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Erchonia EVRL for TMJ Disorder

TS
Overseen ByTravis Sammons
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Erchonia Corporation
Must be taking: Tylenol

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the Erchonia EVRL laser, a low-level laser therapy device, can alleviate chronic jaw pain from TMJ disorder, which affects the joint connecting the jaw to the skull. The study will compare the effects of the actual laser device to a placebo device that looks identical but does not emit therapeutic light. It is suitable for individuals who have experienced constant jaw pain for at least three months and have a diagnosis of TMJ-related pain. Participants must communicate in English and agree to avoid other pain treatments during the study. As an unphased trial, this study provides a unique opportunity to explore a new treatment option for TMJ-related pain.

Do I have to stop taking my current medications for the trial?

Yes, you will need to stop taking any over-the-counter or prescription medications, including muscle relaxants and herbal supplements, intended for pain or inflammation relief during the study. You can only use the study-specific pain relief medication, which is over-the-counter Tylenol.

What prior data suggests that the Erchonia EVRL device is safe for treating TMJ disorder?

Research has shown that the Erchonia® EVRL™ laser treatment is generally easy for people to handle. This device uses a mix of red and violet lasers, which have been used in various treatments without causing harmful side effects. One study examining its safety and effectiveness found that it helps with muscle and joint pain, such as pain from TMJ disorders.

The FDA has approved the Erchonia EVRL for other uses, indicating a strong safety record. The device includes safety features that meet FDA standards to ensure safe laser use. These measures reduce risks and side effects, making the treatment a safe option for many people.12345

Why are researchers excited about this trial?

Unlike traditional treatments for TMJ disorder, which often include medication, physical therapy, or even surgery, the Erchonia® EVRL™ laser device uses a combination of red and violet laser diodes to potentially provide relief. This non-invasive approach targets the affected area with specific wavelengths of light (635 nanometers for red and 405 nanometers for violet), which may reduce pain and inflammation without the side effects associated with pharmaceuticals. Researchers are particularly excited about its portability and ease of use, making it a promising option for those seeking alternatives to conventional care.

What evidence suggests that the Erchonia EVRL is effective for TMJ disorder?

Research has shown that laser therapy can effectively reduce pain and improve outcomes for people with temporomandibular joint disorder (TMJ). In this trial, participants may receive the Erchonia EVRL device, which uses low-level laser therapy (LLLT) at 635 nm to help lessen pain and increase the range of mouth opening for TMJ patients. One study pointed out that the 405 nm violet laser component of the Erchonia EVRL aids surface healing and offers germ-fighting benefits, potentially aiding recovery. Overall, laser therapy is non-invasive and shows promising results in managing long-term jaw pain associated with TMJ.678910

Are You a Good Fit for This Trial?

This trial is for adults aged 22 to 75 who have had constant jaw pain from TMJ disorder for at least 3 months, rate their pain as moderate to severe, and have a confirmed diagnosis by a healthcare professional. Participants must avoid other pain treatments during the study.

Inclusion Criteria

* Subjects score ≥3 points on the validated TMD Pain Screener (long version).
* 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.
I am between 22 and 75 years old.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the Erchonia® EVRL™ or a placebo laser for the treatment of chronic jaw pain

Immediate treatment
1 visit (in-person)

Follow-up

Participants are monitored for changes in pain rating and mouth opening measurements immediately after treatment

Immediate follow-up
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Erchonia® EVRL™

Trial Overview

The study compares the Erchonia EVRL device (a type of low-level laser therapy) with a placebo device to see if it helps relieve chronic jaw pain from TMJ disorder. Neither participants nor researchers know which treatment each person receives.

How Is the Trial Designed?

2

Treatment groups

Active Control

Placebo Group

Group I: Erchonia® EVRL™Active Control1 Intervention
Group II: Placebo LaserPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Erchonia Corporation

Lead Sponsor

Trials
45
Recruited
2,100+

Citations

Effectiveness of Laser Therapy in Treatment of ... - PMC

Laser therapy is an effective treatment for pain management due to its non-invasive nature and capacity for tissue regeneration.

Two Randomized, Double Blind, Placebo- Controlled Trials ...

Conclusion: The data demonstrates the clinical utility of low-level laser for treatment of LBP. Based on efficacy and safety, 635 nm red laser.

Violet Laser Therapy: How 405nm Light Is Expanding LLLT

Explore how violet laser therapy expands low-level laser treatment, offering antimicrobial benefits, surface-level healing support, ...

Effectiveness of the Laser Application in Temporomandibular ...

Laser therapy shows a promising outcome of pain reduction for TMD patients. Therefore, laser therapy can be recommended for the TMD patients' better outcome.

ERCHONIA® HLS™ A Pilot Evaluation of the effect of the ...

The Erchonia HLS Laser is a hand-held single diode, variable hertz laser that is portable, self- contained, lightweight, and battery operated.

EVRL Laser - Red and Violet Therapy Laser

EVRL lasers are a trusted and proven treatment approach, allowing practitioners to change patients' lives without the harmful side effects associated with ...

LLLT Safety: Guidelines for Minimizing Risks and Side Effects

Learn key laser safety guidelines for LLLT to minimize risks. Follow FDA standards, prioritize laser exposure safety, and promote safety in ...

Low-level laser therapy in temporomandibular joint disorders

660 nm (red laser) and 795 nm (infrared) laser 8 J/cm2 in Muscles 4 J/cm2 in Joint, PI, Both lasers are effective in the treatment and remission of TMD symptoms.

K212595 - Travis Sammons - accessdata.fda.gov

The Erchonia EVRL Laser® 510(k): K191257, was based on clinical data from a study that evaluated the safety and efficacy of the Erchonia Laser ...

Erchonia® EVRL™ in TMD and TMJ Pain and TMJ - ICH GCP

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 ...