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NCT05914558 Clinical Trial

Comorbid Painful TMD Among Trigeminal Neuralgia

Temporomandibular Disorder Clinical Trial

— TNTMD  

Official title:
Comorbid Painful Temporomandibular Disorder Among Trigeminal Neuralgia Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05914558
Other study ID # UMN IRB No. 00008873
Secondary ID JHU IRB No. 0038
Status Active, not recruiting
Phase
First received
Last updated
Start date August 1, 2022
Est. completion date August 30, 2024

Study information
Verified date June 2023
Source University of Minnesota
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 5
Est. completion date August 30, 2024
Est. primary completion date August 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Clinical appointment
One clinical interview and examination to confirm the diagnosis of trigeminal neuralgia and temporomandibular disorder.

Locations
Country Name City State
United States John Hopkins University Baltimore Maryland
United States University of Minnesota, Department of Neurosurgery Minneapolis Minnesota

Sponsors (2)
Lead Sponsor Collaborator
University of Minnesota Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Prevalence Prevalence of comorbid painful TMD among TN patient 2 years
Secondary Diagnostic questionnaire The sensitivity, specificity of the diagnostic questionnaire for TN and TMD 2 years
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