Trials
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Randomized Controlled Trial Multicenter Study
Study of therapeutic hypothermia (32 to 35°C) for intracranial pressure reduction after traumatic brain injury (the Eurotherm3235Trial): outcome of the pilot phase of the trial.
Clinical trials in traumatic brain injury (TBI) are challenging. Previous trials of complex interventions were conducted in high-income countries, reported long lead times for site setup and low screened-to-recruitment rates.In this report we evaluate the internal pilot phase of an international, multicentre TBI trial of a complex intervention to assess: design and implementation of an online case report form; feasibility of recruitment (sites and patients); feasibility and effectiveness of delivery of the protocol. ⋯ The pilot data demonstrated good feasibility for this large international multicentre randomized controlled trial of hypothermia to control intracranial pressure. The sample size was reduced to 600 patients because of homogeneity of the patient group and we showed an optimized cooling intervention could be delivered.
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Randomized Controlled Trial
PRECISE - pregabalin in addition to usual care for sciatica: study protocol for a randomised controlled trial.
Sciatica is a type of neuropathic pain that is characterised by pain radiating into the leg. It is often accompanied by low back pain and neurological deficits in the lower limb. While this condition may cause significant suffering for the individual, the lack of evidence supporting effective treatments for sciatica makes clinical management difficult. Our objectives are to determine the efficacy of pregabalin on reducing leg pain intensity and its cost-effectiveness in patients with sciatica. ⋯ This study will establish the efficacy of pregabalin in reducing leg pain intensity in patients with sciatica and provide important information regarding the effect of pregabalin treatment on disability and quality of life. The impact of this research may allow the future development of a cost-effective conservative treatment strategy for patients with sciatica.
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Randomized Controlled Trial Multicenter Study
Alternative Imaging Modalities in Ischemic Heart Failure (AIMI-HF) IMAGE HF Project I-A: study protocol for a randomized controlled trial.
Ischemic heart disease (IHD) is the most common cause of heart failure (HF); however, the role of revascularization in these patients is still unclear. Consensus on proper use of cardiac imaging to help determine which candidates should be considered for revascularization has been hindered by the absence of clinical studies that objectively and prospectively compare the prognostic information of each test obtained using both standard and advanced imaging. ⋯ AIMI-HF will be the largest randomized trial evaluating the role of standard and advanced imaging modalities in the management of ischemic cardiomyopathy and heart failure. This trial will complement the results of the Surgical Treatment for Ischemic Heart Failure (STICH) viability substudy and the PET and Recovery Following Revascularization (PARR-2) trial. The results will provide policy makers with data to support (or not) further investment in and wider dissemination of alternative 'advanced' imaging technologies.
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Randomized Controlled Trial Comparative Study
Three-dimensional evaluation of postoperative swelling in treatment of zygomatic bone fractures using two different cooling therapy methods: a randomized, observer-blind, prospective study.
Surgical treatment and complications in patients with zygomatic bone fractures can lead to a significant degree of tissue trauma resulting in common postoperative symptoms and types of pain, facial swelling and functional impairment. Beneficial effects of local cold treatment on postoperative swelling, edema, pain, inflammation, and hemorrhage, as well as the reduction of metabolism, bleeding and hematomas, have been described.The aim of this study was to compare postoperative cooling therapy applied through the use of cooling compresses with the water-circulating cooling face mask manufactured by Hilotherm in terms of beneficial impact on postoperative facial swelling, pain, eye motility, diplopia, neurological complaints and patient satisfaction. ⋯ Hilotherapy is more efficient in managing postoperative swelling and pain after treatment of unilateral zygomatic bone fractures than conventional cooling.
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Randomized Controlled Trial Multicenter Study
An evaluation of the parents under pressure programme: a study protocol for an RCT into its clinical and cost effectiveness.
Many babies in the UK are born to drug-dependent parents, and dependence on psychoactive drugs during the postnatal period is associated with high rates of child maltreatment, with around a quarter of these children being subject to a child protection plan. Parents who are dependent on psychoactive drugs are at risk of a wide range of parenting problems, and studies have found reduced sensitivity and responsiveness to both the infant's physical and emotional needs. The poor outcomes that are associated with such drug dependency appear to be linked to the multiple difficulties experienced by such parents.An increase in understanding about the crucial importance of early relationships for infant well-being has led to a focus on the development and delivery of services that are aimed at supporting parenting and parent-infant interactions. The Parents under Pressure (PuP) programme is aimed at supporting parents who are dependent on psychoactive drugs or alcohol by providing them with methods of managing their emotional regulation, and of supporting their new baby's development. An evaluation of the PuP programme in Australia with parents on methadone maintenance of children aged 3 to 8 years found significant reductions in child abuse potential, rigid parenting attitudes and child behaviour problems. ⋯ This is one the first UK studies to examine the effectiveness of a programme targeting the parenting of substance-dependent parents of infants and toddlers, in terms of its effectiveness in improving the parent-infant relationship and reducing the potential for child abuse.