A Double-blind, Placebo-controlled Evaluation of the Effect of the Erchonia® EVRL on Chronic Jaw Pain Arising From TMJ

NCT07600203 | Recruiting FDA Device

• 1 other identifier: R-TMJ
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical study is to determine the effectiveness of the Erchonia EVRL, manufactured by Erchonia Corporation (the Company), in providing temporary relief of nociceptive musculoskeletal chronic jaw pain arising from temporomandibular joint (TMJ).

Conditions

TMJ; TMJ Pain; TMD

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• Change in Mouth Opening Measurements

  Baseline and immediately after treatment

Study Arms (2)

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

Interventions

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.

Erchonia® EVRL™

Placebo Device DEVICE

The Placebo Laser has the same appearance as the Erchonia® EVRL™ but does not emit any therapeutic light. 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.

Placebo Laser

Eligibility Criteria

• Age: 22 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• Diagnosed conditions: trigeminal neuralgia, Parkinson's disease, or other neuropathic facial pain disorders
• 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.

Sponsors & Collaborators

• Erchonia Corporation: lead

Study Sites (1)

Acton Dental Associates

Acton, Massachusetts, 01720-5774, United States

RECRUITING

Central Study Contacts

Travis Sammons

CONTACT

888-242-0571; tsammons@erchonia.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: May 20, 2026
• Study Start: May 14, 2026
• Primary Completion (Estimated): December 21, 2027
• Study Completion (Estimated): December 22, 2027
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)