A Prospective, Open-Label, Multicenter Study to Assess the Efficacy of Spinal Cord Stimulation and Identify Patients Who Would Benefit

Objective: To identify patients likely to benefit from spinal cord stimulation (SCS). Materials and Methods: This multicenter, prospective, open-label study included medical centers experienced in SCS therapy, carried out in 13 physicians in seven centers. We recruited 55 patients with complex regional pain syndrome, failed back surgery syndrome, or peripheral vascular disease. Neurostimulators were implanted in 34 patients found to respond to SCS in a preliminary test, who were then followed for six months. Thirty-four patients scored their pain on a visual analog scale (VAS) and completed the EuroQol-5D questionnaire before and after test stimulation and after one and six months. Results: During test stimulation, the mean VAS and quality of life (QOL) scores improved from 74.0 to 23.4 and from 0.430 to 0.664, respectively, in the 34 patients. At six months, the mean VAS score was 29.7 in 29 patients and the mean QOL score was 0.661 in 31 patients.