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Actively Recruiting

Researchers are evaluating the effects of lumbar interbody fusion surgery compared to multidisciplinary rehabilitation in adults aged 20 to 65 years who have persistent low back pain lasting at least one year. This trial aims to determine if lumbar fusion surgery is more effective than multidisciplinary rehabilitation in relieving this chronic condition, which is a leading cause of disability worldwide and often has complex causes that are not fully understood. The study also explores biomarkers, physical activity, sleep disturbances, and cost-effectiveness related to these treatments. Participants are randomly assigned to either the lumbar interbody fusion surgery group or the multidisciplinary rehabilitation group. Those undergoing surgery will have radiologic exams including X-rays and MRI with spectroscopy, blood samples taken at four times including after surgery, and their activity monitored with an accelerometer. The rehabilitation group will receive outpatient multidisciplinary cognitive and physical training-based rehabilitation, also with radiologic exams, blood samples at three intervals, and activity monitoring. Treatment starts within three months after randomization. Throughout the study, participants complete questionnaires measuring disability and symptoms at multiple points. Researchers monitor health outcomes, adverse events especially related to surgery, and collect various biological samples to study potential biomarkers. The main outcome measured is the change in disability after one year. Safety and healthcare use are tracked, and cost-effectiveness of both treatments is evaluated. Participation involves up to two years of follow-up including possible crossover between treatments after one year.

Age: 20Years - 65YearsAll GendersPhase Not Applicable
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