An open label, randomised, pilot study of botulinum toxin type-A in the treatment of chronic tension-type headache

The objective was to assess the effect of botulinum toxin type-A (BTX-A) in treating chronic tension-type headache (CTTH). A single centre, open label, pilot study was carried out at the Headache and Pain Center, Neurology Department, Policlinico San Marco, Bergamo, Italy and the Istituto Ortopedico Galeazzi, Milan, Italy. Sixty consecutive patients meeting accepted criteria for CTTH were randomised into 3 equal groups. Group 1: patients injected in fixed points; Group 2: patients injected using the "follow the pain" approach; and Group 3: as per Group 2 but combined with physiotherapy. Patients were assessed for 4 months using a headache diary, and efficacy was evaluated using a verbal rating scale (VRS), changes in headache frequency and drug intake count. At month 3, all groups showed improvements in VRS, mean headache frequency and mean drug intake, with Group 3 showing the greatest improvements in VRS and drug intake. BTX-A may be a promising therapy for treatment of CTTH using the "follow the pain" approach, especially when combined with adjunctive physiotherapy.