scholarly journals The treatment of multidirectional instability of the shoulder with a rehabilitation programme: Part 2

2016 ◽  
Vol 9 (1) ◽  
pp. 46-53 ◽  
Author(s):  
Lyn Watson ◽  
Sarah Warby ◽  
Simon Balster ◽  
Ross Lenssen ◽  
Tania Pizzari
Keyword(s):  
Clinical Trials ◽  
Randomized Controlled Trial ◽  
New Zealand ◽  
Conservative Management ◽  
Controlled Trial ◽  
Rehabilitation Program ◽  
Clinical Protocol ◽  
Randomized Controlled ◽  
Multidirectional Instability ◽  
Clinical Trials Registry

Background The most commonly recommended initial treatment for multidirectional instability is a rehabilitation program. Although there is evidence to support the effect of conservative management on this condition, the published literature provides little information on the exercise parameters of such programs. Methods This paper is the second part of a two-part series that outlines a six-stage rehabilitation program for multidirectional instability with a focus on scapula control and exercise drills into functional positions. This paper outlines stages 3 to 6 of this rehabilitation program. Results and Conclusions This clinical protocol is currently being tested for efficacy as part of a randomized controlled trial (Australian New Zealand Clinical Trials Registry #ACTRN12613001240730). The information in this paper and additional online supplementary files will provide therapists with adequate detail to replicate the rehabilitation program in the clinical setting.

Comparison of 2 Exercise Rehabilitation Programs for Multidirectional Instability of the Glenohumeral Joint: A Randomized Controlled Trial

2017 ◽  
Vol 46 (1) ◽  
pp. 87-97 ◽  
Author(s):  
Sarah A. Warby ◽  
Jon J. Ford ◽  
Andrew J. Hahne ◽  
Lyn Watson ◽  
Simon Balster ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Glenohumeral Joint ◽  
Controlled Trial ◽  
Rehabilitation Program ◽  
Limiting Factor ◽  
Global Rating ◽  
Primary Analysis ◽  
Level Of Evidence ◽  
Randomized Controlled ◽  
Multidirectional Instability

Background: The recommended initial treatment for multidirectional instability (MDI) of the shoulder is a rehabilitation program, yet there is very low-quality evidence to support this approach. Purpose/Hypothesis: The purpose was to compare the Watson MDI program and Rockwood Instability program among patients with nontraumatic, nonstructural MDI. The hypothesis was that the Watson MDI program would produce clinically and statistically superior outcomes over the Rockwood Instability program. Study Design: Randomized controlled trial; Level of evidence, 2. Methods: Forty-one participants with MDI were randomly allocated to the Watson MDI or Rockwood Instability program. Participants attended 12 weekly physiotherapy sessions for exercise prescription. Outcomes were assessed at baseline and 6, 12, and 24 weeks after randomization. Primary outcomes were the Melbourne Instability Shoulder Score (MISS) and the Western Ontario Shoulder Index (WOSI). Secondary outcomes included the Orebro Musculoskeletal Pain Questionnaire, pain, muscle strength, scapular upward rotation, scapular coordinates, global rating of change, satisfaction scales, limiting angle in abduction range, limiting factor in abduction range, and incidence of dislocation. Primary analysis was by intention to treat based on linear mixed models. Results: Between-group differences showed significant effects favoring the Watson program for the WOSI (effect size [ES], 11.1; 95% CI, 1.9-20.2; P = .018) and for the limiting factor in abduction (ES, 0.1; 95% CI, 0.0-1.6; P = .023) at 12 weeks, and for the WOSI (ES, 12.6; 95% CI, 3.4-21.9; P =. 008), MISS (ES, 15.4; 95% CI, 5.9-24.8; P = .002), and pain (ES, -2.0; CI: -2.3 to -0.7, P = .003) at 24 weeks. Conclusion: For people with MDI, 12 sessions of the Watson MDI program were more effective than the Rockwood program at 12- and 24-week follow-up. Registration: ACTRN12613001240730 (Australian New Zealand Clinical Trials Registry).

scholarly journals Mitochondrial Reprogramming—What Is the Benefit of Hypothermic Oxygenated Perfusion in Liver Transplantation?

2021 ◽  
Vol 2 (2) ◽  
pp. 149-161
Author(s):  
Rebecca Panconesi ◽  
Mauricio Flores Carvalho ◽  
Matteo Mueller ◽  
Philipp Dutkowski ◽  
Paolo Muiesan ◽  
...  
Keyword(s):  
Liver Transplantation ◽  
Clinical Trials ◽  
Randomized Controlled Trial ◽  
Cohort Studies ◽  
Controlled Trial ◽  
Machine Perfusion ◽  
Randomized Controlled ◽  
Hypothermic Perfusion ◽  
Underlying Mechanisms ◽  
Circulatory Death

Although machine perfusion is a hot topic today, we are just at the beginning of understanding the underlying mechanisms of protection. Recently, the first randomized controlled trial reported a significant reduction of ischemic cholangiopathies after transplantation of livers donated after circulatory death, provided the grafts were treated with an endischemic hypothermic oxygenated perfusion (HOPE). This approach has been known for more than fifty years, and was initially mainly used to preserve kidneys before implantation. Today there is an increasing interest in this and other dynamic preservation technologies and various centers have tested different approaches in clinical trials and cohort studies. Based on this, there is a need for uniform perfusion settings (perfusion route and duration), and the development of general guidelines regarding the duration of cold storage in context of the overall donor risk is also required to better compare various trial results. This article will highlight how cold perfusion protects organs mechanistically, and target such technical challenges with the perfusion setting. Finally, the options for viability testing during hypothermic perfusion will be discussed.

Testing Meldonium: Assessing Soviet pragmatic alternatives to the randomized controlled trial

2021 ◽  
pp. 174077452110085
Author(s):  
Anastasiya Chirkova ◽  
Alexander Petrenko ◽  
Pavel Vasilyev
Keyword(s):  
Clinical Trials ◽  
Randomized Controlled Trial ◽  
Soviet Union ◽  
Drug Testing ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Experimental Drugs ◽  
The Soviet Union ◽  
Experimental Drug ◽  
Second World

Background/aims Current research largely tends to ignore the drug-testing model that was developed in the “Second World” as an explicit alternative to the randomized controlled trial. This system can be described as “socialist pharmapolitics,” accounting for the specific features of state socialism that influenced the development and testing of experimental drugs. The clinical trials model employed in the “Second World” was heavily influenced by the Soviet Union, which was by far the most influential player in the socialist bloc during the Cold War. Based on extensive archival research, this article presents an empirical case of a late Soviet clinical trial as a pragmatic alternative to the randomized controlled trial model. It accounts for the divergences between the official model prescribed by the Soviet authorities and the messy realities of healthcare practice. It further outlines different factors that ultimately shaped how clinical trials were organized in Soviet institutions “on the ground.” Accordingly, this article presents a “real-life” history of “socialist pharmapolitics” and outlines the problems that this system faced in practice. Methods Archival research was conducted at the Russian State Archive of Scientific and Technical Documentation in Moscow. Archival files include scientific, technical, and registration documentation such as biochemical, pharmacological, and clinical descriptions of the experimental drug Meldonium, letters between various hospitals, research institutes and the Soviet regulatory body, as well as 26 reports of completed clinical trials. Manual content analysis was used for the interpretation of results. Results This article presents an empirical case of a late Soviet clinical trial as a pragmatic alternative to the randomized controlled trial model. It demonstrates some key differences from the randomized controlled trial model. This article also highlights some of the discrepancies between the model that was officially prescribed by the Soviet authorities and the realities of experimental drug testing in the Soviet Union in the late 1980s and early 1990s. In particular, it notes some elements of randomization, double-blinding, and the use of placebo that were present in Meldonium trials despite being formally denounced by Soviet bioethics. Conclusion The Soviet model for testing experimental drugs differed from the Western one substantially in a number of respects. This difference was not only proclaimed officially by the Soviet authorities, but was for the most part enforced in clinical trials in practice. At the same time, our research demonstrates that there were important differences between the official model and the clinical realities on the ground.

scholarly journals Recruiting to Clinical Trials on the Telephone – a randomized controlled trial

Trials ◽  
2016 ◽  
Vol 17 (1) ◽  
Author(s):  
Kim Thestrup Foss ◽  
Jesper Kjærgaard ◽  
Lone Graff Stensballe ◽  
Gorm Greisen
Keyword(s):  
Clinical Trials ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Randomized Controlled

scholarly journals Preparación psicológica para la intervención quirúrgica: Revisión sistemática de la literatura

Psychologia ◽  
2016 ◽  
Vol 10 (2) ◽  
pp. 73-85
Author(s):  
Francisco Cázares de León ◽  
Stefano Vinaccia ◽  
Japcy Quiceno ◽  
Blanca Montoya
Keyword(s):  
Clinical Trials ◽  
Randomized Controlled Trial ◽  
Psychological Intervention ◽  
Controlled Trial ◽  
Psychological Preparation ◽  
Randomized Controlled ◽  
Palabras Clave ◽  
Revisión Sistemática

El objetivo de este artículo de revisión fue examinar y analizar la eficacia de los tipos de preparación psicológica empleados en los últimos ocho años para disminuir el estrés, la ansiedad y otras emociones de los pacientes ante un procedimiento quirúrgico. Método: Se realizó una revisión de literatura sobre la preparación psicológica en diferentes intervenciones quirúrgicas. Se realizó una búsqueda en la base de datos Medline y SCielo, utilizando las palabras clave: «psychological preparation for surgery» «psychological intervention and surgery» y se delimitó la búsqueda con las palabras «clinical trials» y «randomized controlled trial». Los criterios de inclusión fueron: ensayos clínicos controladosaleatorizados con resultados relacionados con la eficacia de la reducción del estrés, ansiedad y otras emociones. Se encontraron 17 ensayos clínicos que cumplieron los criterios de inclusión en la base de datos PubMed. En base de datos SciELO solo se encontraron dos estudios. Los datos nos muestran que las tendencias en preparación psicológica se han enfocado más a los procedimientos como la cirugía electiva, cirugía pediátrica, procedimientos con agujas, cirugías de corazón, cirugías para el cáncer y para la cirugía bariátrica. Sin embargo, la perspectiva de estas investigaciones tal vez pudiera centrarse en las enfermedades crónica degenerativas y con más estudios mejorados metodológicamente

Digital instruments for reporting of gastrointestinal symptoms in clinical trials: comparison of end-of-day diaries versus experience sampling method (Preprint)

2021 ◽  
Author(s):  
Abraham B. Beckers ◽  
Johanna T.W. Snijkers ◽  
Zsa Zsa R.M. Weerts ◽  
Lisa Vork ◽  
Tim Klaassen ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Randomized Controlled Trial ◽  
Irritable Bowel Syndrome ◽  
Sampling Method ◽  
Sampling Methods ◽  
Controlled Trial ◽  
Smartphone Application ◽  
Randomized Controlled ◽  
Pre Treatment ◽  
Irritable Bowel

BACKGROUND Questionnaires are necessary tools for assessing symptoms of disorders of the brain-gut interaction in clinical trials. We previously reported on the excellent compliance to a smartphone app used as symptom diary in a randomized clinical trial in irritable bowel syndrome (IBS). Other sampling methods, such as the experience sampling method (ESM), are better equipped to measure symptom variability over time, provide useful information regarding possible symptom triggers and are free of ecological and recall bias. The high frequency of measurements, however, could limit the feasibility of ESM in clinical trials. OBJECTIVE This study aimed to compare compliance rates of a smartphone-based end-of-day diary and ESM for symptom assessment in irritable bowel syndrome and functional dyspepsia (FD). METHODS Data from four studies were included. Patients with IBS participated in a randomized controlled trial, which involved a smartphone end-of-day diary of 2+8 weeks (pre-treatment + treatment period), and an observational study, during which patients completed ESM assessments using a smartphone application for one week. Patients with FD participated in a randomized controlled trial, which involved a smartphone end-of-day diary of 2+12 weeks (pre-treatment + treatment period), and an observational study, during which patients completed ESM assessments using a smartphone application for one week. Compliance rates were compared between these two symptom sampling methods. RESULTS Twenty-five patients with IBS and fifteen patients with FD were included. Overall compliance rates for the end-of-day diaries were significantly higher than for ESM (IBS: 92.7% versus 69.8%, FD: 90.1% versus 61.4%, respectively). CONCLUSIONS We here demonstrate excellent compliance rates for smartphone application-based end-of-day diaries as used in two separate clinical trials. Overall compliance rates for ESM were significantly lower, rendering it more suitable for intermittent sampling periods rather than continuously during longer clinical trials.

The Honeypot Study Protocol: A Randomized Controlled Trial of Exit-Site Application of Medihoney Antibacterial Wound Gel for the Prevention of Catheter-Associated Infections in Peritoneal Dialysis Patients

2009 ◽  
Vol 29 (3) ◽  
pp. 303-309 ◽  
Author(s):  
David W. Johnson ◽  
Carolyn Clark ◽  
Nicole M. Isbel ◽  
Carmel M. Hawley ◽  
Elaine Beller ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Peritoneal Dialysis ◽  
New Zealand ◽  
Controlled Trial ◽  
Nasal Carriage ◽  
Site Infection ◽  
Exit Site ◽  
Exit Site Infection ◽  
Randomized Controlled ◽  
Tunnel Infection

Objectives The primary objective of this study is to determine whether daily exit-site application of standardized antibacterial honey (Medihoney Antibacterial Wound Gel; Comvita, Te Puke, New Zealand) results in a reduced risk of catheter-associated infections in peritoneal dialysis (PD) patients compared with standard topical mupirocin prophylaxis of nasal staphylococcal carriers. Design Multicenter, prospective, open label, randomized controlled trial. Setting PD units throughout Australia and New Zealand. Participants The study will include both incident and prevalent PD patients (adults and children) for whom informed consent can be provided. Patients will be excluded if they have had ( 1 ) a history of psychological illness or condition that interferes with their ability to understand or comply with the requirements of the study; ( 2 ) recent (within 1 month) exit-site infection, peritonitis, or tunnel infection; ( 3 ) known hypersensitivity to, or intolerance of, honey or mupirocin; ( 4 ) current or recent (within 4 weeks) treatment with an antibiotic administered by any route; or ( 5 ) nasal carriage of mupirocin-resistant Staphylococcus aureus. Methods 370 subjects will be randomized 1:1 to receive either daily topical exit-site application of Medihoney Antibacterial Wound Gel (all patients) or nasal application of mupirocin if staphylococcal nasal carriage is demonstrated. All patients in the control and intervention groups will perform their usual exit-site care according to local practice. The study will continue until 12 months after the last patient is recruited (anticipated recruitment time is 24 months). Main Outcome Measures The primary outcome measure will be time to first episode of exit-site infection, tunnel infection, or peritonitis, whichever comes first. Secondary outcome measures will include time to first exit-site infection, time to first tunnel infection, time to first peritonitis, time to infection-associated catheter removal, catheter-associated infection rates, causative organisms, incidence of mupirocin-resistant microbial isolates, and other adverse reactions. Conclusions This multicenter Australian and New Zealand study has been designed to provide evidence to help nephrologists and their PD patients determine the optimal strategy for preventing PD catheter-associated infections. Demonstration of a significant improvement in PD catheter-associated infections with topical Medihoney will provide clinicians with an important new prophylactic strategy with a low propensity for promoting antimicrobial resistance.

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