Spinal cord stimulation for chronic refractory pain: Long-term effectiveness and safety data from a multicentre registry

Background Spinal cord stimulation (SCS) is an established therapy for refractory neuropathic pain. To ascertain the balance between treatment benefits and risks, the French National Authority for Health requested a post-market registry for real-world evaluation of the long-term effectiveness and safety of the therapy. Methods A total of 402 patients undergoing implantation with a Medtronic SCS device as either a primo-implant (n = 264) or replacement implant (n = 138) were enrolled across 28 representative sites in France. Outcome measures at 2 years included pain intensity, satisfaction with treatment, improvement of pain relief and daily life activity, willingness to undergo the treatment again and use of pain treatments. A patient was considered a responder if, compared to baseline, predominant pain reduction was >= 50%. Results At the 2-year follow-up visit, predominant pain intensity for primo-implant patients had decreased from baseline (p < 0.001), with responder rates of 55%, 36% and 67% for the lower limbs, back and upper limbs, respectively. Most patients acknowledged an improvement in pain relief (89%) and daily life activity (82%) were satisfied with treatment (91%) and willing to undergo the treatment again (93%). A significant decrease (p < 0.01) in the proportion of patients receiving pain treatment was observed for all drug and non-drug treatments. Reported adverse events were in line with the literature. Pain intensity at 2 years was comparable for patients in the replacement group, supporting the long-term stability and effectiveness of SCS. Conclusion Real-world evaluation of the use of spinal cord stimulation under the recommendations of the French Health Authority shows that two years after the first implantation of an SCS device close to 60% of the patients retain a significant pain reduction and 74% show improvement in pain scores [of at least 30%] with significant decreases in drug and non-drug pain treatments. Significance This observational, prospective study in a real-life setting followed a large cohort of patients suffering from chronic pain and implanted with SCS devices in France. The study assessed the long-term effectiveness and safety of SCS therapy in a representative sample of implanting sites in France.