Trial Outcomes & Findings for The Effect of Low Level Laser Therapy on Neck and Shoulder Pain (NCT NCT03941912)

NCT ID: NCT03941912

Last Updated: 2021-10-14

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

44 participants

Primary outcome timeframe

one day

Results posted on

2021-10-14

Participant Flow

Participant milestones

Participant milestones
Measure	Erchonia EVRL 635 nanometers (nm) and 405 nm dual-diode laser application Erchonia EVRL: Single treatment with the Erchonia EVRL to the neck and shoulders. The treatment applies 635 nanometers (nm) red diode light and 405 nm violet diode light simultaneously.
Overall Study STARTED	44
Overall Study COMPLETED	44
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effect of Low Level Laser Therapy on Neck and Shoulder Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Erchonia EVRL n=44 Participants 635 nanometers (nm) and 405 nm dual-diode laser application Erchonia EVRL: Single treatment with the Erchonia EVRL to the neck and shoulders. The treatment applies 635 nanometers (nm) red diode light and 405 nm violet diode light simultaneously.
Age, Continuous	54.07 years STANDARD_DEVIATION 14.31 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	38 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Region of Enrollment United States	44 participants n=5 Participants
Duration of Neck and Shoulder Pain	76.58 months STANDARD_DEVIATION 110.82 • n=5 Participants

PRIMARY outcome

Timeframe: one day

Outcome measures

Outcome measures
Measure	Erchonia EVRL n=44 Participants 635 nanometers (nm) and 405 nm dual-diode laser application Erchonia EVRL: Single treatment with the Erchonia EVRL to the neck and shoulders. The treatment applies 635 nanometers (nm) red 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)	75 percentage of subjects

Adverse Events

Erchonia EVRL

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Elvira Cawthon

Regulatory Insight, Inc.

Phone: 6154475150

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place