A Double-blind, Placebo-controlled Evaluation of the Effe... | NCT07600203

Status Module

Label	Type	Description	Intervention Names
Erchonia® EVRL™	Active Comparator	The Erchonia® EVRL™ is made up of (1) 635 nanometers red laser diode and (1) 405 nanometers violet laser diode mounted in a portable handheld device.	Device: Erchonia® EVRL™
Placebo Laser	Placebo Comparator	The Placebo Laser has the same appearance as the Erchonia® EVRL™ but does not emit any therapeutic light.	Device: Placebo Device

Name	Type	Description	Arm Group Labels	Other Names
Erchonia® EVRL™	Device	The Erchonia® EVRL™ is a handheld device containing one 635 nm red laser diode and one 405 nm violet laser diode. During treatment, the diodes are positioned approximately 3 to 4 inches from the skin over the temporomandibular joint area. Treatment is administered for a total of 16 minutes, with 8 minutes applied to each side.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With a 30% or Greater Change in Pain Rating on the Visual Analog Scale (VAS)	The Visual Analog Scale (VAS) from baseline to endpoint (immediately after treatment) measurement is calculated for each subject. Individual subject success is defined as a 30% or greater change in VAS pain scores across the evaluation period. A negative (-) percent change indicates a decrease in pain level and is positive for individual subject success. A lower Visual Analog Scale pain score from baseline to study endpoint represents a better outcome, whereas a higher score from baseline to study endpoint represents a worse outcome. For the primary study outcome, the overall study success is defined as a 35% or greater difference between the proportion (number) of individual successes in each treatment group.	Baseline and immediately after treatment

Secondary Outcomes

Measure	Description	Time Frame
Change in Mouth Opening Measurements	Mouth opening measurements will be obtained as part of the Diagnostic Criteria for Temporomandibular Disorders clinical examination. The following measurements will be recorded in millimeters for each subject: pain-free opening, maximum unassisted opening, and maximum assisted opening. Measurements collected at the study qualification visit will serve as baseline values. The same measurements will be repeated immediately after treatment. The change from baseline to immediately after treatment will be calculated for each measurement. An increase in mouth opening measurement from baseline to endpoint represents improved mandibular range of motion.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Able to understand and voluntarily sign the IRB-approved informed consent form.
Adults 22 to 75 years of age.
Subject's self-reported rating for jaw pain on the 0-100 VAS pain scale is 50 or greater (≥ 50).
Constant jaw pain on-going over at least the past 3 months.
Subjects score ≥3 points on the validated TMD Pain Screener (long version).
Subject has a primary diagnosis of TMJ-related nociceptive musculoskeletal pain made by a suitably qualified healthcare professional, confirmed using the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) Axis I, with at least one of the following pain-related diagnoses: myalgia (including local myalgia, myofascial pain, myofascial pain with spreading, myofascial pain with referral) and/or arthralgia.
Subject is willing and able to refrain from consuming any OTC and/or prescription medications including muscle relaxants and/or herbal supplements and/or recreational and medical drugs including cannabis intended for the relief of pain and/or inflammation throughout the course of study participation, except for the study-specific pain relief medication of OTC Tylenol.
Subject agrees to refrain from taking a dosage of the study rescue pain medication of over-the-counter Regular Strength Tylenol® tablets for at least 6 hours before a scheduled VAS jaw pain rating is to be recorded. The subject understands that he may take a dosage of the over-the-counter Regular Strength Tylenol® tablets right after the VAS rating has been recorded, if needed to manage jaw pain.
Subject is willing and able to refrain from engaging in any non-study procedure therapies for the management of his or her jaw pain throughout the course of study participation, including conventional therapies such as physical therapy, occupational therapy and hot or cold packs, as well as alternative therapies such as chiropractic care and acupuncture
Subject is able to communicate fluently in English with the investigator and is able to read and write English sufficiently to comply with the study procedures.

Exclusion Criteria:

Pain that is undiagnosed or determined by a qualified medical/dental professional to be primarily attributable to causes other than TMJ-related nociceptive musculoskeletal pain.
Diagnosis using the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) Axis I does not include at least one of the following pain-related diagnoses: myalgia (including local myalgia, myofascial pain, myofascial pain with spreading, myofascial pain with referral) and/or arthralgia OR includes one or more of the following pain-related diagnoses: disc displacement disorder with reduction, disc replacement disorder with reduction with intermittent locking, disc displacement disorder without reduction with limited opening, disc displacement disorder without reduction without limited opening, degenerative joint disease, headache attributed to RMD, and subluxation.
History of surgical intervention involving the temporomandibular joint within the past 12 months, or any history of total joint replacement or major reconstructive surgery of the TMJ.
Intra-articular TMJ interventions, including corticosteroid injections, botulinum toxin injections, or prolotherapy, within 3 months prior to enrollment.
Neurologic, neuromuscular, or neuropathic conditions affecting the craniofacial region that could confound TMJ pain assessment, including:
1. Diagnosed conditions: trigeminal neuralgia, Parkinson's disease, or other neuropathic facial pain disorders
2. Pain primarily characterized by neuropathic descriptors (burning, shooting, electric-like, sharp/stabbing pain, paresthesias, numbness, or tingling).
TMJ ankylosis or severe structural deformity requiring surgical intervention.
Degenerative disc disease or internal derangement of the temporomandibular joint associated with significant structural degeneration, disc perforation, or requiring surgical intervention.
Diagnosed systemic inflammatory or autoimmune conditions that could confound pain assessment (e.g., active rheumatoid arthritis, lupus) unless stable and well controlled.
Active cancer or treatment for cancer in the past 6 months.
Active infection, wound, or other external trauma to the areas to be treated with the laser.
Medical, physical, or other contraindications for, or sensitivity to, light therapy.
Pregnant, breast feeding, or planning pregnancy prior to the end of study participation.
Serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in past two years.
Developmental disability or cognitive impairment that in the opinion of the investigator would preclude adequate comprehension of the informed consent form and/or ability to record the necessary study measurements.
Any condition or other variable that in the opinion of the investigator may confound or interfere with the evaluation of the effectiveness of the investigational treatment or otherwise render the subject unable to comply with the requirements of the study protocol.