Endogenous Pain Inhibition Deficiency in Chronic TMD Pain

Last updated: September 24, 2024
Sponsor: University of Minnesota
Overall Status: Active - Recruiting

Phase

N/A

Condition

Oral Facial Pain

Treatment

Pain modulation testing

Clinical Study ID

NCT06617494
STUDY00022663
  • Ages 18-74
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

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 andafter 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 participantsmust understand English commands to follow study procedures (e.g., during CPMtesting).

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/TMDcriteria (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 pastmonth)

  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 pastmonth), e.g., low back pain, fibromyalgia, migraine headaches

  5. Not meeting any of the most common pain-related TMD diagnoses as described in theDC/TMD criteria (myalgia, arthralgia, headache attributed to TMD) upon clinical examfollowing the DC/TMD protocol

Chronic painful TMD cases:

  1. Primary TMD case criteria: Myalgia (masticatory muscle pain) based on clinical examfollowing the DC/TMD protocol

  2. Concurrent arthralgia (TMJ pain) and/or headache attributed to TMD allowed

  3. Myofascial pain must meet the following criteria:

  4. Onset >3 months, occurring >15 days/month on average for >3 months

  5. Minimum of 10 jaw pain episodes since onset, each lasting at least 30 minutesand no less than 2 hours within the day, OR unremitting."

Exclusion

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:

  5. Renal failure or dialysis

  6. Heart disease (examples: uncontrolled arrhythmia or hypertension,cardiomyopathy) or heart failure

  7. Non-allergic bronchospasm (chronic obstructive pulmonary disease and emphysema)

  8. Diabetes (type I or II) that is not controlled with medication or diet

  9. Hyperthyroidism

  10. Uncontrolled seizures

  11. Used any injection therapy (e.g., tender or trigger point injections, steroidinjections), acupuncture, biofeedback, or TENS for managing facial/jaw pain within 2weeks before the screening assessment.

  12. If undergoing botulinum toxin injections in the head and neck area, must be 3 monthssince the last set of injections, and refrain from this treatment until studyparticipation has ended

  13. History of major depression or other major psychiatric disorder requiring inpatienthospitalization within the last 6 months before the screening assessment

  14. History of treatment for drug or alcohol abuse within the last 12 months

  15. Current pain medication use (e.g., opioids, ibuprofen, acetaminophen) that cannot bestopped <24 hours before each study visit

  16. Other conditions/diseases associated with altered pain perception: neurological ordevelopment disorders (dementia, autism spectrum disorder), neoplasm, multiplesclerosis, trigeminal neuralgia

  17. Adults lacking the capacity to provide informed consent for themselves

  18. Unable to understand instructions for sensory testing in English.

  19. Thermal threshold for Pain-50 (pre-determined at the beginning of visit 1) isoutside the temperature range of 40ºC to 49ºC

  20. Inability to complete at least four daily ratings between the Informed consent,Pre-visit 1 procedures, and in-person visit 1

  21. Lack of access to electronic devices with internet connection during the studyparticipation

  22. Anything that would place the individual at increased risk or preclude theindividual's full compliance with study procedures or completion of the study. "

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: Pain modulation testing
Phase:
Study Start date:
September 16, 2024
Estimated Completion Date:
December 15, 2025

Connect with a study center

  • University of Minnesota

    Minneapolis, Minnesota 55414
    United States

    Active - Recruiting

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