Objectives: We conducted a systematic review to assess the (cost)effectiveness of spinal cord stimulation (SCS) in relieving certain kinds of pain for people with chronic pain owing to failed back surgery syndrome (FBSS).
Methods: We considered randomized trials, controlled observational studies of adult patients with chronic pain owing to FBSS, and case series with at least 50 patients permanently implanted, at least 60% FBSS patients and at least 1-year follow-up. SCS was additional to usual care and compared with usual care. The primary outcome was reduction of pain. Medline, Embase, Lilacs, Cinahl, and Cochrane Library databases were searched from inception until September 2006. An update search was carried out in January 2008.
Results: For the effectiveness analysis, 1 fully published randomized controlled trial, one randomized controlled trial with 6 month results (both of moderate quality), 1 retrospective cohort study, and 13 case series (all of low quality) were included. The mean period of follow-up was between 6 months and 8.8 years. These studies show that SCS is effective in the treatment of FBSS in terms of pain reduction. The effect was consistent in all analyzed studies. Improvements were also reported for other outcomes, such as quality of life and functional status. All the studies reported some complications, most of which were technical problems. In terms of cost-effectiveness, 3 studies met the inclusion criteria and offered the same conclusion that SCS is both more effective and less costly in the long-term, but there is an initial high cost associated with device implantation and maintenance.