NCT02538523

A Study to Evaluate the Effect of Low Level Laser Light on Low Back Pain

A Double-Blind, Placebo-Controlled Randomized Evaluation of the Effect of the Erchonia FX-635 on Low Back Pain

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Erchonia Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the effect of low level laser light therapy on reducing low back pain. Half of the participants will receive the actual treatment with the active laser and the other half of the participants will receive a placebo treatment with an inactive laser.

Detailed description

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.

Conditions

• Low Back Pain

Interventions

Type	Name	Description
DEVICE	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.
DEVICE	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.

Timeline

• Start date: 2016-04-08
• Primary completion: 2017-10-07
• Completion: 2017-12-10
• First posted: 2015-09-02
• Last updated: 2021-06-10
• Results posted: 2020-02-05

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study