Trials
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Randomized Controlled Trial Comparative Study
Assessment of Truflex articulating stylet versus conventional rigid Portex stylet as an intubation guide with the D-blade of C-Mac videolaryngoscope during elective tracheal intubation: study protocol for a randomized controlled trial.
A variety of videolaryngoscopes with angulated blade have been recently introduced into clinical practice. They provide an indirect view of the glottic structures in normal and challenging clinical settings. Despite the very good visualization of the laryngeal structures by these devices, the insertion and advancement of the endotracheal tube may be prolonged and occasionally fail as it does not conform to the enhanced angulation of the blade. To overcome this handicap, it is recommended to use a pre-shaped, styleted tracheal tube during intubation. Unfortunately, these malleable rigid stylets permit only a fixed shape to the advancing endotracheal tube. This may necessitate withdrawal of endotracheal tube-stylet assembly for reshaping, before undertaking a new attempt. This may cause soft tissue injury and hemodynamic disturbance.This single-blinded randomized clinical trial aims to overcome these handicaps using a novel method of dynamically changing the shape of the advancing endotracheal tube by Truflex articulating stylet as per need during D-blade C-Mac videolaryngoscopy. ⋯ One hundred and fifty four patients between 18 and 60 years of age belonging to either sex undergoing tracheal intubation under uniform general anesthetic technique will be randomly divided into Portex malleable stylet group and Truflex articulating stylet group. The primary efficacy variable of success/failure between the two groups will be analyzed using the chi square test. For comparison of intubation times and the Intubation Difficulty Score, ANOVA will be used. Primary efficacy endpoint results will be successful or failed tracheal intubation in the first attempt, total intubation time and the intubation difficulty score. Secondary efficacy endpoints will be overall user satisfaction graded from 1 to 10 (1 = very poor, 10 = excellent), Cormack and Lehane's grading, glotticoscopy time and ETT negotiation time and total number of intubation attempts. Result of safety endpoints will include dental and airway trauma, hemodynamic disturbances, arrhythmias or cardiac arrest.
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Randomized Controlled Trial
Evaluation of effect of low-level laser therapy on adolescents with temporomandibular disorder: study protocol for a randomized controlled trial.
A number of problems involving the temporomandibular joint (TMJ) and associated structures can lead to temporomandibular disorder (TMD). The aim of the proposed study is to assess the effect of low-level laser therapy on occlusal contacts, mandibular movements, electromyography activity in the muscles of mastication and pain in adolescents with TMD. ⋯ A randomized, controlled, double-blind, clinical trial will be carried out involving 85 male and female adolescents between 15 and 18 years of age. The research diagnostic criteria for TMD will be used to assess all individuals who agree to participate. All participants will be submitted to a clinical examination and electromyographic analysis of the masseter muscles and anterior bundle of the temporal muscles bilaterally, to determine TMD. Based on the clinical findings, the participants will be classified as having or not having TMD. Those with TMD will be divided into four groups, three of which will receive low-level laser therapy and one of which will receive a placebo treatment. The treatments will involve the TMJ region alone, the masseter and temporal muscles alone, or both these regions together. The data will be submitted to descriptive statistical analysis. The chi-square test and Fisher's exact test will be used to determine associations among the categorical variables. The Student's t test and analysis of variance will be used for the comparison of mean electromyographic signals. Pearson's correlation coefficients will be calculated for the analysis of correlations among the continuous variables.
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The development and application of standardised sets of outcomes to be measured and reported in clinical trials have the potential to increase the efficiency and value of research. One of the most notable of the current outcome sets began nearly 20 years ago: the World Health Organization and International League of Associations for Rheumatology core set of outcomes for rheumatoid arthritis clinical trials, originating from the OMERACT (Outcome Measures in Rheumatology) Initiative. This study assesses the use of this core outcome set by randomised trials in rheumatology. ⋯ This observational review suggests that a higher percentage of trialists conducting trials in rheumatoid arthritis are now measuring the rheumatoid arthritis core outcome set. Core outcome sets have the potential to improve the evidence base for health care, but consideration must be given to the methods for disseminating their availability amongst the relevant communities.
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Randomized Controlled Trial
Alexander Technique Lessons, Acupuncture Sessions or usual care for patients with chronic neck pain (ATLAS): study protocol for a randomised controlled trial.
Chronic neck pain is a common condition in the adult population. More research is needed to evaluate interventions aiming to facilitate beneficial long-term change. We propose to evaluate the effect of Alexander Technique lessons and acupuncture in a rigorously conducted pragmatic trial with an embedded qualitative study. ⋯ This study will provide robust evidence on whether there are significant clinical benefits to patients, economic benefits demonstrating value for money, and sufficient levels of acceptability and safety.
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Randomized Controlled Trial Comparative Study
Enhancing activities of daily living of chronic stroke patients in primary health care by modified constraint-induced movement therapy (HOMECIMT): study protocol for a cluster randomized controlled trial.
Stroke leads to constant rehabilitation needs even at the chronic stage. However, although many stroke patients receive physical or occupational therapy in primary health care, treatment prescriptions do not generally specify therapeutic goals; in particular, participation is not established as an explicit therapeutic goal in the ambulatory setting. The primary aim of this study is to evaluate the efficacy of a therapy regimen for chronic stroke patients (modified 'constraint-induced movement therapy (CIMT) at home') with impaired hand or arm function with regard to the prerequisites of participation in everyday activities: a sufficient arm and hand function. 'CIMT at home' will be compared with conventional physical and occupational therapy ('therapy as usual'). ⋯ A modification of the CIMT, feasible in the patients' homes (CIMT at home), appears to be a promising therapeutic approach in the ambulatory care of chronic stroke patients. With proven efficacy and practicality, a participation-oriented, stroke-specific treatment would be available in primary care.