Actively Recruiting
Evaluating the Effectiveness of the Erchonia EVRL Laser Device for Treating Chronic Jaw Pain from TMJ A Double-Blind, Placebo-Controlled Study in Adults Ages 22 to 75
Led by Erchonia Corporation · Updated on 2026-05-20
64
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the Erchonia4 EVRL device to determine its effectiveness in providing temporary relief for chronic jaw pain caused by temporomandibular joint TMJ disorders. This clinical study focuses on nociceptive musculoskeletal pain arising from TMJ and aims to measure changes in pain levels and jaw function. The study compares the Erchonia4 EVRL, a handheld device with red and violet laser diodes, to a placebo device that looks identical but emits no therapeutic light. Treatments involve positioning the device 3 to 4 inches from the skin over the TMJ area, applying laser therapy for 16 minutes total, with 8 minutes on each side. Participants are randomly assigned to receive either the active device or placebo in a triple-blind design. Participants will undergo assessments of pain using a visual analog scale VAS and mouth opening measurements before and immediately after treatment. The primary outcome is the number of participants achieving a 30% or greater reduction in pain rating. The study includes adults aged 22 to 75 with ongoing jaw pain lasting at least three months. Safety and effectiveness will be monitored throughout the trial, which runs until December 2027.
CONDITIONS
Brief Title
A Double-blind, Placebo-controlled Evaluation of the Effect of the Erchonia® EVRL on Chronic Jaw Pain Arising From TMJ
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and voluntarily sign the informed consent form
- Adults aged 22 to 75 years
- Self-reported jaw pain rating of 50 or greater on a 0-100 visual analog scale
- Constant jaw pain ongoing for at least the past 3 months
- Score of 3 or more points on the validated TMD Pain Screener (long version)
- Primary diagnosis of TMJ-related nociceptive musculoskeletal pain confirmed using DC/TMD Axis I, including myalgia and/or arthralgia
- Willing and able to avoid all pain and inflammation medications except over-the-counter Tylenol during study participation
- Agree to avoid taking Tylenol within 6 hours before scheduled pain rating assessments
- Willing and able to refrain from non-study therapies for jaw pain during the study
- Able to communicate fluently in English and comply with study procedures
You will not qualify if you...
- Pain primarily due to causes other than TMJ-related nociceptive musculoskeletal pain
- Diagnosis does not include myalgia or arthralgia or includes certain TMJ disorders requiring different management
- History of TMJ surgery within past 12 months or major joint replacement/reconstructive surgery
- TMJ corticosteroid, botulinum toxin, or prolotherapy injections within 3 months prior to enrollment
- Neurologic, neuromuscular, or neuropathic craniofacial conditions that confound TMJ pain assessment
- TMJ ankylosis or severe structural deformity requiring surgery
- Degenerative disc disease or internal derangement with significant joint degeneration
- Active systemic inflammatory or autoimmune conditions unless stable and controlled
- Active cancer or cancer treatment in past 6 months
- Active infection, wound, or trauma at treatment areas
- Contraindications or sensitivity to light therapy
- Pregnant, breastfeeding, or planning pregnancy during study participation
- Serious mental health illness or recent psychiatric hospitalization
- Developmental disability or cognitive impairment affecting consent or study compliance
- Any condition that may interfere with treatment evaluation or protocol compliance
Research Team
T
Travis Sammons
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