At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Comparison of Botulinum Toxin Versus Placebo Injections to Temporalis and Masseter Muscles in the Management of Myofascial Pain Disorder: A Randomized Clinical Trial
In Brief
A Phase 3 clinical trial evaluating Botulinum toxin type A and 0.9% Sodium Chloride Injection for Pain, Head and 4 related conditions. Completed, enrolled 75 participants across 2 sites.
Detailed 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.
Study Details
Timeline
Interventions
37.5 units injected into each masseter muscle and 12.5 units into each temporalis muscle
1cc syringe