Cardiac shockwave therapy in addition to coronary bypass surgery improves myocardial function in ischaemic heart failure: the CAST-HF trial.

BACKGROUND AND AIMS: In chronic ischaemic heart failure, revascularisation strategies control symptoms but are less effective in improving left ventricular ejection fraction (LVEF). The aim of this trial is to investigate the safety of cardiac shockwave therapy (SWT) as a novel treatment option and its efficacy in increasing cardiac function by inducing angiogenesis and regeneration in hibernating myocardium. METHODS: In this single-blind, parallel-group, sham-controlled trial (cardiac shockwave therapy for ischemic heart failure, CAST-HF; NCT03859466) patients with LVEF ≤40% requiring surgical revascularisation were enrolled. Patients were randomly assigned to undergo direct cardiac SWT or sham treatment in addition to coronary bypass surgery. The primary efficacy endpoint was the improvement in LVEF measured by cardiac magnetic resonance imaging from baseline to 360 days. RESULTS: Overall, 63 patients were randomized, out of which 30 patients of the SWT group and 28 patients of the Sham group attained 1-year follow-up of the primary endpoint. Greater improvement in LVEF was observed in the SWT group (Δ from baseline to 360 days: SWT 11.3%, SD 8.8; Sham 6.3%, SD 7.4, P = .0146). Secondary endpoints included the 6-minute walking test, where patients randomized in the SWT group showed a greater Δ from baseline to 360 days (127.5 m, SD 110.6) than patients in the Sham group (43.6 m, SD 172.1) (P = .028) and Minnesota Living with Heart Failure Questionnaire score on day 360, which was 11.0 points (SD 19.1) for the SWT group and 17.3 points (SD 15.1) for the Sham group (P = .15). Two patients in the treatment group died for non-device-related reasons. CONCLUSIONS: In conclusion, the CAST-HF trial indicates that direct cardiac SWT, in addition to coronary bypass surgery improves LVEF and physical capacity in patients with ischaemic heart failure.

Antibody seroprevalence and rate of asymptomatic infections with SARS-CoV-2 in Austrian hospital personnel.

BACKGROUND: The aims of this study are to determine (i) SARS-CoV-2 antibody positive employees in Austrian trauma hospitals and rehabilitation facilities, (ii) number of active virus carriers (symptomatic and asymptomatic) during the study, (iii) antibody decline in seropositive subjects over a period of around 6 months, (iv) the usefulness of rapid antibody tests for outpatient screening. METHOD: A total of 3301 employees in 11 Austrian trauma hospitals and rehabilitation facilities of the Austrian Social Insurance for Occupational Risks (AUVA) participated in this open uncontrolled prospective cohort study. Rapid lateral flow tests, detecting a combination of IgM and IgM against SARS-CoV-2), two different types of CLIA (Diasorin, Roche), RT-PCR tests and serum neutralization tests (SNTs) were performed. The tests were conducted twice, with an interval of 42.4 ± 7.7 (Min = 30, Max = 64) days. Positive participants were re-tested with CLIA/SNT at a third time point after 188.0 ± 12.8 days. RESULTS: Only 27 out of 3301 participants (0.82%) had a positive antibody test at any time point during the study confirmed via neutralization test. Among positively tested participants in either test, 50.4% did not report any symptoms consistent with common manifestations of COVID-19 during the study period or within the preceding 6 weeks. In the group who tested positive during or prior to study inclusion the most common symptoms of an acute viral illness were rhinitis (21.9%), and loss of taste and olfactory sense (21.9%). Based on the neutralization test as the true condition, the rapid antibody test performed better on serum than whole blood as 84.6% instead of 65.4% could be detected correctly. Concerning both CLIA tests overall the Roche test detected 24 (sensitivity = 88.9%) and the Diasorin test 22 positive participants (sensitivity = 81.5%). In participants with a positive SNT result, a significant drop in neutralizing antibody titre from 31.8 ± 22.9 (Md = 32.0) at T1 to 26.1 ± 17.6 (Md = 21.3) at T2 to 21.4 ± 13.4 (Md = 16.0) at T3 (χ2 = 23.848, df = 2, p < 0.001) was observed (χ2 = 23.848, df = 2, p < 0.001)-with an average time of 42.4 ± 7.7 days between T1 and T2 and 146.9 ± 13.8 days between T2 and T3. CONCLUSIONS: During the study period (May 11th-August 3rd) only 0.82% were tested positive for antibodies in our study cohort. The antibody concentration decreases significantly over time with 14.8% (4 out of 27) losing detectable antibodies.

Effect of extracorporeal shockwave therapy (ESWT) on pulpal blood flow after orthodontic treatment: a randomized clinical trial.

OBJECTIVES: The effect of non-invasive extracorporeal shockwaves on pulpal blood flow in orthodontic patients who have undergone active treatment was investigated. MATERIALS AND METHODS: Seventy-two adult patients were enrolled in the clinical trial and allocated by block randomization to a treatment or a placebo group at a 1:1 ratio. The patients were required to be otherwise healthy. Blinding was performed for the subjects and the outcome assessor. The region of interest was the mandibular incisors and canines, which were vital, unrestored, and had experienced no trauma. The active treatment group received a single shockwave treatment with 1000 impulses at 0.19-0.23 mJ/mm(2) while the placebo group was treated with a deactivated shockwave applicator but acoustic sham. Pulpal blood flow was evaluated four times over a period of 6 months starting from the day of bracket removal, using a laser Doppler device. RESULTS: Thirty patients were evaluated in each group. Orthodontic patients who have undergone active treatment tend to have high levels of pulpal blood flow which decrease over a period of 6 months. Pulpal blood flow did not differ significantly over 6 months between the placebo and treatment group. Shockwave treatment was associated with no significant effect in respect of tooth type, age, sex, or mean blood pressure, and had no unintended pernicious effects. CONCLUSIONS: Extracorporeal shockwaves had no statistically significant effect on pulpal blood flow. Multiple applications of ESWT in a pathological setup may be needed in future studies to demonstrate significant differences. CLINICAL RELEVANCE: The absence of any adverse effects justifies further principal investigations of the use of shockwave treatment in the oral cavity.

Impact of extracorporeal shockwave therapy on tooth mobility in adult orthodontic patients: a randomized single-center placebo-controlled clinical trial.

AIM: This RCT investigated the effect of non-invasive extracorporeal shockwaves on tooth mobility in orthodontic patients after active treatment. MATERIALS AND METHODS: Seventy-two adult patients were included in the study. Immediately after active orthodontic treatment, patients were assigned to a treatment or a placebo group based on block randomization. The orthodontic patients were required to be otherwise healthy. The region of interest was the anterior portion of the mandible. The treatment group received a single shockwave treatment with 1000 impulses while the placebo group was treated with an acoustic sham. Tooth mobility was evaluated over a period of 6 months using a Periotest and manual testing. Pocket probing depths, bleeding on probing and the irregularity index were also assessed. RESULTS: Tooth mobility reduced significantly over 6 months in both groups, but shockwaves achieved significantly more rapid reduction on manual testing. Probing depth was significantly reduced while the irregularity index remained stable. Bleeding on probing was significantly reduced in the treatment group. No anti-inflammatory effect could be derived due to possible initial group differences. CONCLUSIONS: The mobility of teeth aligned by orthodontic treatment reduces over time. Shockwave treatment appeared to reduce tooth mobility more rapidly.

Impact of extracorporeal shock wave therapy (ESWT) on orthodontic tooth movement-a randomized clinical trial.

OBJECTIVES: This randomized clinical trial investigated the effect of extracorporeal shock waves on the amount of orthodontic tooth movement and periodontal parameters. MATERIAL AND METHODS: Twenty-six adult orthodontic patients participated in this clinical trial; all of them receiving lower second molar mesially directed movement. The fixed orthodontic device included superelastic coil springs (200 cN) and miniscrews as temporary anchorage device. The active treatment group received a single shock wave treatment with 1,000 impulses in the region of tooth movement. The placebo group was treated with deactivated shock wave applicator with an acoustic sham. The study period lasted 4 months with a monthly data exploration. RESULTS: No statistically significant difference in posterior-anterior tooth movement between the treatment and placebo group was seen during observation period. Gender had no significant influence on tooth movement in either group. No significant difference occurred in mesio-distal tipping and rotation, but a significant difference (p = 0.035) in bucco-lingual tipping of the molars was found. Periodontal status of the patients (sulcus probing depth, gingival index) did not significantly differ in both groups. The plaque index showed a significant difference (p = 0.003). CONCLUSIONS: Single application of extracorporeal shock wave treatment was associated neither with a statistically significant acceleration of tooth movement nor with an altered periodontal status in vivo. CLINICAL RELEVANCE: Shock waves showed no harmful effects in the investigated area. Their clinical use for lithotripsy during orthodontic therapy might be permitted.

Impact of extracorporeal shock-wave therapy on the stability of temporary anchorage devices in adults: a single-center, randomized, placebo-controlled clinical trial.

INTRODUCTION: In this randomized, placebo-controlled clinical trial, we investigated the effect of noninvasive extracorporeal shock waves on the stability of temporary anchorage devices (TADs) under orthodontic loading. METHODS: Thirty adult orthodontic patients of the Bernhard Gottlieb University Clinic in Vienna, Austria, were enrolled in this clinical trial and allocated by block randomization (size, 4) in a 1:1 ratio to either the treatment or the placebo group. Randomization was performed with software, and the allocations were concealed in sealed envelopes. Eligibility criteria included healthy adult patients with mesially directed orthodontic movement of the mandibular second molar into the extraction site of the mandibular first molar. The fixed orthodontic devices included active superelastic coil springs (200 cN) and TADs in the mandibular alveolar bone. Blinding was performed for the subjects and the outcome assessor. The treatment group received 1 shock-wave application with 1000 impulses at 0.19 to 0.23 mJ per square millimeter in the region of the TADs. The placebo group was treated with a deactivated shock-wave applicator and acoustic sham. The TADs positions were evaluated at placement and after 4 months. The reliability and precision of the impression process of the TADs were evaluated in an in-vitro model. RESULTS: Thirteen participants finished the investigation successfully in the treatment group but only 12 finished in the placebo group because 1 TAD loosened. The difference of the total TAD displacement for the 4-month time period between the placebo and treatment groups was 0.17 ± 0.95 mm (95% CI: -0.96, 0.62). No statistically significant difference between the 2 groups was found when sex was evaluated. Primary stability of the TADs as measured by placement torque, amount of tooth movement, and age of the patients did not influence displacement of the TADs. The reliability and precision of TAD impressions were confirmed. No unintended pernicious effects occurred after shock-wave treatment during the study period. CONCLUSIONS: A single application of extracorporeal shock-wave treatment did not improve the stability of the TADs during orthodontic loading. Sufficient interradicular space should be provided to minimize the risk of periodontal and dental root defects. REGISTRATION: This trial was registered at https://clinicaltrials.gov. PROTOCOL: The protocol was published before trial commencement, NCT01695928. FUNDING: No funding or conflict of interest to be declared.

Combined Electromagnetic and Electrohydraulic Focused ESWT and EMTT for Delayed Calcaneal Union in an Adolescent Parkour Athlete - A Case Report.

This case report describes a novel and unique combination of both electromagnetic and electrohydraulic focused extracorporeal shockwave therapy (ESWT) and extracorporeal magnetotransduction therapy (EMTT) for accelerated healing in a calcaneus epiphyseal fracture with delayed healing in an adolescent Parkour athlete. After a 2.5m jump, the 14-year-old experienced significant heel pain, however avoided telling his parents. After eight weeks, the initial imaging using ultra low dose weight-bearing cone beam CT (WBCT) revealed a calcaneus non-union situation adjacent to the open calcaneal physis. To improve and accelerate bony healing substantially, we chose to apply both combined focused electromagnetic (Storz Ultra, Storz Medical AG, Tägerwillen, CH) and focused electrohydraulic (MTS, Konstanz, Germany) ESWT in a fractioned fashion plus EMTT (Storz Magnetolith, Tägerwillen, CH) in five consecutive weekly sessions while allowing the patient to fully weight bear. The follow-up WBCT after six weeks revealed a near to total healing of the delayed union and being pain-free. Notably, combination therapy with focused ESWT and EMTT did not result in early closure of the calcaneal epiphysis. We conclude that combined focused electromagnetic and electrohydraulic ESWT and EMTT facilitate bony healing in adolescent calcaneal apophyseal fractures without any adverse effects on the open physis. Evidence level IV (case report).

Prospective randomized phase II Trial of accelerated reepithelialization of superficial second-degree burn wounds using extracorporeal shock wave therapy.

BACKGROUND: As extracorporeal shock wave therapy (ESWT) can enhance healing of skin graft donor sites, this study focused on shock wave effects in burn wounds. METHODS: A predefined cohort of 50 patients (6 with incomplete data or lost to follow-up) with acute second-degree burns from a larger study of 100 patients were randomly assigned between December 2006 and December 2007 to receive standard therapy (burn wound debridement/topical antiseptic therapy) with (n = 22) or without (n = 22) defocused ESWT (100 impulses/cm at 0.1 mJ/mm) applied once to the study burn, after debridement. Randomization sequence was computer-generated, and patients were blinded to treatment allocation. The primary endpoint, time to complete burn wound epithelialization, was determined by independent, blinded-observer. A worst case scenario was applied to the missing cases to rule out the impact of withdrawal bias. RESULTS: Patient characteristics across the 2 study groups were balanced (P > 0.05) except for older age (53 ± 17 vs. 38 ± 13 years, P = 0.002) in the ESWT group. Mean time to complete (≥95%) epithelialization (CE) for patients that did and did not undergo ESWT was 9.6 ± 1.7 and 12.5 ± 2.2 days, respectively (P < 0.0005). When age (continuous variable) and treatment group (binary) were examined in a linear regression model to control the baseline age imbalance, time to CE, age was not significant (P = 0.33) and treatment group retained significance (P < 0.0005). Statistical significance (P = 0.001) was retained when ESWT cases with missing follow-up were assigned the longest time to CE and when controls with missing follow-up were assigned the shortest time to CE. CONCLUSIONS: In this randomized phase II study, application of a single defocused shock wave treatment to the superficial second-degree burn wound after debridement/topical antiseptic therapy significantly accelerated epithelialization. This finding warrants confirmation in a larger phase III trial (ClinicalTrials.gov identifier: NCT01242423).

Extracorporeal shock wave therapy (ESWT) for wound healing: technology, mechanisms, and clinical efficacy.

For almost 30 years, extracorporeal shock wave therapy has been clinically implemented as an effective treatment to disintegrate urinary stones. This technology has also emerged as an effective noninvasive treatment modality for several orthopedic and traumatic indications including problematic soft tissue wounds. Delayed/nonhealing or chronic wounds constitute a burden for each patient affected, significantly impairing quality of life. Intensive wound care is required, and this places an enormous burden on society in terms of lost productivity and healthcare costs. Therefore, cost-effective, noninvasive, and efficacious treatments are imperative to achieve both (accelerated and complete) healing of problematic wounds and reduce treatment-related costs. Several experimental and clinical studies show efficacy for extracorporeal shock wave therapy as means to accelerate tissue repair and regeneration in various wounds. However, the biomolecular mechanism by which this treatment modality exerts its therapeutic effects remains unclear. Potential mechanisms, which are discussed herein, include initial neovascularization with ensuing durable and functional angiogenesis. Furthermore, recruitment of mesenchymal stem cells, stimulated cell proliferation and differentiation, and anti-inflammatory and antimicrobial effects as well as suppression of nociception are considered important facets of the biological responses to therapeutic shock waves. This review aims to provide an overview of shock wave therapy, its history and development as well as its current place in clinical practice. Recent research advances are discussed emphasizing the role of extracorporeal shock wave therapy in soft tissue wound healing.

Safe and Effective Treatment of Compromised Clavicle Fracture of the Medial and Lateral Third Using Focused Shockwaves.

A delay or failure to heal is the most common possible complication in clavicle fractures, especially in cases primarily treated conservatively. As the current standard therapy, surgical revision achieves good healing results, but is associated with potential surgery-related complications. Shockwave therapy as a non-invasive therapy shows similar reasonable consolidation rates in the non-union of different localizations, but avoids complications. Compromised clavicle fractures in the middle and lateral third treated with focused high-energy shockwave therapy were compared with those treated with surgical revision (ORIF). In addition, a three-dimensional computer simulation for evaluating the pressure distribution during shockwave application accompanied the clinical study. A comparable healing rate in bony consolidation was achieved in both groups. Significantly fewer complications, however, occurred in the shockwave group. The simulations showed safe application in this instance, particularly in avoiding lung tissue affection. When applied correctly, shockwaves represent a safe and promising therapy option for compromised clavicle fractures in the middle and lateral third.

High-energy extracorporeal shockwave therapy in humeral delayed and non-unions.

INTRODUCTION: Within the last few decades, focused high-energy extracorporeal shockwave therapy (ESWT) has proven to be an effective alternative to standard of care revision surgery in delayed healing fractures or manifest non-unions in various anatomical regions. MATERIALS AND METHODS: A retrospective multi-variant analysis of an open prospective, single-armed clinical study was conducted. Patients receiving focused high-energy ESWT for a delayed healing or an apparent non-union of a humeral fracture between January 1999 and December 2015 at a single trauma center were included in the study. Bony healing was defined as cortical continuity in three of four cortices and pain-free force loading and evaluated using CT scans and clinical examination at three- and six-month follow-ups after ESWT. RESULTS: A total of 236 patients were included. N = 93 (43.8%) showed bony consolidation three months after ESWT and n = 105 (52.5%) after six months. Sub-group analysis showed significantly better healing for the proximal metaphyseal humerus (66.7% after six months, n = 42) compared to the diaphyseal region (48.1%, n = 133) and distal metaphyseal humerus (48.1%, n = 25). Regression analysis indicated significantly increased healing rates for patients of younger ages (p = 0.001) and a fracture diastasis of less than 5 mm (p = 0.002). CONCLUSION: The findings of this study indicate that ESWT can be considered as a treatment option for a well-selected patient population despite the lower healing rates compared to other anatomical regions.

The effect of extracorporeal shock wave therapy in acute traumatic spinal cord injury on motor and sensory function within 6 months post-injury: a study protocol for a two-arm three-stage adaptive, prospective, multi-center, randomized, blinded, placebo-controlled clinical trial.

BACKGROUND: The pathological mechanism in acute spinal cord injury (SCI) is dual sequential: the primary mechanical lesion and the secondary injury due to a cascade of biochemical and pathological changes initiated by the primary lesion. Therapeutic approaches have focused on modulating the mechanisms of secondary injury. Despite extensive efforts in the treatment of SCI, there is yet no causal, curative treatment approach available. Extracorporeal shock wave therapy (ESWT) has been successfully implemented in clinical use. Biological responses to therapeutic shock waves include altered metabolic activity of various cell types due to direct and indirect mechanotransduction leading to improved migration, proliferation, chemotaxis, modulation of the inflammatory response, angiogenesis, and neovascularization, thus inducing rather a regeneration than repair. The aim of this clinical study is to investigate the effect of ESWT in humans within the first 48 h after an acute traumatic SCI, with the objective to intervene in the secondary injury phase in order to reduce the extent of neuronal loss. METHODS: This two-arm three-stage adaptive, prospective, multi-center, randomized, blinded, placebo-controlled study has been initiated in July 2020, and a total of 82 patients with acute traumatic SCI will be recruited for the first stage in 15 participating hospitals as part of a two-armed three-stage adaptive trial design. The focused ESWT (energy flux density: 0.1-0.19 mJ/mm2, frequency: 2-5 Hz) is applied once at the level of the lesion, five segments above/below, and on the plantar surface of both feet within the first 48 h after trauma. The degree of improvement in motor and sensory function after 6 months post-injury is the primary endpoint of the study. Secondary endpoints include routine blood chemistry parameters, the degree of spasticity, the ability to walk, urological function, quality of life, and the independence in everyday life. DISCUSSION: The application of ESWT activates the nervous tissue regeneration involving a multitude of various biochemical and cellular events and leads to a decreased neuronal loss. ESWT might contribute to an improvement in the treatment of acute traumatic SCI in future clinical use. TRIAL REGISTRATION: ClinicalTrials.gov NCT04474106.

Extracorporeal shock wave therapy (ESWT) minimizes ischemic tissue necrosis irrespective of application time and promotes tissue revascularization by stimulating angiogenesis.

OBJECTIVE: To assess the time-dependent treatment effects of extracorporeal shock wave therapy (ESWT) in a standard rodent ischemic epigastric flap model. BACKGROUND: ESWT has been shown to accelerate tissue repair in acute and chronic wounds and improve graft survival, but the mechanism remains incompletely understood. METHODS: Shock waves at 0.1 mJ/mm and 5 impulses/s (total 300 impulses) were applied to the epigastric flap ischemic region at various times pre-, immediately and 24 hours postischemic insult. Flap survival; vascular perfusion; vessel number; von Willebrand factor and smooth muscle actin protein expression as well as in vivo vascular endothelial growth factor receptor 2 expression were evaluated at 1, 3, and 7 days postoperatively in ESWT-treated and untreated controls. RESULTS: Flap perfusion, microvessel number, and survival (through reduced flap contraction and necrosis) were significantly enhanced in the treated groups compared with controls, irrespective of timing of shock wave treatment (preischemia vs. postischemia). Vascular endothelial growth factor receptor 2 expression was dynamically upregulated in response to ESWT. CONCLUSION: Shock wave preconditioning and treatment postischemic insult improves skin flap survival through neovascularization and early upregulation of angiogenesis-related growth factors.

Evidence supporting extracorporeal shock wave therapy for acute and chronic soft tissue wounds.

Objective. Soft tissue wound healing is a complex and well-orchestrated sequence of events on multiple biological levels involving systemic, cellular, and molecular signals. The physiological process of wound healing leads to full tissue repair and regeneration with nearly complete restoration of tissue integrity and functionality. Wounds, particularly among the elderly population, can show delayed or disturbed healing; however, delayed or disturbed healing is also evident in patients with comorbidities such as diabetes, atherosclerosis, venous/arterial insufficiency, reduced mobility due to chronic infirmity, and hypercholesterolemia. Chronic wounds are conditions, which include a wide range of inflammatory and degenerative conditions of the musculoskeletal system. Management of chronic, difficult to heal, or non-healing soft tissue wounds requires a multidisciplinary approach. Often these treatment options have inconsistent and irregular outcomes. Poor response or failure to conservative treatments places a substantial burden on patients, their families, the healthcare system, and society in general. Therefore, the development of a new, effective method of treatment to improve healing of problematic wounds and reduce treatment-related costs is extremely valuable. One such therapy is Extracorporeal Shockwave Therapy (ESWT). ESWT acts through mechanotransduction, which produces therapeutic benefits through complex biological pathways including neovascularization and tissue regeneration in the therapeutic target. Published data thus far suggest that the application of ESWT for soft tissue indications is safe, reliable, cost-effective, and clinically efficacious. The exact biological effects of ESWT on human cells are not completely understood, but are currently undergoing further study. The aim of this review is to provide a general overview of shockwave therapy and its role in the treatment of acute and chronic soft tissue wounds. .

The role of shockwaves in the enhancement of bone repair - from basic principles to clinical application.

Extracorporeal shockwave therapy is a treatment modality, originally introduced into the clinic as lithotripsie, which has also been successfully used in the last two decades in the non-invasive treatment of delayed or non-healing fractures. Initially, the mechanism of action was attributed to microfracture-induced repair, but intensive basic research has now shown that the shockwave generates its effect in tissue via mechanotransduction. Numerous signal transduction pathways have already been demonstrated, which in their entirety trigger an endogenous regeneration process via cell proliferation, migration and differentiation. Clinically, these shockwave-conveyed biological signals support healing of acute, delayed and non-union fractures. The attainable outcome is comparable to surgery but avoiding an open approach with associated potential complications. These advantageous properties with a clearly positive cost-benefit ratio make shockwave therapy a first line treatment in delayed and non-union fractures.

Routine Blood Chemistry Predicts Functional Recovery After Traumatic Spinal Cord Injury: A Post Hoc Analysis.

BACKGROUND: Spinal cord injury (SCI) leads to various degrees of lifelong functional deficits. Most individuals with incomplete SCI experience a certain degree of functional recovery, especially within the first-year postinjury. However, this is difficult to predict, and surrogate biomarkers are urgently needed. OBJECTIVE: We aimed to (1) determine if routine blood chemistry parameters are related to neurological recovery after SCI, (2) evaluate if such parameters could predict functional recovery, and (3) establish cutoff values that could inform clinical decision-making. METHODS: We performed a post hoc analysis of routine blood chemistry parameters in patients with traumatic SCI (n = 676). Blood samples were collected between 24 and 72 hours as well as at 1, 2, 4, 8, and 52 weeks postinjury. Linear mixed models, regression analysis, and unbiased recursive partitioning (URP) of blood chemistry data were used to relate to and predict walking recovery 1 year postinjury. RESULTS: The temporal profile of platelet counts and serum levels of albumin, alkaline phosphatase, and creatinine differentiated patients who recovered walking from those who remained wheelchair bound. The 4 blood chemistry parameters from the sample collection 8 weeks postinjury predicted functional recovery observed 1 year after incomplete SCI. Finally, URP defined a cutoff for serum albumin at 3.7 g/dL, which in combination with baseline injury severity differentiates individuals who regain ambulation from those not able to walk. Specifically, about 80% of those with albumin >3.7 g/dL recovered walking. CONCLUSIONS: Routine blood chemistry data from the postacute phase, together with baseline injury severity, predict functional outcome after incomplete SCI.

Combat Wound Initiative program.

The Combat Wound Initiative (CWI) program is a collaborative, multidisciplinary, and interservice public-private partnership that provides personalized, state-of-the-art, and complex wound care via targeted clinical and translational research. The CWI uses a bench-to-bedside approach to translational research, including the rapid development of a human extracorporeal shock wave therapy (ESWT) study in complex wounds after establishing the potential efficacy, biologic mechanisms, and safety of this treatment modality in a murine model. Additional clinical trials include the prospective use of clinical data, serum and wound biomarkers, and wound gene expression profiles to predict wound healing/failure and additional clinical patient outcomes following combat-related trauma. These clinical research data are analyzed using machine-based learning algorithms to develop predictive treatment models to guide clinical decision-making. Future CWI directions include additional clinical trials and study centers and the refinement and deployment of our genetically driven, personalized medicine initiative to provide patient-specific care across multiple medical disciplines, with an emphasis on combat casualty care.

Effect of unfocused extracorporeal shockwave therapy on bone mineral content of twelve distal forearms of postmenopausal women: a clinical pilot study.

Extracorporeal shockwave therapy showed a pronounced effect on bone mass in previous animal studies. We showed in this pilot study that a single treatment with unfocused shockwave therapy in unselected patients does not show side effects. Although our study did not show any effect of shockwave on BMD, the limited sample size does not definitively exclude this and a study with 174 subjects per group would be needed to show an effect size of 0.3 with a power of 80%. PURPOSE: Unfocused extracorporeal shockwave therapy might stimulate bone formation to reduce the fracture risk. In this study, we assessed the safety of unfocused extracorporeal shockwave therapy and its effects on bone mass. METHODS: A clinical pilot study with twelve female patients free of bone disease undergoing elective surgery of the lower extremity or elective spinal surgery under general anesthesia received 3.000 electrohydraulic-generated unfocused extracorporeal shockwaves (energy flux density 0.3 mJ/mm2) to one distal forearm. The contralateral forearm served as a control. We examined the effect on bone mass with the use of repeated dual energy X-ray absorptiometry measurements and we measured patient discomfort around the therapy. RESULTS: No difference in bone mineral content and density was measured 6 and 12 weeks after therapy. shockwave therapy occasionally caused transient erythema or mild hematoma, but no discomfort in daily life or (late) adverse events. CONCLUSIONS: Unfocused extracorporeal shockwave therapy is a safe treatment, but no increase in bone mass on the forearm was found at 0.3 mJ/mm2 energy flux density. In this study, we were not able to demonstrate that a single treatment with unfocused shockwave therapy in unselected patients had any effect in terms of bone mineral density (BMD) or bone mineral content (BMC). A power analysis indicated that 174 patients per group are required to show an effect size of 0.3 with a power of 80%.