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Transcranial direct current stimulation combined with physical exercise in knee osteoarthritis: a protocol for a randomised controlled clinical trial

Por: Lima · V. B. · Silva · C. A. M. · Silva · S. G. D. d. · Macedo · L. d. B. · de Souza · M. C. · Lins · C. A. d. A. · de Souza · C. G.
Introduction

Osteoarthritis (OA) is a degenerative and progressive joint condition causing pain and disability. Physical exercise is recognised as the most effective intervention since individuals with this condition often experience muscle weakness, balance deficits and chronic pain. Additionally, knee osteoarthritis (KOA) is associated with central sensitisation, contributing to chronic pain conditions. Transcranial Direct Current Stimulation (tDCS), a non-invasive neuromodulation technique, has been employed to induce changes in pain perception by altering cortical excitability, potentially reducing chronic pain.

Methods and analysis

This is a protocol for a randomised controlled trial. Participants will be allocated to two groups: G1 (active tDCS combined with exercise) and G2 (sham tDCS combined with exercise). The intervention protocol will last for 5 weeks, with two sessions per week on non-consecutive days. Pain intensity will be assessed as the primary outcome using the Numeric Rating Scale (NRS). The sample size was calculated based on a minimum clinically important difference of 3 points on the NRS between groups, with a statistical power of 80% and a significance level of 5%. Secondary outcomes will include physical function and global perceived change.

Ethics and dissemination

This protocol was approved by the Research Ethics Committee of the Trairi School of Health Sciences, Federal University of Rio Grande do Norte (Approval Number: 6.801.827), and it is in accordance with the Declaration of Helsinki for human research. Results will be published in peer-reviewed journals and presented at scientific events. This trial is registered in the Brazilian Clinical Trials Registry.

Trial registration number

Brazilian Clinical Trials Registry (RBR-5pb2g33).

Current applications of indocyanine green fluorescence angiography in trauma patients and its potential impact: a systematic review

Por: Breuking · E. A. · de Fraiture · E. J. · Krijgh · D. D. · van Wessem · K. · de Bruin · I. G. · Hietbrink · F. · Ruiterkamp · J.
Objectives

Tissue viability assessment is one of the main challenges in trauma surgery. Vitality assessment using indocyanine green fluorescence angiography (ICG-FA) may improve surgical decision-making. This systematic review gives an overview of current applications of ICG-FA in surgical treatment of traumatic injury and its effects on the incidence of postoperative complications and intraoperative decision-making.

Design

Systematic review according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.

Data sources

PubMed, EMBASE and MEDLINE were searched through 18 December 2023.

Eligibility criteria for selecting studies

Primary research reports regarding indocyanine green (ICG)-fluorescence in patients with traumatic injury were included. Exclusion criteria were use of ICG for treatment of burn wounds, traumatic brain injury or reconstructive surgery, absence of an English or Dutch full-text and non-primary study design.

Data extraction and synthesis

Two independent reviewers performed the search and screening process according to standardised methods. Risk of bias was assessed using the Methodological Index for Non-Randomised Studies. Data were presented in text and overview tables.

Results

Thirteen studies were included, of which six were case series/reports including three or fewer patients. Within the other seven studies, 301 patients received ICG-guided surgery. ICG was used for perfusion assessment in all studies. Injury types consisted of traumatic extremity and abdominal injury. All studies reported beneficial effects such as necrosis detection, determination of resection/debridement margins and reduction of debridement procedures. ICG could improve intraoperative decision-making and significantly decrease postoperative complications. No included studies reported ICG-related complications or adverse events.

Conclusion

The available literature regarding the use of ICG-FA in trauma surgery is limited, and comparability is low. Still, the results are promising and show a large potential of ICG-FA for better and more efficient treatment of trauma patients. Further research with larger samples and comparable conditions is thus necessary and highly recommended.

Prevalence of extrapulmonary tuberculosis in Indonesia: protocol for systematic review and meta-analysis

Background

Extrapulmonary tuberculosis (EPTB) is a significant public health issue in Indonesia, a country with a high tuberculosis burden. EPTB accounts for 15%–20% of global TB cases, with the proportion rising in populations co-infected with HIV. In Indonesia, estimates of EPTB prevalence vary significantly due to inconsistencies in diagnostic criteria, population demographics and methodologies. These variations highlight the need for a systematic review to synthesise existing evidence and provide a comprehensive understanding of EPTB’s epidemiology in Indonesia. This study aims to consolidate findings from various studies to identify prevalence trends, inform public health strategies and address knowledge gaps in diagnosing and managing EPTB.

Methods

This systematic review will follow Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols guidelines and has been registered with PROSPERO (Registration Number: CRD42024601175). A comprehensive search will be conducted in databases including PubMed, Google Scholar, ScienceDirect, Scopus and Southeast Asian Index Medicus to identify studies published between 2005 and 2024. Inclusion criteria include observational studies reporting EPTB prevalence in Indonesia based on clinical, microbiological or radiological diagnoses. Two independent reviewers will conduct study selection, data extraction and quality assessments using the Newcastle-Ottawa Scale. Data will be analysed using a random-effects model to estimate pooled prevalence, and subgroup analyses will explore variability by region, age and clinical setting. The study selection process will be documented using a Preferred Reporting Items for Systematic Reviews and Meta-Analyses flow diagram, and potential publication bias will be evaluated with funnel plots and the trim-and-fill method.

Ethics and dissemination

As this review involves secondary analysis of published data, no ethical approval is required. Findings will be disseminated through peer-reviewed journal publications and conference presentations.

Apnoeic oxygenation during paediatric tracheal intubation: a study protocol for a single-centre, cluster randomised clinical trial (ApOx-Pedi-Trial)

Por: Uzun · D. D. · Zimmermann · B. P. · Knoeller · S. · Kirchner · M. · Mohr · S. · Weigand · M. A. · Zivkovic · A. R. · Schmitt · F. C. F.
Introduction

Adverse events during paediatric anaesthesia are common, with hypoxaemia during the induction period being a leading cause, as infants and children are particularly vulnerable to hypoxaemia during periods of apnoea. The administration of supplementary oxygen, referred to as apnoeic oxygenation, has been shown to prolong safe apnoea times and increase first-pass intubation success rates. Despite these benefits, apnoeic oxygenation is not routinely used in paediatric anaesthesia. Low-flow apnoeic oxygenation, delivered via a standard nasal cannula, is a simple approach to provide supplementary oxygen during paediatric airway management without requiring additional equipment. However, its efficacy in airway management during elective surgeries has not been adequately studied.

Methods and analysis

The ApOx-Pedi-Trial is a single-centre, cluster randomised, controlled clinical trial comparing the use of low-flow apnoeic oxygenation during the induction of general anaesthesia in infants and children up to 6 years of age undergoing elective surgery at the Department of Pediatric Surgery at Heidelberg University Hospital to standard of care (no apnoeic oxygenation). Randomisation is conducted using a weekly cluster randomisation method, where all patients presenting for surgery in a given week either receive apnoeic oxygenation or standard of care during the induction of general anaesthesia, based on the week’s group allocation.

The study population will consist of two independent, age-stratified cohorts (24 months to 6 years), each including 100 patients. Statistical analysis of study endpoints will be conducted separately for each cohort to allow for age-specific assessment of outcomes.

The primary objective of this trial is to evaluate whether apnoeic oxygenation can prevent a decrease in transcutaneous haemoglobin saturation (SpO2) during the induction of general anaesthesia in infants and children. The primary outcome measure will be the lowest recorded SpO2 value throughout the apnoeic period.

Ethics and dissemination

The ApOx-Pedi-Trial received permission from the local ethics committee (Ethics Committee of the medical faculty at Heidelberg University, Heidelberg, Germany) under the registration number S-074–2024. The study is following institutional Guidelines and the Declaration of Helsinki of 1975 in its most recent version. Trial results will be submitted to peer-reviewed journals and presented at national and international conferences.

Trial registration number

The trial is prospectively registered on ClinicalTrials.gov with the number NCT06576596.

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