Spinal cord stimulation versus reoperation for failed back surgery syndrome: a prospective, randomized study design.

Retrospectively reported results of spinal cord stimulation compare favorably with those of neurosurgical treatment alternatives for the treatment of failed back surgery syndrome, including reoperation and ablative procedures. There has been no direct prospective comparison, however, between SCS and other techniques for pain management. Therefore, we have designed a prospective, randomized comparison of spinal cord stimulation and reoperation in patients with persistent radicular pain, with and without low back pain, after lumbosacral spine surgery. Patients selected for reoperation by standard criteria are randomly assigned to initial treatment by one or the other technique. The primary outcome measure is the frequency of crossover to the alternative procedure, if the results of the first have been unsatisfactory after 6 months. Results for the first 27 patients reaching the 6-month crossover point show a statistically significant (p = 0.018) advantage for spinal cord stimulation over reoperation. Many other potentially important outcome measures will now be followed long-term as a larger overall study population accumulates.