Chronic Temporomandibular Disorders (TMD)TMD-CPMNCT06617494
Endogenous Pain Inhibition Deficiency in Chronic TMD Pain
An observational study of Chronic Temporomandibular Disorders (TMD), run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Temporomandibular Disorders (TMD)
- What is being tested?
- Pain modulation testing
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2024to 31 Dec 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: "1- Chronic Temporomandibular disorder (TMD) pain group 2- Age- and sex-matched pain-free controls"
Who may be able to join
- To be eligible to participate in this study, an individual must meet all the following criteria:
- Provide informed consent, documented in a signed and dated form.
- 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.
- All participants of both genders between ages 18 to 74 years.
- 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:
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- Age matching (within ±5 years)
- No previous diagnosis for the most common pain-related TMD as defined in the DC/TMD criteria (myalgia, arthralgia, headache attributed to TMD)
- 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)
- 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
- 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:
- Primary TMD case criteria: Myalgia (masticatory muscle pain) based on clinical exam following the DC/TMD protocol
- Concurrent arthralgia (TMJ pain) and/or headache attributed to TMD allowed
- Myofascial pain must meet the following criteria:
- Onset >3 months, occurring >15 days/month on average for >3 months
- 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."
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Traumatic facial injury or surgery on the face/jaw, arms, or hands
- Presence of pain related to dental and periodontal pathology
- Pregnant
- Has any of the following medical conditions by self-report:
- Renal failure or dialysis
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- Heart disease (examples: uncontrolled arrhythmia or hypertension, cardiomyopathy) or heart failure
- Non-allergic bronchospasm (chronic obstructive pulmonary disease and emphysema)
- Diabetes (type I or II) that is not controlled with medication or diet
- Hyperthyroidism
- Uncontrolled seizures
- 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.
- 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
- History of major depression or other major psychiatric disorder requiring inpatient hospitalization within the last 6 months before the screening assessment
- History of treatment for drug or alcohol abuse within the last 12 months
- Current pain medication use (e.g., opioids, ibuprofen, acetaminophen) that cannot be stopped <24 hours before each study visit
- Other conditions/diseases associated with altered pain perception: neurological or development disorders (dementia, autism spectrum disorder), neoplasm, multiple sclerosis, trigeminal neuralgia
- Adults lacking the capacity to provide informed consent for themselves
- Unable to understand instructions for sensory testing in English.
- Thermal threshold for Pain-50 (pre-determined at the beginning of visit 1) is outside the temperature range of 40ºC to 49ºC
- Inability to complete at least four daily ratings between the Informed consent, Pre-visit 1 procedures, and in-person visit 1
- Lack of access to electronic devices with internet connection during the study participation
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55414
Carla Campbell
About this study
Official title: The Role of Endogenous Pain Inhibition Deficiency in Chronic TMD Pain Pathophysiology
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.
- Being tested
- Pain modulation testing
- Keywords
- Temporomandibular disorders (TMD), Chronic pain, Healthy volunteers
- Medical subject headings
- Temporomandibular Joint Disorders, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain modulation testingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Temporomandibular disorder (TMD) pain group | Not described Receives: Other: Pain modulation testing | |
| Age- and sex-matched pain-free controls | Not described Receives: Other: Pain modulation testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conditioned pain modulation (CPM) effect
The CPM effect is manifested as a reduction of pain intensity evoked by a test stimulus (Ts) presented concurrently or right after a painful conditioning stimulus (Cs) applied to a distant body site.
Measured: 3.5 hours single in-person visit
The relationship between daily pain intensity fluctuation and endogenous pain modulation (EPM) efficiency
The daily presentation of chronic TMD pain is variable, especially in those presenting with pain that affects their daily activities. This variability could be partially attributed to the varying efficiency of EPM in this patient population.
Measured: 14 days: 7 days before and 7 days after the in-person visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start16 Sep 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Temporomandibular Disorders (TMD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Estephan Moana-Filho, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06617494
- Sponsor's protocol ID
- STUDY00022663
- Acronym
- TMD-CPM
- Status last verified
- Aug 2026
- First submitted
- 24 Sep 2024
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No