Trial Outcomes & Findings for A Study to Evaluate the Effect of Low Level Laser Light on Low Back Pain (NCT NCT02538523)

Last Updated: 2021-06-10

Results Overview

The Visual Analog Scale (VAS) assesses level or degree of pain. It is a horizontal line anchored on the left by the label '0: no pain at all' and on the right by the label '100: worst pain imaginable'. The subject marks a location on the 0-100 line that appears to represent any level of pain he or she is experiencing at that time. This marking is measured with a 0 to 100 mm ruler and the number recorded. For the primary study outcome, the percent change in the VAS pain score recorded at baseline and endpoint is calculated for each subject. Individual subject success is a 30% or greater change in VAS pain scores. 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 is defined as a 35% or greater difference between the proportion of individual successes in each treatment group.

Recruitment status

COMPLETED

Study phase

Target enrollment

58 participants

Primary outcome timeframe

Baseline and Two Months Post-Procedure

Results posted on

2021-06-10

Participant Flow

Participant milestones

Participant milestones
Measure	Erchonia FX-635 The Erchonia FX-635 is made up of 3 independent 17 milliWatts (mW), 635 nanometer (nm) red laser diodes mounted in scanner devices with flexible arms positioned equidistant from each other. Erchonia FX-635: The Erchonia FX-635 is applied to the lower back and hips area for 20 minutes per treatment administration, 8 times across 4 weeks, 2 times per week.	Placebo Laser The Placebo Laser has the same appearance as the Erchonia FX-635 but does not emit any therapeutic light. Placebo Laser: The Placebo Laser is applied to the lower back and hips area for 20 minutes per treatment administration, 8 times across 4 weeks, 2 times per week.
Overall Study STARTED	29	29
Overall Study COMPLETED	29	29
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

One subject did not report duration of low back pain.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Erchonia FX-635 n=29 Participants The Erchonia FX-635 is made up of 3 independent 17 milliWatts (mW), 635 nanometer (nm) red laser diodes mounted in scanner devices with flexible arms positioned equidistant from each other. Erchonia FX-635: The Erchonia FX-635 is applied to the lower back and hips area for 20 minutes per treatment administration, 8 times across 4 weeks, 2 times per week.	Placebo Laser n=29 Participants The Placebo Laser has the same appearance as the Erchonia FX-635 but does not emit any therapeutic light. Placebo Laser: The Placebo Laser is applied to the lower back and hips area for 20 minutes per treatment administration, 8 times across 4 weeks, 2 times per week.	Total n=58 Participants Total of all reporting groups
Age, Continuous	46.41 years STANDARD_DEVIATION 17.07 • n=29 Participants	44.72 years STANDARD_DEVIATION 13.02 • n=29 Participants	45.47 years STANDARD_DEVIATION 14.77 • n=58 Participants
Sex: Female, Male Female	13 Participants n=29 Participants	14 Participants n=29 Participants	27 Participants n=58 Participants
Sex: Female, Male Male	16 Participants n=29 Participants	15 Participants n=29 Participants	31 Participants n=58 Participants
Race/Ethnicity, Customized Caucasian	22 Participants n=29 Participants	18 Participants n=29 Participants	40 Participants n=58 Participants
Race/Ethnicity, Customized Hispanic	1 Participants n=29 Participants	7 Participants n=29 Participants	8 Participants n=58 Participants
Race/Ethnicity, Customized African American	3 Participants n=29 Participants	2 Participants n=29 Participants	5 Participants n=58 Participants
Race/Ethnicity, Customized Asian	3 Participants n=29 Participants	2 Participants n=29 Participants	5 Participants n=58 Participants
Region of Enrollment United States	29 participants n=29 Participants	29 participants n=29 Participants	58 participants n=58 Participants
Duration of Low Back Pain	86.39 months STANDARD_DEVIATION 80.46 • n=28 Participants • One subject did not report duration of low back pain.	92.74 months STANDARD_DEVIATION 82.74 • n=29 Participants • One subject did not report duration of low back pain.	89.62 months STANDARD_DEVIATION 80.87 • n=57 Participants • One subject did not report duration of low back pain.

PRIMARY outcome

Timeframe: Baseline and Two Months Post-Procedure

Outcome measures

Outcome measures
Measure	Erchonia FX-635 n=29 Participants The Erchonia FX-635 is made up of 3 independent 17 milliWatts (mW), 635 nanometer (nm) red laser diodes mounted in scanner devices with flexible arms positioned equidistant from each other. Erchonia FX-635: The Erchonia FX-635 is applied to the lower back and hips area for 20 minutes per treatment administration, 8 times across 4 weeks, 2 times per week.	Placebo Laser n=29 Participants The Placebo Laser has the same appearance as the Erchonia FX-635 but does not emit any therapeutic light. Placebo Laser: The Placebo Laser is applied to the lower back and hips area for 20 minutes per treatment administration, 8 times across 4 weeks, 2 times per week.
Percentage of Participants Whose Change in Pain Rating on the Visual Analog Scale (VAS) Met the Individual Subject Success Criteria	21 Participants	8 Participants

SECONDARY outcome

Timeframe: Baseline and Two Months Post-Procedure

The Oswestry Disability Index (ODI) is a 10-item questionnaire to quantify disability for acute or chronic low back pain. Each question is scored on a scale of 0 (least amount of disability) to 5 (most severe disability). The ODI is expressed as a percentage and calculated by dividing the summed score of all questions answered by the total possible score (that is dependent on how many questions are answered) and multiplying by 100. A total score of '0%' means no disability and a total score of '100%' means the maximum disability possible. Therefore, the higher the total score, the worse the disability, and the lesser the total score, the lesser the disability.

Outcome measures

Outcome measures
Measure	Erchonia FX-635 n=29 Participants The Erchonia FX-635 is made up of 3 independent 17 milliWatts (mW), 635 nanometer (nm) red laser diodes mounted in scanner devices with flexible arms positioned equidistant from each other. Erchonia FX-635: The Erchonia FX-635 is applied to the lower back and hips area for 20 minutes per treatment administration, 8 times across 4 weeks, 2 times per week.	Placebo Laser n=29 Participants The Placebo Laser has the same appearance as the Erchonia FX-635 but does not emit any therapeutic light. Placebo Laser: The Placebo Laser is applied to the lower back and hips area for 20 minutes per treatment administration, 8 times across 4 weeks, 2 times per week.
Change in Total Score on the Oswestry Disability Index (ODI)	-12.27 score on a scale Standard Deviation 10.69	-5.18 score on a scale Standard Deviation 12.64

Adverse Events

Erchonia FX-635

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Laser

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