RECRUITING

Brain Connectivity Patterns in Chronic Temporomandibular Joint Disorders

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Conditions

Chronic PainTemporomandibular Joint DisordersTemporomandibular Joint Pain

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Brain Connectivity Patterns in Chronic Temporomandibular Joint Disorders

Quick Facts

Study Start:2022-03-02
Study Completion:2025-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05068908

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Provide signed and dated informed consent form.
  2. * Willing to comply with all study procedures and be available for the duration of study participation.
  3. * 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.
  4. * 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).
  5. * TMD-Pain screener score less than 3 out of 7 (Screener available as part of the DC/TMD)
  6. * No previous diagnosis for the most common pain-related TMD as defined in the DC/TMD criteria (myalgia, arthralgia, headache attributed to TMD)
  7. * 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)
  8. * 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
  9. * 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
  10. * TMD-pain screener score equal to or greater than 3
  11. * Primary TMD caseness criteria: myalgia (masticatory muscle pain) based on clinical exam following the DC/TMD protocol
  12. * Concurrent arthralgia (TMJ pain) and/or headache attributed to TMD allowed
  13. * Myofascial pain must meet the following criteria:
  14. * Onset \>3 months, occurring \>15 days/month on average for \>3 months
  15. * 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
  16. * Low-impact TMD pain cases: Graded Chronic Pain Scale (GCPS) grade IIa or lower
  17. * High-impact TMD pain cases: GCPS grade IIb or greater
  1. * Traumatic facial injury or surgery on the face/jaw, arms or hands
  2. * Presence of pain related to dental or periodontal pathology
  3. * Currently undergoing active orthodontic treatment
  4. * Pregnant or nursing
  5. * Has any of the following medical conditions by self-report:
  6. * Renal failure or dialysis
  7. * Heart disease (examples: uncontrolled arrhythmia or hypertension, cardiomyopathy) or heart failure
  8. * Non-allergic bronchospasm (chronic obstructive pulmonary disease and emphysema)
  9. * Diabetes (Type I or II) that is not controlled with medication or diet
  10. * Hyperthyroidism
  11. * Uncontrolled seizures
  12. * 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
  13. * 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
  14. * History of major depression or other major psychiatric disorder requiring hospitalization within the last 6 months prior to the screening assessments
  15. * History of treatment for drug or alcohol abuse within the last 12 months
  16. * Current pain medication use (e.g. opioids, ibuprofen, acetaminophen) that cannot be stopped \<24 hours prior to each study visit
  17. * Other conditions/diseases associated with altered pain perception: neurological or developmental disorders (dementia, autism spectrum disorder), neoplasm, multiple sclerosis, trigeminal neuralgia
  18. * MRA contraindications including claustrophobia
  19. * 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
  20. * Strictly left-handedness by self-report
  21. * Thermal threshold for Pain-50 (determined at Visit 1) is outside the temperature range of 40-49 degrees Celsius
  22. * Lack of access to electronic device with internet connection during the study
  23. * Inability or unwillingness to receive daily text messages during the study
  24. * Inability to complete at least four daily ratings between the Informed consent, Pre- visit 1 procedures and in-person visit 1
  25. * Anything that would place the individual at increased risk or preclude the individual's full compliance with study procedures or completion of the study.

Contacts and Locations

Study Contact

Estephan J Moana-Filho, DDS, MS, PhD
CONTACT
(612) 624-3338
brainsensestudy@umn.edu
Lauren N Huffman
CONTACT
(612) 625-8926
brainsensestudy@umn.edu

Principal Investigator

Estephan J Moana-Filho, DDS, MS, PhD
PRINCIPAL_INVESTIGATOR
University of Minnesota

Study Locations (Sites)

University of Minnesota
Minneapolis, Minnesota, 55455
United States

Collaborators and Investigators

Sponsor: University of Minnesota

  • Estephan J Moana-Filho, DDS, MS, PhD, PRINCIPAL_INVESTIGATOR, University of Minnesota

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-02
Study Completion Date2025-08

Study Record Updates

Study Start Date2022-03-02
Study Completion Date2025-08

Terms related to this study

Additional Relevant MeSH Terms

  • Chronic Pain
  • Temporomandibular Joint Disorders
  • Temporomandibular Joint Pain