Comorbid Painful TMD Among Trigeminal Neuralgia

Active, not recruiting

• Conditions: Myofascial Pain; Trigeminal Neuralgia; Temporomandibular Disorder; Trigeminal Neuropathy
• Interventions: Diagnostic Test: Clinical appointment

• Registration Number: NCT05914558
• Lead Sponsor: University of Minnesota

Brief Summary

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

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 Timeline

• Study Start: 2022-08-01
• Study First Submitted: 2023-06-13
• Study First Submitted QC: 2023-06-13
• Study First Posted: 2023-06-22
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-06
• Last Update Posted: 2024-10-08
• Primary Completion: 2026-08-30
• Study Completion: 2026-08-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 5

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TN cohort	Clinical appointment	The patient was diagnosed with trigeminal neuralgia which has active symptoms in the past 30 days.

Primary Outcome Measures

Name	Time	Method
Prevalence	2 years	Prevalence of comorbid painful TMD among TN patient

Secondary Outcome Measures

Name	Time	Method
Diagnostic questionnaire	2 years	The sensitivity, specificity of the diagnostic questionnaire for TN and TMD

Trial Locations

Locations (2)

University of Minnesota, Department of Neurosurgery; 🇺🇸 Minneapolis, Minnesota, United States

John Hopkins University; 🇺🇸 Baltimore, Maryland, United States