Onabotulinum toxin A block of the sphenopalatine ganglion in patients with persistent idiopathic facial pain: a randomized, triple-blind, placebo-controlled, exploratory, cross-over study
Jamtøy, Kent Are; Thorstensen, Wenche Moe; Stovner, Lars Jacob; Rosén, Annika; Maarbjerg, Stine; Bratbak, Daniel Fossum; Simpson, Melanie Rae; Tronvik, Erling Andreas
Peer reviewed, Journal article
Published version
Date
2023Metadata
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Original version
10.1177/03331024231187132Abstract
Objective
To investigate the efficacy and safety of injecting onabotulinum toxin A (BTA) towards the sphenopalatine ganglion (SPG) using the MultiGuide® in patients with persistent idiopathic facial pain (PIFP).
Methods
This cross-over, exploratory study compared the injection of 25 units BTA versus placebo in patients who met modified ICDH-3 criteria for PIFP. Daily pain diaries were registered for a 4-week baseline, a 12-week follow-up after each injection, and an 8-week conceptual washout period in between. The primary efficacy endpoint was the change from baseline to weeks 5–8 in average pain intensity using a numeric rating scale. Adverse events were recorded.
Results
Of 30 patients who were randomized to treatment, 29 were evaluable. In weeks 5–8, there was no statistically significant difference in average pain intensity between BTA versus placebo (0.00; 95% CI = −0.57 to 0.57) (P = 0.996). Following both BTA and placebo injections, five participants reported at least a 30% reduction in average pain during weeks 5–8 (P = 1.000). No serious adverse events were reported. Post-hoc analyses indicated a possible carry-over effect.
Conclusions
Injection of BTA toward the SPG with the MultiGuide® did not appear to provide a reduction in pain reduction at 5–8 weeks, although this finding may be influenced by a carry-over effect. The injection appears to otherwise be safe and well-tolerated in patients with PIFP.