Description Module

Description Module

The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.

Description Module path is as follows:

Study -> Protocol Section -> Description Module

Description Module


Ignite Creation Date: 2025-12-26 @ 11:14 AM
Ignite Modification Date: 2025-12-26 @ 11:14 AM
NCT ID: NCT05261828
Brief Summary: The main purpose of this study is to assess the clinical efficiency of an intervention including a short multidisciplinary program of education and rehabilitation and a personalized follow-up, in patients with subacute and chronic low back pain and no severe disability. The secondary objectives are: * to assess the capacity of the program to modify and reduce the risk factors for evolution of patients towards a severe disability, * to estimate the cost-utility ratio of the intervention.
Detailed Description: Non-specific low back pain (LBP) is the leading cause of years lived with disability worldwide. Subacute LBP is commonly defined as back pain lasting between 6 weeks and 3 months, chronic LBP as pain that persists for 3 or more months. In its most severe forms, subacute and chronic LBP can lead to severe disability that combines physical and psychological deconditioning, limitations in basic and complex activities of daily living, professional exclusion and social marginalization. The direct and indirect medical and economic cost of chronic LBP is major for society. Since the eighties, the bio-psycho-social approach has emerged for the treatment of people with chronic LBP and has led to multidisciplinary functional restoration (FR) programs that include physical activity, exercises, education, occupational therapy and psychological and social rehabilitation. However, the efficiency of these programs is inconsistent and their cost-effectiveness is criticized. As FR programs are by definition standardized, the treatment of chronic LBP remains poorly stratified. However, interest in stratified therapeutic strategies has recently emerged and shown promising results. To date, in France, only semi-intensive (\<100h) or intensive (\>100h) FR programs dedicated to severely disabled patients with chronic LBP have been assessed The investigators' main hypothesis is that an intervention consisting in a short multidisciplinary program including education and rehabilitation and a personalized follow-up could reduce the activity limitations of not severely disabled patients with subacute and chronic LBP. The investigators' secondary hypothesis is that such an intervention could also reduce the main risk factors for evolution of patients with LBP towards a severe disability.
Study: NCT05261828
Study Brief:
Protocol Section: NCT05261828