Phase
Condition
Oral Facial Pain
Treatment
Pain modulation testing
Clinical Study ID
Ages 18-74 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 andafter 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 participantsmust understand English commands to follow study procedures (e.g., during CPMtesting).
Pain-free controls:
Age matching (within ±5 years)
No previous diagnosis for the most common pain-related TMD as defined in the DC/TMDcriteria (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 pastmonth)
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
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:
Primary TMD case criteria: Myalgia (masticatory muscle pain) based on clinical examfollowing 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 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:
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
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, steroidinjections), acupuncture, biofeedback, or TENS for managing facial/jaw pain within 2weeks before the screening assessment.
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
History of major depression or other major psychiatric disorder requiring inpatienthospitalization 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 bestopped <24 hours before each study visit
Other conditions/diseases associated with altered pain perception: neurological ordevelopment disorders (dementia, autism spectrum disorder), neoplasm, multiplesclerosis, 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) isoutside 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 studyparticipation
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
Connect with a study center
University of Minnesota
Minneapolis, Minnesota 55414
United StatesActive - Recruiting
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