Diffusion MRI for Quantitative Assessment of Myofascial Pain

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years - 65 Years
Gender All
More 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.
  • - Dental implants with metal on the same side of the temporomandibular pain.
  • - 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06892041
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Weill Medical College of Cornell University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Gene Kim, PhD
Principal Investigator Affiliation Weill Medical College of Cornell University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, NIH
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Masticatory Myofascial Pain Syndrome
Arms & Interventions

Arms

: Normal

Subjects without masticatory myofascial pain syndrome

: Latent/Active Pain Stage

Subjects with latent or active masticatory myofascial pain syndrome

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

New York University, New York, New York

Status

Address

New York University

New York, New York, 10016

Site Contact

Nalini Jeet

[email protected]

212-263-0228

Weill Cornell Medicine, New York, New York

Status

Address

Weill Cornell Medicine

New York, New York, 10065

Site Contact

Elizabeth Lane

[email protected]

646-962-8394