Long-term quality of life and work status after high-dose spinal cord stimulation in patients with failed back surgery syndrome: a secondary analysis of real-world data

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  • 1 Department of Neurosurgery, Universitair Ziekenhuis Brussel, Jette;
  • 2 Center for Neurosciences (C4N), Vrije Universiteit Brussel, Jette;
  • 3 STIMULUS Consortium (reSearch and TeachIng neuroModULation Uz bruSsel), Universitair Ziekenhuis Brussel, Brussels;
  • 4 Pain in Motion International Research Group, Jette;
  • 5 Department of Physical Medicine and Rehabilitation, Universitair Ziekenhuis Brussel, Jette;
  • 6 Department of Public Health (GEWE), Vrije Universiteit Brussel (VUB), Jette;
  • 7 I-CHER, Interuniversity Center for Health Economics Research, Vrije Universiteit Brussel (VUB), Jette; and
  • 8 Department of Radiology, Universitair Ziekenhuis Brussel, Jette, Belgium
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OBJECTIVE

In recent years, the use of high-dose spinal cord stimulation (HD-SCS) as a treatment option for patients with failed back surgery syndrome (FBSS) has drastically increased. However, to the authors’ knowledge a thorough evaluation of health-related quality of life (HRQOL) and work status in these patients has not yet been performed. Moreover, it is unclear whether patients who are treated with HD-SCS can regain the same levels of HRQOL as the general population. Therefore, the aims of this study were to compare the HRQOL of patients who receive HD-SCS to HRQOL values in an age- and sex-adjusted population without FBSS and to evaluate work status in patients who are receiving HD-SCS.

METHODS

HRQOL, measured with the 3-level EQ-5D (EQ-5D-3L), and work status were evaluated in 185 FBSS patients at baseline (i.e., before SCS) and at 1, 3, and 12 months of treatment with HD-SCS. Difference scores in utility values between patients and an age- and sex-adjusted normal population were calculated. One-sample Wilcoxon tests were used to assess the EQ-5D-3L difference scores. Mixed models were used to evaluate the evolution over time in EQ-5D-3L utility scores and EQ-5D visual analog scale (VAS) scores in patients and matched controls. Quality-adjusted life-years (QALYs) were calculated using the area under the curve method.

RESULTS

An overall significant increase in EQ-5D-3L utility scores and EQ-5D VAS scores was found over time in the patient group. Wilcoxon tests indicated that the difference scores in utility values between patients and the normal population were significantly different from zero at all time points. The median incremental QALY after 12 months of HD-SCS was 0.228 (Q1–Q3: 0.005–0.487) in comparison to continued conservative treatment. At 12 months, 13.75% of patients resumed work.

CONCLUSIONS

HD-SCS may lead to significantly increased HRQOL at 12 months in patients with FBSS. Despite the increase, reaching the HRQOL level of matched controls was not achieved. Only a limited number of patients were able to return to work. This finding indicates that specialized programs to enhance return to work may be beneficial for patients undergoing SCS.

ABBREVIATIONS EQ-5D-3L = 3-level EQ-5D; FBSS = failed back surgery syndrome; HD-SCS = high-dose SCS; HRQOL = health-related QOL; NRS = numeric rating scale; QALY = quality-adjusted life-years; QOL = quality of life; SCS = spinal cord stimulation; VAS = visual analog scale.

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Contributor Notes

Correspondence Maarten Moens: Universitair Ziekenhuis Brussel, Jette, Belgium. maarten.moens@uzbrussel.be.

INCLUDE WHEN CITING Published online December 18, 2020; DOI: 10.3171/2020.7.SPINE20764.

Disclosures Maarten Moens has received speaker fees from Medtronic and Nevro, clinical or research support for the study described and honoraria from Medtronic, and support of non–study-related clinical or research effort overseen by the author from Nevro. This study was supported by Medtronic Europe Sàrl, which provided a research grant. Medtronic was not involved in the collection and analysis of the data or in the writing of the manuscript.

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