Photobiomodulation for the Management of Temporomandibular Disorder Pain

Study Purpose

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. Also, we propose to determine if PBM-induced changes in inflammation contribute to PBM's analgesic effects. This study will be a double-blind, sham-controlled, randomized trial testing the efficacy of PBM for pain related to TMD.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 65 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Provides a signed and dated informed consent form.

- Is at least 18 years of age (male or female and any race or ethnicity) - Meets diagnostic criteria for TMD, ( Masticatory Muscle Disorders, 1A: Myalgia) - Has experienced facial pain for at least 3 months.

- At Screening and Baseline Visit (Visit 0), reports an average pain intensity rating over the past week of ≥ 30 on a numerical rating scale (0-100)
Exclusion Criteria:
- Starting a new daily prescription medication for the management of pain within 30 days prior to treatment session; - Use of any injection therapy (e.g., tender or trigger point injections, steroid injections) for the management of pain within 2 weeks prior to the CATI; - Starting occlusal appliance therapy within 30 days prior to CATI; d) history of facial trauma or orofacial surgery within 6 weeks prior to CATI; - Active orthodontic treatment; - Psychiatric hospitalization within one year prior to screening.

- Has known hypersensitivity to laser therapy.

- Currently being treated with chemotherapy or radiation therapy.

- Has been treated with another investigational drug or treatment within 30 days prior to the Screening and Baseline Visit.

- Is pregnant or nursing.

- Anything that, in the opinion of the investigator, would place the participant at increased risk or preclude the participant's full compliance with or completion of the study

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04415281
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Florida
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Margarete Ribeiro-Dasilva, DDS, MS, PhD
Principal Investigator Affiliation	University of Florida
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, NIH
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Pain Related to TMD

Arms & Interventions

Arms

Experimental: Active PBM

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.

Sham Comparator: Sham PBM

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.

Interventions

Device: - THOR® laser system

We chose the THOR® laser system given because their active treatment arm uses both coherent laser and monochromatic LED light. Therefore, we will use three types of active probes in this investigation including, A) Single Laser 810 NM 200 mw; B) Laser Cluster of 810 NM equivalent to 1 WATT and; C) LED Cluster, 34 X 660nm at 10 mw and 35 850nm, 30mw 1390mw total. As detailed in Table 3. We propose to use these three PBM probes in concert for the treatment of TMD pain. Laser A (Single Diode Laser) is designed for isolated trigger points and superficial muscles. Laser B (Cluster Laser) is designed for a more diffuse treatment area,targeting analgesia, anti-inflammatory, and deep tissue repair. Laser C (LED Cluster) is purportedly designed for the presence of diffuse inflammation.

Device: - sham THOR® laser system

sham THOR® laser system

Contact a Trial Team

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University of Florida, Gainesville, Florida

Status

Recruiting

Address

University of Florida

Gainesville, Florida, 32610

Site Contact

Eric o Weber

[email protected]

352-273-7802

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