Diffusion MRI for Quantitative Assessment of Myofascial Pain

September 29, 2025 updated by: Weill Medical College of Cornell University

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Weill Cornell Medicine
        • Principal Investigator:
          • Gene Kim, PhD
        • Contact:
      • New York, New York, United States, 10016
        • Recruiting
        • New York University
        • Contact:
        • Principal Investigator:
          • Els Fieremans

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Participants from the community

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Normal
Subjects without masticatory myofascial pain syndrome
Latent/Active Pain Stage
Subjects with latent or active masticatory myofascial pain syndrome

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Collaborators

New York University
National Center for Complementary and Integrative Health (NCCIH)

Investigators

  • Principal Investigator: Gene Kim, PhD, Weill Medical College of Cornell University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 4, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

March 17, 2025

First Submitted That Met QC Criteria

March 17, 2025

First Posted (Actual)

March 24, 2025

Study Record Updates

Last Update Posted (Estimated)

October 1, 2025

Last Update Submitted That Met QC Criteria

September 29, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-07027694
  • R61AT012270 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All of the individual participant data collected during the trial, after deidentification

IPD Sharing Time Frame

Immediately following publication for a minimum of 2 years after completion of the research project

IPD Sharing Access Criteria

Anyone who wishes to access the data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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