NCT05068908 Brain Connectivity Patterns in Chronic Temporomandibular Joint Disorders
| NCT ID | NCT05068908 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Minnesota |
| Condition | Chronic Pain |
| Study Type | OBSERVATIONAL |
| Enrollment | 95 participants |
| Start Date | 2022-03-02 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 95 participants in total. It began in 2022-03-02 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: Main project * 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 Inclusion criteria: Patients in MRI Optimization group * 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. Exclusion Criteria: Main project * Traumatic facial injury or surgery on the face/jaw, arms or hands * Presence of pain related to dental or periodontal pathology * Currently undergoing active orthodontic treatment * Pregnant or nursing * Has any of the following medical conditions by self-report: * Renal failure or dialysis * Heart disease (examples: uncontrolled arrhythmia or hypertension, cardiomyopathy) or heart failure * Non-allergic bronchospasm (chronic obstructive pulmonary disease and emphysema) * Diabetes (Type I or II) that is not controlled with medication or diet * Hyperthyroidism * Uncontrolled seizures * Used any injection therapy (i.e. tender or trigger point injections, steroid injections), acupuncture, biofeedback, or TENS for the management of facial pain within 2 weeks prior to the screening assessment * If undergoing botulinum toxin injections in the head and neck areas, must be 3 months since last set of injections and refrain from this treatment until study has ended * History of major depression or other major psychiatric disorder requiring hospitalization within the last 6 months prior to the screening assessments * History of treatment for drug or alcohol abuse within the last 12 months * Current pain medication use (e.g. opioids, ibuprofen, acetaminophen) that cannot be stopped \<24 hours prior to each study visit * Other conditions/diseases associated with altered pain perception: neurological or developmental disorders (dementia, autism spectrum disorder), neoplasm, multiple sclerosis, trigeminal neuralgia * MRA contraindications including claustrophobia * GCPS grade assigned at Visit 1 that does not match grade from screening GCPS (low-, high-impact pain) and it is not possible to assign the potential participant to the correct final group, due to the latter having met their recruitment quota * Strictly left-handedness by self-report * Thermal threshold for Pain-50 (determined at Visit 1) is outside the temperature range of 40-49 degrees Celsius * Lack of access to electronic device with internet connection during the study * Inability or unwillingness to receive daily text messages during the study * Inability to complete at least four daily ratings between the Informed consent, Pre- visit 1 procedures and in-person visit 1 * Anything that would place the individual at increased risk or preclude the individual's full compliance with study procedures or completion of the study. Exclusion criteria: MRI Optimization group Pregnant or nursing; * MRI contraindications including claustrophobia; * Adults lacking capacity to provide informed consent for themselves; * Unable to understand instructions for sensory testing in English; * Anything that would place the individual at increased risk or preclude the individual's full compliance with study procedures or completion of the study.
Contact & Investigator
Estephan J Moana-Filho, DDS, MS, PhD
PRINCIPAL INVESTIGATOR
University of Minnesota
Frequently Asked Questions
Who can join the NCT05068908 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 65 Years, studying Chronic Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05068908 currently recruiting?
Yes, NCT05068908 is actively recruiting participants. Contact the research team at brainsensestudy@umn.edu for enrollment information.
Where is the NCT05068908 trial being conducted?
This trial is being conducted at Minneapolis, United States.
Who is sponsoring the NCT05068908 clinical trial?
NCT05068908 is sponsored by University of Minnesota. The principal investigator is Estephan J Moana-Filho, DDS, MS, PhD at University of Minnesota. The trial plans to enroll 95 participants.
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