A Randomized Study Comparing Fusion Surgery With Non-Fusion Surgery for Chronic Low Back Pain in Adults Aged 25 to 65

What this Trial Is About

Chronic low back pain is a common cause of disability and reduced quality of life, affecting up to 80% of people at some point. When pain lasts over a year and does not improve with painkillers or physical therapy, surgery may be considered. This trial investigates whether fusion surgery, which stabilizes parts of the spine, is more effective than surgery without fusion for treating low back pain. The study aims to clarify the true benefit of fusion surgery, considering previous research has shown uncertain results and a possible placebo effect from surgery itself. In this randomized trial, 90 adults aged 25 to 65 with long-lasting mechanical low back pain and confirmed disc degeneration will undergo surgery. During the operation, patients will be randomly assigned to receive either fusion surgery with implants or surgery without fusion and no implants. Neither patients nor the post-surgery care team will know which treatment was given until after six months. The fusion surgery involves placing screws and rods to stabilize the spine, while the non-fusion surgery includes similar surgical exposure without implant placement. Participants will be evaluated before surgery and followed up at 3 months, 6 months, 1 year, 2 years, and 5 years. Assessments include questionnaires on back function and pain, physical tests, imaging, and quality of life measures. The main outcome is the Oswestry Disability Index score at 6 months, measuring the impact of back pain on daily activities. Safety and complications will be monitored, and data will be collected in a spine surgery registry. Participants can withdraw anytime without affecting their care, and results will help determine the true value of fusion surgery for low back pain.

Fusion or Not - a Study on Low Back Pain