Chronic TMD PainNCT07153107
R01_Pilot Jaw Muscle Phenotypes
A study testing Local Heat Therapy in people with Chronic TMD Pain and Temporomandibular Disorder, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic TMD Pain, Temporomandibular Disorder
- What is being tested?
- Local Heat Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2026to 12 Jan 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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,
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- 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."
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Lauren Huffman, 612-625-8926, huffm052@umn.edu
About this study
Official title: R01_PilotStudy2_Jaw Muscle Metabolic and Brain-Derived Phenotypes of Chronic TMD Pain
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
- Being tested
- Local Heat Therapy
- Keywords
- Jaw Pain, Local Heat Therapy
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local Heat TherapyOther
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
| Study group | Role | What they receive |
|---|---|---|
| Self-care with local heat therapy | Active comparator | Not described Receives: Other: Local Heat Therapy |
| Self-care without local heat therapy | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of bad jaw pain fluctuations
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.
Measured: 7 days following intervention
Patient change in proportion of bad jaw pain fluctuations
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.
Measured: 7 days following intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start20 Oct 2026
- Primary completion12 Jan 2027 (estimated)
- Study completion12 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic TMD PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Estephan Moana-Filho, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07153107
- Sponsor's protocol ID
- STUDY00025509
- Status last verified
- Oct 2026
- First submitted
- 25 Aug 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No