Masticatory Myofascial Pain SyndromePhase 2NCT07878780
MRI Study of OnabotulinumtoxinA (OnabotA) Effect on Jaw Muscle Pain
A Phase 2 study testing Onabotulinumtoxin A in people with Masticatory Myofascial Pain Syndrome, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Masticatory Myofascial Pain Syndrome
- What is being tested?
- Onabotulinumtoxin A
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Aug 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Weill Cornell Medicine
New York, New York, 10065
Peter Chernek, 646-962-5951, pec4005@med.cornell.edu
Gwendolyn Reeve, D.M.D., FACS
About this study
Official title: 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
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?
- Conditions
- Masticatory Myofascial Pain Syndrome
- Being tested
- Onabotulinumtoxin A, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Onabotulinumtoxin ADrug
Also called Botox
100 units/4mL.
PlaceboDrug
Also called Unpreserved 0.9% sodium chloride
4mL
| Study group | Role | What they receive |
|---|---|---|
| Botox Injections | Active comparator | Not described Receives: Drug: Onabotulinumtoxin A |
| Placebo Injections | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of muscle fiber diameter of jaw muscles between baseline and 3 month follow up.
Measured by Diffusion MRI in micrometers
Measured: 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
Measured: Baseline; 3 months
Change of tissue diffusivity of jaw muscles between baseline and 3 month follow up.
Measured by Diffusion MRI in micrometer2/millisecond
Measured: Baseline; 3 months
Change of pseudo-diffusivity of jaw muscles between baseline and 3 month follow up.
Measured by Diffusion MRI in micrometer2/millisecond
Measured: Baseline; 3 months
Change of perfusion fraction of jaw muscles between baseline and 3 month follow up.
Measured by Diffusion MRI (no units)
Measured: Baseline; 3 months
Change of T2 (transverse relaxation time) of jaw muscles between baseline and 3 month follow up.
Measured by MRI in milliseconds
Measured: 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
Measured: Baseline; 3 months
Change of FF (fat fraction) of jaw muscles between baseline and 3 month follow up.
Measured by MRI (no units)
Measured: Baseline; 3 months
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline; 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2029 (estimated)
- Study completionAug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Masticatory Myofascial Pain SyndromeStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Gwendolyn Reeve, D.M.D., FACS, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07878780
- Sponsor's protocol ID
- 26-06030338
- Other IDs
- R33AT012270
- Status last verified
- Oct 2026
- First submitted
- 28 Sep 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data and de-identified MR images
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07878780
- Acronym / sponsor ID
- 26-06030338
- Conditions
- Masticatory Myofascial Pain Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2029 (estimated)
- Study completion
- Aug 2031 (estimated)
- First posted
- 16 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Botox Injections | Active comparator | Drug: Onabotulinumtoxin A |
| Placebo Injections | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Onabotulinumtoxin AAlso: Botox100 units/4mL. | Drug | Botox Injections |
| PlaceboAlso: Unpreserved 0.9% sodium chloride4mL | Drug | Placebo Injections |
Primary outcome
Change of muscle fiber diameter of jaw muscles between baseline and 3 month follow up.
Time frame: Baseline; 3 months
Measured by Diffusion MRI in micrometers
Change of muscle fiber permeability of jaw muscles between baseline and 3 month follow up.
Time frame: Baseline; 3 months
Measured by Diffusion MRI in cm/sec
Change of tissue diffusivity of jaw muscles between baseline and 3 month follow up.
Time frame: Baseline; 3 months
Measured by Diffusion MRI in micrometer2/millisecond
Change of pseudo-diffusivity of jaw muscles between baseline and 3 month follow up.
Time frame: Baseline; 3 months
Measured by Diffusion MRI in micrometer2/millisecond
Change of perfusion fraction of jaw muscles between baseline and 3 month follow up.
Time frame: 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.
Time frame: 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.
Time frame: Baseline; 3 months
Measured by MRI in milliseconds
Change of FF (fat fraction) of jaw muscles between baseline and 3 month follow up.
Time frame: Baseline; 3 months
Measured by MRI (no units)
4 secondary outcomes
Change from Baseline in Visual Analog Scale Score at 1 month
Time frame: Baseline; 1 month
Change from Baseline in Visual Analog Scale Score at 3 months
Time frame: Baseline; 3 months
Change in jaw function, assessed by Jaw Function Limitation Score (JFLS) from baseline to 1 month.
Time frame: Baseline; 1 month
Change in jaw function, assessed by Jaw Function Limitation Score (JFLS) from baseline to 3 months.
Time frame: Baseline; 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified data and de-identified MR images
Related trials for Masticatory Myofascial Pain Syndrome
Not yet recruiting
Does Addition of Medial Pterygoid Muscle Injection Improve the Outcome of Botulinum Toxin Therapy for Masticatory Myofascial Pain Syndrome?
Masticatory Myofascial Pain Syndrome
RecruitingObservational study
Diffusion MRI for Quantitative Assessment of Myofascial Pain
Masticatory Myofascial Pain Syndrome
RecruitingPhase 4
EMG-Based Evaluation of Occlusal Splint and Masseter Botox Effects on Head and Neck Muscles
Myofascial Pain Syndrome (MPS), Masticatory Muscle Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gwendolyn Reeve, D.M.D., FACS principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Onabotulinumtoxin A in people with Masticatory Myofascial Pain Syndrome, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter Chernek (646-962-5951, pec4005@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of muscle fiber diameter of jaw muscles between baseline and 3 month follow up. (time frame: Baseline; 3 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.