Search / Trial NCT06617494

Endogenous Pain Inhibition Deficiency in Chronic TMD Pain

Launched by UNIVERSITY OF MINNESOTA · Sep 24, 2024

Apply for Trial

Trial Information

Current as of December 22, 2024

Recruiting

Keywords

Temporomandibular Disorders (Tmd) Chronic Pain Healthy Volunteers

ClinConnect Summary

This clinical trial is studying chronic jaw pain, known as temporomandibular disorders (TMD). Researchers want to understand how well the body can naturally control pain in people with chronic TMD compared to those without this condition. They will use a test that involves applying different types of pain and pressure to the face and other parts of the body to see how effectively participants manage and respond to pain.

To be eligible for the study, participants must be between 18 and 74 years old and able to understand English. They need to sign a consent form and complete daily pain ratings before and after an in-person visit. Individuals currently experiencing chronic jaw pain or those without any jaw pain in the past three months can participate, but several health conditions and recent treatments may exclude some people. Participants can expect to engage in pain testing and provide feedback about their pain experiences, helping researchers gain insight into pain management for TMD.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • To be eligible to participate in this study, an individual must meet all the following criteria:
  • • 1. Provide informed consent, documented in a signed and dated form.
  • • 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. All participants of both genders between ages 18 to 74 years.
  • • 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).
  • Pain-free controls:
  • • 1. Age matching (within ±5 years)
  • • 2. No previous diagnosis for the most common pain-related TMD as defined in the DC/TMD criteria (myalgia, arthralgia, headache attributed to TMD)
  • • 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)
  • • 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
  • • 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
  • Chronic painful TMD cases:
  • • 1. Primary TMD case criteria: Myalgia (masticatory muscle pain) based on clinical exam following the DC/TMD protocol
  • • 2. Concurrent arthralgia (TMJ pain) and/or headache attributed to TMD allowed
  • 3. Myofascial pain must meet the following criteria:
  • • 1. Onset \>3 months, occurring \>15 days/month on average for \>3 months
  • • 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."
  • Exclusion Criteria:
  • An individual who meets any of the following criteria will be excluded from participation in this study:
  • • 1. Traumatic facial injury or surgery on the face/jaw, arms, or hands
  • • 2. Presence of pain related to dental and periodontal pathology
  • • 3. Pregnant
  • 4. Has any of the following medical conditions by self-report:
  • • 1. Renal failure or dialysis
  • • 2. Heart disease (examples: uncontrolled arrhythmia or hypertension, cardiomyopathy) or heart failure
  • • 3. Non-allergic bronchospasm (chronic obstructive pulmonary disease and emphysema)
  • • 4. Diabetes (type I or II) that is not controlled with medication or diet
  • • 5. Hyperthyroidism
  • • 6. Uncontrolled seizures
  • • 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.
  • • 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
  • • 7. History of major depression or other major psychiatric disorder requiring inpatient hospitalization within the last 6 months before the screening assessment
  • • 8. History of treatment for drug or alcohol abuse within the last 12 months
  • • 9. Current pain medication use (e.g., opioids, ibuprofen, acetaminophen) that cannot be stopped \<24 hours before each study visit
  • • 10. Other conditions/diseases associated with altered pain perception: neurological or development disorders (dementia, autism spectrum disorder), neoplasm, multiple sclerosis, trigeminal neuralgia
  • • 11. Adults lacking the capacity to provide informed consent for themselves
  • • 12. Unable to understand instructions for sensory testing in English.
  • • 13. Thermal threshold for Pain-50 (pre-determined at the beginning of visit 1) is outside the temperature range of 40ºC to 49ºC
  • • 14. Inability to complete at least four daily ratings between the Informed consent, Pre-visit 1 procedures, and in-person visit 1
  • • 15. Lack of access to electronic devices with internet connection during the study participation
  • • 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. "

Trial Officials

Estephan Moana-Filho

Principal Investigator

University of Minnesota

About University Of Minnesota

The University of Minnesota is a leading academic institution renowned for its commitment to advancing healthcare through innovative research and clinical trials. With a focus on interdisciplinary collaboration, the university leverages its extensive resources and expertise to conduct cutting-edge studies aimed at improving patient outcomes and addressing critical health challenges. Its robust clinical trial program emphasizes ethical standards, patient safety, and scientific rigor, contributing to the development of novel therapies and interventions that enhance medical practice and public health.

Locations

Minneapolis, Minnesota, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0