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This study is to see if applying green and violet low level laser light to the neck and shoulders can help to reduce pain in the neck and shoulders.
It is the goal of this single (active) group study to evaluate the efficacy of the Erchonia® GVL which simultaneously emits both green (520 nano-meter (nm)) and violet (405 nm) diodes, for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erchonia GVL | Experimental | 520 nanometers (nm) and 405 nm dual-diode laser application |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erchonia GVL | Device | Single treatment with the Erchonia GVL to the neck and shoulders. The treatment applies 520 nanometers (nm) green diode light and 405 nm violet diode light simultaneously. |
| 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. | one day |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gair Laser Chiropractic | West Covina | California | 91790 | United States | ||
| Comey Chiropractic Clinic |
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| ID | Title | Description |
|---|---|---|
| FG000 | Erchonia GVL | 520 nanometers (nm) and 405 nm dual-diode laser application Erchonia GVL: Single treatment with the Erchonia GVL to the neck and shoulders. The treatment applies 520 nanometers (nm) green diode light and 405 nm violet diode light simultaneously. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Erchonia GVL | 520 nanometers (nm) and 405 nm dual-diode laser application Erchonia GVL: Single treatment with the Erchonia GVL to the neck and shoulders. The treatment applies 520 nanometers (nm) green diode light and 405 nm violet diode light simultaneously. |
| 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 |
| 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 | one day |
|
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 GVL | 520 nanometers (nm) and 405 nm dual-diode laser application Erchonia GVL: Single treatment with the Erchonia GVL to the neck and shoulders. The treatment applies 520 nanometers (nm) green diode light and 405 nm violet diode light simultaneously. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elvira Cawthon | Regulatory Insight, Inc. | Results Point of Contact Name | elvira@reginsight.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jul 31, 2020 | Jul 12, 2023 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D059352 | Musculoskeletal Pain |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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| Largo |
| Florida |
| 33771 |
| United States |
| New York ChiroCare | White Plains | New York | 10605 | United States |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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|
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| 0 |
| 43 |
| 0 |
| 43 |
| 0 |
| 43 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |