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BACKGROUND: Patients with fibromyalgia experience chronic, widespread pain. It remains a misunderstood disorder with multimodal treatments providing mixed results. OBJECTIVES: To examine the effects of radial shockwave therapy (RSWT) compared to placebo on pain, pain catastrophizing, psychological indices, blood markers, and neuroimaging. Study-related experiences were also explored qualitatively. METHODS: Quantitative sensory testing (QST), Visual Analog Scale (VAS), Beighton Scoring Screen (BSS), Pain Catastrophizing Scale (PCS), blood biomarker (Interleukin (IL)-6 and IL-10), and brain fMRI were measured pre- and post-treatment along with a post-treatment survey. The RSWT group received five treatments (one week apart over five-week period) to the three most painful areas (500 shocks at 1.5 bar and 15 Hz, then 1000 shocks at 2 bar and 8 Hz, and finally 500 shocks at 1.5 bar and 15 Hz) versus sham treatment for the placebo group. RESULTS: There were no statistically significant differences in the BSS for hypermobility (p = .21; d = .74), PCS (p = .70; d = .22), VAS (p = .17-.61; d = .20-.83) scores, QST for skin temperature and stimuli (p = .14-.65; d = .25-.88), and for the pressure pain threshold (p = .71-.93; d = .05-.21). The VAS scores had clinically significant changes (MCID greater than 13.90) with improved pain scores in the RSWT group. Neuroimaging scans revealed no cortical thickness changes. Post-treatment surveys revealed pain and symptom improvements and offered hope to individuals. CONCLUSION: RSWT was implemented safely, without any negative treatment effects reported, and acted as a pain modulator to reduce sensitivity. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov identification number NCT02760212.

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Background: Low intensity shockwave therapy is an emerging treatment option for men with vasculogenic erectile dysfunction. Radial wave therapy (rWT), which differs from focused shockwave (fSWT) as it produces lower pressure waves with lower peak energy, is used to treat soft tissue and skin conditions and has some data to support its use in vasculogenic erectile dysfunction. There is limited data for the use of rWT for the treatment of erectile dysfunction after nerve-sparing (NS) radical prostatectomy. We report the first trial of rWT for penile rehabilitation after NS radical prostatectomy. Methods: We performed a prospective, non-randomized, open-label trial. Men with good pre-operative erectile function who underwent a NS radical prostatectomy at our institution from 2018-2020 were considered for inclusion. We compared post-operative erectile function outcomes between the rWT (6 weekly treatments initiated approximately 2 weeks post-operatively) plus standard of care (phosphodiesterase type 5 inhibitor) arm and the non-sham controlled standard of care arm. The primary end point for our study was the proportion of men who returned to "near normal" erectile function, defined as IIEF-5 score ≥17 and erectile hardness score (EHS) ≥3, by 3 months post-operatively between the intervention and control arm. We also compared mean IIEF-5 scores and median EHSs between the arms. Results: One hundred and six patients were enrolled, of whom 73 patients had at least one reported survey response between 6 and 12 weeks post-operatively. Five (17%) and 11 (26%) patients recovered erectile function in the control and intervention arms, respectively, which was not a statistically significant difference (P=0.37). However, the intervention arm did have a significantly higher median EHS compared to the control arm (1 vs. 2, P=0.03). There were 4 adverse events related to pain during treatment and required only treatment intensity de-escalation. Conclusions: rWT is safe but did not substantially improve the recovery of early erectile function after NS radical prostatectomy.

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BACKGROUND: Extracorporeal shockwave therapy (ECSWT) is increasingly used to treat different types of musculoskeletal conditions in sport and companion animals. To explore the scientific basis for the treatment, we conducted a systematic review of the literature on ECSWT used in horses, dogs, and cats. METHODS: Relevant articles published in 1980-2020 were identified from three major databases. Each article was assessed for risk of bias. RESULTS: The review identified 27 relevant articles on the effects of ECSWT in horses, nine in dogs, but none in cats. Typically, ECSWT involved one to three treatment sessions at 1- to 3-week intervals. We identified studies on bone mass and bone healing, wound healing, navicular disease, ligament injury, desmitis, sesamoiditis, tendon injury, osteoarthritis, and short-term analgesic effects. Common to all indications was that the scientific evidence was very limited. For each separate indication, there were relatively few studies, many of which had methodological flaws. Where favorable results were reported, they were usually not replicated in independent studies. A few encouraging results were found. CONCLUSIONS: In sport and companion animals, the scientific evidence for clinical effects of ECSWT in horses, dogs, and cats is limited. For some applications, notably short-term pain relief, ligament ailments, and osteoarthritis, the results seem promising and warrant further exploration in high-quality studies.

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BACKGROUND: The first-line clinical strategy for small cartilage/osteochondral defects is microfracture (MF). However, its repair efficacy needs improvement. HYPOTHESIS: Appropriate energy radial shockwave stimulation in MF holes would greatly improve repair efficacy in the porcine osteochondral defect model, and it may obtain comparable performance with common tissue engineering techniques. STUDY DESIGN: Controlled laboratory study. METHODS: Osteochondral defect models (8-mm diameter, 3-mm depth) were established in the weightbearing area of Bama pigs' medial femoral condyles. In total, 25 minipigs were randomly divided into 5 groups: control (Con; without treatment), MF, MF augmentation (MF+; treated with appropriate energy radial shockwave stimulation in MF holes after MF), tissue engineering (TE; treated with compounds of microcarrier and bone marrow mesenchymal stem cells), and sham (as the positive control). After 3 months of intervention, osteochondral specimens were harvested for macroscopic, radiological, biomechanical, and histological evaluations. The statistical data were analyzed using 1-way analysis of variance. RESULTS: Based on the macroscopic appearance, the smoothness and integration of the repaired tissue in the MF+ group were improved when compared with the Con and MF groups. The histological staining suggested more abundant cartilaginous matrix deposition in the MF+ group versus the Con and MF groups. The general scores of the macroscopic and histological appearances were comparable in the MF+ and the TE groups. The high signal areas of the osteochondral unit in the magnetic resonance images were significantly decreased in the MF+ group, with no difference with the TE group. The micro-computed tomography data demonstrated the safety of direct in situ radial shockwave performance. Biomechanical tests revealed that the repaired tissue's Young modulus was highest in the MF+ group and not statistically different from that in the TE group. CONCLUSION: Direct in situ radial shockwave stimulation with appropriate energy significantly improves the short-term repair efficacy of MF. More encouragingly, the MF+ group in our study obtained repair performance comparable with the TE therapy. CLINICAL RELEVANCE: This strategy is easy to perform and can readily be generalized with safety and higher cartilage repair efficacy. Moreover, it is expected to be accomplished under arthroscopy, indicating tremendous clinical transformative value.

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BACKGROUND: The anti-spasticity efficacy of botulinum toxin (BoNT) injection has been well established for patients with chronic stroke; however, extracorporeal shock wave therapy (ESWT), i.e. focused shockwave (FSW) and radial shockwave (RSW), has recently been applied. We aimed to investigate the comparative effectiveness of BoNT vs. ESWT in the reduction of spasticity among stroke survivors. METHODS: PubMed, EMBASE, MEDLINE and Cochrane CENTRAL were searched from the earliest record to September 2021 for randomized controlled trials. Weighted mean differences (WMDs) on the reduction of the Modified Ashworth Scale before or at the 6th post-treatment week (short-term) and between the 7th and 12th weeks (mid-term) after the intervention were calculated. Ranking probabilities of the WMD were simulated to determine which treatment had the potential to possess the best effectiveness. inplasy.com registration: INPLASY202170018. FINDINGS: A total of 33 studies comprising 1,930 patients were enrolled. The network meta-analysis revealed that BoNT injections, FSW and RSW were better in spasticity reduction than the control treatment(s) at the short term, with WMDs of -0.69 (95% CI, -0.87 to -0.50), -0.36 (95% CI, -0.69 to -0.03) and -0.62 (95% CI, -0.84 to -0.40), respectively. Likewise, mid-term effects of BoNT injections, FSW and RSW also revealed superiority, with WMDs of -0.44 (95% CI, -0.62 to -0.26), -0.74 (95% CI, -1.26 to -0.23) and -0.79 (95% CI, -1.07 to -0.51), respectively. Ranking probability analysis revealed that RSW had the highest probability of being the best treatment for spasticity reduction at the short-term (62.2%) and mid-term (72.3%) periods during the follow up. INTERPRETATION: BoNT injections and ESWT are effective in alleviating post-stroke spasticity at the mid-term. The effectiveness of ESWT was comparable to BoNT injections, and RSW had the potential to be the best treatment for spasticity reduction among the three treatment options. More prospective trials incorporating head-to-head comparisons of BoNT injections vs. ESWT are needed to validate the role of ESWT in reducing post-stroke spasticity. FUNDING: The current research project was supported by (1) National Taiwan University Hospital, Bei-Hu Branch; (2) Ministry of Science and Technology (MOST 106-2314-B-002-180-MY3 and 109-2314-B-002-114-MY3); 3) Taiwan Society of Ultrasound in Medicine.

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Achilles tendinopathy is a common condition and many patients have functional limitations after initial conservative treatment. Shockwave therapy has been shown to improve function within patients; however, comparative outcomes for different forms of shockwave are poorly described. In this retrospective cohort study, we describe findings from a quality improvement initiative evaluating safety and functional outcomes after treatment with radial shockwave therapy (n = 58) or combined radial and focused shockwave therapy (n = 29) for patients with Achilles tendinopathy refractory to exercise therapy. All patients were prescribed an eccentric exercise program. We hypothesized both groups would see improvements in function quantified using the Victorian Institute of Sports Assessment-Achilles with similar safety outcomes. Overall, the minimal clinically important difference (defined at 7 for insertional and 12 for noninsertional Achilles tendinopathy) was met in a greater proportion of patients treated with combined shockwave compared to radial shockwave (26 [89.7%] vs 37 [63.8%], p = .022). The change in Victorian Institute of Sports Assessment-Achilles from baseline to final treatment was not different between combined and radial-only groups (23.3 ± 12.6 vs 19.9 ± 18.7, p = .2). Within group differences from baseline to final follow-up measures (mean duration 17.9 ± 14.8 weeks) demonstrated overall functional improvement for both groups (both p < .0001). No serious adverse effects were observed. Our findings suggest combined radial and focused shockwave therapy may provide more predictable functional gains for treatment of Achilles tendinopathy compared to radial shockwave therapy.

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The aim of this study was to investigate the effect of radial extracorporeal shockwave therapy (rESWT) primarily on acute lumbar back pain (aLBP), and secondarily on physical function and quality of life. This randomized, placebo-controlled, single-blinded trial with 12-week follow-up (FU) randomized 63 patients with aLBP 1:1 into two groups receiving either rESWT (intervention) or sham rESWT (placebo) with a manipulated shockwave head not delivering any shockwaves. Both, rESWT and sham procedure were carried out eight times for four weeks. Both groups received additional analgesics and physiotherapy twice a week. Primary patient-reported outcome measure (PROM) was the visual analogue scale for aLBP (VAS-LBP). Secondary PROMs included the Oswestry disability index (ODI), Roland and Morris Disability Questionnaire (RDQ), EuroQol EQ-5D-3L, and the Beck Depression Index (BDI-II). Primary endpoint was a between-arm comparison of mean changes in VAS-LBP from baseline to final FU. At randomization, there were no differences between the two groups in relation to age and PROMs. Both groups showed significant improvement in all PROMs at final FU. VAS-LBP declined by 60.7% (p < 0.001) in the intervention and by 86.4% (p < 0.001) in the sham group. The intervention group showed significantly less pain relief after 4 and 12 weeks. The EQ-5D submodality pain showed significantly inferior results for the intervention (1.5 (0.58)) compared to the sham group (1.1 (0.33)) (p < 0.014) after eight weeks. No significant intergroup differences were observed for RDQ, ODI or BDI-II. Additional rESWT alongside conventional guideline therapy in aLBP does not have any significant effects on pain intensity, physical function, or quality of life. To the best of our knowledge, this is the first study with a high level of evidence reporting the efficacy of rESWT in aLBP treatment and will be a future basis for decision-making.

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BACKGROUND: Low-intensity shockwave therapy (SWT) is an emerging treatment for erectile dysfunction (ED). Devices used for SWT include focused shockwave therapy (fSWT) or radial wave therapy (rWT), which differ in how the waves are generated, their tissue penetration, and the shape of their pressure waves. Most studies of SWT for ED to date have utilized fSWT. Although widely used, the efficacy of rWT for ED is unknown. Our objective is to compare the efficacy of rWT and fSWT for ED at our institution. METHODS: A retrospective chart review was performed to identify all men with ED treated by fSWT or rWT. Men with history suggesting non-vasculogenic ED were excluded. All men received 6 consecutive weekly treatments. The fSWT group received 3,000 shocks per treatment at 0.09 mJ/mm2. The rWT group received 10,000 shocks per treatment at 90 mJ and 15 Hz. Pre-treatment and 6-week post-treatment Sexual Health Inventory in Men (SHIM) scores were measured. Treatment response was categorized on a scale of 1-3 (1 if no improvement, 2 if erections sufficient for intercourse with phosphodiesterase 5 inhibitors (PDE5i), or 3 if sufficient erections without PDE5i). Primary endpoint was self-reported improvement score of 2 or greater. RESULTS: A total of 48 men were included: 24 treated by fSWT and 24 by rWT. There were no significant differences in age, duration of ED, pre-treatment PDE5i use, or pre-treatment SHIM scores between the groups. Following treatment with rWT, the mean SHIM score improved from 9.3 to 16.1 (P<0.001). The mean SHIM following fSWT improved from 9.3 to 15.5 (P<0.001). The mean improvement in SHIM score did not differ between rWT (6.8) and fSWT (6.2) (P=0.42). 54% of men treated by fSWT experienced a significant clinical improvement (≥ grade 2 response) compared to 75% in the rWT group (P=0.42). There were no reported side effects with either device. CONCLUSIONS: In our patient population, both fSWT and rWT were moderately effective treatments for arteriogenic ED with no observable difference in efficacy between the two modalities.

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Objective To compare results of two different frequencies and densities of radial extracorporeal shock wave therapy (rESWT) after 10 sessions. Methods A total of 41 patients with plantar fasciitis were included in this study. Patients were randomly divided into two groups. Both groups were administered 10 sessions of treatment consisting of 15 Hz frequency, 3.0 Bar density and 2000 impulses/ session for the 1st group, and 10 Hz frequency, 2.0 Bar density and 2000 impulses/ session for the 2nd group. Visual analog scale (VAS) and a modification of the clinical rating system of the American Orthopedic Foot and Ankle Society (AOFAS) were used for outcome measurement. The patients were assessed before treatment and followed up four weeks, and 12 weeks after end of treatment. Results Mean VAS scores were reduced after rESWT from 7.52 ± 2.34 (mean ± SEM) at baseline to 0.57 ± 0.68 at 12 weeks in the 1st group and from 6.45 ± 2.04 at baseline to 0.40 ± 0.60 at 12 weeks in the 2nd group. Similar changes were found for mean AOFAS scores from baseline after rESWT but were not observed significance between groups. Conclusion There is no significant different effect between the two treatment groups' results.

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INTRODUCTION: Venous insufficiency and venous leg ulcers each year affect more and more people, especially in developed countries. The challenge of our time is to find an effective method of treating venous leg ulcers, which will further shorten treatment time and reduce the cost of treatment. AIM: To compare the effects of treating venous leg ulcers using ultrasound therapy, radial shock wave therapy and standard care. MATERIAL AND METHODS: Group A consisted of 17 patients. Patients were treated with ultrasound therapy US power density 0.5 W/cm2, pulsed wave with a duty cycle of 1/5, and 1 MHz frequency. Group B consisted of 17 patients. Patients were treated with the radial shock wave R-ESWT using surface energy density 0.17 mJ/mm2, 100 impulses/cm2, frequency of 5 Hz and a pressure of 0.2 MPa. Group C (control group) consisted of 17 patients. Patients in this group received standard care: gauze dressing saturated in 0.9% sodium chloride and elastic bandages changed daily for 4 weeks. RESULTS: Ultrasound therapy with 1 MHz and energy power density 0.5 W/cm2 for 4 weeks resulted in an average reduction of 68% of the area of ulceration. We used for venous leg ulcers 4-week treatment with radial shock wave therapy resulting in a 38% mean percentage reduction of the ulceration area. Standard care reduces the area of ulceration by only 16%. CONCLUSIONS: The use of ultrasound therapy for the treatment of venous leg ulcers is more effective than the use of radial shock wave therapy or standard care alone.

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Background. Venous leg ulcers are difficult to heal wounds. The basis of their physiotherapeutic treatment is compression therapy. However, for many years, the search for additional or other methods to supplement the treatment of venous ulcers, which would shorten the duration of treatment, is underway. One of such methods is the shockwave therapy. Methods. The purpose of our study was to compare radial shockwave therapy (R-ESWT) with focused shockwave therapy (F-ESWT) in venous leg ulcers treatment. Patients were randomly assigned to tree groups. In the first group the radial shockwave therapy (0.17mJ/mm2, 100 impulses/cm2, 5 Hz), in the second group the focused shockwave therapy (0.173mJ/mm2, 100 impulses/cm2, 5 Hz) was used and in third group standard care was used. Patients in shockwave therapy groups were given 6 treatments at five-day intervals. Total area, circumference, Gilman index, maximum length and maximum width of ulcers were measured. The patients from the third group wet gauze dressing with saline and gently compressing elastic bandages were used (standard wound care SWC). Results. Analysis of the results shows that a complete cure of ulcers was achieved in 35% of patients who were treated with radial shockwave, 26% of patients with focused shockwave used. There is statistically significant difference between the standard care and radial shockwave therapy as well as between the standard care and focused shockwave therapy. There is no statistically significant difference between the use of radial and focused shockwave in the treatment of venous leg ulcers (p> 0.05). Conclusion. There is no statistically significant difference between the use of radial and focused shockwave in the treatment of venous leg ulcers. Treatment of venous leg ulcers with shockwaves is more effective than the standard wound care.

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BACKGROUND: Shockwaves and mesenchymal stem cells (MSCs) have been widely accepted as useful tools for many orthopedic applications. However, the modulatory effects of shockwaves on MSCs remain controversial. In this study, we explored the influence of radial shockwaves on human bone marrow MSCs using a floating model in vitro and evaluated the healing effects of these cells on cartilage defects in vivo using a rabbit model. METHODS: MSCs were cultured in vitro, harvested, resuspended, and treated with various doses of radial shockwaves in a floating system. Cell proliferation was evaluated by growth kinetics and Cell Counting Kit-8 (CCK-8) assay. In addition, the cell cycle and apoptotic activity were analyzed by fluorescence activated cell sorting. To explore the "stemness" of MSCs, cell colony-forming tests and multidifferentiation assays were performed. We also examined the MSC subcellular structure using transmission electron microscopy and examined the healing effects of these cells on cartilage defects by pathological analyses. RESULTS: The results of growth kinetics and CCK-8 assays showed that radial shockwave treatment significantly promoted MSC proliferation. Enhanced cell growth was also reflected by an increase in the numbers of cells in the S phase and a decrease in the numbers of cells arrested in the G0/G1 phase in shockwave-treated MSCs. Unexpectedly, shockwaves caused a slight increase in MSC apoptosis rates. Furthermore, radial shockwaves promoted self-replicating activity of MSCs. Transmission electron microscopy revealed that MSCs were metabolically activated by shockwave treatment. In addition, radial shockwaves favored MSC osteogenic differentiation but inhibited adipogenic activity. Most importantly, MSCs pretreated by radial shockwaves exhibited an enhanced healing effect on cartilage defects in vivo. Compared with control groups, shockwave-treated MSCs combined with bio-scaffolds significantly improved histological scores of injured rabbit knees. CONCLUSIONS: In the present study, we found that radial shockwaves significantly promoted the proliferation and self-renewal of MSCs in vitro and safely accelerated the cartilage repair process in vivo, indicating favorable clinical outcomes.

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BACKGROUND: Shockwave treatment is increasingly used for plantar fasciitis and Achilles tendinopathy. To be effective it is believed that high pressure must be achieved in the tissues. We report on the first human cadaveric experiments to characterize pressure from radial shockwave therapy (rSWT) for plantar fasciitis. METHODS: The pressure from rSWT was measured in two cadaveric feet using a needle hydrophone. Maximal pressure and energy flux were calculated from the measurements. RESULTS: The pressure persisted longer than supposed, for up to 400µs. The peak negative pressure was up to two Mega Pascal. The predicted energy in the tissue strongly depended on the time interval used in calculations. CONCLUSIONS: The measured pressure may be sufficiently high to cause cavitation in the tissue, which is one of the proposed healing mechanisms associated with rSWT. The results suggest that the energy is imparted to the tissues for much longer than previously thought.

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BACKGROUND: Both ultrasound and radial shockwave therapies are used to treat tennis elbow syndrome. The aim of this study was to compare the therapeutic efficacy of both therapies by assessing the reduction in pain intensity and frequency, restoration of mobility, and reduction in the need for pain medication. MATERIAL AND METHODS: The study enrolled 60 people, who were randomly divided into two groups of 30 patients: those treated by radial shockwave therapy and those treated by ultrasound therapy. Radial shockwave therapy consisted of 3 sessions at weekly intervals. Ultrasound therapy consisted of 10 treatments performed daily. The clinical status of the patients before treatment, just after treatment, and after 8 weeks was assessed with the Leitinen questionnaire and a visual analogue scale (VAS). RESULTS: Pain reduction, as assessed by VAS scores, was observed in both groups, who were not different at baseline (p=0.807). While both therapies were effective (p<0.005), mean pain intensity assessed by VAS scores in patients treated by radial shockwave therapy was significantly lower compared to those treated by ultrasound therapy; this relationship was present just after treatment completion (p=0.001) and at 8 weeks after treatment completion (p=0.002). CONCLUSIONS: 1. Both radial shockwave and ultrasound therapies cause a reduction in the intensity and frequency of pain that persists for at least 8 weeks, reducing the need for pain medication and improving the function of the treated upper limb. 2. Ultrasound therapy is less effective than radial shockwave therapy.

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PURPOSE: Ultrasound Needling(UN) and Radial Shockwave(RSWT) aim to dissolve deposits in Shoulder Calcific tendinitis. METHODS: RCT in 25 patients to compare short term effectiveness. Outcome measures were pain and functional outcome at 6 weeks and 1 year and decrease of deposits after 6 weeks. RESULTS: UN decreased deposit more than RSWT(P = 0.029). After 6 weeks, Constant, NRS and Oxford improved more in UN. After 1 year, there was no significant difference in NRS(p = 0.45) or Oxford(p = 0.32). CONCLUSION: Compared to RSWT, UN resulted in lower pain and faster resorption of calcifications after 6 weeks. No significant differences were found after 1 year.