Diffusion MRI for Quantitative Assessment of Myofascial Pain

NCT ID: NCT06892041

Last Updated: 2025-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-04

Study Completion Date

2026-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Masticatory Myofascial Pain Syndrome

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Normal

Subjects without masticatory myofascial pain syndrome

No interventions assigned to this group

Latent/Active Pain Stage

Subjects with latent or active masticatory myofascial pain syndrome

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

New York University

OTHER

Sponsor Role collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gene Kim, PhD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

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New York University

New York, New York, United States

Site Status RECRUITING

Weill Cornell Medicine

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Elizabeth Lane

Role: CONTACT

646-962-8394

Facility Contacts

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Nalini Jeet

Role: primary

212-263-0228

Elizabeth Lane

Role: primary

646-962-8394

Other Identifiers

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R61AT012270

Identifier Type: NIH

Identifier Source: secondary_id

View Link

24-07027694

Identifier Type: -

Identifier Source: org_study_id

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