Diffusion MRI to measure jaw muscle changes in masticatory myofascial pain
Development of RPBM for Quantitative Assessment of Myofascial Pain
This study will test whether diffusion MRI can detect differences in the jaw muscles of adults with masticatory myofascial pain syndrome.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Weill Medical College of Cornell University Academic / other |
| Locations | 2 sites (New York, New York and 1 other locations) |
| Trial ID | NCT06892041 on ClinicalTrials.gov |
What this trial studies
This observational study uses diffusion-weighted MRI to quantify tissue properties of the masseter and related jaw muscles in adults with masticatory myofascial pain syndrome. Participants aged 18–65 who meet clinical criteria for normal, latent, or active temporomandibular myofascial pain will undergo MRI scans at Weill Cornell Medicine or New York University. Imaging metrics will be compared with clinical presentation and symptom history to estimate diagnostic accuracy. Individuals with MRI contraindications, recent facial trauma, recent masseter Botox, pregnancy, or recent changes in myofascial pain treatment are excluded.
Who should consider this trial
Good fit: Adults aged 18–65 with clinically defined normal or latent/active temporomandibular myofascial pain who can safely undergo MRI are ideal candidates.
Not a fit: People who are pregnant, have MRI contraindications (for example pacemakers, metal near the head, severe claustrophobia), recent mandibular trauma or recent masseter Botox are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this could provide a noninvasive imaging marker to help diagnose or monitor jaw muscle–related pain.
How similar studies have performed: Diffusion MRI has shown promise in other musculoskeletal applications, but its specific diagnostic use for masticatory myofascial pain is relatively novel and not yet well-established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Men and women 18-65 years of age * Ability to give informed consent * Symptoms meeting criteria for normal or latent/active temporomandibular myofascial pain Exclusion Criteria: * 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
Where this trial is running
New York, New York and 1 other locations
- New York University — New York, New York, United States (Recruiting)
- Weill Cornell Medicine — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Gene Kim, PhD — Weill Medical College of Cornell University
- Study coordinator: Elizabeth Lane
- Email: ell2032@med.cornell.edu
- Phone: 646-962-8394
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.