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Pilot Study of Local Heat Therapy for Chronic Jaw Pain

This study is looking at how local heat therapy, using a device called a "jaw bra" (a head wrap that holds heated gel packs over your cheeks), affects chronic jaw pain (TMD pain) and jaw fatigue. Researchers want to see if heat therapy can reduce pain and fatigue during teeth clenching. They also want to understand what makes some people respond well to heat therapy and others not. You might be able to join if you are 18 or older, have chronic TMD pain, and have a certain number of teeth. The study will measure how much your bad jaw pain fluctuates 7 days after using the heat therapy. The current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 10 participants. It is not specified if it is randomized or blinded.
What's involved
You would use a provided "jaw bra" device with heated gel packs. You would need to be available for the duration of the study participation.
Compensation
Not stated in the trial record.
Follow-up
Your jaw pain fluctuations will be measured 7 days after the intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07153107

R01_Pilot Jaw Muscle Phenotypes

Not Yet Recruiting
NAAges 18+InterventionalBasic science
University of Minnesota
~10 participants
Updated 2026-08-25 on ClinicalTrials.gov
What's tested:Local Heat Therapy

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of bad jaw pain fluctuations
Measured over 7 days following intervention
+1 more outcome measured

Conditions

Chronic TMD Pain
Temporomandibular Disorder

Explore related trials

Temporomandibular Joint Disorder

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

  • Estephan Moana-Filho · PRINCIPAL_INVESTIGATOR · University of Minnesota

Who to contact

Lauren Huffman
[email protected]
612-625-8926
Email the study team

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Do you actually qualify for this trial?

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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:

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:
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."

What this trial measures

  • Proportion of bad jaw pain fluctuations7 days following intervention

    Primary outcome includes the proportion of bad jaw pain fluctuations. A bad jaw pain fluctuation is defined as an increase ≥ 20 points from a previous measure. Jaw pain ratings will be collected daily for 8 days. The proportion of pain fluctuations is defined as the number of bad jaw pain fluctuations relative to the total number of jaw pain ratings.

  • Patient change in proportion of bad jaw pain fluctuations7 days following intervention

    Patient change in proportion of bad pain fluctuations will be assessed by comparing the proportion of bad jaw pain fluctuations between patients receiving heat therapy and matched patients not receiving heat therapy during the wait period.