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Botulinum Injections for Frontal Tension Headache
Kokoska MS, et al.
Posted: December 2004  
J Headache Pain. 2004;5:103-109

In this randomized, double-blind, placebo-controlled study, investigators examined the effectiveness of botulinum toxin type A injections for the treatment of frontal tension-type headaches. Subjects were required to be aged >18 years, have >1 per month episodic or chronic frontal headache (International Headache Society definition). Those with "migraine alone", or who had had a stroke, Bell’s palsy, or surgery of the corrugator or frontalis muscle were excluded. Also excluded were those with lid ptosis or lagophthalmos, current use of amino-glycosides, allergy to botulinum toxin or human albumin, or use of botulinum toxin A.

"Headaches with migrainous features" were reported by 11 (55%) patients in the botulinum group and by 8 (40%) in the placebo group. For the botulinum group, average post-treatment pain intensity was significantly reduced compared with pre-treatment. The botulinum group also experienced a reduction in the average number of headaches per month (23.4 vs. 17.1), as did the placebo group (23.2 vs. 18.4). The difference in reduction between the groups, however, was not statistically significant.

Adverse effects of botulinum toxin injection were described as minor. No statistically significant association was seen with narcotic, MAO inhibitors, or antidepressant use in average number of headaches per month in either group. The investigators could not explain the reduction in number of headaches in the placebo group. They note that other studies report benefit derived from dry needling, and injections of local anesthetics or saline into tender muscle points during tension-type headache. Although the exact mechanism of botulinum toxin A on headache is unknown, some studies point to "a combination of its muscle relaxant and antinociceptive properties." The investigators recommend larger, randomized studies of botulinum toxin A for tension-type headache with a frontal pain distribution.