Application of High Energy Extracorporeal Shockwave Therapy on Musculoskeletal Conditions in US Military Medical Facilities.
MATERIALS AND METHODS
Approval was obtained from the Eisenhower Amy Medical Center institutional review board prior to the performance of this study. All data was de-identified of patient identifiable information by an outside source prior to analysis. From November 2008 to March 2015, all applications of high energy extracorporeal shock wave therapy (ESWT) produced by an electrohydraulic device, OssaTron (High Medical Technology, Alpharetta, GA), were recorded. Data was collected from 22 different medical treatment facilities within the US military including Army, Air Force, and Navy bases. Although a specific treatment method was not described by each facility included in this study, the method used by the authors of this article is illustrated in Figure 1. The treatment area of maximal tenderness on each patient was marked in the preoperative holding area. The patient underwent conscious sedation performed by the anesthesia staff. Hearing protection was placed on the patient as well as all others in the operating room. Ultrasound gel was applied to the patients marked extremity. The area was held under the OssaTron applicator and rotated slightly to apply even treatment to the entire area. The patient was awakened from anesthesia and discharged with instructions to abstain from strenuous activities of the treated extremity and to avoid ice and anti-inflammatory medications for 4 to 6 weeks.
Data was collected including the indication for ESWT treatment, laterality, patient demographics (age and gender), and the protocol used. The data was analyzed for the most common indications treated, typical protocol used for each indication described by kilovolts (kV) and number of shocks, and patient demographics associated with each indication. Descriptive statistics were performed using Microsoft Excel, 2013. A literature review was conducted using PubMed by searching for "extracorporeal shockwave therapy" and musculoskeletal conditions, such as "lateral epicondylitis," "plantar fasciitis," etc. Results were compared to data collected in US military medical facilities.
United States military medical facilities performed 4,766 applications of high energy during the period studied. The facility where this research was synthesized performed 806 applications of ESWT by 4 different orthopedic providers and 2 different podiatric providers, who performed the majority of the procedures. The majority of patients treated at US military medical facilities were male (64%) with an average age of 40.5 years (range 15 to 87, median=40.1). Fifty-four different indications were described by the treating providers; however, not all indications are defined by ICD-9 or ICD-10 codes. Some indications were grouped together for ease of trending data (eg, "plantar fasciitis" and "arch tendonitis" were categorized as "plantar fasciitis"). The trend of applications is increasing as illustrated in Figure 2. Most patients were treated with 1,500 shocks at 18 kV.
The most common indication for high energy ESWT was plantar fasciitis (78% of all applications). Although almost 70% of patients were treated with 1,500 shocks at 18 kV, many other protocols were implemented in the treatment of plantar fasciitis. The average age of patients treated for plantar fasciitis was 40.4 years.
The next most common condition treated was achilles tendonitis, which included 13% of applications. The most common protocol performed was 1,500 shocks at 18 kV (420 of 605 applications); however, 88 patients were treated with 2,000 shocks at 24 kV. Ninety-two percent of the patients were aged 20 to 60 years, with an average age of 42.1.
Lateral epicondylitis was the third most common indication for high energy ESWT, involving 3% of the patients included in this study. The average age of the patients was 45.6 years. Patellar tendonitis represented 2% of patients treated in US military medical facilities. Most of those patients (92%) were aged between 20 to 50 years, with an average age of 32.3.
Additional indications treated were grouped as ankle tendonitis, sesamoiditis, metatarsalgia, delayed union/ non-unions, neuromas, and other. The widest variety of protocols utilized was described in the treatment of fracture non-unions and included 1,000 to 8,000 shocks at 15 kV to 28 kV. Most ankle tendonitis was treated with 2,000 shocks at 24 kV. Seven out of the 12 patients with neuromas were treated with 2,000 shocks at 24 kV. Although the most common protocol utilized for the other indications treated was 1,500 shocks at 18 kV, the less commonly treated indications had a wider variety in treatment protocols.
The effects of ultrasonic shockwaves on the human body were originally discovered during submarine warfare in World War II. Its use in medicine began in 1971 to disintegrate kidney stones, known as lithotripsy. Research on orthopedic applications began in 1985 and in 1988 shock wave treatment was first applied for non-unions and delayed unions. The OssaTron was developed in 1993 to expand the indications of extracorporeal shockwave use to other musculoskeletal conditions. (2)
Shockwaves are generated 3 ways: electrohydraulic, electromagnetic, and piezoelectric. All 3 methods of creating shockwaves have the same general principals. Acoustic waves are generated, propagated through water, and transferred to the human body through a contact medium. (3) The exact effect on tissues of the human body is still unknown. Theories propose that ESWT induces the release of growth factors to promote angiogenesis and differentiation of mesenchymal stem cells, and provides hyper-stimulation analgesia. (4)
A literature review yields plantar fasciitis as the most reviewed indication for ESWT application. Most studies indicate that shockwave therapy improves symptoms of plantar fasciitis in comparison to placebo. (5-17) Despite many reports on the benefits of ESWT, adverse effects also occur. Haake et al found no significant improvement in symptoms between patients treated with ESWT and a control group. In addition, the treatment group had more side effects including skin reddening, pain, hematoma, local swelling, hair loss, nausea, dizziness, and sleep loss. (18) A systematic review by Thomson et al had similar conclusions. (19)
Previously reported results may not be applicable to patients treated in US military medical facilities due to various protocols and techniques used for application. The most relevant literature pertaining to the population in this study includes research performed by Ogden et al, (5, 13) Wang et al, (16) Alvarez, (17) and Weil et al, (20) as they also used the OssaTron to deliver ESWT. In 2001, Ogden reported 56% improved symptoms in comparison to placebo, which led to FDA approval of ESWT application to chronic plantar fasciitis. (5) Wang found that the benefits of ESWT can last as long as 60 to 72 months. (16)
All of the studies cited above involved use of a local anesthetic in addition to or instead of general anesthesia. However, not all US military medical facilities use local anesthesia as allowed under current protocol. Since plantar fasciitis is the most commonly treated condition in US military medical facilities, future studies on outcomes could indicate if patients have improved immediate outcomes with local anesthetic compared to general anesthesia. Results of such study could greatly decrease the cost of using ESWT.
The next most prevalent indication for ESWT application in our study was achilles tendonitis. Most studies on the application of low-energy ESWT for achilles tendonitis support its use. (21-24) Chen et al found that low-energy ESWT promotes TGF-[beta]1, and IGF-1 to improve healing of the achilles tendon. (25) A literature review found no previous studies on the use of the OssaTron for achilles tendonitis, however some research exists on the use of other high energy ESWT devices. In 1998, a study by Rompe et al found that high energy therapy greater than 0.28mJ/[mm.sup.2] may actually cause damage to tendons; however, that study was performed on rabbits and may not be applicable to humans. (26) Studies by Furia (27, 28) on the use of high-energy ESWT in treating insertional and non-insertional achilles tendinopathy found improvement in outcomes after one year. These studies used electromagnetic generation of shock waves. (27, 28) Costa et al (29) also used electromagnetic shock waves and found contradicting data in their randomized control trial with no improvement in pain and 2 cases of tendon ruptures. (29) Overall, data on ESWT for Achilles tendonitis remains inconclusive, and no studies have been performed using the same technique as used in US military medical facilities.
The second largest amount of research on the effects of ESWT was focused on lateral epicondylitis. In 2009, Buchbinder et al, conducted a systematic review analyzing 9 different randomized controlled trials on the use of ESWT for lateral epicondylitis and found no significant difference between symptoms after ESWT and placebo, and increased adverse effects with the use of ESWT. All studies included in their paper had various protocols, devices, and follow-up. (30) Results of other studies have been inconclusive or shown to have no effect. (31-36) Most of those studies used low-energy ESWT.
Studies using electrohydraulic high-energy shockwave have shown more positive results. Collins, Hildreth, and Jafarnia (37) performed a randomized controlled trial investigating the results of the OssaTron on lateral epicondylitis. The treatment group received a Bier block followed by ESWT with 1,500 shocks at 18 kV. After 8 weeks, 40% of patients in the treatment group met criteria of "success" compared to 21% in the placebo group. (37) Studies performed using the OssaTron for lateral epicondylitis were also performed by Wang and Chen (38) and Ko and Chen, (39) with improvement of symptoms with no long-term complications. A systematic review performed by Stasinopoulos and Johnson (40) concluded that the treatment of lateral epicondylitis with ESWT may be dose dependent and the optimal treatment protocol has not yet been determined.
Another common indication for ESWT in US military medical facilities is patellar tendonitis. Wang et al (41) provide the only literature on high energy electrohydraulic ESWT and found excellent results in 43% of patients 2 to 3 years after treatment in the ESWT group, whereas no excellent results were found in the control group. Zwerver et al (42) performed an interesting study looking specifically at the results of high energy ESWT in athletes during the competitive season. They found no long-term benefits to ESWT; however, there was a significant difference favoring the treatment group at one-week follow-up. Most other studies describe improvement in symptoms after treatment with ESWT. (43-45) A systematic review performed by van Leeuwen et al (46) concluded that although ESWT is effective in treating patellar tendonitis, the most effective protocol has not been determined. (46)
In our review, treatment of non-unions showed the most variation in ESWT protocols. Several studies have looked at the effects of various ESWT dosages and timing of treatment in the management of non-unions with satisfactory results. (47-50) A study by Alkhawashki (51) described the use of the OssaTron in the treatment of nonunions. By performing 3000-4000 shocks at 26 kV for large bones and 2000-3000 shocks at 26 kV for small bones, healing occurred in 37 of 49 patients at 10.2 months follow-up. (51) ESWT has been shown to have better results on hypertrophic non-union with a 76% union rate compared to a 29% union rate in atrophic nonunions. (52) Despite these findings, Kuo et al (53) performed a retrospective review on 22 patients with atrophic nonunion of femoral shaft fractures after intramedullary fixation was performed and found a 100% union rate at 12 months after ESWT if ESWT was performed within 12 months after the initial surgery compared to 43% union rate when ESWT was performed greater than 12 months after the initial surgery. They concluded that the timing of ESWT application may matter. (53)
ESWT is most commonly used to treat conditions of tendons and bone; however, it has also been described to treat neuromas. Fridman et al54 describe using the OssaTron to treat Morton's neuromas with 2,000 shocks at 21 kV. Patients treated with ESWT had a 92% improvement in pain 12 weeks after treatment in comparison to 76% in the control group. (54) United States military facilities also applied ESWT on neuromas; however, they used 2,000 shocks at 24 kV. Outcome measures could further describe the optimal intensity of treatment.
Other conditions treated with ESWT by US military medical facilities include several types of tendinopathy in the ankle, metatarsalgia, and sesamoiditis. To our knowledge, there is no literature available describing treatment of these areas.
Evidence exists describing the use of ESWT on multiple other musculoskeletal conditions, such as avascular necrosis of the femoral head, (55, 56) anterior cruciate ligament reconstruction, (57) chronic foot ulcers, (58) knee osteoarthritis, (59) and complex regional pain syndrome. (60) Some, though not all, of these conditions have been treated with ESWT in US military medical facilities. Most outcomes in the literature on these indications illustrate that this treatment modality may be beneficial to expedite healing and prolong or even decrease the need for surgery in these conditions.
Several studies describe the use of ESWT on the shoulder including calcific tendonitis and rotator cuff arthropathies with good results. (61-71) Only 3 applications of ESWT to the shoulder were recorded in US military medical facilities.
Reports on treatment outcomes vary regarding the effectiveness of ESWT. Although electromagnetic, piezoelectric, and electrohydraulic ESWT have the same general principles, differences exist in the amount and way of energy creation and transmission to the body. (1, 72, 73) Research on ESWT differentiates between focused and unfocused and between high, medium, and low energy shockwaves. These differences may help explain the variability in outcomes observed through the literature.
US military medical facilities offer a solution to the inconsistency of treatment protocols. In 2008, the OssaTron became the sole device to provide high energy ESWT on musculoskeletal conditions in US military medical facilities, which improves the uniformity of treatment protocols.
United States military medical facilities service a large population of generally athletic individuals who frequently encounter overuse injuries and would benefit from an expedited return to duty. Future studies are needed to assess the most efficacious protocol and validate results previously described.
Several limitations exist to this study. First, not all indications as described by providers were represented as an ICD-9 or 10 diagnosis code. Although the technique of application of ESWT is assumed to be consistent among providers, variations certainly exist. Providers performing ESWT in this study included orthopedic surgeons and podiatrists, which may overestimate use on foot and ankle conditions. The final limitation of this study is that it does not include outcomes, but suggests areas in which future research on the outcomes of ESWT can be performed in US military medical facilities.
US military medical facilities perform ESWT on indications not previously described in the literature. Due to the large use of ESWT and homogeneity of patient populations and protocols within the US military facilities, there exists great potential for future prospective studies on the outcomes of ESWT application on musculoskeletal conditions to determine effective protocols for active individuals and to expand the indications for ESWT application in the literature. Encouraging the application of ESWT in US military medical facilities on indications supported by literature may improve healing and decrease the need for surgery in certain conditions.
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CPT Corey, LTC Mueller, and Dr Cameron are with the Department of Orthopaedic Surgery, Dwight D. Eisenhower Army Medical Center, Fort Gordon, Georgia.
COL (Ret) Bojescul is with Augusta Orthopedic and Sports Medicine Specialists, Augusta, Georgia.
CPT Sally Corey, MC, USA
LTC Terry Mueller, MC, USA
COL (Ret) John Bojescul, MC, USA
Craig Cameron, DO
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|Author:||Corey, Sally; Mueller, Terry; Bojescul, John; Cameron, Craig|
|Publication:||U.S. Army Medical Department Journal|
|Date:||Jul 1, 2018|
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