Brain Connectivity Patterns in Chronic Temporomandibular Joint Disorders

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

This study addresses the timely problem of painful temporomandibular disorders (TMD), the most common cause of orofacial pain second only to tooth pain. Findings from previous studies suggest that dysregulation of connectivity within specific brain circuits is part of chronic pain pathophysiology. This study will identify connectivity patterns within those brain circuits as potential signatures for pain- related disability in chronic TMD pain participants. New knowledge regarding these brain connectivity patterns is expected to be significant because it will support improved phenotyping of this heterogeneous participant population. It is also expected that this finding can potentially be extrapolated to other chronic pain conditions, such as back pain, migraine headache, and fibromyalgia that are frequently comorbid conditions in chronic TMD participants.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
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• Provide signed and dated informed consent form.

• Willing to comply with all study procedures and be available for the duration of study participation.

• All participants will be females (biological sex by self-report) between ages 18 to 65 years (inclusive), as this includes the majority of the patient population at risk for chronic TMD pain.

• Cases and controls will be matched for age within ±3 years, and all participants must be able to understand commands in English to follow study procedures (e.g., during sensory testing).

∙ Pain-free controls

• TMD-Pain screener score less than 3 out of 7 (Screener available as part of the DC/TMD)

• No previous diagnosis for the most common pain-related TMD as defined in the DC/TMD criteria (myalgia, arthralgia, headache attributed to TMD)

• No significant orofacial pain (jaw pain, TMJ pain) in past 3 months (significant meaning 5 or more days in any month or any pain during the past month)

• No report of significant pain in the last 3 months elsewhere in the body (significant meaning 5 or more days in any month or any pain during the past month), e.g., low back pain, fibromyalgia, migraine headaches

• Not meeting any of the most common pain-related TMD diagnosis as described in the DC/TMD criteria (myalgia, arthralgia, headache attributed to TMD) upon clinical examination following the DC/TMD protocol

∙ Chronic painful TMD cases

• TMD-pain screener score equal to or greater than 3

• Primary TMD caseness criteria: myalgia (masticatory muscle pain) based on clinical exam following the DC/TMD protocol

‣ Concurrent arthralgia (TMJ pain) and/or headache attributed to TMD allowed

• Myofascial pain must meet the following criteria:

‣ Onset \>3 months, occurring \>15 days/month on average for \>3 months

⁃ Minimum 10 jaw pain episodes since onset, each episode lasting at least 30 minutes and no less than 2 hours within the day, OR unremitting

• Low-impact TMD pain cases: Graded Chronic Pain Scale (GCPS) grade IIa or lower

• High-impact TMD pain cases: GCPS grade IIb or greater

• Be age 18-65 (inclusive)

• Provide a signed and dated informed consent form.

• Be willing to comply with all study procedures and be available for the duration of study participation.

• Be able to understand commands in English to follow study procedures.

Locations
United States
Minnesota
University of Minnesota
RECRUITING
Minneapolis
Contact Information
Primary
Estephan J Moana-Filho, DDS, MS, PhD
brainsensestudy@umn.edu
(612) 624-3338
Backup
Lauren N Huffman
brainsensestudy@umn.edu
(612) 625-8926
Time Frame
Start Date: 2022-03-02
Estimated Completion Date: 2026-08-31
Participants
Target number of participants: 95
Treatments
Low-impact chronic painful temporomandibular disorder (TMD) cases
Participants whose chronic painful TMD is determined to be low-impact. Visits include a standardized clinical examination using the Diagnostic Criteria for TMD (DC/TMD) protocol, psychosocial questionnaires completion, sensory and endogenous pain modulation (EPM) testing and a multi-modal Magnetic Resonance Imaging (MRI) data acquisition.
High- impact chronic painful temporomandibular disorder (TMD) cases
Participants whose chronic painful TMD is determined to be high-impact. Visits include a standardized clinical examination using the Diagnostic Criteria for TMD (DC/TMD) protocol, psychosocial questionnaires completion, sensory and endogenous pain modulation (EPM) testing and a multi-modal Magnetic Resonance Imaging (MRI) data acquisition.
Pain-free controls
Participants without chronic painful TMD. Visits include a standardized clinical examination using the Diagnostic Criteria for TMD (DC/TMD) protocol, psychosocial questionnaires completion, sensory and endogenous pain modulation (EPM) testing and a multi-modal Magnetic Resonance Imaging (MRI) data acquisition.
Pilot study-MRI optimization group
A pilot study will be conducted separately from the main project for optimization of MRI parameters, where up to five participants will be recruited as a separate group to undergo only MRI sessions (single study visit). The goal is to optimize the parameters of the main project's MR imaging protocol in order to minimize imaging distortions related to the presence of the thermodes in close proximity to the field of view for the brain.
Sponsors
Leads: University of Minnesota

This content was sourced from clinicaltrials.gov