A Phase 2 interventional study of Onabotulinumtoxin A and Placebo in Masticatory Myofascial Pain Syndrome, sponsored by Weill Medical College of Cornell University. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Weill Medical College of Cornell University · Phase 2, Interventional, and Treatment
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:
Weill Medical College of Cornell University is the lead sponsor of 890 studies on the registry; 164 are open to participants now.
Of its 123 completed or terminated interventional studies of FDA-regulated products, 94 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Drug: Onabotulinumtoxin A
Drug: Placebo
100 units/4mL.
Also known as: Botox
4mL
Also known as: Unpreserved 0.9% sodium chloride
Change of muscle fiber diameter of jaw muscles between baseline and 3 month follow up.
Measured by Diffusion MRI in micrometers
Time frame: Baseline; 3 months
Change of muscle fiber permeability of jaw muscles between baseline and 3 month follow up.
Measured by Diffusion MRI in cm/sec
Time frame: Baseline; 3 months
Change of tissue diffusivity of jaw muscles between baseline and 3 month follow up.
Measured by Diffusion MRI in micrometer2/millisecond
Time frame: Baseline; 3 months
Change of pseudo-diffusivity of jaw muscles between baseline and 3 month follow up.
Measured by Diffusion MRI in micrometer2/millisecond
Time frame: Baseline; 3 months
Change of perfusion fraction of jaw muscles between baseline and 3 month follow up.
Measured by Diffusion MRI (no units)
Time frame: Baseline; 3 months
Change of T2 (transverse relaxation time) of jaw muscles between baseline and 3 month follow up.
Measured by MRI in milliseconds
Time frame: Baseline; 3 months
Change of T2* (effective transverse relaxation time) of jaw muscles between baseline and 3 month follow up.
Measured by MRI in milliseconds
Time frame: Baseline; 3 months
Change of FF (fat fraction) of jaw muscles between baseline and 3 month follow up.
Measured by MRI (no units)
Time frame: Baseline; 3 months
Change from Baseline in Visual Analog Scale Score at 1 month
The Visual Analog Scale ranges from 0 to 10, where higher scores indicate more pain.
Time frame: Baseline; 1 month
Change from Baseline in Visual Analog Scale Score at 3 months
The Visual Analog Scale ranges from 0 to 10, where higher scores indicate more pain.
Time frame: Baseline; 3 months
Change in jaw function, assessed by Jaw Function Limitation Score (JFLS) from baseline to 1 month.
The Jaw Function Limitation Score (JFLS) ranges from 0 to 8, where higher scores indicate more limitation.
Time frame: Baseline; 1 month
Change in jaw function, assessed by Jaw Function Limitation Score (JFLS) from baseline to 3 months.
The Jaw Function Limitation Score (JFLS) ranges from 0 to 8, where higher scores indicate more limitation.
Time frame: Baseline; 3 months
Plan to share: Yes — De-identified data and de-identified MR images
Supporting information: Analytic code
Time frame: Start date - end of study End date - N/A
Access criteria: Investigators who are approved by the NIH HEAL Initiative (Helping to End Addiction Long-Term) or the National Institutes of Health (NIH)
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Onabotulinum toxin A
Weill Medical College of Cornell University →