A Double‐Blind, Placebo‐Controlled Study of Repetitive Transnasal Sphenopalatine Ganglion Blockade With Tx360^® as Acute Treatment for Chronic Migraine

Abstract

ObjectiveTo determine if repetitive sphenopalatine ganglion (SPG) blocks with 0.5% bupivacaine delivered through the Tx360® are superior in reducing pain associated with chronic migraine (CM) compared with saline.BackgroundThe SPG is a small concentrated structure of neuronal tissue that resides within the pterygopalatine fossa (PPF) in close proximity to the sphenopalatine foramen and is innervated by the maxillary division of the trigeminal nerve. From an anatomical and physiological perspective, SPG blockade may be an effective acute and preventative treatment for CM.MethodThis was a double-blind, parallel-arm, placebo-controlled, randomized pilot study using a novel intervention for acute treatment in CM. Up to 41 subjects could be enrolled at 2 headache specialty clinics in the US. Eligible subjects were between 18 and 80 years of age and had a history of CM defined by the second edition of the International Classification of Headache Disorders appendix definition. They 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 of 2:1 to receive 0.5% bupivacaine or saline, respectively. The primary end-point was to compare numeric rating scale scores at pretreatment baseline vs 15 minutes, 30 minutes, and 24 hours postprocedure for all 12 treatments.SPG blockade was accomplished with the Tx360®, which allows a small flexible soft plastic tube that is advanced below the middle turbinate just past the pterygopalatine fossa into the intranasal space. A 0.3 cc of anesthetic or saline was injected into the mucosa covering the SPG. The procedure is performed similarly in each nostril. The active phase of the study consisted of a series of 12 SPG blocks with 0.3 cc of 0.5% bupivacaine or saline provided 2 times per week for 6 weeks. Subjects were re-evaluated at 1 and 6 months postfinal procedure.ResultsThe final dataset included 38 subjects, 26 in the bupivacaine group and 12 in the saline group. A repeated measures analysis of variance showed that subjects receiving treatment with bupivacaine experienced a significant reduction in the numeric rating scale scores compared with those receiving saline at baseline (M = 3.78 vs M = 3.18, P = .10), 15 minutes (M = 3.51 vs M = 2.53, P < .001), 30 minutes (M = 3.45 vs M = 2.41, P < .001), and 24 hours after treatment (M = 4.20 vs M = 2.85, P < .001), respectively. Headache Impact Test-6 scores were statistically significantly decreased in subjects receiving treatments with bupivacaine from before treatment to the final treatment (Mdiff = −4.52, P = .005), whereas no significant change was seen in the saline group (Mdiff = −1.50, P = .13).ConclusionSPG blockade with bupivacaine delivered repetitively for 6 weeks with the Tx360® device demonstrates promise as an acute treatment of headache in some subjects with CM. Statistically significant headache relief is noted at 15 and 30 minutes and sustained at 24 hours for SPG blockade with bupivaca...

An Unusual Location for Sphenopalatine Ganglion in the Pterygopalatine Fossa Which May Facilitate Radiofrequency Neurolysis: A Case Report

“…Therefore, the needle can generate an adequate thermocoagulation in the ganglion. Right stimulation response can justify subsequent thermocoagulation of the SPG leading to adequate pain relief (5)(6)(7)(8)(9)(10).…”

A Narrative Review of Evidence-Based Preventive Options for Chronic Migraine

“…A recent randomized, multicenter, double-blind, placebocontrolled study on greater occipital nerve blockade for the treatment of chronic migraine using saline versus bupivacaine demonstrated a greater reduction in the number of headache days in the bupivacaine group versus placebo (p=0.004) [28]. Sphenopalatine ganglion blockade in the treatment of chronic migraine has been evaluated in a double-blind, placebo-controlled, randomized study of 41 subjects (bupivacaine, n=26 versus saline, n=12) that demonstrated that 0.5 % bupivacaine delivered via a noninvasive device twice a week for 6 weeks was superior to saline with a statistically significant difference in the numerical pain score at 15 min, 30 min, and 24 h after the procedure [29]. Endpoints for longer term efficacy, however, such as the number of headache days 1 month posttreatment, did not meet statistical significance in this small study [30].…”

One occipital nerve block for the short-term prevention of migraine?

“…Perhaps the ''placebo'' was not truly a placebo. (3). Repetitive blocks to the supraorbital and infraorbital nerves showed benefit to migraine patients after a six-month clinical follow-up (4).…”