A prospective, randomized study of spinal cord stimulation versus reoperation for failed back surgery syndrome:...

Spinal cord stimulation (SCS) has been reported to be effective treatment for the failed back surgery syndrome in a number of retrospective case series. Its retrospectively reported results compare favorably with those of neurosurgical treatment alternatives, such as reoperation and ablative procedures. There has been no direct prospective comparison, however, between SCS and other techniques for pain management. We have undertaken a prospective, randomized comparison of SCS and reoperation in patients with persistent radicular pain, with and without low back pain, following lumboscral spine surgery. Patients selected for reoperation by standard criteria have been 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 SCS over reoperation. This is one of many potentially important outcome measures, which are to be followed long-term as a larger overall study population accrues.