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This study is to see if applying pre-treatment with the Erchonia® PPL blue laser therapy, followed sequentially with the standard Erchonia red laser therapy can help reduce nociceptive musculoskeletal pain
It is the goal of this single (active) group study to evaluate the efficacy of the pre-treatment with the Erchonia® PPL blue laser therapy, followed sequentially with the standard Erchonia red laser therapy, is non-inferior to (equivalent to or superior to) the standard Erchonia red laser therapy when applied alone in providing temporary relief of nociceptive musculoskeletal pain
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erchonia® PPL | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erchonia® PPL blue laser therapy, followed sequentially with the standard Erchonia red laser therapy | Device | 450 nanometers (nm) blue dual-diode laser application followed by 640nm red laser application |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With 30% or Greater Change in Pain Rating on the Visual Analog Scale (VAS) | The Visual Analog Scale (VAS) from one day, baseline to endpoint measurement (following 13-minute treatment administration) 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 positive (+) percent change indicates an increase in pain level and is negative for individual subject success. Overall study success criteria is defined as at least 65%±5% (percentage of subjects) meeting the study individual success criteria. | Day 1 |
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Inclusion Criteria:
22 years of age or older
Primary language is English
Subject presents with with one or more of:
Subject is diagnosed with of one or more of the following:
Pain is chronic, having persisted for longer than the past 30 days
Self-reported Pain rating on the 0-100 Visual Analog Scale (VAS) of 50 or greater.
Willing and able to refrain from consuming any over-the-counter and/or prescription medication(s) and/or herbal supplements intended for the relief of pain and/or inflammation, including muscle relaxants throughout the course of study participation.
Willing and able to refrain from engaging in any non-study procedure therapies 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
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laser Chiropractic | West Covina | California | 91790 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Erchonia® PPL | Erchonia® PPL blue laser therapy, followed sequentially with the standard Erchonia red laser therapy: 450 nanometers (nm) blue dual-diode laser application followed by 640nm red laser application |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 13, 2025 |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Erchonia® PPL | Erchonia® PPL blue laser therapy, followed sequentially with the standard Erchonia red laser therapy: 450 nanometers (nm) blue dual-diode laser application followed by 640nm red laser application |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Subjects With 30% or Greater Change in Pain Rating on the Visual Analog Scale (VAS) | The Visual Analog Scale (VAS) from one day, baseline to endpoint measurement (following 13-minute treatment administration) 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 positive (+) percent change indicates an increase in pain level and is negative for individual subject success. Overall study success criteria is defined as at least 65%±5% (percentage of subjects) meeting the study individual success criteria. | Posted | Number | percentage of subjects | Day 1 |
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48 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Erchonia® PPL | Erchonia® PPL blue laser therapy, followed sequentially with the standard Erchonia red laser therapy: 450 nanometers (nm) blue dual-diode laser application followed by 640nm red laser application | 0 | 44 | 0 | 44 | 0 | 44 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Travis Sammons | Erchonia Corp | 888-242-0571 | tsammons@erchonia.com |
| May 8, 2026 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 13, 2025 | May 8, 2026 | ICF_001.pdf |
| ID | Term |
|---|---|
| D059352 | Musculoskeletal Pain |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Unknown or Not Reported |
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