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Comorbid Painful TMD Among Trigeminal Neuralgia

NCT ID: NCT05914558

Last Updated: 2025-12-31

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

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-01

Study Completion Date

2026-08-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Trigeminal Neuralgia Temporomandibular Disorder Myofascial Pain Trigeminal Neuropathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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TN cohort

The patient was diagnosed with trigeminal neuralgia which has active symptoms in the past 30 days.

Clinical appointment

Intervention Type DIAGNOSTIC_TEST

One clinical interview and examination to confirm the diagnosis of trigeminal neuralgia and temporomandibular disorder.

Interventions

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Clinical appointment

One clinical interview and examination to confirm the diagnosis of trigeminal neuralgia and temporomandibular disorder.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johns Hopkins University

OTHER

Sponsor Role collaborator

University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Donald Nixdorf, DDS,MS

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Qiman Gao, DDS,MS,PhD

Role: STUDY_DIRECTOR

University of Minnesota

Locations

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John Hopkins University

Baltimore, Maryland, United States

Site Status

University of Minnesota, Department of Neurosurgery

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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JHU IRB No. 00388974

Identifier Type: OTHER

Identifier Source: secondary_id

UMN IRB No. 00008873

Identifier Type: -

Identifier Source: org_study_id