Comparing Lumbar Interbody Fusion Surgery and Multidisciplinary Rehabilitation for Adults Aged 20 to 65 With Chronic Low Back Pain

What this Trial Is About

Researchers are comparing lumbar interbody fusion surgery with multidisciplinary rehabilitation to find out which is better at relieving persistent low back pain lasting at least one year in adults aged 20 to 65 years. Chronic low back pain is a leading cause of disability worldwide, with complex causes and limited effective treatments. This study aims to provide clearer evidence on treatment effects and explore new ways to diagnose and tailor treatments using advanced imaging and biomarkers. Participants will be randomly assigned to either lumbar interbody fusion surgery or a multidisciplinary rehabilitation program. The surgery involves fusion of one or two lumbar spine levels through either a transforaminal lumbar interbody fusion TLIF or anterior lumbar interbody fusion ALIF procedure, including stabilization with screws. The rehabilitation consists of 2.5 to 5-hour sessions, 2 to 4 days per week, for 3 to 5 weeks, focusing on cognitive and physical therapy guided by specialists. Both groups will undergo detailed imaging, blood tests, and activity monitoring throughout the study. Participants will provide information about their pain, disability, physical activity, and sleep patterns at several points during the study using questionnaires and accelerometers. Blood samples and imaging will be collected at baseline and follow-ups to assess biomarkers. Safety and adverse events will be closely monitored, especially for surgery participants, with clinical exams, blood tests, and scans. The main measure is the change in disability at one year, with additional evaluations up to two years. The study also assesses cost-effectiveness and quality of life impact over the follow-up period.

The Lumbar Interbody Fusion vs. Multidisciplinary Rehabilitation (LIFEHAB) Trial