R01_Pilot Jaw Muscle Phenotypes

Study Purpose

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 will respond to heat therapy and consequently experience reduced jaw pain and fatigue during teeth clenching. The study will assess the clinical characteristics of those participants who respond and do not respond to local heat therapy, in order to determine the common clinical characteristics for those in each response category.

Recruitment Criteria

Accepts Healthy Volunteers

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

No
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.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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: 1.
Onset >3 months, occurring >15 days/month on average in the last three months from the screening session. 2. 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 Criteria:

  • - 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: 1.
Renal failure or dialysis, 2. Heart disease (examples: uncontrolled arrythmia or hypertension, cardiomyopathy) or heart failure, Non-allergic bronchospasm (chronic obstructive pulmonary disease and emphysema), 3. Diabetes (type I or II) that is not controlled with medication or diet, 4. Hyperthyroidism, 5. 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.
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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.

NCT07153107
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.

N/A
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 Not yet recruiting
Countries United States
Conditions

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

Chronic TMD Pain, Temporomandibular Disorder
Arms & Interventions

Arms

Active Comparator: Self-care with local heat therapy

No Intervention: Self-care without local heat therapy

Interventions

Other: - Local Heat Therapy

This will use a simple device provided to participants named "jaw bra", which is a head wrap with straps that goes around the chin and head that holds heated gel packs over the cheeks area

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 5037649, Minnesota 5037779

Status

Address

University of Minnesota

Minneapolis 5037649, Minnesota 5037779, 55455

Site Contact

Lauren Huffman

[email protected]

612-625-8926