Trial Outcomes & Findings for The Effect of the Erchonia GVL Low Level Laser Therapy on Neck and Shoulder Pain (NCT NCT04895618)
NCT ID: NCT04895618
Last Updated: 2023-08-21
Results Overview
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.
COMPLETED
NA
43 participants
one day
2023-08-21
Participant Flow
Participant milestones
| Measure |
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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|---|---|
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Overall Study
STARTED
|
43
|
|
Overall Study
COMPLETED
|
43
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effect of the Erchonia GVL Low Level Laser Therapy on Neck and Shoulder Pain
Baseline characteristics by cohort
| Measure |
Erchonia GVL
n=43 Participants
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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Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
39 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=39 Participants
|
|
Age, Continuous
|
48.32 years
STANDARD_DEVIATION 12.20 • n=39 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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11 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
43 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: one dayThe 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.
Outcome measures
| Measure |
Erchonia GVL
n=43 Participants
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.
|
|---|---|
|
Percentage of Subjects With 30% or Greater Change in Pain Rating on the Visual Analog Scale (VAS)
|
81.4 percentage of subjects
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Adverse Events
Erchonia GVL
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Elvira Cawthon
Regulatory Insight, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place