TNTMD: Comorbid Painful TMD Among Trigeminal Neuralgia

Sponsor
University of Minnesota (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05914558
Collaborator
Johns Hopkins University (Other)
5
2
25
2.5
0.1

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
5 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Comorbid Painful Temporomandibular Disorder Among Trigeminal Neuralgia Patients
Actual Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Aug 30, 2024
Anticipated Study Completion Date :
Aug 30, 2024

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Prevalence [2 years]

    Prevalence of comorbid painful TMD among TN patient

Secondary Outcome Measures

  1. Diagnostic questionnaire [2 years]

    The sensitivity, specificity of the diagnostic questionnaire for TN and TMD

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 John Hopkins University Baltimore Maryland United States 21287
2 University of Minnesota, Department of Neurosurgery Minneapolis Minnesota United States 55455

Sponsors and Collaborators

  • University of Minnesota
  • Johns Hopkins University

Investigators

  • Principal Investigator: Donald Nixdorf, DDS,MS, University of Minnesota
  • Study Director: Qiman Gao, DDS,MS,PhD, University of Minnesota

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Donald Nixdorf, DDS, MS, Professor., University of Minnesota
ClinicalTrials.gov Identifier:
NCT05914558
Other Study ID Numbers:
  • UMN IRB No. 00008873
  • JHU IRB No. 00388974
First Posted:
Jun 22, 2023
Last Update Posted:
Jun 22, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 22, 2023