Health Problem: Headache is a common disorder affecting more than 45 million individuals in the United States. There are several types of headache, with symptoms that vary with the underlying pathophysiology. Headaches can be primary, such as migraine, cluster, and tension headaches; or secondary to systemic, intracranial, or extracranial causes. Migraine affects 18% of women and 6% of men, and 5% of women and 2.8% of men suffer from chronic daily headaches (headaches occurring on at least 15 days per month).

Technology Description: Cranial and neck muscles that appear responsible for migraine headaches are located by visual inspection and palpation or with the use of electromyography (EMG). Injection of botulinum toxin type-A (BTX-A) into the selected muscles can be performed with or without EMG guidance. BTX-A treatment usually involves multiple injections into several different muscles, and it may be necessary to repeat this treatment every 3 to 6 months.

Controversy: The underlying physiological cause of migraines is not fully understood. Therefore, botulinum toxin (BTX) treatment may have limited benefit as a therapy that addresses secondary symptoms rather than the primary cause of this disorder.

Key Questions:

  • Does BTX reduce the frequency, severity, or duration of migraine headache?

  • Does BTX improve the quality of life in patients who have migraine headache?

  • How does efficacy of BTX compare with other active or prophylactic treatments for migraine headache?

  • Is BTX safe for the treatment of migraine headache?

  • Have definitive patient selection criteria been established for the use of BTX for the prevention of migraine headache?

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