Objective. To assess the effectiveness and safety of extracorporeal shockwave therapy (ESWT) for the treatment of chronic low back pain (CLBP). Methods. This was a systematic review and meta-analysis of randomized controlled trials (RCTs) designed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analysis statement standard. We identified relevant studies by searching multiple electronic databases, trial registries, and websites up to April 30, 2021, and examining reference lists. We selected RCTs that compared ESWT, in unimodal or multimodal therapeutic approaches, with sham ESWT or other active therapies. Two investigators independently extracted data and assessed the risk of bias and quality of the evidence. The main outcomes were pain intensity and disability status, examined as standardized mean differences (SMD) with 95% confidence intervals (CI). The risk of bias was assessed by using Cochrane Back and Neck (CBN) Group risk of bias tool and Jadad score, and GRADE was applied to determine the confidence in effect estimates. Heterogeneity was explored using sensitivity analysis and meta-regression. Results. Ten RCTs, including a total of 455 young to middle-aged individuals (29.2–55.8 years), were identified. Compared with control, the ESWT group showed lower pain intensity at month 1 ( SMD = − 0.81 , 95% CI −1.21 to −0.42), as well as lower disability score at month 1 ( SMD = − 1.45 , 95% CI −2.68 to −0.22) and at month 3 ( SMD = − 0.69 , 95% CI −1.08 to −0.31). No serious shockwave-related adverse events were reported. Conclusion. The use of ESWT in CLBP patients results in significant and quantifiable reductions in pain and disability in the short term. However, further well-conducted RCTs are necessary for building high-quality evidence and promoting the application of ESWT in clinical practice.
Background The effectiveness and safety of intraoperative intravenous magnesium (IIM) on spine surgery remain uncertain, as recent randomized controlled trials (RCTs) yielded conflicting results. The purpose of this study was to determine the impact of IIM on spine surgery.Methods A literature search was performed on multiple electronic databases, ClinicalTrial.gov and Google Scholar on July 12th 2021, and reference lists were examined. We selected RCTs comparing the effects of IIM with placebo treatment on spine surgery. We calculated pooled standard mean difference (SMD) or risk ratio (RR) with 95% confident interval (CI) under a random-effect model. We assessed risk of bias using Cochrane risk-of-bias tool and Jadad score was applied to assess the quality of each included trial. Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) was used to determine the confidence in effect estimates. Sensitivity analysis was conducted by omitting each included study one by one from the pooled analysis. PROSPERO Registration: CRD42021266170.Findings Fourteen trials of 781 participants were included. Low-to moderate-quality evidence suggested that IIM reduces postoperative morphine consumption at 24 h (SMD: -1¢61 mg, 95% CI: -2¢63 to -0¢58) and intraoperative remifentanil requirement (SMD: -2¢09 ug/h, 95% CI: -3¢38 to -0¢81). High-quality evidence suggested that IIM reduces the risk of postoperative nausea and vomiting compared with placebo (RR: 0¢43, 95% CI: 0¢26 to 0¢71). Besides, moderate-quality evidence suggested that recovery orientation time in the IIM group is longer than control group (SMD: 1¢13 min, 95% CI: 0¢83 to 1¢43).Interpretation IIM as adjuvant analgesics showed overall benefits on spine surgery in terms of reducing analgesic requirement and postoperative nausea and vomiting; however, potential risks of IIM, such as delayed anesthetic awakening, should not be ignored. Future evidence will inform the optimal strategy of IIM administration for patients undergoing spine surgery.
ObjectiveTo assess the mid-long-term clinical and radiological outcomes of zero-profile (ZP) compared with stand-alone (ST) cages for two-level anterior cervical discectomy and fusion (ACDF).MethodsWe included 77 patients (39 women and 38 men) who underwent two-level ACDF between May 5, 2016, and May 5, 2020, and who were followed up for at least 1 year. The subjects were divided into the ST (n = 38) and ZP (n = 39) group. For the evaluation of functional status, Japanese Orthopedic Association (JOA), Neck Disability Index (NDI), and Visual Analogue Scale (VAS) scores were used. Additionally, radiological outcomes and procedure complications were observed at final follow-up.ResultsBoth groups had excellent clinical outcomes at the final follow-up. There were no significant intergroup (ZP vs. ST) differences in the fusion rate (91.02% vs. 90.79%, P > 0.05) and postoperative dysphagia (15.4% vs. 2.6%, P = 0.108). However, the disc height at the final follow-up in the ZP group was higher than that in the ST group (6.86 ± 0.84 vs. 6.17 ± 1.03, P = 0.002). The ZP group accomplished a lower loss of cervical lordosis (18.46 ± 4.78 vs. 16.55 ± 4.36, P = 0.071), but without reaching statistical significance.ConclusionACDF with either ZP or ST cages turns out to be a dependable strategy for two-level ACDF in terms of clinical results. However, compared with the ST, the ZP cage may achieve a significantly lower loss of disc height.
Study design Retrospective cross-sectional study. Objective To investigate the prevalence, characteristics, and risk factors of spine-related malpractice claims in China in a 2-year period. Methods The arbitration files of the Chinese Medical Association (CMA) were reviewed for spine-related malpractice claims. Descriptive statistics and correlation analysis were conducted on claim characteristics, clinical data, plaintiff’s main allegations, and arbitration outcomes. Results A total of 288 cases of spinal claims filed in the CMA between January 2016 and December 2017 were included. Most claims were found in lumbar degenerative disorders (59.4%), lumbar trauma (13.2%), and cervical degenerative disorders (11.8%). The most common adverse events (AEs) leading to claims were new neurologic deficit (NND) (47.6%), infection (11.5%), and insufficient symptom relief (10.4%). The most common patient allegation was surgical error (66.0%), although the main arbitrated cause of AEs was disease/treatment itself (49.0%), while providers were judged as mainly responsible in only 47.3% cases. In multivariate regression analysis, cervical spine, misdiagnosis/mistreatment, and unpredictable emergency correlated with more severe damage to patients; minimally invasive surgery was predictive of judgment in plaintiff’s favor, while claims in the eastern region and unpredictable emergencies were predictive of defendant’s favor; only NND was associated with being arbitrated as surgical error in surgical cases where surgeons accepted major liability. Conclusion The current study provided a descriptive overview and risk factor analysis of spine-related malpractice claims in China. Gaining improved understanding of the facts and causes of malpractice claims may help providers reduce the risk of claims and subsequent litigation.
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