Status:
NOT_YET_RECRUITING
R01_Pilot Jaw Muscle Phenotypes
Lead Sponsor:
University of Minnesota
Conditions:
Chronic TMD Pain
Temporomandibular Disorder
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The proposed study will assess the effect of local heat therapy on jaw pain and jaw fatigue secondary to a teeth clenching task in chronic TMD pain cases. Researchers expect that most participants wil...
Eligibility Criteria
Inclusion
- Provide signed and dated informed consent form.
- Willing to comply with all study procedures and be available for the duration of study participation.
- Be 18 years or older.
- Have a minimum set of teeth present, be it natural, implant-supported or fixed prosthodontics: all anterior teeth (incisors, canines), at least one premolar, at least one molar (first or second molar; third molars not considered).
- TMD-Pain screener score equal to or greater than 3
- 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 in the last three months from the screening session
- Minimum of 10 jaw pain episodes since onset, each episode lasting at least 30 minutes and no less than 2 hours within the day, OR unremitting
Exclusion
- Traumatic facial injury or surgery on the face/jaw, arms or hands;
- Presence of pain related to dental and periodontal pathology;
- Currently undergoing active orthodontic treatment;
- Pregnant;
- Has any of the following medical conditions by self-report:
- Renal failure or dialysis,
- Heart disease (examples: uncontrolled arrythmia 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 the management of facial/jaw pain within 2 weeks prior to the screening assessment; If undergoing botulinum toxin injections in the head and neck area, must be 3 months since last set of injections and refrain from this treatment until study participation has ended
- History of major depression or other major psychiatric disorder requiring hospitalization within the last 6 months prior to 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 prior to each study visit;
- Current use of medically prescribed muscle relaxants for the duration of study participation;
- Other conditions/diseases associated with altered pain perception: neurological or development disorders (dementia, autism spectrum disorder), neoplasm, multiple sclerosis, trigeminal neuralgia;
- Adults lacking capacity to provide informed consent for themselves;
- Unable to understand instructions for study procedures in English.
- Anything that would place the individual at increased risk or preclude the individual's full compliance with study procedures or completion of the study."
Key Trial Info
Start Date :
January 31 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 12 2027
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT07153107
Start Date
January 31 2026
End Date
January 12 2027
Last Update
December 3 2025
Active Locations (1)
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1
University of Minnesota
Minneapolis, Minnesota, United States, 55455