RecruitingNCT05068908

Brain Connectivity Patterns in Chronic Temporomandibular Joint Disorders

Sponsor

University of Minnesota

Enrollment

95 participants

Start Date

Mar 2, 2022

Study Type

OBSERVATIONAL

Conditions

Chronic Pain Temporomandibular Joint Disorders Temporomandibular Joint Pain

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

Sex: FEMALEMin Age: 18 YearsMax Age: 65 Years

Inclusion Criteria23

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.

Exclusion Criteria30

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.
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.