Purpose: To compare the 9-year outcome in patients with chronic low back pain treated by instrumented lumbar fusion versus cognitive intervention and exercises.
Methods: The main outcome measure was the Oswestry Disability Index (ODI). Secondary outcome measures included pain, fear-avoidance beliefs, trunk muscle strength, medication, and return to work.
Results: One-third of the patients randomized to cognitive intervention and exercises had crossed over and been operated and one-third of the patients allocated to lumbar fusion had been re-operated. The intention-to-treat analysis detected no differences between the two groups. The mean adjusted treatment effect for ODI was 1.9 (95 % CI -7.8 to 11.6). Analysed according to the treatment received, more operated patients used pain medication and were out of work.
Conclusions: The outcome at 9 years was not different between instrumented lumbar fusion and cognitive intervention and exercises.