Diffusion MRI for Quantitative Assessment of Myofascial Pain | NCT06892041

Studies
Diffusion MRI for Quantitative Assessment of Myofascial Pain

NCT06892041

Sponsor

Weill Medical College of Cornell University

Status

Recruiting

Last Update Posted

Oct 1, 2025Actual

Enrollment

90Estimated

Phase

Not provided

Conditions

Masticatory Myofascial Pain Syndrome

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R61AT012270	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 4, 2025Actual

Primary Completion Date

Jul 2026Estimated

Completion Date

Jul 2026Estimated

First Submitted Date

Mar 17, 2025

First Submission Date that Met QC Criteria

Mar 17, 2025

First Posted Date

Mar 24, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 29, 2025

Last Update Posted Date

Oct 1, 2025Actual

Name	Class
National Center for Complementary and Integrative Health (NCCIH)	NIH
New York University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

90Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Normal		Subjects without masticatory myofascial pain syndrome
Latent/Active Pain Stage		Subjects with latent or active masticatory myofascial pain syndrome

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	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.		Day 1

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Participants from the community

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Elizabeth Lane	Contact	646-962-8394		ell2032@med.cornell.edu

Overall Officials

Name	Affiliation	Role
Gene Kim, PhD	Weill Medical College of Cornell University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
New York University	Recruiting	New York	New York	10016	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

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

Types

Not provided

Time Frame

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

Access Criteria

Anyone who wishes to access the data

URL

Not provided