R01_Pilot Jaw Muscle Phenotypes

NCT07153107 | Not Yet Recruiting

• 1 other identifier: STUDY00025509
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Keywords

Jaw Pain; Local Heat Therapy

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  7 days following intervention

Study Arms (2)

Self-care with local heat therapy

ACTIVE COMPARATOR

Other: Local Heat Therapy

Self-care without local heat therapy

NO INTERVENTION

Interventions

Local Heat Therapy OTHER

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

Self-care with local heat therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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

You may not qualify 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;
• 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;

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Study Officials

• Estephan Moana-Filho

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lauren Huffman

CONTACT

612-625-8926; huffm052@umn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2025
• First Posted: September 3, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): January 12, 2027
• Study Completion (Estimated): January 12, 2027
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)