Side-effects of extracorporeal shock wave therapy (ESWT) in the treatment of tennis elbow

Apart from a few observational reports, there are no studies on the side-effects of extracorporeal shock wave therapy (ESWT) in the treatment of insertion tendopathies. Within the framework of a randomised, placebo-controlled, single-blind, multicentre study to test the effectiveness of ESWT in the case of lateral epicondylitis (LE), side-effects were systematically recorded. A total of 272 patients from 15 centres was allocated at random to active ESWT (3 x 2000 pulses, energy flux density ED(+) 0.04 to 0.22 mJ/mm(2) under local anaesthesia) or placebo ESWT. In all, 399 ESWT and 402 placebo treatments were analysed. More side-effects were documented in the ESWT group (OR = 4.3, CI = [2.9; 6.3]) than in the placebo group. Most frequently, transitory reddening of the skin (21.1%), pain (4.8%) and small haematomas (3.0%) were found. Migraine was registered in four and syncopes in three instances after ESWT. ESWT for LE with an energy flux density of ED(+) 0.04 to 0.22 mJ/mm(2) is a treatment method which has very few side-effects. The possibility of migraine being triggered by ESWT and the risk of a syncope should be taken into account in the future. No physical shock wave parameters could be definitely identified as the cause of the side-effects observed.     

No influence of low-energy extracorporeal shock wave therapy (ESWT) on spinal nociceptive systems

The analgesic effects of high-energy extracorporeal shock wave therapy (ESWT) were discovered by chance during its application for urolithiasis and for bone pseudarthrosis. Despite the extensive use of ESWT, the mechanisms of its antinociceptive effects are still unclear. A gate control mechanism and other antinociceptive mechanisms have been postulated. The aim of this study was to investigate the possible influence of low-energy ESWT on the expression of the transmitters substance P (SP) and calcitonin gene-related peptide (CGRP) in the lumbar spinal cord of the rat. Immunohistochemical analysis of the expression of the neuropeptides CGRP and SP was performed in rats treated either once with 1000 impulses or three times with 1000 impulses, with two different energy flux densities being used (0.043 and 0.11 mJ/mm²). The animals were killed either 4 or 72 h after the ESWT. No regulatory effect of ESWT on the expression of SP or CGRP in the dorsal horns was found. Because the application of ESWT showed no significant changes in the sensory system, it is unlikely that the application of ESWT triggers the endogenous pain control system of the rat through hyperstimulation analgesia. Furthermore, these results show that low-energy ESWT had no side effects on the rat spinal cord. Received: January 9, 2001 / Accepted: August 25, 2001     

体外冲击波对肾脏生物学效应的实验研究

雄性家兔４５只，分为３组，分别接受三个能量级（２０ｋＶ，７５０ＳＷ；１４ｋＶ，１５００ＳＷ；１０ｋＶ，３０００ＳＷ）体外冲击波处理。结果表明，２组动物急性肾损伤程度较其它两组病变轻微。体外冲击波对肾脏的生物学效应表现为尿酶γＧＴ升高；超微结构显示肾小管上皮细胞变性坏死；组织学显示肾内和肾周出血。实验第２８天的生物学效应表现为吸收和（或）纤维化修复。体外冲击波能量（包括电压和冲击次数）与其对肾脏生物学效应程度相关。     

体外震波对骨和骨疾病的作用及其机制

体外震波（extracorporeal shock wave，ESW）于20世纪80年代中期开始用于骨科领域，目前，它作为一种非侵入性治疗方法用于治疗多种骨相关疾病。为指导其进一步用于临床治疗并提高疗效，了解它对正常骨组织的影响和对骨疾病的治疗作用及其机制非常重要。现已有不少学者对这些方面进行了相关的基础与临床研究，取得了明显进展。本文就体外震波对骨和骨疾病的作用及其机制综述如下。     

The effect of extracorporeal shock wave lithotripsy on pancreatic enzymes

In order to assess the effect of electromagnetic shock waves on pancreatic tissue, we studied serum and urinary amylase and serum lipase levels prior to, 1 hour, 1 day and 1 week after extracorporeal shock wave lithotripsy (ESWL) in 150 patients with upper urinary tract stones. A control group consisted of 22 patients with lower ureteric stones who underwent ESWL. All three parameters increased after ESWL (p<0.001), however, this increase was within normal laboratory limits. There was no difference between the right and left renal units. In the control group there was no change of pancreatic enzymes after ESWL. High energy shock waves may cause some elevations of pancreatic enzymes, probably due to altered cell membrane permeability, however, ESWL with an electromagnetic shock wave emitter system does not cause significant injury to the pancreatic tissue.     

不同能量冲击波对猪肾近期病理损伤的实验研究

目的探讨体外冲击波能量大小与肾脏损伤的关系。方法将体重28—35kg的白猪36头，根据冲击电压的不同，随机分为A、B、C、D、E组，其中E组为对照组。每组按观察时间不同又分为4个亚组，分别于冲击后即刻、1周、2周和3周取双侧肾脏，肉眼和光镜下观察其形态的改变。结果所有受冲击的肾脏均有损伤性改变，且损伤随电压的增加而加重，随时间的推移而逐渐恢复，当电压超过13kV后，所引起的损伤是不可逆的（至少短期内）。结论当冲击电压≤13kV时，冲击波所引起的损伤在1—3周内基本可以恢复，而一旦超过13kV，则会造成肾脏不可逆性病理改变。本实验结果为临床ESWL能量参数的选择提供了参考依据。     

Low-energy extracorporeal shock-wave treatment (ESWT) for tendinitis of the supraspinatus. A prospective, randomised study

We have performed a controlled, randomised study to analyse the effects of low-energy shock-wave therapy (ESWT) on function and pain in tendinitis of the supraspinatus without calcification. There were 20 patients in the treatment group and 20 in the control group. The former group received 6,000 impulses (energy flux density, 0.11 mJ/mm2) in three sessions after local anaesthesia. The control group had 6000 impulses of sham ESWT after local anaesthesia. The patients were examined at six and 12 weeks after treatment by an independent observer who evaluated the Constant score and level of pain. We found an increase in function and a reduction of pain in both groups (p < or = 0.001). Statistical analysis showed no difference between the groups for the Constant score and for pain. We therefore do not recommend ESWT for the treatment of tendinitis of supraspinatus.     

体外冲击波治疗难治性IIIB型慢性前列腺炎的临床研究

目的 探讨体外冲击波治疗IIIB型慢性前列腺炎的临床疗效。方法 将32例ⅢВ型慢性前列腺炎患者随机分为治疗组（20例）及对照组（12例）,治疗组患者给予低能量级别冲击波治疗。对照组给予体外电场热疗。两组均每周治疗１次,连续治疗4次,4次为一疗程,两组患者分别于治疗前、治疗后4周进行NIH—CPSI评分,并对两组患者疗效进行比较。结果　治疗前2组患者的疼痛／不适评分、排尿评分、生活质量影响评分及NIH-CPSI总分组间均无统计学差异（P＞0.05）。两组治疗后疼痛／不适评分、排尿评分、生活质量影响评分及NIH-CPSI总分较治疗前差异有统计学意义（P＜0.05）。治疗组治疗后的疼痛／不适评分、排尿评分、生活质量影响评分及NIH-CPSI总分下降幅度明显高于对照组治疗后下降幅度（P＜0.05）。治疗组在治疗后的总有效率明显高于对照组（均P＜0.05）。结论　体外冲击波治疗慢性前列腺炎（IIIB）有较好的近期疗效,但其远期疗效有待进一步追踪观察。     

Use of extracorporeal shock-wave therapy (ESWT) in the treatment of non-unions

Presently, extracorporeal shock-wave therapy (ESWT) is not yet a standard therapeutic technique in orthopaedics. The mechanism for the analgesic effect or the effect of shock waves on osseous defects are still unknown. With the help of a review of the literature, indications and success rates for ESWT in the treatment of non-unions are outlined, while adequate impulse and energy rates are defined according to the present state of knowledge. Non-union is defined as an absent healing process after a duration of 6 months. The aim of this study is to rate the published data. A total of 52 papers referring to ESWT of the locomotor system are reviewed, with a focus on the 635 patients from 10 publications who underwent ESWT to treat non-unions. Validation was performed for each paper dealing with this topic according to the internationally accepted system of the American Association of Spine Surgery as types A-E. Conclusions regarding possible applications in therapy were taken only from high-quality publications of types A and B. This advice can be regarded as scientifically as well as economically sound. The investigations concerning non-union hardly live up to scientific standards. No serious complications were observed. Because of the complication rate in operative treatment of non-unions, ESWT seems to be justifiable. The techniques of ESWT, energy density levels and impulse rates will be described. Atrophic non-unions seem to represent a poorer starting point in comparison with hypertrophic non-unions. Most investigations showed a consolidation of the non-union during a period of 3 months following ESWT, so that in case of treatment failure, operative treatment in the form of a re-osteosynthesis would only be delayed for this period of time. The advantages of ESWT are its non-invasiveness and low rate of complications. The primary aim of further research should be the evaluation of adequate energy density levels and impulse rates for various indications in accordance with evidence-based medicine. Long-term results need to become available before ESWT can be compared with established methods.     

High-energy extracorporeal shock wave treatment of nonunions

Forty-three consecutive patients who did not have healing of tibial or femoral diaphyseal and metaphyseal fractures and osteotomies for at least 9 months after injury or surgery were examined prospectively for use of high-energy extracorporeal shock waves. Former treatment modalities (cast, external fixator, plate osteosynthesis, limitation of weightbearing) remained unchanged. In all cases a 99mTechnetium dicarboxyphosphonate regional two-phase bone scintigraphy was performed before one treatment with 3,000 impulses of an energy flux density of 0.6 mJ/mm2. Radiologic and clinical followups were done at 4-week intervals starting 8 weeks after shock wave treatment. The success criterion was bridging of all four cortices in the anteroposterior and lateral radiographic views, in oblique views, or by conventional tomography. An independent observer described bony consolidation in 31 of 43 cases (72%) after an average of 4 months (range, 2-7 months). Twenty-nine of 35 (82.9%) patients with a positive bone scan had healing of the pseudarthrosis compared with two of eight (25%) patients with a negative bone scan. Six of these eight patients with negative scans were heavy smokers. No complications were observed. High-energy shock wave therapy seemed to be an effective noninvasive tool for stimulation of bone healing in properly selected patients with a diaphyseal or metaphyseal nonunion of the femur or tibia. Additional controlled studies are mandatory.     

Application of extracorporeal shock wave on bone: preliminary report

BACKGROUND: We have studied the effect of extracorporeal shock waves (ESW) on bone. ESW emitted by the new powerful generator provides three to six times greater energy than a common lithotriptor. Because the ESW causes fracture of rabbit femurs and induces new bone formation, we have called this treatment as ESWIB (ESW-induced bone formation). The purpose of this study is to confirm the effect of ESWIB on a canine model, which is more similar to clinical cases, and to apply ESWIB on nonunion of clinical cases. METHODS: In our basic research, ESWIB was applied on six canine femurs as follows: group I with 100, 500, 1,000 shots and group II with 100, 500, 1,000 shots. A femur was extracted immediately after ESWIB in group I and 2 months after ESWIB in group II. Blood tests, including blood cell counts and blood chemistry studies, were performed before and after ESWIB in group II. In our clinical research, we applied ESWIB to six patients of delayed or nonunion of the fracture. The sites of the ESWIB application were three tibiae, one radius, one femur, and one humerus. Average age of the patients, the period from the previous surgery, and the period until fusion was achieved were 38.6 years, 14.0 months, and 4.3 months, respectively. RESULTS: In our basic research, group I, 500 or more shots caused periosteum detachment. In addition, small fractures of the inner surface of the cortex were observed. However, gross fracture with displacement was not observed. In group II, 500 or more shots caused callus formation beneath the detached periosteum. Subcutaneous hemorrhage was seen in all dogs, and the degree of bleeding was directly proportional to the number of the shots. The blood was absorbed within a week. The level of serum creatine kinase was significantly high 2 days after ESWIB, but it recovered in a week. In our clinical research, four of the patients achieved union without any complications except mild subcutaneous bleeding. CONCLUSIONS: We predict that ESWIB will be one of the tactics for treatment of the delayed union or nonunion of the fracture in the future.     

Physical-technical principles of extracorporeal shockwave therapy (ESWT)

Extracorporeal shock waves in orthopaedics are currently applied in the treatment of chronic enthesiopathies such as lateral epicondylitis, plantar heel spur, as well as in calcifying tendinitis of the shoulder or in bony nonunions. Detailed knowledge of physical parameters and properties of shock waves appear to be necessary to determine clinically relevant dose-effect relations and to make shock wave devices, clinical results, and basic science in shock wave therapy more comparable. This study gives an overview of physical parameters and properties in shock wave therapy. Measurement technologies, types of shock wave devices, and mechanisms of shock waves are also described.     

Clinical study of extracorporeal shock wave lithotripsy

Extracorporeal shock wave lithotripsy was performed on 81 patients with urolithiasis (35 patients with ureteral stones, 25 patients with renal stones less than 2 cm in diameter, and 21 patients with renal stones more than 2 cm in diameter) at Kanbara Hospital from August to October, 1986. A 4 Fr catheter was placed transurethrally in the ureter up to the stone to identify the stone position and the degree of fragmented stones. In four patients with staghorn calculi, a double-J catheter was placed in the ureter to prevent stone street formation. More than 50% of the patients with renal stones less than 2 cm in maximum diameter and ureteral stones had satisfactorily excreted fragments or sand of crushed stones not later than 2 weeks after the operation. However, in patients with renal stones more than 2 cm in maximum diameter, it took much more time to discharge the crushed stones compared with the foregoing two groups and some patients needed further management to remove the remnants. Combined treatment, ureteral catheterization or endoscopic operation with ESWL is recommended for treatment of renal stones larger than 2 cm in diameter.     

体外冲击波对兔输尿管形态及组织学影响的研究

目的 :探讨冲击波 (SW )对输尿管形态的影响。方法 :将 4 2只成年兔随机分为 7组 ,每组 6只。第 1组为正常对照组 ;第 2～ 6组为液电式SW组 ;第 7组为电磁式SW组。各组接受冲击并在冲击后不同时间取材。全部标本行常规病理检查并予评分。结果 :第 2～ 5组和第 7组 ,肉眼可见焦点周围组织有出血、水肿等改变 ,输尿管直径较冲击前显著增加 (P <0 .0 1 )。光镜下可见平滑肌细胞变性及管腔狭窄 ,病理量化评分显著高于正常组 (P <0 .0 5 ) ;电镜下则有肌细胞线粒体破坏等改变。第 6组形态改变不明显 ,病理评分和正常组的区别无显著性意义。结论 :临床剂量的冲击波能导致输尿管多种病理变化。冲击后第 5天 ,输尿管形态已基本恢复正常。由液电式和电磁式冲击波所致的输尿管急性损伤程度无明显的区别     

低能量ESWL对兔肾的影响

目的 探讨低能量冲击波ESWL对肾组织结构和肾功能的影响。方法 12只兔经皮行肾穿刺造影定位，然后用低能量冲击波碎石机分别采用9KV和6KV两种工作能量作模拟ESWL操作。ESWL操作后五天抽血做肾功能测定，光镜下观察肾组织显微结构的变化。结果 ESWL后五天兔肾组织结构发生了损伤性改变，同时血浆的肌酐值增高，9KV组与6KV组相比有显著差异(P＜0．01)；9KV组与6KV组相比有显著差异(P＜0．01)。实验组血浆尿素氮也有增高，6KV组与对照组相比差异明显，P＜0．01。结论 低能量ESWL可引起肾组织和肾功能的损伤，其损伤程度可随着工作能量加大而加重。     

The effect of extracorporeal shock wave lithotripsy on the rat spinal cord

Study design:Experimental study.Objectives:To determine the effects of extracorporeal shock wave lithotripsy (ESWL) on the rat spinal cord.Methods:Animals were randomly divided into three groups. Groups 1 and 2 consisted of five rats each that underwent ESWL (2000 impulses at 15 kV and 2000 impulses at 18 kV, respectively) and group 3 contained five control rats (no shock wave treatment). ESWL-treated and control rats were compared with regard to light and electron microscopic findings of the adjacent spinal cord.Results:Gross neurological outcomes were normal in all groups. Light microscopic examination of group 1 showed extensive extravasation of red blood cells over all the interstitial spaces. Group 2 also had haemorrhagic areas and an irregular organization of axons in the white matter. Transmission electron microscopic examination of group 1 indicated extravasated red blood cells through the endothelium and swollen axoplasm, degenerated mitochondria, destruction of myelin sheaths and a slight increase in the number of lysosomes. Extravasated red blood cells were also seen in group 2. The axoplasmic mitochondria were enlarged, but no sign of mitochondrial degeneration was observed. Lamellar degeneration of myelin sheaths and abundant lysosomes were more predominant in group 2 than in group 1.Conclusion:Extracorporeal shock wave lithotripsy caused not only haemorrhage but also damage to neuronal structures except the nucleus. Our findings showed that higher-energy ESWL caused more myelin degeneration in the spinal cord.Spinal Cord (2008) 46, 627-632; doi:10.1038/sc.2008.31; published online 15 April 2008.     

An experimental study on residual lithiasis after shock wave lithotripsy

The main objective of this paper was to study residual lithiasis after extracorporeal shock wave lithotripsy (post-ESWL), with the aim of contributing to the development of effective prophylactic measures. In vivo regrown calcium oxalate monohydrate (COM) post-ESWL residual fragments were studied by stereoscopic microscopy, infrared spectroscopy and scanning electron microscopy with an energy dispersive X-ray analyzer. An in vitro system was also used to study the regrowth of post-ESWL fragments of COM calculi. The regrowth was evaluated as the relative increase in the weight of the fragments. The effects of a calcium oxalate crystallization inhibitor (phytate) were also evaluated. All of the in vivo regrown COM real residual post-ESWL fragments exhibited practically the same internal structural features. The in vitro studies demonstrated that the regrowth of post-ESWL residual fragments, in the absence of crystallization inhibitors, occurred even using normocalciuric/normooxaluric urine and could be detected at 24 h. At 144–240 h, the formation of new COM columnar zones was observed. The presence of 1.5 mg/l of phytate totally blocked the growth process. When hypercalciuric/normooxaluric urine was used, significant amounts of disorganized calcium oxalate dihydrate (COD) crystals were formed. The in vitro regrowth of post-ESWL COM fragments was clearly influenced by the presence of crystallization inhibitors. These data also demonstrate the importance that effective prophylactic therapies could exert on preventing recurrence.