Evaluation of the Effect of the Erchonia® EVRL on Chronic Jaw Pain Arising From TMJ
WithdrawnNot applicableNCT07600203
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 details
- 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
- Conditions
- TMJ
- TMJ Pain
- TMD
- Interventions
- Device: Erchonia® EVRL™
- Device: Placebo Device
- Sponsor
- Erchonia Corporation
- Start date
- 2026-05-14
- Primary completion
- 2026-09-18
- Sex
- All
- Age range
- from 22 Years to 75 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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, my…
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07600203