Trial Outcomes & Findings for Study of Low Level Laser Therapy to Treat Low Back Pain (NCT NCT01835756)

Last Updated: 2016-02-02

Results Overview

Primary outcome success for an individual subject was defined as a 30% or greater change (decrease) in VAS pain score at 4 months post-procedure relative to baseline. The VAS is a straight line scale that is marked on one end with a '0' for 'no pain' and at the other end with '100' for 'worse pain imaginable.' A higher score indicates a greater level of pain, and a lower score indicates a lower level of pain. A negative (-) percent change in VAS rating 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 was defined as a 35% or greater difference in the proportion of individual primary outcome successes in each treatment group, in favor of the active treatment group.

Recruitment status

COMPLETED

Study phase

Target enrollment

62 participants

Primary outcome timeframe

4 Months

Results posted on

2016-02-02

Participant Flow

Participant milestones

Participant milestones
Measure	Erchonia MLS The Erchonia MLS contains 10 independent diodes, each emitting 17 milliwatts (mW), 635 nanometers (nm) of red laser light. It is applied to the lower back and hips area for 30 minutes per treatment administration, 6 times across 3 weeks, 2 times per week.	Placebo Laser The Placebo Laser has the same appearance as the Erchonia MLS but does not emit any therapeutic light.
Overall Study STARTED	31	31
Overall Study COMPLETED	31	31
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Low Level Laser Therapy to Treat Low Back Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Erchonia MLS n=31 Participants The Erchonia MLS contains 10 independent diodes, each emitting 17 milliwatts (mW), 635 nanometers (nm) of red laser light. The Erchonia MLS is applied to the lower back and hips area for 15 minutes per treatment administration, 6 times across 3 weeks, 2 times per week.	Placebo Laser n=31 Participants The Placebo Laser has the same appearance and treatment application as the Erchonia MLS but does not emit any therapeutic light.	Total n=62 Participants Total of all reporting groups
Age, Continuous	53.90 years STANDARD_DEVIATION 12.62 • n=5 Participants	49.48 years STANDARD_DEVIATION 16.39 • n=7 Participants	51.69 years STANDARD_DEVIATION 14.68 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	13 Participants n=7 Participants	29 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	18 Participants n=7 Participants	33 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	30 Participants n=5 Participants	27 Participants n=7 Participants	57 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	31 participants n=5 Participants	31 participants n=7 Participants	62 participants n=5 Participants
Duration of Low Back Pain	92.65 months STANDARD_DEVIATION 95.42 • n=5 Participants	93.45 months STANDARD_DEVIATION 110.86 • n=7 Participants	93.05 months STANDARD_DEVIATION 102.60 • n=5 Participants
Visual Analog Scale (VAS) Degree of Low Back Pain Rating	61.19 units on a scale STANDARD_DEVIATION 13.24 • n=5 Participants	55.94 units on a scale STANDARD_DEVIATION 10.74 • n=7 Participants	58.56 units on a scale STANDARD_DEVIATION 12.35 • n=5 Participants

PRIMARY outcome

Timeframe: 4 Months

Outcome measures

Outcome measures
Measure	Erchonia MLS n=31 Participants The Erchonia MLS contains 10 independent diodes, each emitting 17 milliwatts (mW), 635 nanometers (nm) of red laser light, applied to the lower back and hips area for 15 minutes per treatment administration, 6 times across 3 weeks, 2 times per week.	Placebo Laser n=31 Participants The Placebo Laser has the same appearance and administration application as the active Erchonia MLS but does not emit any therapeutic light.
Difference in the Proportion of Primary Outcome Successes Between Treatment Groups	27 participants	9 participants

SECONDARY outcome

Timeframe: Baseline and 4 Months

The VAS is a straight line scale that is marked on one end with a '0' for 'no pain' and at the other end with '100' for 'worse pain imaginable.' A higher score on the VAS indicates a greater level of pain, and a lower score indicates a lower level of pain.A decrease in the VAS pain rating indicates a reduction in low back pain and is positive for study success. An increase in the VAS pain rating indicates a worsening of low back pain and is negative for study success. The mean change in low back pain score recorded on the Visual Analog Scale (VAS) from baseline to 4 months post-procedure was calculated for each treatment group.

Outcome measures

Outcome measures
Measure	Erchonia MLS n=31 Participants The Erchonia MLS contains 10 independent diodes, each emitting 17 milliwatts (mW), 635 nanometers (nm) of red laser light, applied to the lower back and hips area for 15 minutes per treatment administration, 6 times across 3 weeks, 2 times per week.	Placebo Laser n=31 Participants The Placebo Laser has the same appearance and administration application as the active Erchonia MLS but does not emit any therapeutic light.
Change in Low Back Pain Visual Analog Scale (VAS) Score	-39.32 units on a scale Standard Deviation 22.50	-5.52 units on a scale Standard Deviation 20.17

SECONDARY outcome

Timeframe: 4 Months

At study endpoint, the subject was asked to rate how satisfied he or she was with any overall change in low back pain attained following the procedure administration phase with the Erchonia MLS Laser, using the following five-point scale: Very Satisfied Somewhat Satisfied Neither Satisfied nor Dissatisfied Not Very Satisfied Not at All Satisfied Results are reported as the number of subjects who reported being 'Very Satisfied' or 'Somewhat Satisfied' with the study outcome.

Outcome measures

Outcome measures
Measure	Erchonia MLS n=31 Participants The Erchonia MLS contains 10 independent diodes, each emitting 17 milliwatts (mW), 635 nanometers (nm) of red laser light, applied to the lower back and hips area for 15 minutes per treatment administration, 6 times across 3 weeks, 2 times per week.	Placebo Laser n=31 Participants The Placebo Laser has the same appearance and administration application as the active Erchonia MLS but does not emit any therapeutic light.
Satisfaction With Study Outcome	26 participants	7 participants

Adverse Events

Erchonia MLS

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

Clinical Consultant

Regulatory Insight, Inc.

Phone: 615-712-9743

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place