RECRUITING

Endogenous Pain Inhibition Deficiency in Chronic TMD Pain

Talk to us

Conditions

Chronic Temporomandibular Disorders (TMD)Temporomandibular disorders (TMD)Chronic painHealthy volunteers

Quick Navigation

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

Temporomandibular disorders (TMDs) involve a range of conditions with varied causes, affecting a large portion of the U.S. population and posing challenges for diagnosis and management, especially in chronic cases. Despite advances in understanding TMD pathophysiology, the role of central sensitization, particularly deficient endogenous pain inhibition, remains unclear. The conditioned pain modulation (CPM) test, used to assess pain inhibition in chronic TMD pain, has produced inconsistent results due to varying testing parameters. The proposed cross-sectional study will investigate the efficiency of endogenous pain inhibition in individuals with chronic TMD pain compared to controls by applying noxious and non-noxious stimuli to facial and non-facial sites. The findings aim to clarify the impact of weaker pain inhibition over the face, how the conditioning stimulus' painfulness affects inhibition and the relationship between pain inhibition and fluctuations in TMD pain intensity.

Official Title

The Role of Endogenous Pain Inhibition Deficiency in Chronic TMD Pain Pathophysiology

Quick Facts

Study Start:2024-09-16
Study Completion:2025-12-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06617494

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 74 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Provide informed consent, documented in a signed and dated form.
  2. 2. Will comply with all study procedures, including daily ratings filling before and after the in-person study visit, and be available for the study duration.
  3. 3. All participants of both genders between ages 18 to 74 years.
  4. 4. Cases and controls will be matched for age within ±5 years, and all participants must understand English commands to follow study procedures (e.g., during CPM testing).
  5. 1. Age matching (within ±5 years)
  6. 2. No previous diagnosis for the most common pain-related TMD as defined in the DC/TMD criteria (myalgia, arthralgia, headache attributed to TMD)
  7. 3. No significant orofacial pain (jaw pain, TMJ pain) in the past 3 months (""significant"" meaning 5 or more days in any month or any pain during the past month)
  8. 4. 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. 5. Not meeting any of the most common pain-related TMD diagnoses as described in the DC/TMD criteria (myalgia, arthralgia, headache attributed to TMD) upon clinical exam following the DC/TMD protocol
  10. 1. Primary TMD case criteria: Myalgia (masticatory muscle pain) based on clinical exam following the DC/TMD protocol
  11. 2. Concurrent arthralgia (TMJ pain) and/or headache attributed to TMD allowed
  12. 3. Myofascial pain must meet the following criteria:
  13. 1. Onset \>3 months, occurring \>15 days/month on average for \>3 months
  14. 2. Minimum of 10 jaw pain episodes since onset, each lasting at least 30 minutes and no less than 2 hours within the day, OR unremitting."
  1. 1. Traumatic facial injury or surgery on the face/jaw, arms, or hands
  2. 2. Presence of pain related to dental and periodontal pathology
  3. 3. Pregnant
  4. 4. Has any of the following medical conditions by self-report:
  5. 1. Renal failure or dialysis
  6. 2. Heart disease (examples: uncontrolled arrhythmia or hypertension, cardiomyopathy) or heart failure
  7. 3. Non-allergic bronchospasm (chronic obstructive pulmonary disease and emphysema)
  8. 4. Diabetes (type I or II) that is not controlled with medication or diet
  9. 5. Hyperthyroidism
  10. 6. Uncontrolled seizures
  11. 5. Used any injection therapy (e.g., tender or trigger point injections, steroid injections), acupuncture, biofeedback, or TENS for managing facial/jaw pain within 2 weeks before the screening assessment.
  12. 6. If undergoing botulinum toxin injections in the head and neck area, must be 3 months since the last set of injections, and refrain from this treatment until study participation has ended
  13. 7. History of major depression or other major psychiatric disorder requiring inpatient hospitalization within the last 6 months before the screening assessment
  14. 8. History of treatment for drug or alcohol abuse within the last 12 months
  15. 9. Current pain medication use (e.g., opioids, ibuprofen, acetaminophen) that cannot be stopped \<24 hours before each study visit
  16. 10. Other conditions/diseases associated with altered pain perception: neurological or development disorders (dementia, autism spectrum disorder), neoplasm, multiple sclerosis, trigeminal neuralgia
  17. 11. Adults lacking the capacity to provide informed consent for themselves
  18. 12. Unable to understand instructions for sensory testing in English.
  19. 13. Thermal threshold for Pain-50 (pre-determined at the beginning of visit 1) is outside the temperature range of 40ºC to 49ºC
  20. 14. Inability to complete at least four daily ratings between the Informed consent, Pre-visit 1 procedures, and in-person visit 1
  21. 15. Lack of access to electronic devices with internet connection during the study participation
  22. 16. 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

Carla Campbell
CONTACT
(612-625-6976
camp2757@umn.edu

Principal Investigator

Estephan Moana-Filho
PRINCIPAL_INVESTIGATOR
University of Minnesota

Study Locations (Sites)

University of Minnesota
Minneapolis, Minnesota, 55414
United States

Collaborators and Investigators

Sponsor: University of Minnesota

  • Estephan Moana-Filho, 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 Date2024-09-16
Study Completion Date2025-12-15

Study Record Updates

Study Start Date2024-09-16
Study Completion Date2025-12-15

Terms related to this study

Keywords Provided by Researchers

  • Temporomandibular disorders (TMD)
  • Chronic pain
  • Healthy volunteers

Additional Relevant MeSH Terms

  • Chronic Temporomandibular Disorders (TMD)