Botulinum Toxin Versus Placebo Injections to Temporalis and Masseter Muscles
Status:
Recruiting
Trial end date:
2022-12-31
Target enrollment:
Participant gender:
Summary
This study aims to determine whether the injection of botulinum toxin A or placebo
(unpreserved 0.9% sodium chloride) into the masseter and temporalis muscles provides pain
relief and improved jaw function in those who suffer from myofascial pain disorder. The study
hypothesis is that botulinum toxin A injection is superior to placebo. The specific research
questions are:
1. Is the injection of botulinum toxin A superior to placebo for the improvement in pain?
2. Is the injection of botulinum toxin A superior to placebo for the improvement in
function or quality of life (QOL)?
3. Are there any adverse effects that result from injection of botulinum toxin A or placebo
into the masseters and temporalis muscles? Limited data exists to support the use of
botulinum toxin A in the management of myofascial pain disorder of the masticatory
region. Botulinum toxin A is not FDA approved for intra-muscular injection within the
masticatory region. Its use in the masticatory region is considered off-label but
performed without significant known complications. This study will provide the
opportunity to quantitate and qualitate any complications in a large prospective sample
of patients.
Phase:
Phase 3
Details
Lead Sponsor:
Weill Medical College of Cornell University
Collaborators:
Allergan Columbia University New York Presbyterian Hospital University of Illinois at Chicago
Treatments:
abobotulinumtoxinA Botulinum Toxins Botulinum Toxins, Type A onabotulinumtoxinA