Botulinum Toxin Versus Placebo Injections to Temporalis and Masseter Muscles

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

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

Criteria

Inclusion Criteria:

• 18-65 years of age

• Ability to give informed consent

• Myofascial pain of masticatory muscles as defined according to the RDC/TMD criteria

• Baseline pain measured by the subject ≥3.5/10 on visual analog scale

Exclusion Criteria:

• Baseline pain measured by the subject <3.5/10 on visual analog scale

• Central/Neuropathic pain disorder affecting the masticatory muscles

• Temporomandibular Joint Arthralgia that is more severe than the myofascial pain disorder affecting the masticatory muscles

• Previous Temporomandibular Joint Surgery

• Systemic arthropathies

• Fibromyalgia

• Allergy to study medications

• Traumatic injury of masticatory muscles or temporomandibular joint within last 12 months

• Mandibular fracture within last 12 months

• Pregnancy or breast feeding

• Cervical radiculopathy or surgery

• Prior botox injection in the masticatory muscles

• Initiation of additional treatment of MPD within the past 3 months