OBJECTIVES: Spinal Cord Stimulation (SCS) is considered to be an effective therapy for patients affected by Failed Back Surgery Syndrome refractory to conventional medical management (CMM). PRECISE Study aims to evaluate the costs and clinical benefits of SCS (plus CMM) versus CMM alone on a 2-year  horizon in Italy. Here 12-months results are reported. METHODS: PRECISE Study is an observational, pre-post, multi-centre study. Eighty patients were enrolled to be screened for SCS and, if responders, to be implanted. Health care and non-health care resources use and costs, clinical outcomes and HR-QoL data were collected before and after the implantation. The 12-months data was analyzed and compared to pre-implantation results. Mean monthly resources use, costed in euros 2008, was evaluated according to three perspectives: patient, National Healthcare System (NHS), Society. RESULTS: Seventy-two (90%) patients responded to screening and were implanted. Out of them, 62 (mean age 57; 61% female) completed the 12-months follow-up; ten patients discontinued the therapy for: therapy failure (10%), complications/technical issues (60%), other reasons (30%). SCS significantly reduced pain, and improved function and HR-QoL: mean pain intensity decreased from 7.4±1.3 to 4.4±2.5 (pain Numerical Rating Scale), 53 patients (85%) experienced an improvement in function measured with Oswestry Disability Index and EQ-VAS increased from 37 to 59. The mean utility score was 0.49 (baseline: 011). Patient’s monthly out-of-pocket expenditure halved from €161.45 to €80.04. Excluding upfront costs (screening and implantation), total NHS monthly per-patient expenditure diminished from €163.77 to €100.17, Society monthly per-patient expenditure from €461.89 to €253.27. Including them, NHS and Societal monthly costs per-patient were €1,318.30 and €1,471.40, respectively. CONCLUSIONS: SCS with CMM is more effective than CMM alone in controlling pain and improving HR-QoL. Excluding the upfront costs related to the implantation, SCS allows a reduction in resources consumption and productivity losses from all the possible perspectives of analysis (patient, NHS, Society).