Chronic TMD Pain study: Local Heat Therapy
Official title R01_Pilot Jaw Muscle Phenotypes
ClinicalTrials.gov ID: NCT07153107
What this study is testing
- What it's testing
- This study aims to find out if applying heat to the jaw helps reduce pain and tiredness during teeth clenching. It also looks for common traits in people who do and do not respond to the heat.
- Who it's for
- People with chronic pain related to the temporomandibular joint (the jaw joint).
- What's involved
- Participants will have heat applied to their jaw and then perform a teeth clenching task. Researchers will measure pain and fatigue levels to see how the heat affects them.
- Time commitment
- The source text does not specify the total duration or number of visits required.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- TMD-Pain screener score equal to or greater than 3
You likely can't join if
- 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;
- Renal failure or dialysis,
- Heart disease (examples: uncontrolled arrythmia or hypertension, cardiomyopathy) or heart failure, Non-allergic bronchospasm (chronic obstructive...
See the full eligibility 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
- 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
- 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
- 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;
- Renal failure or dialysis,
- 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
- 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."
The study team makes the final eligibility decision.
Where it is enrolling
- Minneapolis, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Minneapolis, Minnesota, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.