Using light therapy to relieve pain from jaw disorders

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the use of photobiomodulation (PBM) therapy to alleviate pain associated with temporomandibular disorders (TMD). It employs a double-blind, sham-controlled, randomized design to assess the efficacy of the THOR® laser system in providing pain relief. Participants will be monitored for their pain levels and overall response to the treatment over the course of the study. The aim is to establish a new therapeutic approach for managing TMD pain, which currently lacks FDA-approved treatments.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Male or female, aged 18 years and older
* Meets the CATI pre-screening criteria during pre-screening visit \[participant-reported facial pain for at least 3 months and an average pain intensity rating for the week preceding CATI of ≥30 on a numerical rating scale (NRS, 0-100)\].
* Willing to provide signed and dated informed consent
* Willing to to comply with all study procedures and to be available for the duration of the study
* Meets diagnostic criteria for TMD (Masticatory Muscle disorder, 1 A: Myalgia) during Visit 0
* Completes a minimum of 4 of 7 daily symptom diary (DSD) entries prior to Visit 1 (Randomization visit), and the weekly average pain score on this DSD is ≥30 of 100

Exclusion Criteria:

* Active rheumatologic disease
* Has a medical condition, laboratory finding, or physical exam finding (e.g., renal failure or dialysis, uncontrolled diabetes mellitus, or uncontrolled seizures) that precludes participation as determined by the investigator
* Initiated occlusal appliance therapy within 30 days prior to CATI
* Initiated non-pharmacologic therapy, such as acupuncture, biofeedback, and/or TENS within 30 days prior to CATI
* Is in active orthodontic treatment
* Received any injection therapy (e.g., tender or trigger point injections, steroid injections) for the management of pain within 14 days prior to the CATI
* Has a history of facial trauma or orofacial surgery within 6 weeks prior to CATI
* Has a history of psychiatric hospitalization within one year prior to CATI
* Currently pregnant or lactating
* Has a known hypersensitivity to laser therapy
* Currently being treated with chemotherapy or radiation therapy
* Is undergoing treatment with another investigational drug or treatment initiated within 30 days prior to the Screening and Baseline Visit
* Initiated a new daily prescribed or over-the counter medication for the management of pain within 30 days prior to Screening and Baseline Visit.
* Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study as determined by the investigator

Where it's running

• University of Florida
  Gainesville, Florida, United States Recruiting

Study contacts

• Study coordinator: Selenia Rubio, MD
• Email: srubio7@ufl.edu
• Phone: 352-273-5590

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Two-Door Doulas: Enhanced vs Standard Medicaid Doula Care in Pregnancy

  This trial tests whether an enhanced, earlier, and more frequent doula support program helps pregnant people on Medicaid feel less depression and anxiety after birth compared with the standard Medicaid doula care in Florida.

  Recruiting University of Florida · Gainesville, Florida · NCT07799805

• Just-in-Time Coping Prompts for College Students

  We’re testing whether sending brief coping tips at moments of emotional shift can influence how college students react online, drink, or eat when feelings spike.

  Recruiting University of Florida · Gainesville, Florida · NCT07789314

• Momentary Coping Prompts and Hair Steroids in College Students

  This trial tests whether sending brief coping prompts at moments of emotional volatility helps college students respond to emotions, while collecting hair samples to see if long-term stress hormones relate to those responses.

  Recruiting University of Florida · Gainesville, Florida · NCT07782398

• VM100: a nutritional supplement to see if it improves quality of life for boys with Duchenne

  This Phase 2 study tests VM100, a nutritional drink, in boys aged 8 and up with Duchenne muscular dystrophy to see if it can improve quality of life and reduce fatigue.

  Recruiting Phase 2 University of Florida · Gainesville, Florida · NCT07766980

• Muscle health before and after lung transplant in adults

  This study tests how respiratory and leg muscle health relates to physical function and recovery in adults awaiting and after lung transplantation.

  Recruiting University of Florida · Gainesville, Florida · NCT07747337

• Acute intermittent hypercapnia-based interventions for upper airway and axial control in Parkinsonism

  This randomized pilot study tests whether a single session of acute intermittent hypercapnic hypoxia or hypercapnic normoxia can improve upper airway and axial motor function in adults with Parkinsonism.

  Recruiting at 2 sites University of Florida · Gainesville, Florida and 1 other locations · NCT07674264

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.