Emerging Concepts In Shockwave Therapy

When musculoskeletal extracorporeal shockwave therapy (ESWT) was first introduced in the United States with the first FDA approval in 2000, there was a great deal of controversy and posturing among manufacturers of ESWT technologies. Each company was determined to create an exclusive market for their product at the expense of the competition. One of the most common targets for criticism was the level of energy of the technology. Based on industry biases, high-energy ESWT was considered the most effective for the musculoskeletal system. Those devices that failed to reach high energy were considered inferior.
Interestingly, there was no standard to measure energy levels and each technology measured its energy level differently. Accordingly, comparisons were not valid. When questioned as to which companies used high energy and which companies used low energy, physicists who were experts in ESWT usually were unable to answer the question because of the lack of standardization.
As the battle for differentiation continued, some of the companies claiming to have high-energy ESWT devices successfully differentiated themselves to the CPT coding committee and were able to receive a standard CPT code (28890) that required “high energy, performed under anesthesia other than local and using an ultrasonic targeting device for the treatment of plantar fasciitis.” At that time, research from outside of the United States tended to favor high-energy ESWT. While some insurance companies would not cover any ESWT, others would only cover “high-energy” ESWT based on the “flawed” research and an effective lobby by the more powerful ESWT companies.1
High-energy ESWT was often differentiated by the need for anesthesia other than local (intravenous sedation, ankle block -CPT 28890). The high-energy shockwave devices did have the advantage of providing treatment in one session but were also extraordinarily expensive to the patient with the combination of technology expense, procedural expense and anesthesia expense. Few private practitioners could afford the investment of a high-energy device and private partnerships emerged to make devices available on a rental basis. Unfortunately, the cost of high-energy ESWT became prohibitive to the insurance companies as well as to many patients.

What The Research Says About Radial Shockwave
However, during the last several years, more and more research indicates that low-energy, radial shockwave (rESWT) is as effective as high-energy ESWT and at a better value to the podiatric physician, insurance company and, most importantly, to the patient.2
After previously being a staunch believer in high-energy ESWT as being the only effective shockwave technology for the musculoskeletal system, I decided to take another look at rESWT due to some interesting papers published by Rompe and Gerdesmeyer.3 Based on my experience at international shockwave conferences and personal experience with our own FDA clinical trials with both high-energy and low-energy devices, I converted to being a believer in low-energy shockwave.
The Weil Foot and Ankle Institute was one of multiple sites in the United States and Europe that participated in a FDA Clinical Trial on the EMS Swiss DolorClast between 2002 and 2005. In addition to the physicians at our site, Barry Scurran, DPM, John Stienstra, DPM, and foot and ankle orthopedist, Carol Frey, MD, were U.S. investigators along with physicians at five European sites. Ludger Gerdesmeyer, MD, PhD, of Munich, Germany, served as the principal investigator for the DolorClast FDA study. This prospective, randomized, placebo-controlled, double-blind study effectively proved the safety and efficacy of the low-energy EMS DolorClast for the treatment of chronic, proximal plantar fasciitis.
Gerdesmeyer recently presented this research at the Annual Scientific Conference of the American Academy of Orthopedic Surgeons in San Francisco in March 2008. Gerdesmeyer showed an 85 percent improvement in the treated group versus a 43 percent improvement in the placebo group at one year following the treatment. When looking only at pain on first steps out of bed in the morning, the treated group had 88 percent success at a year versus 50 percent for the placebo group. The results of daily activities showed the treated group was much more successful (86 percent) than the placebo group (35 percent) at one year. Additionally, the research paper has been submitted to the American Journal of Sports Medicine for publication. If the study is accepted, it will be published later this year.
Not only have researchers shown rESWT to be effective but the utilization of biofeedback has proven to enhance the outcomes of the treatment.3,4 The treatment uses biofeedback when the patient actually feels the pain of the treatment. Research has revealed that when the physician directs and specifically targets treatment based on the area of maximum pain, this enhances the results. In situations when the treatment includes biofeedback, no local or sedative anesthetic whatsoever is required.
It is critical that the patient feels the full effects of the treatment and that the physician accurately directs that treatment. The treatment typically includes a low intensity initially to target the critical areas of treatment accurately and to get the patient acclimated to the slight discomfort. As the treatment proceeds, patients will find the higher energy levels increasingly more tolerable and energy levels increase throughout the procedure.

What Are The Advantages Of rESWT?
Patients undergo treatment at three separate visits, which are separated by seven to 14 days and usually last less than 10 minutes. This procedure occurs in an office-based setting. Patients typically feel slight immediate improvement, walk out with no assistive devices and return to activities of daily life and work immediately after the procedure is complete. There have been no adverse events and no patient has required the use of a local anesthetic.
The newer technologies that employ low-energy ESWT have also become very cost-effective for the medical practitioner, insurance and the self-paying patient. These new devices are now affordable for an individual practitioner or small group. There are also lease arrangements available, making the devices accessible to many more physicians. Patients must undergo treatment by or under the direct supervision of a licensed medical practitioner.
While most insurance companies do not currently cover ESWT of any variety, these less expensive devices can allow practitioners to offer their patients an effective, safe and reliable ESWT treatment at a self-pay cost that is no longer prohibitive. I believe this technology should be considered the same as LASIK is considered for the ophthalmology world. LASIK is a proven technology that is also performed as a self-pay procedure.
Furthermore, rESWT technology is also easily accessible, does not require anesthesia and patients can have treatments and return to life and work immediately that day without the need for a recovery period. The alternative to ESWT for chronic plantar fasciitis (plantar fasciosis) or chronic Achilles tendinitis (Achilles tendinosis) is often surgical intervention.

Weighing Shockwave Costs With Treatment Benefits

As responsible medical practitioners, we must continue to provide the best care in a cost effective manner. When one compares open tendon fascia surgery and rESWT, there is a striking difference. Open surgical intervention for the aforementioned common conditions will cost approximately $4,000 to $5,000 in direct surgical costs to third-party carriers. Costs include $700 to $1,500 for the professional fee, $1,500 to $3,000 for the technical component (hospital or surgery center), and $500 to $1,000 for anesthesia fees. The indirect costs associated with surgical intervention are the chance of significant complications requiring some intervention (2 to 5 percent) and the resultant expense of care needed for complications.
Other indirect costs associated with open surgery are lost time from work and changes in activities of daily living. It is not uncommon for postoperative plantar fasciitis patients to miss work for two to six weeks while Achilles tendon surgery carries a similar timeframe for immobilization and partial weightbearing. It is difficult to get an accurate determination of the overall cost of someone being away from work as this varies based on the individual’s job and the more difficult to put a number on cost of interference in activities of daily life. However, there is no doubt that there are tangible dollars and social costs that are significant with both.
With rESWT, the typical costs range from $900 to $1,500 for three treatments. There is no facility fee or anesthesia fee. There are no complications associated with rESWT that would create any additional expenses. There is virtually no loss of work with the exception of the time one expends to undergo the procedure. Social costs are also reduced as patients can return to almost all activities of daily life without restrictions. Radial ESWT exhibits strong cost benefits in both absolute dollars and less tangible but equally important work and social costs.

Where Will The Future Of Shockwave Therapy Lead?
Recently, EMS has submitted a request to the American Medical Association (AMA) for a CPT code for low-energy rESWT. The AMA has acknowledged receipt of the request and plans to investigate its appropriateness thoroughly.
While nothing is imminent, there is a strong belief that the AMA will move forward and create a CPT code for low-energy rESWT and that would be a strong precursor toward getting insurance coverage for the procedure.
While researchers have clearly shown the benefits of low-energy rESWT in FDA clinical trials and other high-level research studies, studies have also assessed the use of the technology for Achilles tendon pathology. Rompe, Furia and Maffulli prospectively evaluated the benefits of low-energy rESWT against standard chronic Achilles tendonitis treatments and found statistically significant benefits with low-energy ESWT.5 Due to the tremendous disability and recovery involved with surgical intervention of the Achilles tendinosis, low-energy rESWT is a viable alternative in this realm.
In addition to plantar fascia and Achilles tendon pathology, physicians have successfully utilized low-energy rESWT to treat other tendinopathies of the foot and ankle, sesamoidal problems and symptomatic Morton’s neuroma. Physicians also commonly utilize low-energy rESWT to treat other soft tissue orthopedic disorders throughout the body.
One of the most exciting and interesting aspects of emerging concepts with low-energy rESWT have developed in the wound care realm. Companies that were once exclusive providers of high-energy ESWT have begun developing and testing technology to treat both acute and chronic wounds. The ideology of the technology companies has shifted whereby they understand that low-energy shockwaves have tremendous healing potential that physicians may be able to apply to wounds.
Early animal studies, which were reported at the Annual Scientific Conference of the International Society for Medical Shockwave Treatment (ISMST), have shown statistically significant rates of wound healing with the use of low-energy rESWT in comparison to placebo.
There are also reports of early human studies being performed in the U.S. and abroad to show the efficacy of low-energy rESWT in the treatment of both acute (military) wounds and chronic, non-healing diabetic wounds. While this is in the early stages of research, the possibilities of this treatment modality for a difficult group of patients are intriguing.

Final Thoughts
Over the last eight years, ESWT has had a bumpy road in the U.S. Initially, industry bias confused the physicians, patients and insurance companies. Technology was expensive and many physicians were “burned” with leasing relationships. Then questionable inclusion criteria in Australian research created a negative perception on the efficacy of the technology.
However, as the technology has evolved and credible research has surfaced, ESWT and, in particular, low-energy rESWT have emerged and become mainstays for the treatment of many soft tissue podiatric and orthopedic disorders. It has been proven consistently that low-energy rESWT has both financial and functional advantages over high-energy ESWT and surgical procedures for the same conditions.
One should consider low-energy rESWT as an appropriate and cost-effective treatment alternative for a wide array of musculoskeletal problems that affect the foot and ankle.

Dr. Weil is the Fellowship Director of the Weil Foot and Ankle Institute in Des Plaines, Ill. He is a Fellow of the American College of Foot and Ankle Surgeons.
Dr. Weil is a consultant for Orthometrix (high-energy ESWT) and EMS Dolorclast (low-energy rESWT). He has received research grants from both companies to study the benefits of ESWT in common conditions of the foot and ankle.

References:

1. Ogden JA. Extracorporeal shock wave therapy for plantar fasciitis: randomised controlled multicentre trial. Br J Sports Med 2004; 38:382.
2. Gollwitzer H, Diehl P, von Korff A, Rahlfs VW, Gerdesmeyer L. Extracorporeal Shock Wave Therapy for Chronic Painful Heel Syndrome: A Prospective, Double Blind, Randomized Trial Assessing the Efficacy of a New Electromagnetic Shock Wave Device. J Foot Ankle Surg 2007; 46:348-357
3. Rompe JD, Meurer A, Nafe B, Hofmann A, Gerdesmeyer L. Repetitive low-energy shock wave application without local anesthesia is more efficient than repetitive low-energy shock wave application with local anesthesia in the treatment of chronic plantar fasciitis. J Orthop Res 2005; 23:931-941.
4. Labek G, Auersperg V, Ziernhold M, Poulios N, Bohler N. Influence of local anesthesia and energy level on the clinical outcome of extracorporeal shock wave-treatment of chronic plantar fasciitis. Z Orthop Ihre Grenzgeb 2005; 143:240-246
5. Rompe JD, Nafe B, Furia JP, Mafulli N. Eccentric Loading, Shock-Wave Treatment, or a Wait-and-See Policy for Tendinopathy of the Main Body of Tendo Achilles: A Randomized Controlled Trial. Am J Sports Med 2007; 35:374-383 Additional References
6. Weil LS Jr. Extracorporeal shock wave therapy for the treatment of chronic plantar fasciitis: indications, protocol, intermediate results, and a comparison of results to fasciotomy, JFAS, 41(3), 166-72, 2002.
7. Rompe JD, Furia JP, Weil LS Jr, Maffulli N. Shockwave therapy for chronic plantar fasciopathy, British Medical Bulletin, April, 2007; 1–26.