Masticatory Myofascial Pain SyndromeNCT06892041
Diffusion MRI for Quantitative Assessment of Myofascial Pain
An observational study of Masticatory Myofascial Pain Syndrome, run by Weill Medical College of Cornell University at 2 sites in United States.
Trial summary
The purpose of this study is to assess the diagnostic accuracy of diffusion MRI for evaluation of the jaw muscles for patients with masticatory myofascial pain syndrome. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Masticatory Myofascial Pain Syndrome
- How many people
- 90 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Sep 2025to Jul 2026
- Phase
- Observational
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants from the community
Who may be able to join
- Men and women 18-65 years of age
- Ability to give informed consent
- Symptoms meeting criteria for normal or latent/active temporomandibular myofascial pain
Who cannot join
- Contraindications to MRI scanning including severe obesity or difficulty in laying in a supine position, intracranial clips, metal implants, external metallic devices/objects/clips within 10mm of the head, suspected or confirmed metal in the eyes (history of welding or similar activity), claustrophobia, cardiac pacemaker or pacing wires
- Pregnancy or breast feeding
- Traumatic injury of masticatory muscles or temporomandibular joint within last 12 months
- Mandibular fracture within last 12 months
- Initiation of additional treatment of myofascial pain within the past 1 month
- Received masseter Botox within the last 4 months
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
New York University
New York, New York, 10016
Nalini Jeet, 212-263-0228, Nalini.Jeet@nyulangone.org
Els Fieremans
- Recruiting
Weill Cornell Medicine
New York, New York, 10065
Elizabeth Lane, 646-962-8394, ell2032@med.cornell.edu
Gene Kim, PhD
About this study
Official title: Development of RPBM for Quantitative Assessment of Myofascial Pain
The purpose of this study is to assess the diagnostic accuracy of diffusion MRI for evaluation of the jaw muscles for patients with masticatory myofascial pain syndrome.
- Conditions
- Masticatory Myofascial Pain Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Normal | Subjects without masticatory myofascial pain syndrome | |
| Latent/Active Pain Stage | Subjects with latent or active masticatory myofascial pain syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in mean diffusion MRI parameters of temporalis and masseter muscles between patients at the normal stage and those at the latent/active pain stage.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start4 Sep 2025
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 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), New York University
- Responsible party
- Sponsor
- Investigators
- Gene Kim, PhD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06892041
- Sponsor's protocol ID
- 24-07027694
- Other IDs
- R61AT012270
- Status last verified
- Sep 2025
- First submitted
- 17 Mar 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of RPBM for Quantitative Assessment of Myofascial Pain
- ClinicalTrials.gov ID
- NCT06892041
- Acronym / sponsor ID
- 24-07027694
- Conditions
- Masticatory Myofascial Pain Syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), New York University
- Study start
- 4 Sep 2025 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 24 Mar 2025 (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 purpose of this study is to assess the diagnostic accuracy of diffusion MRI for evaluation of the jaw muscles for patients with masticatory myofascial pain syndrome.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal | – | –Subjects without masticatory myofascial pain syndrome |
| Latent/Active Pain Stage | – | –Subjects with latent or active masticatory myofascial pain syndrome |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants from the community
Key inclusion criteria (3 listed)
- Men and women 18-65 years of age
- Ability to give informed consent
- Symptoms meeting criteria for normal or latent/active temporomandibular myofascial pain
Key exclusion criteria (6 listed)
- Contraindications to MRI scanning including severe obesity or difficulty in laying in a supine position, intracranial clips, metal implants, external metallic devices/objects/clips within 10mm of the head, suspected or confirmed metal in the eyes (history of welding or similar activity), claustrophobia, cardiac pacemaker or pacing wires
- Pregnancy or breast feeding
- Traumatic injury of masticatory muscles or temporomandibular joint within last 12 months
- Mandibular fracture within last 12 months
- Initiation of additional treatment of myofascial pain within the past 1 month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Difference in mean diffusion MRI parameters of temporalis and masseter muscles between patients at the normal stage and those at the latent/active pain stage.
Time frame: Day 1
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 1 Oct 2025.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification
Related trials for Masticatory Myofascial Pain Syndrome
Not yet recruitingPhase 2
MRI Study of OnabotulinumtoxinA (OnabotA) Effect on Jaw Muscle Pain
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
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.
Gene Kim, PhD principal investigator
Weill Medical College of Cornell University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Masticatory Myofascial Pain Syndrome, run by Weill Medical College of Cornell University at 2 sites 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 3 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Elizabeth Lane (646-962-8394, ell2032@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in mean diffusion MRI parameters of temporalis and masseter muscles between patients at the normal stage and those at the latent/active pain stage. (time frame: Day 1). 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 1 Oct 2025.