Pilot Study of Injection of OnabotulinumtoxinA Toward the Sphenopalatine Ganglion for the Treatment of Classical Trigeminal Neuralgia.
botulinum toxin
pterygopalatine ganglion
sensitization
sphenopalatine ganglion
trigeminal neuralgia
Journal
Headache
ISSN: 1526-4610
Titre abrégé: Headache
Pays: United States
ID NLM: 2985091R
Informations de publication
Date de publication:
09 2019
09 2019
Historique:
accepted:
15
04
2019
pubmed:
26
7
2019
medline:
14
7
2020
entrez:
26
7
2019
Statut:
ppublish
Résumé
The sphenopalatine ganglion (SPG) has previously been targeted in trigeminal neuralgia (TN), but its role in this condition has not been established. To investigate the safety of injecting onabotulinumtoxinA (BTA) toward the SPG using the MultiGuide Twenty-five international units (IU) of BTA were injected toward the SPG in a prospective, open-label study in 10 patients with refractory classical TN. All patients were recruited and treated on an out-patient basis at St. Olav's University Hospital in Trondheim (Norway). adverse events (AEs). Primary efficacy outcome: number of TN attacks at weeks 5-8 after injection compared to baseline. A treatment responder was predefined as at least 50% reduction in the median number of attacks per day between baseline and weeks 5-8. Other efficacy outcomes were intensity of attacks (numeric rating scale, 0 to 10) and functional level (1 to 4; 1 best and 4 worst) at weeks 5-8 after injection compared to baseline. Percentage of the day with concomitant persistent pain was registered at baseline and at weeks 1-4, 6, 8, and 12 after injection. Patient global impression of change (PGIC) was ascertained at month 3. For the primary endpoint, we analyzed data for all 10 patients. For efficacy outcomes we analyzed data for 9 patients (1 patient violated protocol). We registered 13 AEs, none of which were serious. The median number of TN attacks during the 4-week baseline and weeks 5-8 after injection was 5.5 (range: 1.0-51.5) and 5 (range: 0-225.0), respectively (P = .401). Four patients were treatment responders. The median intensity of attacks at baseline and weeks 5-8 after injection was 6 (range: 3.0-8.5) and 3 (range: 0.0-9.0) respectively (P = .024). The median functional level at baseline was 2 (range: 1.0-3.3) and at month 2, 1 (range 1.0-4.0; P = .750). Median percentage of the day with concomitant persistent pain was 75% (minimum 37.5%, maximum 100%) at baseline and 18.75% (minimum 0%, maximum 100%) at week 8 (P = .023). Injection of BTA toward the SPG using the MultiGuide
Sections du résumé
BACKGROUND
The sphenopalatine ganglion (SPG) has previously been targeted in trigeminal neuralgia (TN), but its role in this condition has not been established.
OBJECTIVE
To investigate the safety of injecting onabotulinumtoxinA (BTA) toward the SPG using the MultiGuide
METHODS
Twenty-five international units (IU) of BTA were injected toward the SPG in a prospective, open-label study in 10 patients with refractory classical TN. All patients were recruited and treated on an out-patient basis at St. Olav's University Hospital in Trondheim (Norway).
PRIMARY OUTCOME
adverse events (AEs). Primary efficacy outcome: number of TN attacks at weeks 5-8 after injection compared to baseline. A treatment responder was predefined as at least 50% reduction in the median number of attacks per day between baseline and weeks 5-8. Other efficacy outcomes were intensity of attacks (numeric rating scale, 0 to 10) and functional level (1 to 4; 1 best and 4 worst) at weeks 5-8 after injection compared to baseline. Percentage of the day with concomitant persistent pain was registered at baseline and at weeks 1-4, 6, 8, and 12 after injection. Patient global impression of change (PGIC) was ascertained at month 3.
RESULTS
For the primary endpoint, we analyzed data for all 10 patients. For efficacy outcomes we analyzed data for 9 patients (1 patient violated protocol). We registered 13 AEs, none of which were serious. The median number of TN attacks during the 4-week baseline and weeks 5-8 after injection was 5.5 (range: 1.0-51.5) and 5 (range: 0-225.0), respectively (P = .401). Four patients were treatment responders. The median intensity of attacks at baseline and weeks 5-8 after injection was 6 (range: 3.0-8.5) and 3 (range: 0.0-9.0) respectively (P = .024). The median functional level at baseline was 2 (range: 1.0-3.3) and at month 2, 1 (range 1.0-4.0; P = .750). Median percentage of the day with concomitant persistent pain was 75% (minimum 37.5%, maximum 100%) at baseline and 18.75% (minimum 0%, maximum 100%) at week 8 (P = .023).
CONCLUSIONS
Injection of BTA toward the SPG using the MultiGuide
Identifiants
pubmed: 31342515
doi: 10.1111/head.13608
pmc: PMC6771650
doi:
Substances chimiques
Neuromuscular Agents
0
Botulinum Toxins, Type A
EC 3.4.24.69
Types de publication
Clinical Trial
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1229-1239Subventions
Organisme : NTNU (Norwegian University of Science and Technology) and "The Liaison Committee for Education, Research and Innovation in Central Norway" (Samarbeidsorganet)
ID : 46056923
Pays : International
Informations de copyright
© 2019 Authors. Headache: The Journal of Head and Face Pain published by Wiley Periodicals, Inc. on behalf of American Headache Society.
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