Low-level laser therapy technology developer Erchonia (Melbourne, FL) has received U.S. FDA clearance to market its FX 635 low-level laser for the temporary relief of chronic, nociceptive musculoskeletal pain in the whole body.
The company received FDA clearance after submitting results from double-blind and placebo-controlled clinical trials with 255 patients. Those treated with the FX 635 laser documented a 49% average pain reduction post-treatment protocol. No other therapies were used in conjunction with the laser treatment.
For comparison, the SPACE randomized clinical trial1 compared using opioids and non-opioids to treat overall chronic musculoskeletal pain. In the study, 119 patients were treated with opioids, and 119 patients were treated with non-opioids. At three months, results showed a reduction in pain of only 20% with opioids and 26% with non-opioids, mainly NSAIDS. This study also implemented many adjunctive therapies such as exercise, physical therapy, and chiropractic care.
Based on the study's results, the treatment is more effective than opioids or NSAIDS when treating chronic musculoskeletal pain when comparing the SPACE study results with those the company submitted to the FDA, according to Charlie Shanks, VP of Erchonia.
Although this new FDA approval is not limited to one specific area of the body, market clearance was also based on the company's previous Level 1 blinded and controlled clinical trials on chronic neck and shoulder pain in 2002; plantar fasciitis (heel pain) in 2014; and low back pain in 2018. The company's other FDA market clearances for post-surgical pain in 2004 and 2008 were not part of this FDA submission, as they were acute pain studies, not chronic pain.
1. E. E. Krebs et al., JAMA, 319, 9, 872-882 (2018); https://dx.doi.org/10.1001/jama.2018.0899.
For more information, please visit erchonia.com.