Recruiting NCT06892041
Diffusion MRI for Quantitative Assessment of Myofascial Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Masticatory Myofascial Pain Syndrome. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Development of RPBM for Quantitative Assessment of Myofascial Pain
Overview
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.
Primary outcome measures
- 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]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
United States · 2 centers
- New York University — New York
- Weill Cornell Medicine — New York
Identifiers
NCT: NCT06892041 · 24-07027694 · R61AT012270