Clinical trial NCT05916235: Photobiomodulation for Management of Temporomandibular Disorder Pain
Official title: Photobiomodulation for Management of Temporomandibular Disorder Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain Related to TMD
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2023-06-23
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Pain Level Change with PBM treatment using a Numerical Rating Scale
timeFrame: Through study completion; about 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
References: