swelling is also produced. The inflammatory process is controlled by a group of chemicals within the body. When unknown triggers liberate these chemicals, they relax the smooth muscle layers of small blood vessels. Vasodilatation (expansion) of these capillaries and opening of previously inactive capillaries can result in as much as a tenfold increase in local blood flow, causing local temperature and pressure within the vessels to rise. In addition to vasodilatation, these chemicals increase vascular permeability by shrinking cells surrounding the blood vessels creating gaps. The end result, edema, is caused by increased blood flow and "leaky" blood vessels. This combination encourages fluid and large protein molecules in the blood stream to leave the vessels, and enter the adjacent space. The local swelling produced exerts a constant pressure on a section of a main sensory (maxillary) nerve for conduction of head pain. Local application of cold, vasoconstriction, reverses the above effect. In simple terms, cold reduces swelling.
Most of the anti-migraine drugs (the ergots, triptans, etc.) are systemic vasoconstrictors. Common examples of this vasoconstriction include: chest tightness after taking Imitrex, resulting from cardiac smooth muscle constriction, and uterine muscle constriction from dihydroergotamine (DHE), which prevents pregnant women from taking DHE. When this constant swelling increases, the headache occurs. One of our treatments, used in the studies described on the home page, is administered by a hand-held device that circulates ice water through hollow metal tubes shaped to fit the swollen area causing local vasoconstriction. Our other treatments, Helium-Neon laser and local anti-inflammatory cream, also produce a local anti-inflammatory effect.
In addition to single-visit acute headache treatment, we use repetitive treatment (often in combination with other modalities), for headache prevention, facial pain2 and neck muscle spasm3. After each treatment, tenderness gradually returns, but to a lesser degree. When this area becomes normal, the body must totally recreate this swelling to produce a headache. Because of this factor, the headache triggers (wine, chocolate) are also nullified in successfully treated patients. Many successfully treated headache patients remain symptom-free for many years. Others return periodically (from 3 to 30 months). They are usually treated twice, and then dismissed again. With our relatively recent anti-inflammatory cream, home headache prevention has, in many cases, reduced or eliminated office treatment. However, because the cream is investigational, under FDA guidelines, it is only available through our office following a diagnostic exam.
The chilling process has been cleared by the US FDA and has been declared a non-significant risk by the New York Medical College Institutional Review Board. Because of the absence of side-effects on several thousand applications, this therapy is ideal for pregnant and nursing women, children, and medically compromised patients.
The therapies, as described above, has also proven extremely effective in treating neck muscle spasm. As in headache, the laterality and severity of the intraoral tenderness is directly proportional to the laterality and severity of cervical pain3. However, the mechanism differs from that of headache, where the intraoral inflammation generates symptoms directly. In neck pain, the muscle spasm causes the intraoral tenderness, which further perpetuates the neck muscle spasm. One example of a similar loop: muscle spasm creates lactic acid, which further perpetuates muscle spasm. We have demonstrated increased neck range of motion and decreased electrical energy (EMG) in the posterior neck muscles are measured during chilling3.
Our device for maxillary nerve chilling has been cleared for use by the US FDA, because of its effectiveness in reduction of swelling and cervical muscle spasm. Our research, demonstrating increased cervical range of motion and decreased electrical energy (EMG) has been published in The Journal of Orthopaedic & Sports Physical Therapy3. In addition, Golf Illustrated has written about the device and its use to treat neck muscle spasm in professional golfers.
In addition to migraine and tension-type headache, we have had excellent results in treating post-traumatic headache. Because of the large number of M/V/A patients referred to us for TMJ problems, we are particularly experienced in treatment of this condition. A common presenting triad is TMJ/cervical muscle spasm/post-traumatic headache. Treatment reduces or eliminates the headache initially. Similar to the headaches described earlier, it returns, but to a lesser degree after each treatment. Because the cervical muscle spasm is treated simultaneously, treatment is particularly effective. In cases of neurological involvement with significant upper extremity symptoms, treatment is less effective
1. Friedman MH, Luque FA, Larsen EQ. Ipsilateral intraoral maxillary area tenderness and elevated temperature during unilateral headache. Headache Quart 1997;8(4):341-344.
2. Friedman MH. Atypical facial pain: the consistency of ipsilateral maxillary area tenderness and elevated temperature. J Am Dent Assoc 1995;126:855-860.
3. Friedmen MH, Nelson AJ. Head and neck pain review: traditional and new perspectives. J Orthop Sports Phys Ther 1996; 24(4):268-278
Local Inflammation as a Mediator of Migraine and Tension-Type Headache
Mark H. Friedman, DDS
Address all correspondence to Mark H. Friedman, DDS, Westchester Head & Neck Pain Center, 2 Overhill Rd., Ste. 260, Scarsdale, NY 10583.
From the Clinical Associate Professor of Medicine, New York Medical College; Clinical Associate, Professor of Anatomy & Cell Biology, New York Medical College, Valhalla, NY; Clinical Associate Professor of Dentistry, Westchester Medical Center, Valhalla, NY.
Copyright 2004 By the American Headache Society
intraoral tenderness - inflammation - migraine - tension-type headache - topical nonsteroidal anti-inflammatory drugs
Objective. -- To demonstrate the relationship of migraine and tension-type headache to a localized maxillary gingival inflammation.
Background. -- Intraoral tenderness has been observed consistently in the most common types of primary headache disorders. The laterality and degree of tenderness is related to laterality and severity of reported symptoms, both during headache and in the interictal state.
Methods. -- Bilateral posterior maxillary palpation and local temperature recordings were performed during unilateral migraine and tension-type headache. Local anti-inflammatory techniques, ie, local chilling and a topical anti-inflammatory gel, were used in these tender areas in episodic migraine and tension-type headache patients.
Results. -- Ipsilateral intraoral tenderness and increased local temperature were consistently observed during unilateral migraine and tension-type headache, suggesting local inflammation. Intraoral chilling and topical application of a nonsteroidal anti-inflammatory drug were highly effective for the treatment of migraine and tension-type headache, both in the acute phase and for headache prevention.
Conclusion. -- These results suggest that a local intraoral inflammation may be associated with the pathogenesis of these common headaches.
Accepted for publication April 12, 2004.
Intra-oral Chilling vs Oral Sumatriptan for Acute Migraine
Mark H. Friedman, D.D.S.,1 Stephen J. Peterson, M.D.,2 Caren F. Behar,M.D.,3 Zareen Zaidi, M.D.4 Heart Dis 2001;3:357-361.
Symptomatic migraine patients were randomly divided into three groups and treated either with a device that chills the area around the maxillary nerve, a placebo treatment (tongue chilling), or oral Sumitriptan. They recorded pre-treatment headache severity (0 - 10 scale), and then at one, two, four, and 24 hours after treatment initiation.
1 Clinical Associate Professor of Anatomy; Clinical Associate Professor of Medicine, New York Medical College
2 Professor of Clinical Medicine; Chief, Division of General Internal Medicine, New York Medical College
3 Clinical Assistant Professor of Medicine, New York Medical College
4 Former Instructor of Medicine, New York Medical College
Intra-oral Topical Non-Steroidal Anti-Inflammatory Drug Application for Headache Prevention
Mark H. Friedman, D.D.S.,1 Stephen J. Peterson, M.D.,2 William H. Frishman, M.D.,3 Caren F. Behar,M.D.,4 Heart Dis (in press)
Patients recorded headache duration (hours) and severity (0-10 scale) for 60 days. During the second thirty days they applied an anti-inflammatory gel daily to a specific intra-oral area. Values represent total monthly headache hours multiplied by average headache severity.
1 Clinical Associate Professor of Anatomy; Clinical Associate Professor of Medicine, New York Medical College
2 Professor of Clinical Medicine; Chief, Division of General Internal Medicine, New York Medical College
3 Professor of Medicine & Pharmacology, Chairman of Medicine, New York Medical College; Chief of Medicine, Westchester Medical Center
4 Clinical Assistant Professor of Medicine, New York Medical College
**4. MEDICINE: CURE MIGRAINES WITHOUT MEDICATION. DR. MARC FRIEDMAN, D.D.S., of the WESTCHESTER HEAD AND NECK PAIN CENTER in New York: "Treatment is based on the discovery that headache patients have an inflamed tender area above the upper molar teeth. Unrelated to the teeth or gums, this local inflammation creates a swelling, which puts pressure against the adjacent maxillary nerve - - causing the headache. This is contrary to current theories that describe a migraine as caused by an inflammation in the outer covering of the brain." Friedman demonstrated this link in a multi-hospital study by comparing the tenderness and temperature of the upper molar area in patients during one- sided migraine or tension headaches. He showed that with these patients, the temperature and tenderness were consistently greater on the symptomatic side, and these are signs of inflammation. Friedman says that his Intraoral Vasoconstriction device, held by the patients during treatment, works by chilling the inflamed area to eliminate the swelling and reduces pressure against the nerve for headache relief. News Contact: Meghan Berger, email@example.com Phone: +1-212-213-6444 (12/16/04)
Local Inflammation as a Mediator of Migraine and Tension-Type Headache.
Headache. 44(8):767-771, September 2004.
Friedman, Mark H. DDS
Objective: To demonstrate the relationship of migraine and tension-type headache to a localized maxillary gingival inflammation.
Background: Intraoral tenderness has been observed consistently in the most common types of primary headache disorders. The laterality and degree of tenderness is related to laterality and severity of reported symptoms, both during headache and in the interictal state.
Methods: Bilateral posterior maxillary palpation and local temperature recordings were performed during unilateral migraine and tension-type headache. Local anti-inflammatory techniques, ie, local chilling and a topical anti-inflammatory gel, were used in these tender areas in episodic migraine and tension-type headache patients.
Results: Ipsilateral intraoral tenderness and increased local temperature were consistently observed during unilateral migraine and tension-type headache, suggesting local inflammation. Intraoral chilling and topical application of a nonsteroidal anti-inflammatory drug were highly effective for the treatment of migraine and tension-type headache, both in the acute phase and for headache prevention.
Conclusion: These results suggest that a local intraoral inflammation may be associated with the pathogenesis of these common headaches.
Copyright (C) 2004 Blackwell Publishing Ltd.
Intraoral chilling versus oral sumatriptan for acute migraine.
Friedman MH, Peterson SJ, Behar CF, Zaidi Z.
Department of Dentistry, Westchester Medical Center, New York Medical College, Valhalla, New York, USA.
Migraine pathophysiology is associated with a dural inflammation. Recent evidence suggests that the primary inflammation occurs in a maxillary nerve segment, accessible intraorally. Local tenderness, related to symptom laterality, has been palpated consistently in asymptomatic migraine patients, and significant migraine relief has been obtained from chilling confined to this area. Thirty-five symptomatic episodic migraine patients were enrolled in this study, comparing 40 minutes of bilateral intraoral chilling, 50 mg of oral sumatriptan, and 40 minutes of sham (tongue) chilling. Hollow metal tubes chilled by circulating ice water were held in the maxillary molar periapical areas by the patient. Pain and nausea were recorded at baseline and 1, 2, 4, and 24 hours after start of treatment, using a numeric symptom-relief scale. Significant mean headache relief was obtained by maxillary chilling and sumatriptan at all four time intervals, with poor relief obtained by placebo. Maxillary chilling was more effective than sumatriptan at all four time intervals. Significant nausea relief was obtained by maxillary chilling and sumatriptan at posttreatment and 2 and 4 hours later. At 24 hours, some headache and nausea recurrence was noted with sumatriptan. The repeated-measures analysis of variance indicated that both treatments, drug (P = 0.024) and maxillary chilling (P = 0.001), reduced the headache, as compared with the control group. Tenderness suggests local inflammation associated with vasodilatation and edema. Because chilling can resolve local edema, these findings raise the possibility that an intraoral inflammation may be a factor in migraine etiology.
- Clinical Trial
- Randomized Controlled Trial
- Research Support, Non-U.S. Gov't
PMID: 11975819 [PubMed - indexed for MEDLINE]
In The News
Our method of cooling the maxillary nerve has proven extremely effective in treating neck muscle spasm. In fact, the FDA has recently cleared our device for treatment of muscle spasm. The Journal of Orthopedic and Sports Physical Therapy has published an article on our treatment. In addition, Golf Illustrated has written about the device and its use to treat neck muscle spasm in pro golfers.
A Unique Treatment For Neck Pain
Neck pain and muscle spasm are fairly common among golfers, particularly those who play and practice a lot, and even more particularly among older players. It can be a slight, frequent twinge or a more sustained ache in the lower neck, upper back and shoulders. The usual treatment is aspirin or other painkillers, or physical therapy and exercise. Now, there is something entirely different.
Dr. Mark Friedman, a former dentist in Westchester County, N.Y., who now specializes in treating head and neck pain, has developed a non-invasive treatment for neck pain that derives from his work on migraine headaches. At least four golf professionals in the New York metropolitan area report that the treatment has been extremely effective.
Dr. Friedman notes that his treatment is for immediate relief of deep muscle pain and spasm. Says Dr. Friedman, "I came to realize that the main cause of neck pain (and headache) is excess tissue fluid (swelling) that presses on key sensory nerves in the upper back corners of the mouth above the third molar." This swelling is caused by excessive blood flow in the area.
Once he found the cause and area of pain, the therapy became obvious to Dr. Friedman. Apply cold to reduce the blood flow, allowing the tissue fluid to return to the circulation. How to apply the cold? Ice cubes are inconvenient - too bulky and they melt quickly. Dr. Friedman found that the longer the treatment, up to a half-hour or 45 minutes, the better and more long-lasting the relief. (He does not say the treatment will eliminate the problem entirely, but that the frequency and severity of the problem lessens with each treatment). As a result, he has invented a device called the Cryotron¨, which consists of two slender plastic-sheathed metal tubes about 3-inches long that are chilled by ice water flowing through them via a small pump. They are shaped to exactly fit in the upper corners of the mouth and are held in place by the patient.
Dr. Friedman (an avid golfer, which is how and why he got interested in the problem) has gotten FDA clearance on the procedure. He described the technique extensively in the October 1996 issue of The Journal of Orthopaedic and Sports Physical Therapy. It is now used by
Dr. Friedman as well as the Westchester County Medical Center Emergency Room. The device, not quite ready for mass production, is something to look forward to. - Al Barkow
The New York Times, Sunday, June 16, 1996
Migraine? A doctor Comes Up With Relief
by Cynthia Magriel Wetzler
FF A Relentless, jabbing paint in the skull, an urge to vomit, a need to lie down in a quiet, dimly lighted place -- that's the migraine headache. For the nearly 24 percent of men and women in the Unites States who suffer from migraines, relief has been elusive. For many, the powerful medications most often prescribed by doctors are either intolerable or merely palliative. The headaches keep coming back.
FF Dr. Mark Friedman, a Mount Vernon dentist specializing in jaw problems and headache, may have discovered an alternative, noninvasive treatment, which has the potential of revolutionizing the way doctors look at and treat migraines.
FF Dr. Friedman, a dentist and anatomy professor at New York Medical College in Valhalla, has had articles in medical, dental and physical therapy publications. As he treated more than 1,000 headaches patients, he became convinced that the cause of migraine is not inflammation and edema (swelling) around the outer covering of the brain as many neurologists believe, but a persistent inflammation in the area of the maxillary nerve.
FF "Since 1990, I have observed a tender spot in the upper last molar area in patients with headaches," he said. "If the headache is one sided, I have also measured a higher temperature of the tender area on the headache side. The tenderness and warmth is caused by excessive local blood flow -- causing edema, which presses on sensitive nerve endings."
FF To reduce the edema and knock out the headache, he designed an ice-water device called a Cryotron, two small metal tubes covered by a disposable plastic sheath that are chilled by ice water generated by a small pump. The migraine patient inserts the device into the mouth to cool the inflamed area around the maxillary nerve, the spot that Dr. Friedman believes is the source of the headache. In migraine and tension headache sufferers, this spot is always tender, whether the person is having a headache, making the person particularly susceptible to a headache.
FF After 40 minutes of treatment, Dr. Friedman said, more than 90 percent of his patients with a headache have left his office free of pain. They return for four or five treatments, with or without headaches (which after the first treatment are usually decreased), and the majority have reported in follow-up calls to be headache free. "The treatment is pathetically uncomplicated," he said.
FF Dr. Friedman's alternative approach is being studied on acute-migraine and tension-headache patients in the emergency room at Westchester County Medical Center here.
FF In his office recently, Dr. Nicholas J. Nehrbauer, director of emergency medicine at the medical center, said: "Headaches for emergency medicine are problematical. Patients can't leave for home after a whopping dose of narcotic. We inject them with pain medication, such as Demerol, morphine or Percodan, all with potent side effects, along with a second medication to reduce the nausea both from the headache and the narcotic. We must monitor them, and they could be here for up to five hours before they are able to leave." The new nonnarcotic headache medication Imitrex may knock out one headache, but about half of the patients report another headache within the same day.
FF "I don't think every migraine patient left the E.R. pain free," said Dr. Nehrbauer, which is why he is lending his support to a pilot study in the emergency room of Dr. Friedman's treatment for migraine. With Dr. Friedman as principal investigator and Dr. Nehrbauer and Dr. F. Antonio Luque, a neurologist at the center, as co-investigators, the study is causing both ripples of hope and resistance in the medical community.
FF "That the source was detected through the mouth is the breakthrough," Dr. Friedman said. "When I realized that localized edema is the key to headaches, then the design of the Cryotron just followed, and I knew it would work. If I weren't involved in jaw pain, there is no way I would have poked around in there."
FF Dr. Friedman said he never expected such resistance to his treatment. "A lot of health professionals resent this, and it has not been easy getting it off the ground," he said. "My findings bring up the possibility that current headache theory may have to be revised."
FF Dr. Nehrbauer said: "What we are suggesting here is that there may be a totally new, effective way of treating migraine. Physicians are used to treating pain with pain medication. It may take them some time."
FF Among advantages for emergency room medicine of this noninvasive treatment Dr. Nehrbauer cited a small subculture of patients who shop hospitals for narcotics.
FF "They complaint of headaches," he said. "We can see a fracture but not a headache, and they can present a convincing story. They would not be interested in this nonnarcotic treatment and would try somewhere else."
FF Karen Farkas, a kidney-transplant coordinator who had suffered chronic migraines for five months, had trouble believing the simple treatment could bring her relief. "How could this be?" she said. "But it worked."
FF Other patients, including pregnant women and cardiac patients who should avoid narcotics, have reported the same results from th