Background and Aims The Product Surveillance Registry (PSR, Medtronic) is a prospective, long-term, multicentre registry to monitor the performance and safety of Medtronic Spinal Cord Stimulation (SCS) systems. We present an exploration of the effect of SCS with 2 rechargeable systems (RestoreSensor and Intellis) in patients with Back Pain of Failed Back Surgery Syndrome (BP-FBSS) on Health-Related Quality of Life (HR-QoL), and functional disability (Oswestry Disability Index, ODI).
Methods Patients with a diagnosis of BP-FBSS, a general pain score ≥5, and an initial implant were included. EQ-5D and ODI scores were summarized at baseline, 6-months, and for the change from baseline to 6-months (paired t-tests evaluated within-group change).
Results EQ-5D UK scores showed statistically significant and clinically relevant improvements for both RestoreSensor and Intellis from baseline to 6 months; 0.47±0.21 to 0.57±0.28 (n=78; P=0.001), and 0.45±0.25 to 0.60±0.26 (n=82; P<0.0001), respectively.
ODI scores reduced from 51.1±13.3 to 45.1±16.4 (n=76; P=0.001) and 50.9±12.6 to 39.3±16.6 (n=85; P<0.0001), for RestoreSensor and Intellis, respectively.
Conclusions To assess clinical relevance, research suggest a minimum clinically important difference (MCID) of 0.081 in EQ-5D in a subgroup of patients with back pain and 9.2 in ODI in patients with FBSS. Our analysis shows statistically significant and clinically relevant improvements in health-related quality of life, and functional disability from baseline to 6-months in patients diagnosed with BP-FBSS and implanted with a rechargeable SCS-system.
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