Endogenous Pain Inhibition Deficiency in Chronic TMD Pain

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years - 74 Years
Gender All
More Inclusion & Exclusion 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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06617494
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Minnesota
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Estephan Moana-Filho
Principal Investigator Affiliation University of Minnesota
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Chronic Temporomandibular Disorders (TMD)
Arms & Interventions

Arms

: Chronic Temporomandibular disorder (TMD) pain group

: Age- and sex-matched pain-free controls

Interventions

Other: - Pain modulation testing

During the visit, noxious heat stimuli will be applied bilaterally to the face and distant body sites as part of conditioned pain modulation (CPM) testing. The test stimuli will be individually tailored to be moderately painful, while the conditioning stimulus will vary in intensity: moderately painful, non-painful, and sham heat. Participants will also record daily TMD pain intensity ratings for seven days before and after the visit.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Minnesota, Minneapolis, Minnesota

Status

Recruiting

Address

University of Minnesota

Minneapolis, Minnesota, 55414

Site Contact

Carla Campbell

[email protected]

(612-625-6976