Treatment of Tension-type Headache With Botulinum Toxin Type A: A Double-Blind, Placebo-Controlled Study


Address all correspondence to Dr. Jens D. Rollnik, Medical School of Hannover, Department of Neurology, D-30623 Hannover, Germany.


Objective.–To determine whether injections of botulinum toxin could be of therapeutic value in the treatment of tension-type headache.

Background.–Botulinum toxin A is very effective at reducing muscle tenderness and pain in many diseases. Increased muscle tension may contribute to tension-type headache.

Methods.–We performed a double-blind, placebo-controlled study with 21 patients fulfilling the International Headache Society criteria for tension-type headache. Participants were randomly assigned to treatment (pericranial injection of 10 × 20 mouse units botulinum toxin A) or placebo (injection of isotonic saline in the same manner).

Results.–After 4, 8, and 12 weeks, no significant differences between placebo and treatment could be observed (with respect to visual analog scale, frequency and duration of headache attacks, consumption of analgesics, pressure pain threshold, total tenderness score, and quality-of-life parameters).

Conclusions.–The findings of our study strongly support the hypothesis that peripheral mechanisms, such as increased muscle tenderness, only play a minor role in the pathogenesis of tension-type headache.