Effectiveness of a pain neuroscience education programme on the physical activity of patients with chronic low back pain compared with a standard back school programme: protocol for a randomised controlled study (END-LC)

Introduction
Education is recognised as an effective and necessary approach in chronic low back pain. Nevertheless, data regarding the effectiveness of education in promoting physical activity in the medium term or long term are still limited, as are the factors that could lead to successful outcomes. Our study aims to assess the effectiveness of a pain neuroscience education programme compared with traditional back school on physical activity 3 months and 1 year after educational sessions coupled with a multidisciplinary rehabilitation programme. Additionally, we seek to evaluate the effects of these educational interventions on various factors, including pain intensity and psychobehavioural factors. Finally, our goal is to identify the determinants of success in educational sessions combined with the rehabilitation programme.

Methods and analysis
The study will involve 82 adults with chronic low back pain. It will be a monocentric, open, controlled, randomised, superiority trial with two parallel arms: an experimental group, ‘pain neuroscience education’, and a control group, ‘back school’. The primary outcome is the average number of steps taken at home over a week, measured by an actigraph. Secondary outcomes include behavioural assessments. Descriptive and inferential analysis will be conducted. Multivariate modelling will be performed using actimetric data and data from the primary and secondary outcomes.

Ethics and dissemination
The Committee for Personal Protection of Ile de France VII (CPP) gave a favourable opinion on 22 June 2023 (National number: 2023-A00346-39). The study was previously registered with the National Agency for the Safety of Medicines and Health Products (IDRCB: 2023-A00346-39). Participants signed an informed consent during the inclusion visit. This protocol is the version submitted to the CPP entitled ‘Protocol Version N°1 of 03/29/2023’. The results of the study will be presented nationally and internationally through conferences and publications.

Trial registration number
NCT05840302.

Leggi
Giugno 2024

Standard cardiopulmonary resuscitation versus chest compressions only after out-of-hospital cardiac arrest: a protocol for a systematic review and meta-analysis

Introduction
The 2020 American Heart Association guidelines encourage lay rescuers to provide chest compression-only cardiopulmonary resuscitation to simplify the process and encourage cardiopulmonary resuscitation initiation. However, recent clinical trials had contradictory results about chest compression-only cardiopulmonary resuscitation. This study will aim to compare standard and chest compressions-only cardiopulmonary resuscitation after out-of-hospital cardiac arrest.

Methods and analysis
This study will retrieve only randomised and quasi-randomised controlled trials from the Cochrane Library, PubMed, Web of Science and Embase databases. Data on study design, participant characteristics, intervention details and outcomes will be extracted by a unified standard form. Primary outcomes to be assessed are hospital admission, discharge, and 30-day survival, and return of spontaneous circulation. The Grading of Recommendations, Assessment, Development and Evaluation framework will evaluate the quality of evidence. Cochrane’s tool for assessing the risk of bias will evaluate risk deviation. If the I2 statistic is lower than 40%, the fixed-effects model will be used for meta-analysis. Otherwise, the random-effects model will be used. The search will be performed following the publication of this protocol (estimated to occur on 30 December 2024).

Discussion
This study will evaluate the effect of chest compression-only cardiopulmonary resuscitation after out-of-hospital cardiac arrest and provide evidence for cardiopulmonary resuscitation guidelines.

Ethics and dissemination
No patient or public entity will be involved in this study. Therefore, the study does not need to be ethically reviewed. The results of the study will be disseminated through peer-reviewed journal publications and committee conferences.

PROSPERO registration number
CRD42021295507.

Leggi
Maggio 2024