Device Chills Out Migraines Without Medication Gets FDA Clearance

Main Category: Headache / Migraine
Article Date: 07 Dec 2004 - 10:00 PDT

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Migraine headaches are a painful condition affecting 28 million Americans, and tension headaches are even more common. According to one of the world's most prominent headache scientists, tension headaches represents one of the most costly diseases in modern society because of its high prevalence. What if there were non-invasive, non-narcotic treatments for these headaches?

When used for severe migraine and tension headaches in a major medical center emergency department study, which included pregnant women, this medical device allowed relief and dismissal of 80% of these patients in less than one hour. In a New York Medical College Department of Medicine controlled acute migraine study, it proved more successful than Imitrex, the most widely prescribed migraine medication. In both studies, no side effects were reported.

These results were recently published by Dr. Mark Friedman, in Headache, the American Headache Society journal. Because of these outstanding study results, this technique was approved for treating migraines by the FDA (June 2004).

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 migraine as caused by an inflammation in the outer covering of the brain. Dr. 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. In these patients, the temperature and tenderness was consistently greater on the symptomatic side.

Tenderness and increased local temperature are signs of inflammation. Dr. Friedman's (Intraoral Vasoconstriction) IVC device, held by the patient during treatment, works by chilling the inflamed area to eliminate the swelling. This reduces pressure against the nerve for headache relief.

Since this tenderness and swelling exists even in the headache-free state, headache patients are much closer to a headache, even when pain-free, and treatment is effective for headache prevention even during these periods.

A topical anti-inflammatory gel, designed to adhere to and penetrate the gum tissue, applied by the patient at home, works as a powerful headache preventive. Dr. Friedman measured a value called Headache Burden, which equals total monthly headache hours multiplied by average headache intensity (0-10 scale). Used for a month, the gel showed an 81% decrease in migraine, tension, and post-traumatic headache frequency and severity. The Journal of Heart Disease (2002) published this study, because unlike typical migraine drugs, these treatment(s) do not affect the coronary vessels. Following the first treatment, patients return soon for 1 - 3 more treatments, even if they are between headaches. They receive the home application gel at the second treatment. Dr. Friedman plans to make the chilling device available to the general public.

These treatments work exceptionally well for pregnant and medically compromised patients.

About Dr. Mark Friedman: Dr. Mark Friedman directs the Westchester Head & Neck Pain Center in Scarsdale, NY. He is a dentist, who is also an Associate Professor of Medicine and of Anatomy at New York Medical College, and former director of the TMJ Clinic at Westchester Medical Center. His practice is limited to headache, TMJ, and facial pain. He has given over 250 lectures and courses, and has published over 50 articles and textbook chapters in the dental, medical, and TMJ field, as well as co-authoring a TMJ textbook. He was formerly on the editorial board of the Journal of Orthopaedic & Sports Physical Therapy. His latest publications involve headache, a field in which he holds seven U.S. Patents. He was the principal investigator and primary author of the above studies.

This technique was approved by the FDA on 5/7/04.

Meghan Berger
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