No difference in 9-year outcome in CLBP patients randomized to lumbar fusion versus cognitive intervention and exercises
To compare the 9-year outcome in patients with chronic low back pain treated by instrumented lumbar fusion versus cognitive intervention and exercises.
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.
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.
The outcome at 9 years was not different between instrumented lumbar fusion and cognitive intervention and exercises.