Centre Hospitalier Paul Coste Floret, Lamalou les Bains, France
Clinical Research and Epidemiology Unit, Montpellier University Hospital, Univ Montpellier, Montpellier, France.
BMJ Open. 2024 Jun 3;14(6):e080079. doi: 10.1136/bmjopen-2023-080079.
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.
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.
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.
NCT05840302.
教育被认为是治疗慢性下背痛的有效且必要手段。然而，关于教育在中长期内促进身体活动的有效性的数据仍然有限，能够导致成功结果的因素也是如此。我们的研究旨在评估疼痛神经科学教育计划与传统腰背学校教育在结合多学科康复计划后 3 个月和 1 年时对身体活动的影响。此外，我们还试图评估这些教育干预对各种因素的影响，包括疼痛强度和心理行为因素。最后，我们的目标是确定结合康复计划的教育课程成功的决定因素。
该研究将纳入 82 名慢性下背痛的成年人。这将是一项单中心、开放、对照、随机、优效试验，有两个平行组：实验组为“疼痛神经科学教育”，对照组为“腰背学校”。主要结局是通过计步器测量的一周内在家中平均步数。次要结局包括行为评估。将进行描述性和推断性分析。将使用计步器数据和主要及次要结局数据进行多变量建模。
法兰西岛第七区个人保护委员会（CPP）于 2023 年 6 月 22 日发表了有利意见（国家编号：2023-A00346-39）。该研究之前已在国家药品和健康产品安全局（IDRCB：2023-A00346-39）注册。参与者在纳入访问期间签署了知情同意书。本方案是提交给 CPP 的方案版本 1，标题为“2023 年 3 月 29 日第 1 版”。该研究结果将通过会议和出版物在全国和国际上公布。
NCT05840302。
