Long-Term Efficacy of a Double-Blind, Placebo-Controlled, Randomized Study for Repetitive Sphenopalatine Blockade With Bupivacaine vs Saline With the Tx360 ® Device for Treatment of Chronic Migraine

Background.—This study aims to determine if repetitive sphenopalatine ganglion (SPG) blockades with 0.5% bupivacaine delivered with the Tx360 ® device results in long-term improvement in chronic migraine (CM).The SPG is a small concentrated structure of neuronal tissue that resides within the pterygopalatine fossa in close proximity to the sphenopalatine foramen and is innervated by the maxillary division of the trigeminal nerve. In a previous article, these authors reported repetitive SPG blockades with 0.5% bupivacaine delivered by the Tx360 ® device, which was an effective and well-tolerated intervention to incrementally decrease baseline headache intensity of subjects with CM. Methods.—This was a double-blind, parallel-arm, placebo-controlled, randomized pilot study using a novel intervention for acute treatment in CM. A total of 41 subjects were enrolled at two headache specialty clinics in the USA. Eligible subjects were between 18 and 80 years of age and had a history of CM defined by International Classification of Headache Disorders-II definition. Subjects were allowed a stable dose of migraine preventive medications that was maintained throughout the study. Following a 28-day baseline period, subjects were randomized by computer-generated lists 2:1 to receive 0.3 cc of 0.5% bupivacaine or saline, respectively, delivered with the Tx360 ® twice a week for 6 weeks. Secondary end-points reported in this