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72 Improvement of health-related quality of life and functional disability in patients with fbss pain and implanted with a rechargeable spinal cord stimulation system
  1. R Buschman1,
  2. A Calodney2,
  3. J Hatheway3,
  4. S Eldabe4,
  5. L Cantin5,
  6. E Buchser6,
  7. N Grunow7 and
  8. R Slangen8
  1. 1Medtronic Trading NL B.V., Eindhoven, Netherlands
  2. 2Precision Spine and Care, Tyler, USA
  3. 3Northwest Pain Care, Spokane, USA
  4. 4The James Cook University Hospital, Middlesbrough, UK
  5. 5Hôpital Enfant-Jésus, Québec, Canada
  6. 6Hôpital de Morges, Morges, Switzerland
  7. 7Clinical Biostatistics, Medtronic, plc, Minneapolis, USA
  8. 8Post Approval Clinical Surveillance, Medtronic, Maastricht, Netherlands


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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