Study Ignores Proven Success of High-Energy Treatments While Proving Low-Energy Treatments Have No Substantial Healing Benefits
WE AT INNOVATION IN ORTHOPAEDICS WOULD LIKE to commend the media for addressing the fact that low-energy Extracorporeal Shock Wave Therapy for plantar fasciitis offers no substantial benefit. The article was taken off the wire and was an excerpt from the Buchbinder study published in JAMA (Journal of the American Medical Association) in September of 2002. We have been aware of these findings for nearly two years since our high-energy shock wave device, the OssaTron®, was approved by the FDA. Unfortunately the published article did not differentiate low and high-energy machines and was presented to the media as a condemnation of all shock wave therapies. The purpose of this article is to clarify differences between low- and high-energy technologies, as well as differentiate
the OssaTron® clinical results.
There are basically three types of technology available for Extracorporeal Shock Wave Therapy (ESWT): electrohydraulic, the only high-energy model; electro-magnetic, the low-energy technology that has proven to be non-beneficial; and piezioelectric, another type of low-energy technology that is not currently on the market or FDA approved. To the non-medical person, this may not mean much, but there is a significant difference in healing response between the high- and low-energy machines.
OssaTron® Extracoiporeal Shock Wave Therapy continues to be the gold standard treatment for kidney stones in the successful treatment lithotripsy. Using the same concept for orthopedic utilization, ESWT is indicated for diagnosis such as plantar fasciitis, tendonitis, and exclusive to OssaTroa® high-energy technology, delayed healing of bone fractures, All of these conditions are characterized by poor heating, increased sear tissue formation, and a decrease in circulation to the affected tissue,
In fascia, tendon or bone indications, high-energy Extracorporeal Shock Wave Therapy delivers shock waves to this scar tissue, causing microscopic injury thereby promoting a process called 'neovascularization.' This process increases blood supply, allowing nutritional tissue cells to penetrate the area of scarring and promote reengineering and healing of the injured cells. It appears that the use of low-energy devices that can be performed in a physician's office without sedation does not create the magnitude of tissue damage necessary to trigger the neovascularization process. Furthermore, it does not appear that repeat treatments, as portrayed in the Buchbinder study, compensate for this deficiency.
Unlike low-energy machines, the OssaTron® ESWT Orthotripsy must be performed in a surgery center by a trained physician and with anesthesia, whereas the low-energy machines are able to be performed in an office by a technician and require from three to five treatments, yielding the results quoted by the AMA, In the double-blind, placebo-controlled study utilizing the high-energy machine OssaTron for the indication of plantar fasciitis presents an 81% success rate at a three-month follow up visit success defined by a stringent criteria set by approved FDA protocol. The long-term, follow-up studies show that 93% of those subjects who showed success at three months maintained their success criteria at one year follow up.
The high-energy OssaTron Orthotripsy has been studied for safety and effectiveness for tennis elbow (lateral epicondylitis) as well. The results are comparable to the indicated heel spurs (plantar fasciitis). The results have been submitted to the FDA in an application for approval.
It has been well documented that high-energy extracorporeal shock wave therapy has enhanced the quality of life of patients suffering from plantar fasciitis. We merely want to clarify the differences in technology and maintain our commitment to poviding a valid, effective, non-surgical approach to numerous chronic orthopedic conditions.