Recruiting

Heat Therapy

Sponsor:

University of Minnesota

Code:

NCT07153107

Conditions

Chronic TMD Pain

Temporomandibular Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Local Heat Therapy

Study Details

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 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.

Conditions

Chronic TMD Pain

Temporomandibular Disorder

Study ID

NCT07153107

Start date

Oct 20, 2026

Status verified date

Oct, 2026

Completion date

Jan 12, 2027

Anticipated

Primary completion date

Jan 12, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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."

Study Design

Enrollment

10 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

active comparator: Self-care with local heat therapy

no intervention: Self-care without local heat therapy

Interventions

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

Primary outcome measure

  • Proportion of bad jaw pain fluctuations [ Time Frame: 7 days following intervention ]
  • Patient change in proportion of bad jaw pain fluctuations [ Time Frame: 7 days following intervention ]

Central Contacts and Locations

Central contacts

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

More Information

Sponsor

University of Minnesota

Last update posted

Oct 23, 2026

Last verified

Oct, 2026

Keywords

  • Jaw Pain
  • Local Heat Therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by University of Minnesota on 2026-10-23. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.