Trials
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Neck pain is a highly prevalent medical condition that incurs substantial social burden. Although manual therapy is widely used for treatment of neck pain, the body of evidence supporting its effectiveness and safety is not conclusive. The aim of this study is to examine the effect, safety, and cost-effectiveness of Chuna manual therapy, a traditional Korean manual therapy for treatment of various musculoskeletal complaints. ⋯ This study will evaluate the comparative effectiveness of Chuna manual therapy and usual care on chronic neck pain. Adverse events, and costs and effectiveness (utility) data will be evaluated to assess safety and exploratory cost-effectiveness (economic evaluation). This study aims to provide evidence on the effectiveness, safety, and cost-effectiveness of Chuna manual therapy.
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Gait difficulties are common and frequently devastating to people with Parkinson's disease (PD). These difficulties are often followed by an increased risk of falls, leading to injury, hospitalization and mortality. The dysfunction in the basal ganglia-thalamocortical motor circuits and reduced activity in the premotor and primary motor cortices has raised interest in transcranial direct current stimulation (tDCS) as an adjunct intervention in PD. tDCS might provide a potentially safe and non-invasive treatment by modulating cortical excitability and behavioural outcomes. The aim of this study is to compare the effects of different monopolar and bipolar montages of tDCS administered to the motor cortex and cerebellum on gait speed in PD. ⋯ This study will investigate the short-term effects of anodal tDCS over the premotor and primary motor cortices on gait abilities using monopolar and bipolar montages in people with PD. The outcomes will inform future studies aimed at inducing longer-lasting changes in neural excitability and performance using multisession tDCS designs in PD.
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Maternal obesity is a risk factor for adverse maternal, fetal, and neonatal events. Numerous clinical trials are currently exploring the effectiveness of antenatal and peripartum interventions in improving pregnancy outcomes that can in future inform clinical practice. However, the heterogeneity in outcome reporting limits our ability to compare outcomes across studies, and there is a lack of stakeholder representation in outcome choice. A pragmatic solution to this problem is the development of a core outcome set (COS) that defines the minimum criteria for outcome reporting in clinical trials undertaken in this population, arrived at by the involvement of relevant stakeholders. ⋯ COSSOPP will engage patients, clinicians, researchers, and other relevant stakeholders in determining the core set of outcomes that should be reported and measured in order to harmonize outcome reporting in studies evaluating the effectiveness of antepartum and peripartum interventions in obese pregnant women. This protocol provides a detailed overview of the steps involved in the development of a COS, to guide researchers in developing COS within their areas of specialization. COMET CORE OUTCOME SET REGISTRATION: http://www.comet-initiative.org/studies/details/939 .
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Intrahepatic cholestasis of pregnancy (ICP) is the most common liver disorder specific to pregnancy and presents with maternal pruritus, raised concentrations of serum bile acids and abnormal liver function tests. ICP is associated with increased rates of spontaneous and iatrogenic preterm labour, fetal hypoxia, meconium-stained amniotic fluid and intrauterine death. Some clinicians treat ICP with ursodeoxycholic acid (UDCA) to improve maternal pruritus and biochemical abnormalities. However, there are currently no data to support the use of UDCA to improve pregnancy outcome as none of the trials performed to date have been powered to address this question. ⋯ Current practice in the UK at the time of trial commencement for the treatment of ICP is inconsistent, with some units routinely prescribing UDCA, others prescribing very little and the remainder offering it variably. Our previous pilot trial of UDCA in women with ICP demonstrated that the trial would be feasible, and the research question remains active and unanswered. Results are highly likely to influence clinical practice, through direct management and impact on national and international guidelines.
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Lung dysfunction commonly occurs after cardiopulmonary bypass (CPB). Randomized evidence suggests that the presence of expiratory flow limitation (EFL) in major abdominal surgery is associated with postoperative pulmonary complications. Appropriate lung recruitment and a correctly set positive end-expiratory pressure (PEEP) level may prevent EFL. According to the available data in the literature, an adequate ventilation strategy during cardiac surgery is not provided. The aim of this study is to assess whether a mechanical ventilation strategy based on optimal lung recruitment with a best PEEP before and after CPB and with a continuous positive airway pressure (CPAP) during CPB would reduce the incidence of respiratory complications after cardiac surgery. ⋯ This study will help to establish a correct ventilatory strategy before, after, and during CPB. The main purpose is to establish if a ventilation based on a simple and feasible respiratory test may preserve lung function in cardiac surgery.