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Phase 2Not yet recruiting

MRI Study of OnabotulinumtoxinA (OnabotA) Effect on Jaw Muscle Pain

MRI-based Comparison of OnabotulinumtoxinA (OnabotA) Versus Placebo Injections to the Temporalis and Masseter Muscles in the Management of Myofascial Pain Syndrome: A Randomized Clinical Trial

Sponsor
Weill Medical College of Cornell University (Academic or other)
Enrollment
120 planned
Conditions
Masticatory Myofascial Pain Syndrome
Interventions
Onabotulinumtoxin A; Placebo
Ages
adults, older adults
Registry
NCT07878780

Full record on ClinicalTrials.gov

From the registry

The goal of this clinical trial is to learn which magnetic resonance images are best able to assess and predict if a participant with masticatory myofascial pain syndrome will benefit from Botox injections, as compared to placebo (saline, salt water). The main questions the study aims to answer are: * Will diffusion MR images will be best able to assess and predict if a participant with masticatory myofascial pain syndrome will benefit from Botox injections? * Will Botox injections reduce masticatory myofascial pain and improve jaw function?

Primary outcomes

  • Change of muscle fiber diameter of jaw muscles between baseline and 3 month follow up.
  • Change of muscle fiber permeability of jaw muscles between baseline and 3 month follow up.
  • Change of tissue diffusivity of jaw muscles between baseline and 3 month follow up.
  • Change of pseudo-diffusivity of jaw muscles between baseline and 3 month follow up.

History

  1. Study completion expected

  2. Primary completion expected

  3. Registered

  4. Started