Surgery – Miscellaneous – Methods
Reexamination Certificate
2000-06-15
2002-09-17
Dvorak, Linda C. M. (Department: 3739)
Surgery
Miscellaneous
Methods
C606S001000, C607S088000, C607S089000
Reexamination Certificate
active
06450170
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to a new method for the treatment of migraine, tension-type headaches, atypical facial pain, post-traumatic headache, cervical pain and muscle spasm.
In accordance with the invention, the method of treatment for these headaches, atypical facial pain, cervical pain and muscle spasm comprises the application of low power laser light to the area of intra-oral tenderness which has been found by the inventor herein to be associated with the aforesaid conditions. This zone of tenderness and an increased local temperature are in the area of the plexus formed by the posterior superior alveolar branch of the ipsilateral maxillary nerve. The zone of tenderness is located bilaterally when the symptoms are bilateral and unilaterally when the symptoms are one sided.
In the case of tension (muscle contraction) headaches in the frontalis or forehead and/or orbital region, the laser emitted radiation can also be applied to the supraorbital nerve as it emerges from the supraorbital notch or foramen over the eye or at the infraorbital foramen beneath the eye, or at the mandibular foramen in the mandible This laser application is performed either separately or in conjunction with the laser treatment directed to the area of intra-oral tenderness. The intra-oral tenderness associated with migraine, tension-type headaches, post-traumatic headache, cervical muscle spasm and atypical facial pain is markedly decreased or disappears immediately after intra-oral laser application, returning in approximately three hours to a few days, but most importantly it has been found that with repeated applications, the tenderness returns to a lesser degree along with a decrease in symptoms. For the above-noted conditions, a marked decrease or elimination of the above noted conditions' frequency and intensity takes place. Immediate relief is often noted when the patient is symptomatic.
In practicing the method of the invention, low level lasers of several types were used including Helium-Neon lasers emitting light at 632.8 nm, and Gallium Arsenide diode lasers emitting light at 635 nm and Gallium Aluminum Arsenide diode lasers emitting light at 830 nm. It is also possible to use a combination of different types of low level emitting lasers simultaneously; i.e., Helium-Neon and Gallium Aluminum Arsenide, or other low-level use lasers such as a CO
2
infrared laser.
Headaches can be classified into three main groups: vascular such as migraine or cluster, tension or muscle contraction and traction and inflammatory headaches. The latter group may be caused by stroke, hypertension, hemorrhage from an aneurysm, brain tumor, infections or inflammation.
Migraine is the most common type of headache causing patients to consult a physician. According to the American Council for Headache Education, migraine type headache is reported to occur in 18% of females and 6% of males in the United States. Considering this incidence, the economics of migraine, time lost from work, inefficiency etc., is substantial. Effective treatment can increase the patient's ability to live a normal and productive life. In addition to pain, the symptoms most commonly associated with migraine include nausea and vomiting, photophobia, phonophobia, pallor, and a desire to lie down.
Multiple humoral agents have been postulated as being the major factor in migraine. These include serotonin, histamine, prostaglandins, platelet factors, endorphins, substance P, and bradykinea. Low power density lasers have been shown to act on prostaglandin (PG) synthesis, increasing the change of PGG
2
and PGH
2
into PG
12
. These products are known to have an anti-inflammatory action. The etiology of migraine has been studied by many investigators. Research has implicated the meninges as the source for vascular head pain, as an unknown trigger activates perivascular trigeminal axons which release vasoactive neuropeptides (substance P, calcitonin gene-related peptide, histamine, bradykinin, prostaglandins etc.). These agents produce a local sterile inflammation, causing transmission of nociceptive impulses to the brain stem and higher centers, for the registration of head pain (Moskowitz MA, Trends in Pharmacological Sciences, August 1992. The intra-oral zone of tenderness located in the area of the root apices of the maxillary molars appears to be increased, with subsequent local swelling. The swelling exerts pressure on the maxillary nerve, resulting in trigeminal axonal activation. In the presence of this lowered threshold, various other triggers can cause the headache, for example, hormones, wine, chocolate, changing weather fronts, etc.
Migraine therapy is either prophylactic or symptomatic. Prophylactic medication may be selected for a patient with 2-4 headaches per month, if they are severe enough to interfere with daily activities. Beta blockers such as propranolol (Inderal) are the most common. Other medications, often used, are serotonin antagonists such as methysergide maleate (Sansert), calcium channel blockers (Verapamil), amitriptyline (Elavil), and ergotamine preparations with belladonna alkaloids and phenobarbital. These all have significant side effects such as sedation, loss of energy and drive, dry mouth, constipation, weight gain and gastrointestinal cramping and distress. For symptomatic treatment, ergotamine with caffeine (Cafergot) is commonly used. Other medications include isometheptene mucate (Midrin), NSAID's (Motrin, etc.), dihydroergotamine, the newer medication sumitriptan (Imitrex) which has to be injected intramuscularly and a rapidly expanding class of oral triptans including oral sumitriptan, all of which constrict blood vessels throughout the body, including the coronary vessels. When narcotics, such as Fiorinal with codeine are frequently used, additional hazards include the considerable potential for rebound headache and habituation.
Most neurologists regard atypical facial pain as psychogenic and poorly responsive to all forms of medication. Amitriptyline at bed-time and/or various analgesics and narcotics, are commonly used for this condition for extended time periods, often for decades.
Other modes of treatment for these conditions include: (a) acupuncture, (b) biofeedback, and (c) chiropractic. Acupuncture and chiropractic have been used for headache relief, but studies have failed to show that treatment is much more effective than placebo. Acupuncture requires a highly trained acupuncturist. Biofeedback-training in muscular relaxation may be helpful for muscle contraction headache in selected individuals, but controlled studies have not demonstrated success in the above conditions. It is also very time consuming, requiring many treatments. The applicant herein has described the application of low power lasers to the treatment of various conditions including those referred to herein in U.S. Pat. No. 5,514,168. The treatment therein described involves low power of a very different magnitude (considerably lower) than contemplated herein.
The etiology of tension-type headaches is currently regarded as unknown, and treatment remains non-specific. Pharmacologic agents such as NSAID'S , antidepressant compounds (tricyclics or MAO inhibitors) and prophylactic anti-migraine drugs have been used. Behavioral treatments such as bio-feedback have provided some relief for some patients. Strategies for coping with stress and physical therapy however, have limited use in certain patients.
Tension-type headache was formerly described as muscle contraction headache. It is of uncertain pathogenesis but some kind of mental or muscular tension may play a causative role. Tension-type headaches fall into two classifications: episodic and chronic. The diagnostic criteria for episodic tension -type headache are: (1) At least 10 previous headache episodes fulfilling the following criteria and the number of days with such headache, less than 180/year. (2) Headache lasting from 30 minutes to 7 days. (3) At least two of the following pain characteristics: pressure/tightening (nonp
Dvorak Linda C. M.
Farah Ahmed
Sommer Evelyn M.
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