Effectiveness of a Pain Neuroscience Education program on the physical activity of patients with Chronic Low Back Pain compared to a standard back school program, a randomized controlled study - END-LC

IntroductionEducation is recognized as an effective and necessary method in chronic low back pain. Nevertheless, the data on the effectiveness of education in physical activity in the medium or long term are not yet well known, nor the factors that could lead to practice such or such education. Our study aims to measure the effectiveness of a pain neuroscience education compared to a back school on physical activity three months and one year after educational sessions coupled with a multidisciplinary rehabilitation program. The study also seeks to measure the effects of these two types of education on several other factors including the intensity of pain and psycho-behavioral factors. Finally, it aims to identify the determinants of the success of the educational sessions coupled with the rehabilitation program. Methods and analysisThe study will involve eighty-two adults with chronic low back pain. The study will be monocentric, prospective, open, controlled, and randomized, of superiority, with two parallel arms with an experimental group "pain neuroscience education" and a control group "back school". The primary outcome will be the average number of steps taken at home over a week measured by an actigraph. Secondary outcomes include behavioral assessments. Descriptive and inferential analysis will be carried out on the primary and secondary judgment criteria. Multivariate modeling will be carried out using actimetric data and data from the main and secondary outcomes. Ethics and disseminationa favorable opinion was given by the Committee for Personal Protection of Ile de France VII on June 22, 2023 (National number: 2023-A00346-39). The study was previously registered with the National Agency or the Safety of Medicines and Health Products (IDRCB : 2023-A00346-39). This protocol is the version submitted to the Committee for Personal Protection of Ile de France VII entitled "Protocol Version N{degrees}1 of 03/29/2023". Trial RegistrationNCT05840302. Article SummaryStrengths and limitations of this study O_LIThe use of an actigraph as a measuring tool of physical activity in ecological context to evaluate effectiveness of an education in low back pain. C_LIO_LIThe follow-up at three months and one year after the rehabilitation program. C_LIO_LIThe study includes an analysis of actimetric data, behavioral, occupational and psychological variables to determine the predictive factors for the success of educational sessions. C_LIO_LIThe monocentric design of this study is a limitation. C_LI