Questions remain concerning effectiveness and risks of spinal cord stimulation (SCS) for chronic back and leg pain after spine surgery ("failed back surgery syndrome" [FBSS]). This prospective, population-based controlled cohort study evaluated outcomes of workers' compensation recipients with FBSS who received at least a trial of SCS (SCS group, n=51) versus those who (1) were evaluated at a multidisciplinary pain clinic and did not receive SCS (Pain Clinic, n=39) or (2) received neither SCS nor pain clinic evaluation (Usual Care, n=68). Patients completed measures of pain, function, medication use, and work status at baseline and 6, 12, and 24 months later. We also examined work time loss compensation over 24 months. Few (<10%) patients in any group achieved success at any follow-up on the composite primary outcome encompassing less than daily opioid use and improvement in leg pain and function. At 6 months, the SCS group showed modestly greater improvement in leg pain and function, but with higher rates of daily opioid use. These differences disappeared by 12 months. Patients who received a permanent spinal cord stimulator did not differ from patients who received some pain clinic treatment on the primary outcome at any follow-up (<10% successful in each group at each follow-up) and 19% had them removed within 18 months. Both trial and permanent SCS were associated with adverse events. In sum, we found no evidence for greater effectiveness of SCS versus alternative treatments in this patient population after 6 months.
Copyright 2009 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.