Temporal and spectral characteristics of the impulsive waves produced by a clinical ballistic shock wave therapy device.

This study characterizes the temporal and spectral property of the mechanical impulsive waves produced by a clinical ballistic shock wave therapy device. The impulsive waves were generated by a projectile impacting a metallic shock wave transmitter, and were measured using a laser vibrometer that detects vibrations on the front surface of the shock wave transmitter. The shock wave transmitter considered in the measurement has a circular flat surface tip with a diameter of 15 mm. The results showed that the measured impulsive wave was resonated at 93.4 kHz and modulated with a relatively low frequency of 3.7 kHz to form a heavily damped pulse wave lasting for longer than 2 ms. Multiple impulsive waves produced at high output settings, were observed for the first time, and their clinical implication needs to be elucidated in the future study. Despite measurements made on the cavitation free air born impulsive waves, the study was justified by the experimental clarification that their temporal and spectral properties were characteristically similar to those of the impulsive waves produced in water, more representative to clinical conditions. The present results are expected to deliver critical information for assessing the shock wave dose delivered from a clinical radial extracorporeal shock wave device to patients.

Efficacy of extracorporeal shockwave therapy in the treatment of postherpetic neuralgia: A pilot study.

Established conventional treatments for postherpetic neuralgia (PHN) and postherpetic itch (PHI) are difficult and often disappointing. In this study, the authors investigated the effect and mechanisms of extracorporeal shockwave therapy (ESWT) on pain and itch associated with PHN and PHI.Thirteen patients, 50 to 80 years of age, with symptoms associated with PHN or PHI (duration of persistent pain >3 months) and complaints of pain or itch rated >4 on a numerical rating scale (NRS), were included. ESWT was administered using a shockwave device (Piezo Shockwave, Richard Wolf GmbH, Knittlingen, Germany) to skin areas affected by pain or itch. An energy flux density of 0.09 to 0.16 mJ/mm at a frequency of 5 Hz and 2000 impulses was administered at 3-day intervals for 6 sessions. The NRS, 5D-Itch Scale, and Patients Global Impression of Change (PGIC) scale were used to evaluate the efficacy of ESWT.NRS scores of pain and itch and 5D-Itch Scale scores decreased significantly compared with before treatment and at the end of the treatment sessions (P < .0001, P = .001, P = .0002, respectively). There was a statistically significant difference between PGIC scores, which were checked every 2 sessions (P < .0001).ESWT is a noninvasive modality that significantly reduced PHN-associated pain and itch.

The Basic Physics of Waves, Soundwaves, and Shockwaves for Erectile Dysfunction.

INTRODUCTION: Over the past decade, low-intensity extracorporeal shockwave therapy (Li-ESWT) has emerged as a treatment modality for erectile dysfunction (ED). To better appreciate the differences between the various devices for the treatment of ED, it is imperative for physicians to understand the underlying physics of the different shockwave generators. AIM: In this article, we explain the physics of shockwaves by establishing a foundation regarding the basics of waves, specifically soundwaves. We also describe the different shockwave generators available and assess their potential clinical utility. METHODS: We reviewed basic principles of wave propagation, randomized controlled trials investigating Li-ESWT for ED and other medical diseases, and individual industry shockwave generator websites, in order to describe the basic physics underlying Li-ESWT. MAIN OUTCOME MEASURE: We primarily aimed to describe the physics underlying shockwave generators and to provide a framework for understanding the relevant subtypes and adjustable parameters. RESULTS: A wave is a disturbance in a medium that transports energy without permanently transporting matter. In shockwaves, a soundwave is generated with a speed faster than the local speed of sound. Shockwaves are classically generated by three different types of energy sources: electrohydraulic, electromagnetic, or piezoelectric, which all create a shockwave through the conversion of electric potential energy to mechanical energy. Importantly, radial pressure waves do not behave the same as conventional shockwaves and are more like "ordinary" sound waves in that they achieve a significantly lower peak pressure, a slower rise time, and propagate outwards without a focal point. CLINICAL IMPLICATIONS: Li-ESWT is not currently approved by the U.S. Food and Drug Administration and is considered investigational in the United States. However, it is currently available to patients under clinical trial protocols and it is important to understand the basic physics of shockwaves to understand the differences between the different shockwave devices. STRENGTH & LIMITATIONS: This is a comprehensive review of the physics underlying Li-ESWT but only tangentially explores the biological impact of shockwaves. CONCLUSION: Physicians currently using or those contemplating purchasing a Li-ESWT device should understand the basic physics underlying the device, as well as which treatment protocols were used to demonstrate clinical efficacy in treating ED. Katz JE, Clavijo RI, Rizk P, et al. The Basic Physics of Waves, Soundwaves, and Shockwaves for Erectile Dysfunction. Sex Med Rev 2020;8:100-105.

Cavitation-induced traumatic cerebral contusion and intracerebral hemorrhage in the rat brain by using an off-the-shelf clinical shockwave device.

Traumatic cerebral contusion and intracerebral hemorrhages (ICH) commonly result from traumatic brain injury and are associated with high morbidity and mortality rates. Current animal models require craniotomy and provide less control over injury severity. This study proposes a highly reproducible and controllable traumatic contusion and ICH model using non-invasive extracorporeal shockwaves (ESWs). Rat heads were exposed to ESWs generated by an off-the-shelf clinical device plus intravenous injection of microbubbles to enhance the cavitation effect for non-invasive induction of injury. Results indicate that injury severity can be effectively adjusted by using different ESW parameters. Moreover, the location or depth of injury can be purposefully determined by changing the focus of the concave ESW probe. Traumatic contusion and ICH were confirmed by H&E staining. Interestingly, the numbers of TUNEL-positive cells (apoptotic cell death) peaked one day after ESW exposure, while Iba1-positive cells (reactive microglia) and GFAP-positive cells (astrogliosis) respectively peaked seven and fourteen days after exposure. Cytokine assay showed significantly increased expressions of IL-1ß, IL-6, and TNF-α. The extent of brain edema was characterized with magnetic resonance imaging. Conclusively, the proposed non-invasive and highly reproducible preclinical model effectively simulates the mechanism of closed head injury and provides focused traumatic contusion and ICH.

Radial shockwave therapy for male erectile rejuvenation in a dermatology and/or medical aesthetic practice.

INTRODUCTION: Erectile dysfunction is defined as the inability to achieve and maintain an erection to satisfactorily complete intercourse. Treatment depends on the cause and includes phosphodiesterase 5 inhibitor medications, penile pumps, implants, and surgery. Low-intensity shockwave therapy has been shown to be effective and safe for the treatment of erectile dysfunction. OBJECTIVE: We explored the role of low-intensity radial shockwave therapy for erectile dysfunction treatment in a dermatology and/or medical aesthetic practice setting. MATERIALS AND METHODS: A literature review was conducted on radial low-intensity shockwave technology in use for erectile rejuvenation to explore its positioning, safety, efficacy, tolerability, subject satisfaction, and usability in a dermatology and/or medical aesthetic setting. RESULTS: Low-intensity shockwave therapy was shown to be effective in subjects with organic erectile dysfunction, and the treatment effect was maintained for up to 2 years post-treatment. The treatment is reported to be safe and well-tolerated and have little downtime. Many dermatologists use low-intensity shockwave therapy for the treatment of cellulite and other conditions. This type of treatment is now available for erectile dysfunction and seems an attractive and safe option for subjects with organic vascular erectile dysfunction. CONCLUSIONS: Studies and clinical experience suggest that male erectile rejuvenation using low-intensity radial shockwave therapy seems an attractive option. The treatment can be safely, and effectively, delivered by trained staff as part of the total package that is available to men in a dermatology and/or medical aesthetic practice.

Development of a Shock-Wave Catheter Ablation System for Ventricular Tachyarrhythmias: Validation Study in Pigs In Vivo.

Background Although radiofrequency catheter ablation is the current state-of-the-art treatment for ventricular tachyarrhythmias, it has limited success for several reasons, including insufficient lesion depth, prolonged inflammation with subsequent recurrence, and thromboembolisms due to myoendocardial thermal injury. Because shock waves can be applied to deep lesions without heat, we have been developing a shock-wave catheter ablation ( SWCA ) system to overcome these fundamental limitations of radiofrequency catheter ablation. In this study, we evaluated the efficacy and safety of our SWCA system for clinical application to treat ventricular tachyarrhythmia. Methods and Results In 33 pigs, we examined SWCA in vivo for the following 4 protocols. First, in an epicardial substrate model (n=8), endocardial SWCA significantly decreased the sensing threshold (pre- versus postablation: 11.4±3.8 versus 6.8±3.6 mV ; P<0.05) and increased the pacing threshold (pre- versus postablation: 1.6±0.8 versus 2.0±1.1 V; P<0.05), whereas endocardial radiofrequency catheter ablation failed to do so. Second, in a myocardial infarction model (n=3), epicardial SWCA of the border zone of the infarcted lesion was as effective as ablation of the normal myocardium. Third, in a coronary artery application model (n=10), direct application of shock waves to the epicardial coronary arteries caused no adverse effects in either the acute or chronic phase. Fourth, with an epicardial approach (n=8), we found that 90 shots per site provided an ideal therapeutic condition to create deep lesions with less superficial damage. Conclusions These results indicate that our new SWCA system is effective and safe for treatment of ventricular tachyarrhythmias with deep arrhythmogenic substrates.

Uso da terapia por ondas de choque para o tratamento do linfedema associado ao câncer de mama: uma revisão sistemática / Use of shockwave therapy for the treatment of lymphedema associated to breast cancer: a systematic review

O linfedema associado ao câncer de mama é causa de prejuízo significativo da qualidade de vida deste grupo de pacientes e constitui complicação frequente das intervenções necessárias nesse tipo de câncer. Sabe-se que o tratamento utilizado no linfedema associado ao câncer de mama envolve a Terapia Física Complexa (TFC), cuja eficácia é limitada e não atua diretamente na patogênese dessa comorbidade. Conforme já demonstrado em alguns estudos, o uso da Terapia por Ondas de Choque (TOC) demonstra-se potencialmente benéfico para reduzir o linfedema pela indução de neoangiogênese e linfangiogênese. Objetivo: Avaliar o impacto da TOC no tratamento do linfedema associado ao câncer de mama comparado ao uso da TFC. Métodos: Foram utilizadas as seguintes bases de dados: PubMed/MedLine; BIREME; LILACS; The Cochrane Library e EMBASE, e através de busca manual de artigos. Adotou-se o método de pesquisa PICO e os descritores MeSH ajustados conforme a respectiva base de dados. Resultados: Foram encontrados um total de 262 artigos e selecionados por leitura do título ou resumo um total de 17 estudos. Seis foram excluídos por serem duplicatas, totalizando 11 artigos eleitos para verificação dos critérios de inclusão. Destes, nenhum artigo atendeu ao delineamento da metodologia proposta para esta revisão. Três deles se destacaram por se aproximarem mais da temática proposta e foram discutidos. Conclusão: É necessária a realização de estudos com qualidade metodológica adequada para avaliar o potencial benefício do uso da TOC, visando contribuir para a composição de um tratamento mais eficaz, seguro e que atue na patogênese da doença.

Lymphedema associated with breast cancer is a cause of significant impairment of the quality of life and is a frequent complication of the necessary interventions in this type of cancer. It is known that the treatment used in lymphedema associated with breast cancer involves Complex Physical Therapy (CPT), whose efficacy is limited and does not act directly in the pathogenesis of this comorbidity. As demonstrated in some studies, the use of Shock Wave Therapy (TSWT) is potentially beneficial in reducing lymphedema by inducing neoangiogenesis and lymphangiogenesis. Objective: To evaluate the impact of TSWT on the treatment of lymphedema associated with breast cancer compared to the use of CPT. Methods: The following databases were used: PubMed / MedLine; BIREME; LILACS; The Cochrane Library and EMBASE, and through manual article search. We adopted the PICO search method and the Mesh descriptors were adjusted according to the respective database. Results: A total of 262 articles were found and selected by reading the title or abstract a total of 17 studies. Six were excluded because they were duplicates, totaling 11 articles elected to verify the inclusion criteria. Of these, no article met the outline of the methodology proposed. Three of them were closer to the proposed theme and were discussed. Conclusion: It is necessary to carry out studies with adequate methodological quality to evaluate the potential benefit of the use of TSWT, in order to contribute to the composition of a more effective and safe treatment, that acts in the pathogenesis of the disease.

Medical Devices; General and Plastic Surgery Devices; Classification of the Extracorporeal Shock Wave Device for Treatment of Chronic Wounds. Final order.

The Food and Drug Administration (FDA or we) is classifying the extracorporeal shock wave device for treatment of chronic wounds into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the extracorporeal shock wave device for treatment of chronic wounds' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Clinical study to evaluate the performance of a noninvasive focused ultrasound device for thigh fat and circumference reduction compared to control.

BACKGROUND AND OBJECTIVES: An FDA-cleared focused ultrasound device (UltraShape, Syneron Candela® , Yokneam, Israel) for noninvasive abdominal fat reduction produces localized mechanical cellular membrane disruption in adipocytes. This study seeks to determine the safety and efficacy of this device for use on the thighs. STUDY DESIGNS/MATERIALS AND METHODS: Fourteen women aged 33-60 were selected to receive 3 biweekly treatments to one thigh with the other thigh serving as an internal control. The subjects had a BMI range of 18-30 kg/m2 and a weight range of 54-83 kg. After the third treatment, patients were followed at 4, 8, and 16 weeks. Fat thickness was measured by both caliper and ultrasound. In addition, thigh circumference and the patient's weight were measured. Pain, edema, erythema, and adverse events as well as investigator and patient overall satisfaction were recorded at all visits. RESULTS: In comparison with the control, there was a statistically significant average reduction in fat thickness measured by calipers at all time points with a 22.20% (P = .0165) improvement in 16 weeks. By ultrasound, there was a 19.23% (4.03 mm P = .0051) reduction in fat thickness at 16 weeks with statistically significant improvement at the other follow-up visits. At 16 weeks, thigh circumference improved, on average, 2.8 cm (P = .0059) at the midline. 90.0% of the subjects were satisfied with the results at 16 weeks, and the investigator was 100% satisfied. No adverse events were reported; no edema was observed in any subject. All subjects experienced mild erythema. All reported zero pain on a 0-10 scale. CONCLUSION: Focused ultrasound is safe, effective, and well tolerated to improve the circumference and fat thickness of the thighs without significant side effects. There were no significant adverse events. Investigators and subjects were highly satisfied with the results.

Application of High Energy Extracorporeal Shockwave Therapy on Musculoskeletal Conditions in US Military Medical Facilities.

Outcomes of extracorporeal shockwave therapy (ESWT) vary due to the heterogeneity of application protocols and patient characteristics. United States military medical facilities offer a unique environment to study the effects of ESWT due to the large use, consistent protocol, and ability to care for young active individuals. A retrospective review was conducted from November 2008 to March 2015 to assess types of musculoskeletal conditions treated by ESWT in US military medical treatment facilities, the demographics of patients treated with ESWT (age and gender), the trend throughout the time in question, and the protocols implemented. A literature review was performed to compare the use in US military facilities to reported data. In this study we report how US military medical facilities are using ESWT to treat musculoskeletal conditions and outcomes reported in literature. The purpose of our research is to raise awareness of this treatment modality and areas for further research within the US military medical facilities.

Development of a novel shock wave catheter ablation system-A validation study in pigs in vivo.

Aims: Although the radiofrequency catheter ablation (RFCA) is widely used for the treatment of tachyarrhythmias, it has three fundamental weaknesses as a thermal ablation system, including a limited lesion depth, myoendocardial injury linking to thromboembolism, and prolonged inflammation followed by subsequent recurrences. In order to overcome these limitations, we have been developing a shock wave (SW) catheter ablation (SWCA) system as a novel non-thermal therapy. In the present study, we validated our new SWCA system with increased SW intensity. Methods and results: In a total of 36 pigs, we applied our new SWCA to ventricular muscle in vivo for the following protocols. (i) Epicardial approach (n = 17): The lesion depth achieved by the SWCA from the epicardium was examined. High intensity SW achieved 5.2 ± 0.9 mm lesions (35 applications), where there was a strong correlation between SW intensity and lesion depth (R = 0.80, P < 0.001, 54 applications). (ii) Endocardial approach (n = 6): The extent of endocardial injury with the two energy sources was examined by electron microscopy (8 applications each). Shock wave catheter ablation markedly reduced myoendothelial injury compared with RFCA (4.3 ± 1.2 vs. 79.6 ± 4.8%, P < 0.01). The electrophysiological effects on the SW lesions were also confirmed using three-dimensional mapping system. (iii) Time-course study (n = 6 each): The healing process after ablation therapy was examined. We found transient inflammatory responses and accelerated reparative process with preserved blood flow in the SWCA group. Conclusion: These results indicate that our SWCA system is characterized, as compared with RFCA, by deeper lesion depth, markedly less myoendocardial injury and accelerated tissue repair process.

Ondas de choque de baja intensidad como alternativa terapéutica de la disfunción eréctil: experiencia inicial en el Hospital Italiano de Buenos Aires y revisión de la bibliografía / Low Intensity Shock Waves as a Therapeutic Alternative for Erectile Dysfunction: Initial Experience at the Hospital Italiano de Buenos Aires and Review of The Literature

Objetivos: los inhibidores de fosfodiesterasa revolucionaron el tratamiento de la disfunción eréctil. Las ondas de choque de baja intensidad emergen como una alternativa terapéutica no invasiva. Materiales y métodos: estudio de cohorte prospectiva y observacional, en el que se evaluó la respuesta de 17 pacientes sexualmente activos al tratamiento con ondas de choque de baja intensidad a los 3 y 6 meses, mediante el Indice Internacional de Función Eréctil (IIEF-6), las preguntas 2 y 3 del Sexual Encounter Profile (SEP-2 y SEP-3), y el Erection Hardness Score (EHS) para evaluar la rigidez peneana, así como una evaluación de satisfacción global con el tratamiento (GAQ) y de recomendación del mismo. Resultados: 6 pacientes presentaban disfunción eréctil leve y 11 disfunción eréctil moderada-severa. Ambos grupos mostraron diferencias estadísticamente significativas en el IIEF-6, SEP-2, SEP-3 y EHS, a los 3 y 6 meses. Sin embargo, no todos los pacientes se mostraron satisfechos o recomendarían el tratamiento, sobre todo en aquellos con disfunción eréctil moderada-severa previo al tratamiento. Conclusión: las ondas de choque de baja intensidad son un tratamiento emergente para la disfunción eréctil, aunque aun sin evidencia clara de su eficacia e indicaciones. Los dispares resultados de los grupos se han debido probablemente a la heterogeneidad de las condiciones basales de los pacientes.(AU)

Objectives: Iphosphodiesterase inhibitors revolutionized the treatment of erectile dysfunction. Low intensity shockwave therapy emerge as a non-invasive therapeutic alternative. Materials and methods: this was a prospective and observational study, in which 17 sexually active patients were evaluated 3 and 6 months after treatment with low intensity shockwave therapy, using the International Index of Erectile Function (IIEF-6), questions 2 and 3 of the Sexual Encounter Profile (SEP-2 and SEP-3), and the Erection Hardness Score (EHS) to assess penile rigidity, as well as a global satisfaction evaluation with the treatment (GAQ) and if they would recommend it to others. Results: 6 patients showed mild erectile dysfunction and 11 moderatesevere erectile dysfunction. Both groups showed statistically significant differences in IIEF-6, SEP-2, SEP-3 and EHS, after 3 and 6 months. However, not all of them were satisfied with the treatment or would recommend it to others, especially those with moderate-severe basal erectile dysfunction. Conclusion: low intensity shockwave therapy is an emergent treatment for erectile dysfunction, although there is no sufficient evidence of its efficacy and indications. The differences between groups were due probably to the heterogeneity of the basal conditions of the patients.(AU)

Noninvasive body contouring.

In a society where stigma surrounds cosmetic procedures and yet a thin and sculpted physique is idealized, noninvasive body contouring satisfies the demand to reduce excess and undesired body fat in areas that persist despite exercise and diet. Numerous devices are available to meet this need; however, choosing the "perfect" device is challenging because the science and data are often limited with variable results. In this paper, we review 7 US Food and Drug Administration-approved noninvasive body contouring therapies in hopes of providing some clarity to this area.

Terapia de ondas de choque focal para osteoartrose de joelho: um ensaio clínico randomizado duplo-cego / Focused extracorporeal shockwave therapy (f-ESWT) for knee osteoarthritis: a double-blind randomized clinical trial

Objetivo: Avaliar eficácia da terapia de ondas de choque focal (f-ESWT) comparada ao placebo para dor e incapacidade em pacientes com osteoartrose de joelho (OA). Métodos: Ensaio clínico randomizado, duplo-cego, placebo controlado, pacientes com OA primária de joelhos realizaram exercícios (alongamentos de isquiotibiais e fortalecimento de quadríceps) e randomizados em f-ESWT ou placebo. Todos os pacientes foram submetidos a 4 sessões semanais de 7.000 pulsos, e no grupo f-ESWT a energia foi de até 0.15mJ/mm2. O desfecho primário foi a escala analógica visual (VAS) para dor em 1 mês. Os desfechos secundários foram WOMAC, TUG, Lequesne e índice de resposta OMERACT-OARSI em 1 e 3 meses; bem como VAS aos 3 meses e eventos adversos (EAs). O teste de Mann-Whitney U e o teste exato Fisher foram utilizados com alfa = 5% e poder = 80% em uma análise de intenção de tratar. Os desfechos contínuos foram relatados como média ± desvio padrão. Resultados: 18 pacientes (9 em cada grupo), idade de 60.6±8.7 com 33.3% homens. Não houve diferença significativa entre grupos em qualquer variável. F-ESWT não foi superior ao placebo em 1 mês: VAS = -2,97 ± 3,18 e -2,68 ± 2,33 cm, respectivamente, p = 0,96. Somente o TUG no 1º mês foi significativo: 9.09 ± 2.30 e 11.01 ± 2.85 seg, p = 0.01. Conclusão: f-ESWT não foi superior ao placebo para osteoartrose de joelhos. Este estudo foi insuficiente para detectar diferenças. Novos estudos devem usar WOMAC A (subescala dor) como desfecho primário e recrutar 92 pacientes.

Objective: To assess the efficacy of focused extracorporeal shockwave therapy (f-ESWT) when compared to placebo for pain and disability in patients with knee osteoarthritis (OA). Methods: Randomized, parallel, double-blind, placebo-controlled clinical trial. Patients with primary knee OA were given a set of exercises (hamstring stretching and quadriceps strengthening) and randomized into f-ESWT or placebo (sham probe). All patients were submitted to 4 weekly sessions of 7,000 pulses, and in the f-ESWT group energy was up to 0.15mJ/mm2. Primary outcome was visual analog scale (VAS) for pain at 1 month. Secondary outcomes were WOMAC, TUG, Lequesne's index and OMERACT-OARSI responder index at 1 and 3 months; as well as VAS at 3 months and adverse events (AEs). Both patients and outcome assessors were blinded. Mann-Whitney U test and Fisher's exact test were used with alpha=5% and power=80% in an intention-to-treat analysis. Continuous outcomes were reported as mean± standard deviation. Results: 18 patients were included (9 in each group), aging 60.6±8.7, with 33.3% males. There was no significant difference at baseline across groups in any variables. f-ESWT was not superior to placebo at 1 month: VAS=-2.97±3.18 and -2.68±2.33cm, respectively, p=0.96. TUG at 1 month had significant differences: 9.09±2.30 and 11.01±2.85sec, p=0.01. No serious AEs were observed. Conclusions: f-ESWT was not superior to placebo for knee OA. This RCT was underpowered to detect differences in this study. New RCTs should use WOMAC A (pain subscale) as primary outcome and recruit at least 92 patients.

A state-of-art review of low intensity extracorporeal shock wave therapy and lithotripter machines for the treatment of erectile dysfunction.

INTRODUCTION: Current treatment for erectile dysfunction (ED) mostly attempts to improve erectile function with limited impact on altering the underlying pathophysiology of ED. Recent animal experiments have supported the notion that low intensity extracorporeal shockwave therapy (LIESWT) significantly improves penile hemodynamics and might induce structural changes that regenerate penile tissue. Areas covered: This review article provides an overview of the basic mechanics and clinical studies pertaining to LIESWT and its use in the field of ED. We identify several key aspects of LIESWT and compare contemporary LIESWT machines and their clinical outcomes. Expert commentary: There is emerging and strong literature to support the use of LIESWT in men with ED, with many clinical studies reported encouraging results in the use of LIESWT with improved erectile function, good safety records, and short-term durability. However, there is a need to define which subgroup of ED population is best suited and the LIESWT treatment protocol including LIESWT template, modality of shock waves energy, emission frequency, and total energy delivery. More stringent randomised controlled trials are warranted before there is widespread acceptance of this LIESWT technology as the standard of care in ED.

Combined Therapy with Shock Wave and Retrograde Bone Marrow-Derived Cell Transplantation for Osteochondral Lesions of the Talus.

Multiple treatment strategies have been developed for osteochondral lesions (OCLs) of the talus. The purpose of this retrospective study was to assess retrograde autologous bone marrow cell (BMC) transplantation via core drilling (CD) combined with focused extracorporeal shock wave treatment (ESWT) in undisplaced OCL of the talus. A total of 69 patients with unilateral osteochondral lesions of the talus (Hepple grade I-III) were divided into two groups: 41 patients received combined therapy of ESWT and BMC transplantation (group A), while 28 were administered BMC transplantation alone (group B). The patients were followed up clinically and radiographically for a minimum of 2 years. Mean follow-up was 4.1 ± 2.8 years. AOFAS scores increased more significantly while pain intensity levels decreased in group A after treatment, compared with group B values (P < 0.001). In MRI follow-up, a more remarkable improvement of OCLs of the talus was observed in group A compared with group B (P = 0.040). Therefore, the combined technique reported here is a highly effective therapeutic option in OCLs of the talus with intact cartilage. It promotes patient recovery with pain control, and improves clinical outcome for more than 2 years after surgery.

Capacitive Micromachined Ultrasound Transducers for Interstitial High-Intensity Ultrasound Therapies.

Capacitive micromachined ultrasound transducers (CMUTs) exhibit several potential advantages over conventional piezo technologies for use in therapeutic ultrasound (US) devices, including ease of miniaturization and integration with electronics, broad bandwidth (>several megahertz), and compatibility with magnetic resonance imaging (MRI). In this paper, the electroacoustic performance of CMUTs designed for interstitial high-intensity contact US (HICU) applications was evaluated and the feasibility of generating US-induced heating and thermal destruction of biological tissues was studied. One-dimensional CMUT linear arrays as well as a prism-shaped 2-D array composed of multiple 1-D linear arrays mounted on a cylindrical catheter were fabricated. The electromechanical and acoustic characteristics of the CMUTs were first studied at low intensity. Then, the acoustic output during continuous wave (CW) driving was studied while varying the bias voltage ( VDC ) and driving voltage ( VAC ). US heating was performed in tissue-mimicking gel phantoms under infrared (IR) or MR-thermometry monitoring. Acoustic intensities compatible with thermal ablation were obtained by driving the CMUTs in the collapse-snapback operation mode ( [Formula: see text]). Hysteresis in the acoustic output was observed with varying VDC . IR- and MR-thermometry monitoring showed directional US-induced heating patterns in tissue-mimicking phantoms (frequency: 6-8 MHz and exposure time: 60-240 s) extending over 1.5-cm depth from the CMUT surface. Irreversible thermal damage was produced in turkey breast tissue samples ( [Formula: see text]). Multidirectional US-induced heating was also achieved in 3-D with the CMUT catheter. These studies demonstrate that CMUTs can be integrated into HICU devices and be used for heating and destruction of tissue under MR guidance.

Design of HIFU Transducers for Generating Specified Nonlinear Ultrasound Fields.

Various clinical applications of high-intensity focused ultrasound have different requirements for the pressure levels and degree of nonlinear waveform distortion at the focus. The goal of this paper is to determine transducer design parameters that produce either a specified shock amplitude in the focal waveform or specified peak pressures while still maintaining quasi-linear conditions at the focus. Multiparametric nonlinear modeling based on the Khokhlov-Zabolotskaya-Kuznetsov (KZK) equation with an equivalent source boundary condition was employed. Peak pressures, shock amplitudes at the focus, and corresponding source outputs were determined for different transducer geometries and levels of nonlinear distortion. The results are presented in terms of the parameters of an equivalent single-element spherically shaped transducer. The accuracy of the method and its applicability to cases of strongly focused transducers were validated by comparing the KZK modeling data with measurements and nonlinear full diffraction simulations for a single-element source and arrays with 7 and 256 elements. The results provide look-up data for evaluating nonlinear distortions at the focus of existing therapeutic systems as well as for guiding the design of new transducers that generate specified nonlinear fields.

Experimental validation of a nonlinear derating technique based upon Gaussian-modal representation of focused ultrasound beams.

A technique useful for performing derating at acoustic powers where significant harmonic generation occurs is illustrated and validated with experimental measurements. The technique was previously presented using data from simulations. The method is based upon a Gaussian representation of the propagation modes, resulting in simple expressions for the modal quantities, but a Gaussian source is not required. The nonlinear interaction of modes within tissue is estimated from the nonlinear interaction in water, using appropriate amounts of source reduction and focal-point reduction derived from numerical simulations. An important feature of this nonlinear derating method is that focal temperatures can be estimated with little additional effort beyond that required to determine the focal pressure waveforms. Hydrophone measurements made in water were used to inform the derating algorithm, and the resulting pressure waveforms and increases in temperature were compared with values directly measured in tissue phantoms. For a 1.05 MHz focused transducer operated at 80 W and 128 W, the derated pressures (peak positive, peak negative) agreed with the directly measured values to within 11%. Focal temperature rises determined by the derating method agreed with values measured using a remote thermocouple technique with a difference of 17%.

Benefício da terapia de ondas de choque no tratamento de úlceras cutâneas: uma revisão da literatura / Benefits of extracorporeal shockwave in the treatment of skin ulcers: a literature review

A terapia de ondas de choque (TOC) extracorpórea possui ação analgésica e anti-inflamatória. Com a evolução e compreensão de seus mecanismos físicos e biológicos, foi se estudando a sua aplicação em outras patologias, principalmente em afecções ósseas e musculo-tendíneas. Recentemente, estudos em modelos animais demonstraram a sua capacidade angiogênica e maior taxa de re-epitelização local. Estas pesquisas levaram ao início do uso de TOC radial de baixa energia no tratamento e manejo de diversas lesões de pele de difícil tratamento. As úlceras cutâneas possuem diversas etiologias, variando desde úlceras de pressão, queimaduras, úlceras venosas ou arteriais e também úlceras diabéticas. Seu tratamento é um desafio, devido ao seu tempo prolongado de tratamento (resultando em dificuldades quanto ao seguimento clínico) e também elevados custos. Objetivo: Avaliar a eficácia da TOC na cicatrização de úlceras de diversas etiologias: diabéticas, por pressão, queimaduras, pós-traumáticas, vasculares venosas e arteriais, por meio de uma revisão da literatura. Métodos: Foi realizada uma revisão da literatura, sendo incluídos estudos clínicos em humanos Resultados: 9 artigos preencheram os critérios de inclusão. Os estudos inclusos compreenderam 788 pacientes. Os manuscritos trouxeram uma variedade de padrão de intervenções diferentes. Houve heterogeneidade no tempo de intervenção, número de pulsos e na frequência de sessões, bem como na quantidade de sessões, densidade de energia aplicada, e também no tipo de ondas de choque utilizados nas terapias. Alguns dos trabalhos descritos encontraram uma maior taxa na cicatrização e fechamento completo de lesões em pacientes com lesões crônicas, que não responderam ao tratamento conservador. Porém, há poucos estudos na literatura com qualidade metodológica adequada. Conclusão: A TOC surge como uma alternativa promissora para pacientes que não respondem bem à terapia conservadora. Os resultados são promissores porém com evidências limitadas quanto a diminuição do tempo de cicatrização e na aceleração do fechamento de lesões. Os estudos selecionados não relataram efeitos colaterais significativos, sendo uma terapia segura

Extracorporeal shockwave therapy (ESWT) has analgesic and anti-inflammatory effects. With the evolution and comprehension of its biological and physical mechanisms, the application of ESWT on other pathologies has also been studied, especially in musculoskeletal diseases. Recently, studies on animal models have shown its angiogenic capacity and a higher rate of local re-epithelization. These small studies led to few trials using low-energy, radial ESWT to treat problematic chronic skin ulcers. Skin ulcers have diverse etiologies, ranging from pressure ulcers, burns, venous or arterial ulcers, and even diabetic ulcers. Their treatment is usually a challenge, due to the long-term treatment and high costs. Objective: To review the literature and evaluate the efficacy of ESWT in caring for skin ulcers of various etiologies: diabetic ulcers, pressure ulcers, burns, post-traumatic ulcers, venous and arterial ulcers. Method: A literature review was made, with only human trials included. Results: 9 articles were selected that fulfilled the eligibility criteria. The studies included evaluations of 788 patients. The manuscripts demonstrated a large variability regarding the interventions made. There was heterogeneity regarding intervention time, number of pulses, frequency of sessions, and also the number of sessions, energy density used, and the type of shock wave used in therapies. Some of the included trials found a higher rate of complete wound healing and faster epithelization in patients with chronic lesions, unresponsive to the traditional measures. However, there were few studies in the literature with proper methodological quality. Conclusion: ESWT is a promising alternative for the treatment of patients unresponsive to conventional measures. The results are promising, although the evidence regarding wound healing and acceleration of wound healing is still limited. The studies selected did not report any significant side effects