Trials
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Randomized Controlled Trial Comparative Study
Effect of manual versus mechanically assisted manipulations of the thoracic spine in neck pain patients: study protocol of a randomized controlled trial.
Neck pain is a common musculoskeletal condition with a point prevalence of around 15% in males and 23% in females that often presents in physiotherapy practice. Physical therapy and/or manipulation therapy is generally the first management option for patients with mechanical neck pain. Physical therapists treat mechanical neck pain with a number of interventions including joint mobilization and/or manipulation, therapeutic exercises or education. However, manipulation of the cervical spine carries some risks. Treating the thoracic spine for neck pain is an alternative approach. Emerging evidence suggests that it may be effective for treating neck pain without the risks associated with cervical spine manipulation. A new electromechanical device has recently been developed and tested for delivering multiple high velocity, low amplitude thrust manipulations to the spine. This device incorporates both auditory and visual systems that provide real time feedback on the applied treatment. The objective of this study is to compare the short- and long-term effects of manual versus mechanically assisted manipulations of the thoracic spine for neck pain patients. ⋯ It is expected that both interventions will improve neck pain. This would be a significant finding, as thoracic spine manipulation for neck pain does not carry the same risk of injury as cervical spine manipulation. In addition, the results may provide useful information about therapeutic options for health care providers and patients for the problem of neck pain.
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Randomized Controlled Trial Multicenter Study
PReVENT--protective ventilation in patients without ARDS at start of ventilation: study protocol for a randomized controlled trial.
It is uncertain whether lung-protective mechanical ventilation using low tidal volumes should be used in all critically ill patients, irrespective of the presence of the acute respiratory distress syndrome (ARDS). A low tidal volume strategy includes use of higher respiratory rates, which could be associated with increased sedation needs, a higher incidence of delirium, and an increased risk of patient-ventilator asynchrony and ICU-acquired weakness. Another alleged side-effect of low tidal volume ventilation is the risk of atelectasis. All of these could offset the beneficial effects of low tidal volume ventilation as found in patients with ARDS. ⋯ PReVENT is the first randomized controlled trial comparing a low tidal volume strategy with a high tidal volume strategy, in patients without ARDS at onset of ventilation, that recruits a sufficient number of patients to test the hypothesis that a low tidal volume strategy benefits patients without ARDS with regard to a clinically relevant endpoint.
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Randomized Controlled Trial Multicenter Study
Clinical assessment of Shenfu injection loading in the treatment of patients with exacerbation of chronic heart failure due to coronary heart disease: study protocol for a randomized controlled trial.
Acute exacerbation is a common cause of hospitalization in patients with chronic heart failure, and coronary heart disease is the most common cause. Shenfu injection, a Traditional Chinese Medicine injection, widely used in the adjuvant treatment of patients with acute exacerbation of chronic heart failure, shows some treatment effect in improving the symptoms and the quality of life, but it lacks the rigorous clinical evaluation of research reports. This paper describes the protocol for the clinical assessment of Shenfu injection loading in the treatment of patients with acute exacerbation of chronic heart failure. ⋯ This trial will assess the effect of loading Shenfu injection in the treatment of patients with acute exacerbation of chronic heart failure caused by coronary heart disease (yang-qi deficiency syndrome) on the symptoms and signs of heart failure, exercise tolerance, and other aspects, and observe its influence on the short-term prognosis with follow-up. The results of the study will provide clinical research evidence for application of Shenfu injection in the treatment.
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Randomized Controlled Trial
Evaluating early administration of the hydroxymethylglutaryl-CoA reductase inhibitor simvastatin in the prevention and treatment of delirium in critically ill ventilated patients (MoDUS trial): study protocol for a randomized controlled trial.
The incidence of delirium in ventilated patients is estimated at up to 82%, and it is associated with longer intensive care and hospital stays, and long-term cognitive impairment and mortality. The pathophysiology of delirium has been linked with inflammation and neuronal apoptosis. Simvastatin has pleiotropic properties; it penetrates the brain and, as well as reducing cholesterol, reduces inflammation when used at clinically relevant doses over the short term. This is a single centre randomised, controlled trial which aims to test the hypothesis that treatment with simvastatin will modify delirium incidence and outcomes. ⋯ This trial will test the efficacy of simvastatin on reducing delirium in the critically ill. If patients receiving the statin show a reduced number of days in delirium compared with the placebo group, the inflammatory theory implicated in the pathogenesis of delirium will be strengthened.
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Randomized Controlled Trial Multicenter Study
What is the effect of a formalised trauma tertiary survey procedure on missed injury rates in multi-trauma patients? Study protocol for a randomised controlled trial.
Missed injury is commonly used as a quality indicator in trauma care. The trauma tertiary survey (TTS) has been proposed to reduce missed injuries. However a systematic review assessing the effect of the TTS on missed injury rates in trauma patients found only observational studies, only suggesting a possible increase in early detection and reduction in missed injuries, with significant potential biases. Therefore, more robust methods are necessary to test whether implementation of a formal TTS will increase early in-hospital injury detection, decrease delayed diagnosis and decrease missed injuries after hospital discharge. ⋯ The findings of this study may alter the delivery of international trauma care. If formal TTS is (cost-) effective this intervention should be implemented widely. If not, where already partly implemented, it should be abandoned. Study findings will be disseminated widely to relevant clinicians and health funders.