Study of Low Level Laser Therapy to Treat Low Back Pain
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|ClinicalTrials.gov Identifier: NCT01835756|
Recruitment Status : Completed
First Posted : April 19, 2013
Results First Posted : February 2, 2016
Last Update Posted : February 2, 2016
|Condition or disease||Intervention/treatment||Phase|
|Low Back Pain||Device: Erchonia MLS Device: Placebo Laser||Not Applicable|
Back pain is a common musculoskeletal disorder affecting 80% of people at some point in their lives. It is the second most common neurological ailment in the United States, second only to headache, and it is the most common cause of job-related disability and a leading contributor to missed work. Around $50 billion is spent in the U.S. each year to treat low back pain. Men and women are equally affected, with the most common age affected being between 30 and 50 years.
Most low back pain stems from benign musculoskeletal problems, referred to as non-specific low back pain, which is the etiology being evaluated in this study. It is caused by lumbar sprain or strain a stretch injury to the ligaments, tendons, and/or muscles of the low back.
Current mainstream treatment approaches for low back pain due to lumbar sprain strain focus on reducing pain and inflammation, including rest; oral and topical over-the-counter and prescription medications; local heat applications; massage and exercise. Alternative treatment options include acupuncture; chiropractic manipulation; biofeedback; traction; transcutaneous electrical nerve stimulation (TENS); and ultrasound. Surgical procedures are also a treatment option for low back pain, and although the outcomes are often poor and do not last, back surgery remains the 3rd most common form of surgery in the United States, with about 300,000 back surgeries performed annually.
Low Level Laser Therapy (LLLT) communicates information to the receptors on the membrane of the cell and mitochondrion (the enzymatic engine of the cell). This energetic information reaches the cell's DNA, which directly controls cell function. When the cells receive better information, they work better, as do the tissues they comprise, like bones, cartilage, tendons, ligaments, etc. In this way, LLLT promotes the healing and regeneration of damaged tissues, having both local effects on tissue function and also systemic effects carried throughout the body by the blood and acupuncture meridians. The key basic physiological effects of low level laser light include increased cell membrane polarization and permeability; Adenosine-5-triphosphate (ATP) production and respiratory chain activity; enzyme activity; collagen and epithelial production; capillary formation; macrophage (immune) activity; analgesic effects due to elevated endorphin production, electrolytic nerve blockage, and improved blood and lymph flow; anti-inflammatory effect due to improved circulation and accelerated tissue regeneration; and increased production of antioxidants. Of additional benefit is that light energy from low level lasers will only be absorbed by cells and tissues that are not functioning normally and has no effect on healthy cells.
Therefore, low level laser therapy has the potential benefit of providing an effective means of reducing low back pain that is simple, quick, non-invasive and side-effect free.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||62 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Double-Blind, Placebo-Controlled Randomized Evaluation of the Effect of the Erchonia ML Scanner (MLS) on Low Back Pain Clinical Study|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||September 2014|
|Actual Study Completion Date :||September 2014|
Active Comparator: Erchonia MLS
The Erchonia® MLS contains 10 independent diodes, each emitting 17 milliwatts (mW), 635 nanometers (nm) of red laser light.
Device: Erchonia MLS
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 Comparator: Placebo Laser
The Placebo Laser has the same appearance as the Erchonia MLS but does not emit any therapeutic light.
Device: Placebo Laser
The Placebo Laser has the same appearance and administration application as the Erchonia MLS but does not emit any therapeutic light.
- Difference in the Proportion of Primary Outcome Successes Between Treatment Groups [ Time Frame: 4 Months ]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.
- Change in Low Back Pain Visual Analog Scale (VAS) Score [ Time Frame: 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.
- Satisfaction With Study Outcome [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01835756
|United States, Arizona|
|South Mountain Chiropractic Center|
|Chandler, Arizona, United States, 86226|
|Mark B. Burdorf DC|
|Scottsdale, Arizona, United States, 85260|
|Principal Investigator:||Trevor Berry, DC|
|Principal Investigator:||Mark B Burdorf, DC, DACNB|