This new headache treatment is based on the finding that headache patients have an inflamed tender area above the upper molar teeth. The inflammation creates a local swelling, which exerts pressure on the adjacent maxillary nerve, causing the headache. This is contrary to current theories ascribing the cause to a swelling of the meninges, the outer covering of the brain. Researchers demonstrated this link in a multi-centered study by measuring the temperature and palpating for 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 symptomatic side was consistently higher (37 of 40) and more tender (39 of 40) respectively, than it was on the opposite side, as well as directly proportional to symptom severity. Tenderness and elevated temperature are signs of inflammation. In the Emergency Department and Imitrex studies, a device called the Intra-Oral Vasoconstriction device (IVC) was used to chill the inflamed area to reduce the swelling, which takes the pressure off the nerve to eliminate the headache.
These findings were made by a dentist, Dr. Mark Friedman, who was also the principal investigator for all three studies. In addition to his private practice, he is also a Clinical Associate Professor of Medicine and of Anatomy and Cell Biology at New York Medical College. Co-authors of these studies were Drs. Stephen Peterson, Eric Larsen, and Caren Behar.
Doctors at New York Medical College were initially skeptical of Dr. Friedman’s therapy. “I sent him my worst cases, the ones I thought he would fail with,” said Dr. Peterson, Chief of the New York Medical College Department of General Internal Medicine, “these were impossible cases.” Dr. Peterson became involved in testing the treatment after it was used on his twelve-year-old niece who had developed a three-month long headache following successful brain surgery. The headache was eliminated after one treatment.
Despite the impressive results of the IVC studies, the new treatment that has the most promise clinically is a topical anti-inflammatory gel applied to the same area for migraine, tension, and post-traumatic headache prevention. In a new home application pilot study conducted at Dr. Friedman’s private office, the treatment was far more effective than any available preventative headache medication. The study measured a value called Headache Burden, which equals total monthly headache hours multiplied by average headache intensity (0-10 scale). Daily gel application resulted in an 81% reduction in Headache Burden as well as a significant reduction in the use of analgesics. Dr. Friedman is excited about the ease of gel application noting that patients are more likely to use a home treatment that only takes a few seconds.
Dr. William Frishman, Chairman of the Department of Medicine at New York Medical College and one of the co-authors of this study is enthusiastic about the safety of these treatments. “Since they are local treatments, they avoid the potential side effects of the systemic drugs that are used for migraine.” said Dr. Frishman.
A large-scale controlled study of the anti-inflammatory gel is being developed.