Surgery for Lumbar Radiculopathy/ Sciatica

[Pages:348]Surgery for Lumbar Radiculopathy/ Sciatica

Final evidence report

April 13, 2018

Health Technology Assessment Program (HTA) Washington State Health Care Authority

PO Box 42712 Olympia, WA 98504-2712

(360) 725-5126 hca.hta

shtap@hca.

Prepared by:

RTI International?University of North Carolina Evidence-based Practice Center Research Triangle Park, NC 27709

This evidence report is based on research conducted by the RTI-UNC Evidence-based Practice Center through a contract between RTI International and the State of Washington Health Care Authority (HCA). The findings and conclusions in this document are those of the authors, who are responsible for its contents. The findings and conclusions do not represent the views of the Washington HCA and no statement in this report should be construed as an official position of Washington HCA.

The information in this report is intended to help the State of Washington's independent Health Technology Clinical Committee make well-informed coverage determinations. This report is not intended to be a substitute for the application of clinical judgment. Anyone who makes decisions concerning the provision of clinical care should consider this report in the same way as any medical reference and in conjunction with all other pertinent information (i.e., in the context of available resources and circumstances presented by individual patients).

This document is in the public domain and may be used and reprinted without permission except those copyrighted materials that are clearly noted in the document. Further reproduction of those copyrighted materials is prohibited without the specific permission of copyright holders. None of the individuals involved in producing this report reported any financial or non-financial conflicts of interest regarding the topic presented in this report.

Acknowledgments

The following individuals from the RTI-UNC Evidence-based Practice Center contributed to this report:

Lead Investigator: Leila Kahwati, MD, MPH Co-Investigator: Rachel Palmieri Weber, PhD Clinical Advisor: Moe Lim, MD Analysts: Rachel Clark, BA; Katrina Burson, RN, MS Scientific Reviewer: Meera Viswanathan, PhD Library/Document Preparation: Mark Howell, MLS; Loraine Monroe; Laura Small, BA

The following individuals independently peer-reviewed the Draft Report; these individuals did not receive any compensation in exchange for their review:

Timothy Carey, MD, MPH; Distinguished Professor of Medicine, School of Medicine, University of North Carolina

Roger Chou, MD; Professor of Medicine, School of Medicine, Oregon Health & Science University

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Contents

List of Appendices .............................................................................................................. ii List of Figures ..................................................................................................................... ii List of Tables ...................................................................................................................... ii List of Abbreviations ........................................................................................................ vii Executive Summary ................................................................................................................ ES-1 Structured Abstract ............................................................................................................. ES-1 ES-1. Background ............................................................................................................. ES-1 ES-2. Methods................................................................................................................... ES-3 ES-3. Results..................................................................................................................... ES-8 ES-3.1 Literature Yield ................................................................................................. ES-8 ES-3.2 Efficacy ............................................................................................................. ES-8 ES-3.3 Safety .............................................................................................................. ES-23 ES 3.4 Cost ................................................................................................................. ES-28 ES-3.5 Synthesis of Clinical Practice Guidelines ....................................................... ES-30 ES-4. Discussion ............................................................................................................. ES-33 ES-4.1 Summary of the Evidence ............................................................................... ES-33 ES-4.2 Limitations of the Evidence Base ................................................................... ES-35 ES-4.3 Other Related HTAs ....................................................................................... ES-36 ES-4.4 Payer Coverage ............................................................................................... ES-36 ES-4.5 Limitations of this HTA.................................................................................. ES-37 ES-4.6 Ongoing Research and Future Research Needs .............................................. ES-38 ES-5. Conclusion ............................................................................................................ ES-38 Full Technical Report ................................................................................................................... 1 Structured Abstract ................................................................................................................... 1 1. Background ......................................................................................................................... 3 1.1 Condition Description ................................................................................................. 3 1.2 Disease Burden............................................................................................................ 4 1.3 Technology Description ............................................................................................. 4 1.4 Regulatory Status ........................................................................................................ 5 1.5 Policy Context ............................................................................................................. 6 1.6 Washington State Agency Utilization Data................................................................. 6 2. Methods............................................................................................................................... 7 2.1 Research Questions and Analytic Framework for Systematic Review of Primary

Research Studies.......................................................................................................... 7 2.2 Clinical Practice Guideline Synthesis ....................................................................... 14 3. Results............................................................................................................................... 15 3.1 Literature Search ....................................................................................................... 15 3.2 Efficacy ..................................................................................................................... 16 3.3 Safety......................................................................................................................... 74 3.4 Cost and Cost-Effectiveness...................................................................................... 91 3.5 Clinical Practice Guideline Synthesis ....................................................................... 98 4. Discussion ....................................................................................................................... 107 4.1 Summary of the Evidence ....................................................................................... 107 4.2 Limitations of the Evidence Base............................................................................ 115

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4.3 Other related HTAs ................................................................................................. 118 4.4 Selected payer coverage policies............................................................................. 118 4.5 Limitations of this HTA .......................................................................................... 125 4.6 Ongoing Research and Future Research Needs ...................................................... 126 5. Conclusion ...................................................................................................................... 126 6. References....................................................................................................................... 127

List of Appendices

Appendix A. State of Washington Health Care Authority Utilization Data............................... A-1 Appendix B. Search Strategy ...................................................................................................... B-1 Appendix C. Additional Methods ............................................................................................... C-1 Appendix D. Evidence Tables .................................................................................................... D-1 Appendix E. Excluded Studies ....................................................................................................E-1 Appendix F. Individual Study Risk of Bias Assessments............................................................F-1 Appendix G. Meta-analyses........................................................................................................ G-1

List of Figures

Figure ES-1. Analytic framework for HTA on surgery for lumbar radiculopathy ................ ES-3

Figure 1. Figure 2. Figure 3.

Figure 4.

Figure 5.

Figure 6.

Figure 7.

Analytic framework for HTA on surgery for lumbar radiculopathy ...................... 8 Study flow diagram for HTA on surgery for lumbar radiculopathy ..................... 15 Evidence map of surgery compared with nonsurgical interventions for treatment of symptomatic lumbar radiculopathy ................................................................ 108 Evidence map of minimally-invasive surgery compared with discectomy or microdiscectomy for treatment of symptomatic lumbar radiculopathy .............. 110 Evidence map of microdiscectomy compared with discectomy for treatment of symptomatic lumbar radiculopathy..................................................................... 112 Evidence map of repeat lumbosacral decompression compared with spinal cord stimulation for treatment of recurrent symptomatic lumbar radiculopathy ........ 113 Evidence map of revision endoscopic discectomy compared with revision microdiscectomy for treatment of recurrent symptomatic lumbar radiculopathy ............................................................................................................................. 114

List of Tables

Table ES-1. Table ES-2.

Table ES-3. Table ES-4.

Table ES-5.

Surgical interventions used to treat lumbar radiculopathy ............................... ES-1 Population, intervention, comparator, outcome, timing, setting and other study selection criteria for HTA on surgery for lumbar radiculopathy ............ ES-4 Strength of evidence grades and definitions19 .................................................. ES-7 Surgical and comparator interventions used among 22 included studies for EQ1.............................................................................................................. ES-9 Summary of efficacy outcome findings and strength of evidence ratings comparing surgery to nonsurgical interventions in persons with symptomatic lumbar radiculopathy (EQ1)...................................................... ES-10

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Table ES-6. Summary of efficacy outcome findings and strength of evidence ratings

comparing minimally-invasive surgery to standard surgery in persons

with symptomatic lumbar radiculopathy (EQ1) ............................................. ES-13

Table ES-7. Summary of efficacy outcome findings and strength of evidence ratings

comparing microdiscectomy to discectomy in persons with symptomatic

lumbar radiculopathy (EQ1) ........................................................................... ES-18

Table ES-8. Summary of efficacy findings and strength of evidence ratings comparing

repeat lumbosacral decompression surgery with spinal cord stimulation for

treatment of lumbar radiculopathy relapses (EQ2) ......................................... ES-20

Table ES-9. Summary of efficacy findings and strength of evidence ratings comparing

revision endoscopic discectomy with revision microdiscectomy for

treatment of relapsed lumbar radiculopathy (EQ2) ........................................ ES-21

Table ES-10. Summary of safety outcome findings and strength of evidence ratings

comparing surgery to nonsurgical interventions in persons with

symptomatic lumbar radiculopathy (SQ1)...................................................... ES-23

Table ES-11. Summary of safety outcome findings and strength of evidence ratings

comparing minimally-invasive surgery to standard surgery in persons

with symptomatic lumbar radiculopathy (SQ1).............................................. ES-25

Table ES-12. Summary of safety outcome findings and strength of evidence ratings

comparing microdiscectomy to discectomy in persons with symptomatic

lumbar radiculopathy (SQ1) ........................................................................... ES-27

Table ES-13. Summary of safety outcome findings and strength of evidence ratings

comparing repeat lumbosacral decompression to spinal cord stimulation in

persons with relapsed lumbar radiculopathy (SQ1)........................................ ES-28

Table ES-14. Summary of safety outcome findings and strength of evidence ratings

comparing revision endoscopic surgery to revision microdiscectomy in

persons with relapsed lumbar radiculopathy (SQ1)........................................ ES-28

Table ES-15. Summary of cost-effective findings comparing surgery to nonsurgical

interventions in persons with symptomatic lumbar radiculopathy (CQ1) ...... ES-29

Table ES-16. Summary of cost-effective findings comparing minimally-invasive

surgery to standard surgery in persons with symptomatic lumbar

radiculopathy (CQ1) ....................................................................................... ES-30

Table ES-17. Summary of costs comparing microdiscectomy to discectomy in persons

with symptomatic lumbar radiculopathy (CQ1) ............................................. ES-30

Table ES-18. Synopsis of clinical practice guidelines related to lumbar radiculopathy or

herniated intervertebral lumbar disc ............................................................... ES-31

Table ES-19. Overview of payer coverage policies.............................................................. ES-37

Table 1.

Description of surgical interventions used to treat lumbar radiculopathy .............. 5

Table 2.

Population, intervention, comparator, outcome, timing, setting and other

study selection criteria for HTA on surgery for lumbar radiculopathy .................. 9

Table 3.

Strength of evidence grades and definitions19 ...................................................... 14

Table 4.

Study and population characteristics of the seven randomized controlled

trials comparing surgery to nonsurgical interventions for management of

lumbar radiculopathy (EQ1) ................................................................................. 17

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Table 5. Table 6. Table 7. Table 8. Table 9. Table 10. Table 11. Table 12. Table 13. Table 14. Table 15. Table 16. Table 17. Table 18. Table 19.

Study and population characteristics of the twelve randomized controlled trials comparing minimally-invasive surgery to standard surgery for management of lumbar radiculopathy (EQ1) ....................................................... 20 Study and population characteristics of the 3 randomized controlled trials comparing microdiscectomy to discectomy for the management of lumbar radiculopathy (EQ1).............................................................................................. 24 Surgical and comparator interventions used among 22 included studies for EQ1 ...................................................................................................................... 25 Summary of efficacy outcomes reported by included studies, including score range, minimally important clinical difference, and required sample size to detect various between-group differences ............................................................ 27 Summary of findings and strength of evidence ratings comparing surgery to nonsurgical interventions for pain in persons with symptomatic lumbar radiculopathy (EQ1).............................................................................................. 29 Summary of findings and strength of evidence ratings comparing minimallyinvasive surgery to standard surgery for pain in persons with symptomatic lumbar radiculopathy (EQ1) ................................................................................. 37 Summary of findings and strength of evidence ratings comparing microdiscectomy to discectomy for pain in persons with symptomatic lumbar radiculopathy......................................................................................................... 44 Summary of findings and strength of evidence ratings comparing surgery to nonsurgical interventions for functioning/disability in persons with symptomatic lumbar radiculopathy (EQ1)............................................................ 45 Summary of findings and strength of evidence ratings comparing minimallyinvasive surgery to standard surgery for functioning/disability in persons with symptomatic lumbar radiculopathy (EQ1) ................................................... 50 Summary of findings and strength of evidence ratings comparing microdiscectomy to discectomy for functioning/disability in persons with symptomatic lumbar radiculopathy....................................................................... 56 Summary of findings and strength of evidence ratings comparing surgery to nonsurgical interventions for quality of life in persons with symptomatic lumbar radiculopathy (EQ1) ................................................................................. 57 Summary of findings and strength of evidence ratings comparing minimallyinvasive surgery to standard surgery for quality of life in persons with symptomatic lumbar radiculopathy (EQ1)............................................................ 58 Summary of findings and strength of evidence ratings comparing microdiscectomy to discectomy for quality of life in persons with symptomatic lumbar radiculopathy (EQ1)............................................................ 59 Summary of findings and strength of evidence ratings comparing surgery to nonsurgical interventions for neurologic symptoms in persons with symptomatic lumbar radiculopathy (EQ1)............................................................ 60 Summary of findings and strength of evidence ratings comparing minimallyinvasive surgery to standard surgery for neurologic symptoms in persons with symptomatic lumbar radiculopathy (EQ1) ................................................... 61

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Table 20. Table 21. Table 22 Table 23.

Table 24.

Table 25.

Table 26. Table 27. Table 28. Table 29. Table 30. Table 31. Table 32. Table 33.

Summary of findings and strength of evidence ratings comparing surgery to nonsurgical interventions for outcomes related to return to work in persons with symptomatic lumbar radiculopathy (EQ1) ...................................... 62 Summary of findings and strength of evidence ratings comparing minimallyinvasive surgery to standard surgery for return to work outcomes in persons with symptomatic lumbar radiculopathy (EQ1) ................................................... 64 Summary of findings and strength of evidence ratings comparing microdiscectomy to discectomy for return to work outcomes in persons with symptomatic lumbar radiculopathy (EQ1)............................................................ 65 Study and population characteristics of the two randomized controlled trials comparing revision surgical interventions to spinal cord stimulation or an alternative revision surgery for the management of lumbar radiculopathy relapses (EQ2)....................................................................................................... 69 Summary of findings for pain, functioning, neurological symptoms and quality of life for RCTs for repeat lumbosacral decompression surgery compared with spinal cord stimulation for treatment of lumbar radiculopathy relapses (EQ2)....................................................................................................... 70 Summary of findings for pain, functioning, quality of life, neurologic s ymptoms and return to work comparing revision endoscopic discectomy to revision microdiscectomy for treatment of lumbar radiculopathy relapses (EQ2)..................................................................................................................... 71 Summary of findings and strength of evidence ratings comparing surgery to nonsurgical interventions for mortality in persons with symptomatic lumbar radiculopathy (SQ1).............................................................................................. 74 Summary of findings and strength of evidence ratings comparing minimallyinvasive surgery to standard surgery for mortality in persons with symptomatic lumbar radiculopathy (SQ1)............................................................ 75 Summary of findings and strength of evidence ratings comparing microdiscectomy to discectomy for mortality in persons with symptomatic lumbar radiculopathy (SQ1) ................................................................................. 76 Summary of findings and strength of evidence ratings of repeat lumbosacral decompression compared with spinal cord stimulation for mortality in persons with recurrent lumbar radiculopathy (SQ1) .......................................................... 77 Summary of findings and strength of evidence ratings of revision endoscopic surgery compared with revision microdiscectomy for mortality in persons with recurrent lumbar radiculopathy (SQ1) .......................................................... 77 Summary of findings and strength of evidence ratings for surgical morbidity in persons with symptomatic lumbar radiculopathy who undergo surgical intervention (SQ1) ................................................................................................ 78 Summary of findings and strength of evidence ratings comparing minimallyinvasive surgery to standard surgery for surgical morbidity in persons with symptomatic lumbar radiculopathy (SQ1)............................................................ 79 Summary of findings and strength of evidence ratings comparing microdiscectomy to discectomy for surgical morbidity in persons with symptomatic lumbar radiculopathy (SQ1)............................................................ 81

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Table 34. Table 35. Table 36. Table 37. Table 38. Table 39. Table 40. Table 41. Table 42. Table 43. Table 44. Table 45. Table 46. Table 47. Table 49. Table 50.

Summary of findings and strength of evidence ratings of repeat lumbosacral decompression compared with spinal cord stimulation for surgical morbidity in persons with recurrent lumbar radiculopathy (SQ1) .......... 82 Summary of findings and strength of evidence ratings of revision endoscopic surgery compared with revision microdiscectomy for surgical morbidity in persons with recurrent lumbar radiculopathy (SQ1)............................................. 82 Summary of findings and strength of evidence ratings comparing surgery to nonsurgical interventions for reoperations in persons with symptomatic lumbar radiculopathy (SQ1) ................................................................................. 83 Summary of findings and strength of evidence ratings comparing minimallyinvasive surgery to standard surgery for reoperations in persons with symptomatic lumbar radiculopathy (SQ1)............................................................ 84 Summary of findings and strength of evidence ratings comparing microdiscectomy to discectomy for reoperations in persons with symptomatic lumbar radiculopathy (SQ1) ................................................................................. 87 Summary of findings and strength of evidence ratings of repeat lumbosacral decompression compared with spinal cord stimulation for reoperations in persons with recurrent lumbar radiculopathy (SQ1)............................................. 88 Summary of findings and strength of evidence ratings of revision endoscopic surgery compared with revision microdiscectomy for reoperations in persons with recurrent lumbar radiculopathy (SQ1) .......................................................... 88 Summary of findings and strength of evidence ratings comparing surgery to nonsurgical interventions for persistent opioid use in persons with symptomatic lumbar radiculopathy (SQ1)............................................................ 89 Summary of findings and strength of evidence ratings comparing minimallyinvasive surgery to standard surgery for persistent opioid use in persons with symptomatic lumbar radiculopathy (SQ1)............................................................ 90 Summary of findings and strength of evidence ratings of repeat lumbosacral decompression compared with spinal cord stimulation for persistent opioid use in persons with recurrent lumbar radiculopathy (SQ1) .................................. 90 Study characteristics of the seven studies that evaluated cost effectiveness of surgery for lumbar radiculopathy (CQ1) .............................................................. 91 Summary of findings and strength of evidence ratings comparing surgery to nonsurgical interventions for cost and cost-effectiveness in persons with symptomatic lumbar radiculopathy (CQ1) ........................................................... 94 Summary of findings and strength of evidence ratings comparing minimallyinvasive surgery to standard surgery for cost and cost-effectiveness in persons with symptomatic lumbar radiculopathy (CQ1) ................................................... 96 Summary of findings and strength of evidence ratings comparing microdiscectomy to discectomy for direct surgical costs in persons with symptomatic lumbar radiculopathy (CQ1) ........................................................... 98 Overview of payer coverage policies.................................................................. 119 Selected payer coverage for surgery for lumbar radiculopathy .......................... 120

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