TMJNCT07600203
Evaluation of the Effect of the Erchonia® EVRL on Chronic Jaw Pain Arising From TMJ
A study testing Erchonia® EVRL™ in people with TMJ and TMJ Pain, run by Erchonia Corporation at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 22 to 75 years
- What is being tested?
- Erchonia® EVRL™
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2026to 18 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Acton Dental Associates
Acton, Massachusetts, 01720-5774
About this study
Official title: A Double-blind, Placebo-controlled, Randomized Evaluation of the Effect of the Erchonia® EVRL on Chronic Jaw Pain Arising From TMJ Clinical Study Protocol
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).
- Being tested
- Erchonia® EVRL™, Placebo Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Placebo DeviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Placebo Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and immediately after treatment
Secondary outcomes (1)
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.
Measured: Baseline and immediately after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start14 May 2026
- Primary completion18 Sep 2026
- Study completion18 Sep 2026
Why it stopped: Study terminated due to insufficient participant enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TMJStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erchonia Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07600203
- Sponsor's protocol ID
- R-TMJ
- Status last verified
- Sep 2026
- First submitted
- 14 May 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled, Randomized Evaluation of the Effect of the Erchonia® EVRL on Chronic Jaw Pain Arising From TMJ Clinical Study Protocol
- ClinicalTrials.gov ID
- NCT07600203
- Acronym / sponsor ID
- R-TMJ
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study terminated due to insufficient participant enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Erchonia CorporationIndustry (pharma, biotech, devices)
- Study start
- 14 May 2026 (actual)
- Primary completion
- 18 Sep 2026 (actual)
- Study completion
- 18 Sep 2026 (actual)
- First posted
- 20 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erchonia® EVRL™ | Active comparator | Device: Erchonia® EVRL™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. |
| Placebo Laser | Placebo comparator | Device: Placebo DeviceThe Placebo Laser has the same appearance as the Erchonia® EVRL™ but does not emit any therapeutic light. |
Who may qualify
- Ages
- 22 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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).
Key exclusion criteria (17 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erchonia® EVRL™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. | Device | Erchonia® EVRL™ |
| Placebo DeviceThe 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. | Device | Placebo Laser |
Primary outcome
Number of Participants With a 30% or Greater Change in Pain Rating on the Visual Analog Scale (VAS)
Time frame: Baseline and immediately after treatment
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.
1 secondary outcome
Change in Mouth Opening Measurements
Time frame: Baseline and immediately after treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erchonia® EVRL™ in people with TMJ and TMJ Pain, run by Erchonia Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With a 30% or Greater Change in Pain Rating on the Visual Analog Scale (VAS) (time frame: Baseline and immediately after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.