Masticatory Myofascial Pain Syndrome
Conditions
Brief summary
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?
Interventions
100 units/4mL.
DRUGPlacebo
4mL
Sponsors
Weill Medical College of Cornell University
National Center for Complementary and Integrative Health (NCCIH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant is at least 18 years of age * Participant has a unilateral or bilateral myofascial pain diagnosis according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD), diagnosed by a provider
Exclusion criteria
* Participant is pregnant, breastfeeding, or plans to become pregnant * Participant has known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation * Participant has received Botox within the past 4 months * Participant cannot undergo an MRI. Reasons a participant cannot undergo MRIs for this study include having a pacemaker or having claustrophobia * Participant has dental implants with metal on the same side/sides of their jaw pain
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of muscle fiber diameter of jaw muscles between baseline and 3 month follow up. | Baseline; 3 months | Measured by Diffusion MRI in micrometers |
| Change of muscle fiber permeability of jaw muscles between baseline and 3 month follow up. | Baseline; 3 months | Measured by Diffusion MRI in cm/sec |
| Change of tissue diffusivity of jaw muscles between baseline and 3 month follow up. | Baseline; 3 months | Measured by Diffusion MRI in micrometer2/millisecond |
| Change of pseudo-diffusivity of jaw muscles between baseline and 3 month follow up. | Baseline; 3 months | Measured by Diffusion MRI in micrometer2/millisecond |
| Change of perfusion fraction of jaw muscles between baseline and 3 month follow up. | Baseline; 3 months | Measured by Diffusion MRI (no units) |
| Change of T2 (transverse relaxation time) of jaw muscles between baseline and 3 month follow up. | Baseline; 3 months | Measured by MRI in milliseconds |
| Change of T2* (effective transverse relaxation time) of jaw muscles between baseline and 3 month follow up. | Baseline; 3 months | Measured by MRI in milliseconds |
| Change of FF (fat fraction) of jaw muscles between baseline and 3 month follow up. | Baseline; 3 months | Measured by MRI (no units) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Visual Analog Scale Score at 1 month | Baseline; 1 month | The Visual Analog Scale ranges from 0 to 10, where higher scores indicate more pain. |
| Change from Baseline in Visual Analog Scale Score at 3 months | Baseline; 3 months | The Visual Analog Scale ranges from 0 to 10, where higher scores indicate more pain. |
| Change in jaw function, assessed by Jaw Function Limitation Score (JFLS) from baseline to 1 month. | Baseline; 1 month | The Jaw Function Limitation Score (JFLS) ranges from 0 to 8, where higher scores indicate more limitation. |
| Change in jaw function, assessed by Jaw Function Limitation Score (JFLS) from baseline to 3 months. | Baseline; 3 months | The Jaw Function Limitation Score (JFLS) ranges from 0 to 8, where higher scores indicate more limitation. |
Countries
United States
Contacts
CONTACTPeter Chernek
PRINCIPAL_INVESTIGATORGwendolyn Reeve, D.M.D., FACS
Weill Medical College of Cornell University
Outcome results
None listed