Photobiomodulation for Management of Temporomandibular Disorder Pain (ULLTRA)

University of Florida

Status: Enrolling

Conditions: Pain Related to TMD

Treatments: Device: THOR® laser system

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05916235

UH3DE030433 (U.S. NIH Grant/Contract)

IRB202300986

UG3DE030433-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 130 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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130 participants in 2 patient groups

Experimental: Active PBM

Experimental group

Description:

PBM has been used clinically in the treatment of musculoskeletal and other pain conditions for over 30 years. Despite the low quality of the existing evidence, PBM has been increasingly used in other countries for the treatment of TMD. However, in the US PBM is not widely used for the treatment of TMD pain. Due to the multifactorial nature of chronic TMD pain, we propose that a multimodal PBM protocol targeting multiple pathophysiological mechanisms will be the optimal approach for PBM implementation in patients with TMD.

Treatment:

Device: THOR® laser system

Sham PBM

Sham Comparator group

Description:

When applying PBM therapy, there are some heating elements in the treatment device, and most of the sham treatment devices available do not offer this feature, which increases the likelihood of unblinding both the patient and the interventionist. The THOR® LX2.3 PBM machine includes this new feature, such that the sham condition mimics the heating activity of the active treatment.

Treatment:

Device: THOR® laser system