Examining brain connectivity in chronic jaw pain conditions

Brain Connectivity Patterns in Chronic Temporomandibular Joint Disorders

This study is trying to see how brain connections are linked to chronic jaw pain in people with temporomandibular joint disorders to better understand their pain and disability.

Quick facts

• Study type: Observational
• Enrollment: 95 (estimated)
• Ages: 18 Years to 65 Years
• Sex: Female
• Sponsor: University of Minnesota (Academic / other)
• Locations: 1 site (Minneapolis, Minnesota)
• Trial ID: NCT05068908 on ClinicalTrials.gov

What this trial studies

This observational study investigates the brain connectivity patterns associated with chronic temporomandibular joint disorders (TMD), which are a leading cause of orofacial pain. By analyzing specific brain circuits involved in pain processing, the study aims to identify connectivity signatures that correlate with pain-related disability in TMD patients. The research employs psychophysical methods to assess pain facilitation and inhibition, providing insights into the underlying mechanisms of chronic pain. The findings may also have implications for understanding other chronic pain conditions that often co-occur with TMD.

Who should consider this trial

Good fit: Ideal candidates for this study are females aged 18 to 65 who experience chronic temporomandibular joint pain.

Not a fit: Patients with significant orofacial pain unrelated to TMD or those who do not meet the inclusion criteria will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved diagnosis and treatment strategies for patients suffering from chronic pain conditions.

How similar studies have performed: Previous studies have documented brain circuit dysregulation in chronic pain, suggesting that this approach may yield valuable insights, although the specific focus on TMD is less explored.

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.

Where this trial is running

Minneapolis, Minnesota

• University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)

Study contacts

• Principal investigator: Estephan J Moana-Filho, DDS, MS, PhD — University of Minnesota
• Study coordinator: Estephan J Moana-Filho, DDS, MS, PhD

Conditions Chronic Pain; Temporomandibular Joint Disorders; Temporomandibular Joint Pain