Is Low-Energy ESWT Better Than High-Energy ESWT For Plantar Fasciitis?

Pages: 52 - 58
Author(s): 
Lowell Weil Jr., DPM, MBA, FACFAS and David Zuckerman, DPM

   

Yes. Lowell Weil Jr., DPM, MBA, FACFAS cites emerging research on low-energy ESWT and says it can be a cost-effective treatment for plantar fasciitis and other conditions.

   When musculoskeletal extracorporeal shockwave (ESWT) was introduced in the United States with its 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 itself at the expense of its 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 and those devices that failed to reach high energy were considered inferior.

   Interestingly, there was no standard to measure energy levels. Each technology had a different gauge of energy level so comparisons were not valid. When physicists who were experts in ESWT were questioned as to which companies had high-energy devices and which companies had low-energy devices, they 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 devices successfully differentiated themselves to the CPT coding committee. These companies received 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 U.S. 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 then more powerful shockwave companies.1

   High energy ESWT often differentiated itself by the need for anesthesia other than local (intravenous sedation, ankle block: CPT 28890). The high-energy shockwave devices do have the advantage of providing treatment through one session but are 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.

A Closer Look At The Merits Of Low-Energy ESWT

   However, during the last several years, more and more research has emerged and indicated that low-energy shockwave is as effective as high-energy ESWT 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 ESWT for the musculoskeletal system,” I decided to take another look at low-energy ESWT due to some interesting papers published by Rompe and Gerdesmeyer.3,4 Subsequently, based on my experience at international shockwave conferences and personal experience with FDA clinical trials with both high-energy and low-energy devices, I became a believer in low-energy ESWT.5

   Subsequently, a multicenter study examined the safety and efficacy of using radial extracorporeal shockwave therapy (rESWT) to treat chronic recalcitrant plantar fasciitis.3

   Not only has research shown low-energy ESWT to be effective but the utilization of biofeedback has proven to enhance the outcomes of the treatment.6,7 One would utilize biofeedback when the patient actually feels the pain of the treatment. Research has found that when the patient directs and specifically targets treatment based on the area of maximum pain, this enhances the results. In the situations when patients are receiving biofeedback, one would utilize no local or sedative anesthetic whatsoever. It is critical that the patient feels the full effects of the treatment and accurately directs that treatment.

   Typically in this treatment scenario, one would use a low intensity initially to accurately target the critical areas of treatment and to get the patient acclimated to the slight discomfort from the treatment. As the treatment proceeds, patients will find the higher energy levels (which are still low energy) increasingly more tolerable and energy levels increase throughout the procedure.

   Patients typically undergo treatments at three separate visits. These visits are separated by seven to 14 days and usually last less than 10 minutes. One would perform this procedure in an outpatient office-based setting. Patients typically feel slight immediate improvement and walk out with no assistive devices. They return to activities of daily life and work immediately after the procedure is complete.

    Technologies that employ low-energy ESWT have also become very cost effective for the medical practitioner, insurance and the self-paying patient. These devices can now be affordable for an individual practitioner or small group. There are also lease arrangements available that make the devices accessible to many more physicians and the treatment must be performed 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.

Comparing ESWT To Surgical Intervention: How The Numbers Stack Up In Terms Of Costs

   The alternative to ESWT for chronic plantar fasciitis (plantar fasciosis) or chronic Achilles tendinitis (Achilles tendinosis) is often surgical intervention.

   Open surgical intervention for these common conditions will cost approximately $4,000 to $5,000 in direct surgical costs to third party carriers. The costs break down to $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 that intervention.

   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 determine the accurate overall cost of someone being away from work as this is different from person to person based on the job. Likewise, it is more difficult to put a number on the cost of interference in activities of daily life. Without a doubt, however, there are tangible dollars and social costs that are significant with both.

   With low-energy ESWT, the typical costs range from $900 to $1,500 total for three treatments. There is no facility fee or anesthesia fee. There are no complications associated with low-energy ESWT that would create any additional expenses. There is virtually no loss of work with the exception of the time expended to have the procedure performed. Social costs are also reduced as patients can return to almost all activities of daily life without restrictions.

   Shockwave, whether one uses high-energy or low-energy ESWT, exhibits strong cost benefits in both absolute dollars and less tangible but equally important work and social costs.

Can ESWT Be Effective For Other Conditions?

   While FDA clinical trials and other high-level research studies have clearly shown the benefits of low-energy ESWT, its use has also been proven for Achilles tendon pathology. Rompe and colleagues prospectively evaluated the benefits of low-energy ESWT against standard chronic Achilles tendonitis treatments, and found statistically significant benefits with low-energy ESWT.8 Due to the tremendous disability and recovery period involved with surgical intervention of the Achilles tendinopathy, low-energy ESWT distinguishes itself in this realm.

   In addition to treating plantar fascia and Achilles tendon pathology, physicians have employed low-energy ESWT for successful treatment of other tendinopathies of the foot and ankle, sesamoidal problems and symptomatic Morton’s neuroma.

   One of the most exciting and interesting aspects of emerging concepts with low-energy ESWT has come 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 companies understand that low-energy shockwaves have tremendous healing potential that one may be able to apply to the huge world of wounds. Early animal studies have shown statistically significant rates of healing of wounds with the use of low-energy ESWT in comparison to placebo.9

   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 are intriguing for a difficult group of patients.

Final Thoughts

   Over the last 10 years, ESWT in the U.S. has had a bumpy road. Initially, industry bias confused the physicians, patients and insurance companies. Technology was expensive and many physicians were “burned” with LLC 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 emerged, ESWT and, in particular, low-energy ESWT, have become mainstays for treatments of many soft tissue podiatric and orthopedic disorders. Researchers have consistently proven that low-energy ESWT has both financial and functional advantages over high-energy ESWT and surgical procedures for the same conditions.

   Physicians should consider low-energy ESWT an appropriate and cost effective treatment alternative for a wide array of musculoskeletal problems that affect the foot and ankle.

Dr. Weil is President of the International Society of Medical Shock Wave Therapy (www.ismst.com). He is the first podiatric physician to hold this office. He is also the Fellowship Director of the Weil Foot and Ankle Institute in Des Plaines, Ill.

References

1. Ogden JA. Extracorporeal shock wave therapy for plantar fasciitis: randomised controlled multicentre trial. Br J Sports Med 2004; 38(4):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(5):348-357
3. Gerdesmeyer L, Weil L Jr, et al. Radial extracorporeal shock wave therapy is safe and effective in the treatment of chronic recalcitrant plantar fasciitis: results of a confirmatory randomized placebo-controlled multicenter study. Am J Sports Med. 2008 Nov;36(11):2100-9.
4. Rompe JD, Furia JP, Weil L Jr., Maffulli N. Shockwave therapy for chronic plantar fasciopathy. Br Med Bull 2007; 81-82:183-208.
5. Weil L Jr. Extracorporeal shock wave therapy for the treatment of chronic plantar fasciitis: indications, protocol, intermediate results, and a comparison of results to fasciotomy. JFAS 2002; 41(3):166-72
6. 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(2):240-246
7. 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(4):931-941.
8. 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(3):374-383
9. Kuo YR, Wang CT. Extracorporeal shock-wave therapy enhanced wound healing via increasing topical blood perfusion and tissue regeneration in a rat model of STZ-induced diabetes. Wound Repair Regen 2009 Jul-Aug; 17(4):522-30.
Editor’s note: The 13th Annual ISMST Congress will be held June 26-28, 2010 in Chicago. All aspects of conditions that ESWT treats will be presented at the ISMST Congress with prominent international experts participating. Visit www.shockwavetherapy.org for more details.

   

No. David Zuckerman, DPM notes that high-energy ESWT is less painful and long-term studies bear out the efficacy of the high-energy protocol.

   My interest in extracorporeal shockwave therapy (ESWT) stemmed from a desire to treat chronic plantar fasciitis without the risks and complications that are inherent to common plantar fascia releases. As a co-founder and Medical Director of Excellence Shock Wave Therapy for the past 10 years, I have personally trained a network of over 500 podiatric physicians and surgeons in high-energy ESWT.

   No precise definition of high-energy ESWT has been established. However, estimates for high-energy ESWT levels have ranged from 0.6 mJ/mm2 to higher amounts.1 The FDA protocol for the Dornier Epos Ultra is 1,300 joules per session for plantar fasciosis.2 Typically the use of a regional nerve block is required.

   The Ossatron (Sanuwave), Epos Ultra (Dornier), Orbasone (Orthometrix) and Orthospec (Medispec) are high-energy ESWT devices that are approved by the Food and Drug Administration (FDA).

   At Excellence Shockwave Therapy, we use high-energy, FDA-approved devices in a single session protocol that eliminates the need for and costs of multiple sessions. This makes the entire ESWT process more cost-effective, comfortable and convenient for the patient and the doctor.

   Typical low-energy protocols use a minimum of three repetitive sessions with additional treatment sessions needed if there is no relief.3 I have not been able to find any published literature showing more than three additional sessions with low-energy ESWT being significantly successful. If a patient is still in pain after three low-energy ESWT treatment sessions, we have found that high-energy ESWT can alleviate the patient’s pain.

   For most patients undergoing high-energy ESWT, follow-ups are not necessary. However, high-energy ESWT protocols do include a second treatment session if needed. Both the literature and years of clinical experience support the increased positive results with a second treatment.4,5

   Can one provide more than two high-energy ESWT sessions if the patient’s pain is not completely resolved? Although this scenario is rare, multiple treatments can be effective. The vast majority of patients with high-energy ESWT will only require one treatment. However, patients with stubborn cases of plantar fasciitis from both the U.S. and Europe have had pain-free results with three high-energy ESWT treatments.4 If three sessions of high-energy ESWT have not facilitated pain relief, surgery is the next step.

What Long-Term Results Reveal About The Efficacy Of ESWT

   When one looks at the long-term study results, high-energy protocols pull away from the pack. Wang notes a more than 80 percent success rate with a 10 percent recurrence rate after a seven-year follow-up on patients treated with 1,500 impulses of shockwaves at 16 kV to the affected heel in a single session.6

   The Epos Ultra FDA trial showed a Roles Maudsley success rate of 61.6 percent obtaining an excellent or good result.2 The Epos Ultra is the only device that has multiple placebo-controlled outcome studies showing excellent results.7,8 The Ossatron high-energy ESWT showed a one-year success rate of over 80 percent.9-11

   One study compared the low-energy protocol versus the high-energy protocol in the treatment of calcific tendinosis in the shoulder. The study authors determined that high-energy ESWT was more effective than low-energy ESWT as far as shoulder function, self-rated pain and smaller calcification size.7

Addressing Questions Of Pain During Treatment

   In regard to low-energy ESWT, studies have reported a certain degree of pain and discomfort. In fact, in the DolorClast FDA premarket approval study, researchers used a local anesthetic if the procedure became too painful. The study noted that 30 patients (23.26 percent) reported pain and/or discomfort. Twenty patients experienced pain during one treatment session, seven had pain during two sessions and three had pain during three sessions.12

   The Sonocur low-energy ESWT device (Siemens) is indicated for chronic tennis elbow but physicians have used it off-label for chronic plantar fasciitis. The FDA Summary of Safety and Effectiveness reported that in the company’s pilot study on patients with chronic tennis elbow, 50 percent of patients experienced pain during the procedure with 17.8 percent experiencing nausea, 8.9 percent of the patients reporting sweating and 7.1 percent reporting dizziness.13

   Although the high-energy ESWT treatment can hurt the patient, one can avoid this with the right nerve block. In my clinical experience, I have found the most effective block to be a posterior tibial nerve block, a sural nerve block and placement of a small amount of anesthesia directly into the skin where the shockwave head approaches on the medial side. This block results in a very comfortable treatment for the patient.

   Combining pain feedback with ultrasound is the most effective protocol because we all know the pain will be at or near the plantar fascia insertion. Pain feedback is helpful to determine where one should center the treatment. The use of ultrasound is beneficial when it comes to locating the specific pain site and focusing the shockwaves.

   With pain feedback alone, once the area has become numb from the low-energy shockwaves, you lose the ability to know you are in the right position. At Excellence Shock Wave Therapy, we cannot overstress the importance of ultrasound with the use of ESWT. With ultrasound, the physician will always know if the patient has moved out of the treatment area and where the shockwaves are going.

   The proper covering of the insertional area with shockwaves is part of the Dornier Epos Ultra’s treatment protocol. In my opinion, this is one of the leading factors for the 94 percent success rate after a one-year follow-up.3

   I am not aware of any low-energy ESWT devices that have undergone FDA review and/or approval for chronic plantar fasciitis. The DolorClast Radial ESWT device does have FDA approval for plantar fasciitis. This is a new device that was introduced in the U.S. without any long-term studies published in America. It technically does not generate a focused shockwave.14

In Conclusion

   High-energy ESWT has stood the test of time. It is FDA approved as a single session protocol. One-year follow-up studies show excellent outcomes. Long-term studies confirm the excellent outcomes as well as a very low recurrence of the pathology.

   The low-energy protocol can be painful. It requires multiple sessions, sometimes more than three. Long-term follow-up studies are rare for these devices and those that currently exist have shown a high recurrence rate.

Dr. Zuckerman is the Podiatric Medical Director of Excellence Shock Wave Therapy in Woodstown, N.J.

References

1. Introduction to the physics and technology of extracorporeal shockwave therapy (ESWT). Storz Medical AG, Kreuzlingen, Switzerland, Oct. 2003.
2. Food and Drug Administration. Epos Ultra. Summary of safety and effectiveness. PMA number P000048, Jan. 15, 2002.
3. Personal communications with Siemens.
4. Theodore GH, Buch M, Amendola A, Bachmann C, Fleming LL Zingas C. Extracorporeal shockwave therapy for the treatment of plantar fasciitis. Foot and Ankle Int 2004 May; 25(5): 290-7.
5. Zuckerman DH, Ashcraft D. Using the Dornier Epos Ultra High Protocol one year follow-up for two consecutive years. Presented at the International Congress of the International Society of Medical Shockwave Therapy, Juan les Pins, France, 2008.
6. Wang CJ, Wang FS, Yang KD Weng LH. Long-term results of extracorporeal shockwave treatment for plantar fasciitis. Am J Sports Med 2006 Apr; 34(4): 592-6.
7. Gerdesmeyer L, Wagenpfeil S, Haake M, Maier M, Loew M, Wortler K, et al. Extracorporeal shock wave therapy for the treatment of chronic calcifying tendonitis of the rotator cuff: a randomized controlled trial. JAMA 2003 Nov 19; 290(19):2573-80.
8. Furia JP. Extracorporeal shockwave therapy in the treatment of chronic insertional Achilles tendinopathy. Am J Sports Med 2006; 34(5):733-740.
9. Ogden JA, Cross GL, Williams SS. Bilateral chronic proximal fasciopathy: treatment with electrohydraulic orthotripsy. Foot Ankle Int 2004 May; 25(5):298-302.
10. Ogden JA, Alvarez RG, Levitt Rl Johnson JE, Marlow ME. Electrohydraulic high-energy shockwave treatment for chronic plantar fasciitis. J Bone Joint Surg Am 2004 Oct; 86-A(10):2216-28.
11. Wang CJ Chen HS, Tuang TW. Shockwave therapy for patients with plantar fasciitis: one–year follow-up study. Foot Ankle Int 2002 Mar; 23(3):204-7.
12. Food and Drug Administration. DolorClast. Summary of safety and effectiveness. PMA number P050004, May 8, 2007.
13. Food and Drug Administration. Sonocur. Summary of safety and effectiveness. PMA number P010039, July 19, 2002.
14. Cleveland RO, Chitnis PV, McClure SR. Acoustic field of a ballistic shock wave therapy device. Ultrasound Med Biol 2007; 33(8):1327-1335.

For further reading, see “What Studies Say About Shockwave Therapy” in the November 2002 issue of Podiatry Today.

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