Clinical Trial

Preparatory Lifestyle Program Before Functional Restoration for Chronic Low Back Pain

Study acronym: PFRP-FRP
Completed
View on ClinicalTrials.gov →
Summary
Chronic low back pain is a major public health issue worldwide, affecting hundreds of millions of people. Intensive multidisciplinary rehabilitation programs, such as the Functional Restoration Program (FRP), are effective in improving physical capacity, quality of life, and return to work in these patients. However, many patients reach these programs in a deconditioned state and may struggle to engage fully with the intensive demands. Additionally, during the waiting period before entering such programs, patients often receive no structured support, which may worsen sedentary behavior and physical deconditioning. This study examined whether adding a 12-week preparatory phase before the FRP could help patients enter the intensive program in better condition and prevent deterioration during the waiting period. The preparatory phase, called PFRP, was designed as a lifestyle-based intervention emphasizing patient autonomy: participants attended one 2-hour supervised session per week at the Day Hospital and were encouraged to practice exercises at home between sessions. The program also included therapeutic education about pain and self-management strategies. Twenty-four adults with chronic low back pain were included in two groups. The PFRP group (14 participants) received the 12-week preparatory phase followed by the 4-week FRP. The control group (10 participants) received the FRP alone after an equivalent waiting period. Assessments were conducted at four time points: at the start of the preparatory phase or waiting period (T0), at FRP entry (T1), at FRP exit (T2), and four months after FRP completion (T3). The two co-primary outcomes were sedentary behavior (measured by the ONAPS questionnaire) and the impact of pain on daily activities (measured by the DALLAS questionnaire). Secondary outcomes included physical fitness, fear-avoidance beliefs, pain intensity, and psychological well-being. The study aimed to evaluate (1) whether the preparatory phase prevents behavioral and functional deterioration during the waiting period, and (2) whether it supports better medium-term maintenance of improvements after the intensive program.
Trial Details
NCT Number NCT07649707
Lead Sponsor University of Artois
Collaborators: Centre Hélène Borel, Fondation Hopale, Université de Lille - SHERPAS (URePSSS, ULR 7369)
Conditions Low Back Pain, Chronic Pain
Enrollment 24 participants
Start Date 2023-01-01
Primary Completion 2024-07-01 (estimated)
Study Completion 2024-07-01 (estimated)
Updated on ClinicalTrials.gov 2026-06-16