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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).

Time-lapse imaging systems for embryo incubation and assessment to improve reproductive outcomes in women undergoing in vitro fertilisation: study protocol for an individual participant data meta-analysis of randomised controlled trials

Por: Bhide · P. · Chan · D. Y. L. · Ahlström · A. · del Campo · L. · Kieslinger · D. · Lundin · K. · Park · H. · Fauque · P. · Kahraman · S. · Khan · K. S. · Kovacs · P. · Lambalk · C. B. · Thangaratinam · S. · Vergouw · C. G. · van Wely · M. · Zamora · J.
Introduction

Time-lapse imaging (TLI) systems for embryo incubation and assessment are hypothesised to improve the success rates of in vitro fertilisation (IVF) treatment by providing undisturbed culture conditions for embryos and/or providing more information on embryo development (morphokinetic parameters) to improve predictive accuracy for embryo selection. Despite numerous aggregate meta-analyses showing uncertainty of benefit, IVF clinics globally continue to invest significant resources into this technology with little translation of evidence into guidelines or policy frameworks. This may be attributed to heterogeneity in participant populations and/or variations in the use of TLI, as highlighted in the aggregate meta-analyses.

Methods and analysis

Our research proposal for evidence synthesis using individual participant data meta-analysis will provide greater power than aggregate meta-analysis to detect differential treatment effects for effectiveness (live birth, clinical pregnancy) and safety (pregnancy loss, multiple births, congenital malformations) outcomes across three comparisons (overall effect, undisturbed culture and morphokinetic parameters). We will also analyse if there are specific subgroups of women who may benefit from the intervention and if variations in use of the intervention show any benefits. We have incorporated the results of the literature search used for the latest Cochrane review (7 January 2019) into this review and will include all the trials included therein. We will further update the literature search to include new evidence by searching the electronic databases MEDLINE, EMBASE, CINAHL and CENTRAL from 07/01/2019 to date, outcomes for all ongoing trials reported in the 2019 Cochrane review, trial registers for newer ongoing/completed trials and the citation lists of all the newly identified trials for any relevant references. The search strategy will include a combination of subject headings and text words relating to or describing the participants and the intervention, with no language restrictions. Two authors will independently screen the titles and abstracts, and full text of articles retrieved from the search, to finalise a list of trials suitable for inclusion in the review. We will include randomised controlled trials that assess TLI systems for either undisturbed culture and/or use of morphokinetic parameters for embryo selection in women having IVF/ICSI treatment using their own oocytes.

Ethics and dissemination

Ethical approval is not required for this study. We plan to disseminate the findings of the research to all stakeholders, including the National Institute for Health and Care Excellence and other international guideline development groups, through publication in peer-reviewed journals, presentation at conferences, newsletters, meetings and websites of the funders, fertility charities and patient support groups.

PROSPERO registration number

CRD42024564332.

Effectiveness of Choosing Wisely recommendations in reducing physiotherapists intentions to refer for imaging and use electrotherapy for low back pain: a randomised controlled experiment

Por: Kharel · P. · Maher · C. G. · Gamble · A. R. · Ferreira · G. E. · Zadro · J. R.
Question

What is the effect of Choosing Wisely recommendations on physiotherapists’ intentions to refer for imaging and use electrotherapy for low back pain?

Design

Three-arm parallel-group online randomised controlled trial.

Participants

Physiotherapists who treat people with low back pain.

Intervention

Participants were randomised to receive: (a) two original Australian Physiotherapy Association Choosing Wisely recommendations about low back pain, (b) two optimised versions of these recommendations based on previous research and (c) no recommendations. Participants were then directed to read three clinical vignettes of a person with low back pain and respond to questions regarding each vignette.

Outcome measures

Primary outcomes were physiotherapists’ intentions to refer for imaging and use electrotherapy for low back pain. Secondary outcomes were physiotherapists’ intentions to use other treatments for low back pain, the influence of the recommendations on decision-making in the vignettes and familiarity with the recommendations.

Results

723 participants opened the survey and 473 (65%) provided complete responses. Across all vignettes, there were no statistically significant differences in intentions to refer for imaging or use electrotherapy between those who received Choosing Wisely recommendations versus no recommendation (imaging ORs ranging from 0.7 (95% CI 0.5 to 1.0) to 0.9 (0.6 to 1.4); electrotherapy ORs ranging from 0.9 (0.5 to 1.7) to 1.1 (0.7 to 2.0)). Similarly, no significant differences were observed between those who received optimised versus original recommendations for all three vignettes.

Conclusion

Our study suggests simply presenting Choosing Wisely recommendations to physiotherapists does not influence their intentions to refer for imaging or use electrotherapy for low back pain, even if the language of the recommendations is optimised.

Orofacial functions with emphasis on breathing and chewing patterns in individuals with and without molar incisor hypomineralisation: observational study protocol conducted in a dental clinic in Brazil

Introduction

Molar incisor hypomineralisation (MIH) is a qualitative developmental defect of the enamel with a complex, multifactorial nature and a significant genetic component. Individuals with MIH have a compromised stomatognathic system manifested by muscle hyperactivity under postural and dynamic conditions. However, there is a gap in knowledge on the specific functional abnormalities that these individuals experience. Early identification and intervention, with a focus on the prevention of orofacial dysfunctions and deviations in facial growth and development, are aspects of the utmost importance. Therefore, the aim of the proposed study is to perform a comparative analysis of orofacial functions with an emphasis on breathing and chewing patterns in individuals with and without MIH. The secondary objective is to assess whether dentin hypersensitivity and the severity of MIH lesions are associated with alterations in orofacial functions.

Methods and analysis

Assessments will be performed using the Nordic Orofacial Test-Screening (NOT-S). Descriptive analyses will characterise the sample. The Shapiro-Wilk test will assess normality. For normally distributed data, analysis of variance and Tukey’s post hoc test will be used. For non-normal data, the Mann-Whitney U test will be applied. The 2 test will analyse categorical variables and compare NOT-S domains between groups. Potential confounders (eg, age, sex, socioeconomic status) will be controlled through stratification or as covariates. Logistic and Poisson regressions will model associations for categorical and count-based outcomes, respectively. Statistical significance will be set at p

Ethics and dissemination

This protocol has been approved by the Human Research Ethics Committee of Nove de Julho University (certificate number: 83969924.2.0000.5511; approval date: 22 November 2024). Participants will agree to take part in the study by signing an informed consent form. The findings will be published in a peer-reviewed journal. The collected data will be available on request.

Trial registration number

NCT06692257.

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