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Not yet recruiting NCT07153107

R01_Pilot Jaw Muscle Phenotypes

No phase Interventional Chronic TMD Pain Temporomandibular Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Local Heat Therapy.
Who it may be relevant to
Registry conditions: Chronic TMD Pain, Temporomandibular Disorder. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

R01_PilotStudy2_Jaw Muscle Metabolic and Brain-Derived Phenotypes of Chronic TMD Pain

Overview

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.

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

Primary outcome measures

  • 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]

Eligibility 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:
  • 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

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:
  • 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; 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."

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Basic science

Study locations

United States · 1 center
  • University of Minnesota — Minneapolis

Identifiers

NCT: NCT07153107 · STUDY00025509

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗