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 pterygo...

Full description

Saved in:
Bibliographic Details
Published in:Headache 2015-04, Vol.55 (4), p.529-542
Main Authors: Cady, Roger K., Saper, Joel, Dexter, Kent, Cady, Ryan J., Manley, Heather R.
Format: Article
Language:English
Subjects:
Adolescent
Adult
Aged
Anesthetics, Local - administration & dosage
Bupivacaine - administration & dosage
Catheterization - instrumentation
Catheterization - methods
Chronic Disease
chronic migraine
Double-Blind Method
Drug Administration Schedule
Drug Delivery Systems - instrumentation
Drug Delivery Systems - methods
episodic migraine
Female
Headaches
Humans
Male
Middle Aged
Migraine
Migraine Disorders - diagnosis
Migraine Disorders - drug therapy
Pain Measurement - drug effects
Pain Measurement - methods
Pilot Projects
Quality of life
Research Submission
Research Submissions
Sodium Chloride - administration & dosage
sphenopalatine ganglion block
Sphenopalatine Ganglion Block - methods
Studies
Time Factors
Treatment Outcome
Tx360
Young Adult
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary: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 manuscript include post‐treatment measures including number of headache days and quality of life measures. Results The final data set included 38 subjects: 26 in the bupivacaine group and 12 in the saline group. Our primary end‐point for the study, difference in numeric pain rating scale scores, was met and reported in a previous article. The supplemental secondary end‐points reported in this manuscript did not reach statistical significance. When looking collectively at these end‐points, trends were noticed and worthy of reporting. Subjects receiving bupivacaine reported a decrease in the number of headache days 1 month post‐treatment (Mdiff = −5.71), whereas those receiving saline only saw a slight improvement (Mdiff = −1.93). Headache Impact Test 6 scores were decreased in the bupivacaine group at 1 month (Mdiff = −5.13) and 6 months (Mdiff = −4.78) post‐treatment, but only a modest reduction was seen for those receiving saline at 1 and 6 months, respectively (Mdiff = −2.08, Mdiff = −1.58). Furthermore, subjects receiving bupivacaine reported a reducti
ISSN:0017-8748
1526-4610
DOI:10.1111/head.12546