Photobiomodulation for Management of Temporomandibular Disorder Pain
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Pain Related to TMD
In brief
Photobiomodulation (PBM), is FDA-approved for temporary relief of muscle and joint pain, but there is no indication for TMD. Our goal in this study is to conduct a clinical trial of multimodal PBM for TMD pain. This study will be a double-blind, sham-controlled, randomized trial testing the efficacy of PBM for pain related to TMD.
Key facts
- Study ID
- NCT05916235
- Run by
- University of Florida
- People needed
- 130
- Starts
- 2024-02-08
- Expected to finish
- 2028-10-01
- Last updated by the study team
- 2025-10-24
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 is running
- University of Florida — Gainesville, Florida, United States (enrolling)
Full record on ClinicalTrials.gov
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