Comorbid Painful TMD Among Trigeminal Neuralgia (TNTMD)

Comorbid Painful Temporomandibular Disorder Among Trigeminal Neuralgia Patients

An observational study following up with trigeminal neuralgia patients to understand their comorbid facial pain condition, specifically temporomandibular disorder.

Study Overview

• Status: Withdrawn
• Conditions: Myofascial Pain; Temporomandibular Disorder; Trigeminal Neuralgia; Trigeminal Neuropathy
• Intervention / Treatment: Diagnostic test: Clinical appointment

Detailed Description

This multi-center prospective observational cohort study aims to investigate the prevalence of comorbid Temporomandibular disorders (TMD) among trigeminal neuralgia (TN) patients. Trigeminal neuralgia patients with active TN status from three clinical sites (University of Minnesota, School of Dentistry, Orofacial Pain Clinic; Mhealth Fairview, Clinical Surgical Center, Neurosurgery Clinic; John Hopkins University, Anesthesiology, and Critical Care Clinic) could enroll in this study voluntary. All the patients will be evaluated by a provider using standard clinical assessment for TN and TMD, along with validated RedCap questionnaires for TN and TMD diagnosis, and be followed up every six months for 1-2 years.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • John Hopkins University
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota, Department of Neurosurgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients that visited three clinical centers in the study who sought care for their facial pain were diagnosed with trigeminal neuralgia, with active symptoms in the past 30 days.

Description

Inclusion Criteria:

• Patients visited the three clinical sites for facial pain
• Patients diagnosed with trigeminal neuralgia
• Has active pain symptoms in the past 30 days

Exclusion Criteria:

• Non-English speakers
• Patients with psychiatric disorders that might alter pain perception
• Adults lack the capacity to provide informed consent.
• Persons under the age of 18.
• All vulnerable populations.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
TN cohort; The patient was diagnosed with trigeminal neuralgia which has active symptoms in the past 30 days.	Diagnostic test: Clinical appointment; One clinical interview and examination to confirm the diagnosis of trigeminal neuralgia and temporomandibular disorder.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence	Prevalence of comorbid painful TMD among TN patient	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic questionnaire	The sensitivity, specificity of the diagnostic questionnaire for TN and TMD	2 years

Collaborators and Investigators

• Sponsor: University of Minnesota
• Collaborators: Johns Hopkins University
• Investigators: Principal Investigator: Donald Nixdorf, DDS,MS, University of Minnesota; Study Director: Qiman Gao, DDS,MS,PhD, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2026

Study Registration Dates

• First Submitted: June 13, 2023
• First Submitted That Met QC Criteria: June 13, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): December 31, 2025
• Last Update Submitted That Met QC Criteria: December 23, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Mouth Diseases; Stomatognathic Diseases; Nervous System Diseases; Muscular Diseases; Joint Diseases; Jaw Diseases; Mandibular Diseases; Cranial Nerve Diseases; Craniomandibular Disorders; Facial Neuralgia; Facial Nerve Diseases; Temporomandibular Joint Disorders; Trigeminal Neuralgia; Trigeminal Nerve Diseases
• Other Study ID Numbers: UMN IRB No. 00008873; JHU IRB No. 00388974 (Other Identifier: John Hopkins Univeristy)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The final results will be shared with all the participants as a summary.
• IPD Sharing Time Frame: By end of 2024
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No