Efficacy of Intralesional Botulinum Toxin A for Treatment of Painful XXXX : A Randomized Clinical Trial.

@entity1 @entity11708 @entity158
IMPORTANCE: @entity11708 can be associated with severe @entity158 in which nerve conduction may have a key role. Medical management of painful @entity11708 is generally unsatisfactory. OBJECTIVE: To assess the efficacy of intralesional botulinum toxin A in the management of @entity158 associated with @entity11708 . DESIGN, SETTING, AND @entity1 : Randomized, double-blind, placebo-controlled pilot study conducted from January 5, 2009, to March 27, 2014. The setting was a single-center study at the National Institutes of Health among @entity1 18 years or older with @entity11708 characterized by @entity158 at least once weekly and @entity158 of at least 4 on a @entity158 scale ranging from 0 to 10. INTERVENTIONS: Eighteen @entity1 were randomized to receive intralesional botulinum toxin A (5 U per 1 cm2) or equivalent volumes of intralesional saline placebo. MAIN OUTCOMES AND MEASURES: The primary outcomes were the differences in average lesional @entity158 assessed by the Brief Pain Inventory and visual analog scale before and after ice provocation over a 4-week period. RESULTS: No significant difference in average lesional @entity158 was observed between the study arms. @entity158 was reported in the botulinum toxin vs placebo arms by visual analog scale scores before ice provocation (median, 0.00; range, -3.30 to 0.70 for botulinum toxin and median, 0.40; range, -1.30 to 1.50 for placebo; P   =   .06); however, this finding was nonsignificant. No significant difference was observed in change in @entity158 after ice provocation. A significant difference was seen between the arms in skin-related quality of life by total Dermatology Life Quality Index (median, -4.00; range, -8.00 to 2.00 for botulinum toxin and median, 0.00; range, -1.00 to 4.00 for placebo; P   =   .007) and with the specific @entity158 -related question on the Dermatology Life Quality Index (median, -1.00; range, -2.00 to 1.00 for botulinum toxin and median, 0.00; range, -1.00 to 0.00 for placebo; P   =   .048). No significant difference was found in @entity158 as ascertained by @entity1 Global Impression of Change at week 4. No serious adverse events related to botulinum toxin use were observed. CONCLUSIONS AND RELEVANCE: The use of botulinum toxin to treat painful @entity11708 was associated with improved quality of life and with a trend toward improved @entity158 at rest. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00971620.
