Trials
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Randomized Controlled Trial Comparative Study
Short-term study on risk-benefit outcomes of two spinal manipulative therapies in the treatment of acute radiculopathy caused by lumbar disc herniation: study protocol for a randomized controlled trial.
That patients with acute radiculopathy caused by lumbar disc herniation (LDH) will benefit from spinal manipulation (SM) treatment has been taken for granted, despite no solid evidence to support that claim. There is a demand for a win-win SM treatment that is both effective and less risky, and we attempt to use this trial to demonstrate such a treatment. In this study, Feng's Spinal Manipulative Therapy (FSM) is selected as the observational SM. FSM can be performed with either manipulation or mobilization, and also can be easily mimicked as a sham SM. ⋯ Two hundred and sixteen qualified hospitalized participants will be randomly allocated to one of the three following groups: sham SM, mobilization, or manipulation, according to a ratio of 1:1:1. Participants in each group will receive specific FSM treatments four times, along with basic therapies over a course of 2 weeks. Two days after each SM appointment, risk outcomes will be assessed using a questionnaire developed to identify accompanying unpleasant reactions (AUR). The pain pressure threshold (PPT) will be measured paraspinally on the tender spot beside the involved joint before and immediately after each SM treatment. Relative risk (RR) of AUR, number needed to harm (NNH) and the 95% confidence intervals of each group will be calculated and compared. Benefit outcomes will be assessed by analyzing the following data recordings: the Numerical Rating Scale (NRS), Oswestry Disability Index (ODI), and Global Perceived Effect (GPE) before enrollment and at the 7th, and 15th day after the treatment. Analyses will include comparisons of NRS, ODI and changes at the different visit times among the three groups by Repeated Measures Data ANOVA, an evaluation of reduced scores of NRS and ODI after the therapy to determine if they meet the minimum acceptable outcome (MAO), and the determination of the minimal clinically important difference (MCID) by the average improvement in NRS and ODI scores of all participants who have been allocated to the category 'improved' on the GPE assessment.
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Postoperative delirium (POD) is a manifestation of acute postoperative brain dysfunction that is frequently observed after cardiac surgery. POD is associated with short-term complications such as an increase in mortality, morbidity, costs and length of stay, but can also have long-term sequelae, including persistent cognitive deficits, loss of independence, and increased mortality for up to 2 years. The noble gas xenon has been demonstrated in various models of neuronal injury to exhibit remarkable neuroprotective properties. We therefore hypothesize that xenon anesthesia reduces the incidence of POD in elderly patients undergoing cardiac surgery with the use of cardiopulmonary bypass. ⋯ Older patients undergoing cardiac surgery are at particular risk to develop POD. Xenon provides remarkable hemodynamic stability and has been suggested in preclinical studies to exhibit neuroprotective properties. The present trial will assess whether the promising profile of xenon can be translated into a better outcome in the geriatric population.
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Central to the design of a randomised controlled trial is the calculation of the number of participants needed. This is typically achieved by specifying a target difference and calculating the corresponding sample size, which provides reassurance that the trial will have the required statistical power (at the planned statistical significance level) to identify whether a difference of a particular magnitude exists. Beyond pure statistical or scientific concerns, it is ethically imperative that an appropriate number of participants should be recruited. Despite the critical role of the target difference for the primary outcome in the design of randomised controlled trials, its determination has received surprisingly little attention. This article provides guidance on the specification of the target difference for the primary outcome in a sample size calculation for a two parallel group randomised controlled trial with a superiority question. ⋯ Specification of the target difference for the primary outcome is a key component of a randomized controlled trial sample size calculation. There is a need for better justification of the target difference and reporting of its specification.
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Randomized Controlled Trial
Surgeon, staff, and patient radiation exposure in minimally invasive transforaminal lumbar interbody fusion: impact of 3D fluoroscopy-based navigation partially replacing conventional fluoroscopy: study protocol for a randomized controlled trial.
Some symptomatic degenerative conditions of the lumbar spine may be treated with spinal fusion if conservative treatment has failed. The minimally invasive technique of transforaminal lumbar interbody fusion (MIS TLIF) is increasingly used but has been found to generate increased radiation exposure to the patient and staff. Modern three-dimensional (3D) C-arm devices are capable of providing conventional two-dimensional fluoroscopic images (x-rays) as well as 3D image sets for intraoperative navigation. This study was designed to compare the radiation exposure between these two intraoperative imaging techniques in MIS TLIF procedures. ⋯ Results of this randomized study will help to compare the radiation exposure to the operating staff and patient during MIS TLIF procedures using conventional fluoroscopy versus 3D fluoroscopy-based navigation combined with conventional fluoroscopy. Furthermore, recommendations regarding the appropriate use of the investigated intraoperative imaging techniques will be made to improve radiation protection and to reduce radiation exposure.
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Medication safety for older persons represents an ongoing challenge. Inappropriate prescriptions--those with a high risk of evidence-based harm--persist in up to 25% of seniors, and account for a significant proportion of avoidable emergency department visits. This project is the sequel to the EMPOWER study, in which a novel consumer-targeted written knowledge transfer tool aimed at empowering older adults to act as drivers of benzodiazepine de-prescription resulted in a 27% reduction of inappropriate benzodiazepine use at 6-month follow-up (number needed to treat (NNT) = 4). Failure to discontinue in the EMPOWER study was attributable to re-emerging symptoms among participants, prescribing inertia, and lack of knowledge and skills for substituting alternate therapy among physicians and pharmacists. To maximize de-prescription of inappropriate therapy, educational medication-risk reduction initiatives should be tested that simultaneously include patients, physicians and pharmacists. The objective of this trial is to: 1) test the beneficial effect of a new de-prescribing paradigm enlisting pharmacists to transfer knowledge to both patients and prescribers in a 2-pronged approach to reduce inappropriate prescriptions, compared to usual care and 2) evaluate the transferability of the EMPOWER study concept to other classes of inappropriate prescriptions. ⋯ System change to effectively reduce medication risk among community-dwelling seniors requires a coordinated approach targeting physicians, pharmacists and patients. This trial will test the feasibility and effectiveness of a tripartite approach to de-prescribing.