Using light therapy to relieve pain from jaw disorders
Photobiomodulation for Management of Temporomandibular Disorder Pain
This study is testing whether light therapy can help relieve pain for people suffering from jaw disorders like temporomandibular disorders (TMD).
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | University of Florida Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Gainesville, Florida) |
| Trial ID | NCT05916235 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have been experiencing facial pain related to TMD for at least three months.
Not a fit: Patients with active rheumatologic diseases or other significant medical conditions that could interfere with the study may not benefit from this trial.
Why it matters
Potential benefit: If successful, this treatment could provide a non-invasive option for patients suffering from chronic TMD pain.
How similar studies have performed: While photobiomodulation has been FDA-approved for other types of pain, this specific application for TMD is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Gainesville, Florida
- University of Florida — Gainesville, Florida, United States (Recruiting)
Study contacts
- Study coordinator: Selenia Rubio, MD
- Email: srubio7@ufl.edu
- Phone: 352-273-5590
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.