Intraoral Administration of Botox in Patients With Dentoalveolar Neuropathic Pain
Status:
Recruiting
Trial end date:
2021-12-31
Target enrollment:
Participant gender:
Summary
Onabotulinum toxin type A (BoNT-A) is a potent neurotoxin that has been reported to have an
effect on afferent (sensory) neurons independent of its action on muscle tone and secretory
glands at the periphery.In human studies, the use of BoNT-A has proven to reduce the severity
and intensity of attacks in chronic tension type headaches and chronic neck pain. The PREEMPT
study concluded that BoNT-A could be used as a preventive therapy in chronic migraine
patients and FDA approval was obtained. According to the International Association for the
Study of Pain (IASP), BoNT-A is recommended for the management of peripheral neuropathic pain
with subcutaneous administration of 50-200 units (50-200U) to onabotulinum toxin A to the
painful neuropathic area every 3 months as a third line of treatment. To our knowledge, there
are no clinical trials published investigating the effect of intraoral administration of
BoNT-A in continuous dentoalveolar neuropathic pain. The aim of this pilot study is to
investigate the potential therapeutic effect of intraoral administration of BoNT-A in
patients suffering from continuous neuropathic pain.
HYPOTHESIS:
There will be statistically significant differences in reported pain intensity after the
intraoral administration of BOTOX® in patients suffering from chronic continuous
dentoalveolar neuropathic pain.
A single subject experiment will be conducted with 10 patients where 50 U of BonT-A will be
injected into the painful dentoalveolar area. Eligible subjects will complete a pain diary
indicating their pain intensity by means of a visual analog scale during one month to
establish a baseline. After the first injection, subjects will continue to monitor the VAS
daily for 3 months and the infiltration will be repeated a second time following the same
protocol. Patient's response will be monitored with the daily pain diary.
Phase:
Phase 2
Details
Lead Sponsor:
Isabel Moreno Hay
Collaborator:
Allergan Sales, LLC
Treatments:
abobotulinumtoxinA Botulinum Toxins, Type A onabotulinumtoxinA