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Using the SAFE Principles When Evaluating Electrical Stimulation Therapies for the Pain of Failed Back Surgery Syndrome
Article first published online: 7 JUL 2011
© 2011 International Neuromodulation Society
Neuromodulation: Technology at the Neural Interface
Volume 14, Issue 4, pages 299–311, July/August 2011
How to Cite
Krames, E. S., Monis, S., Poree, L., Deer, T. and Levy, R. (2011), Using the SAFE Principles When Evaluating Electrical Stimulation Therapies for the Pain of Failed Back Surgery Syndrome. Neuromodulation: Technology at the Neural Interface, 14: 299–311. doi: 10.1111/j.1525-1403.2011.00373.x
Conflict of Interest: Dr. Krames is a consultant for Advanced Bionics, Medtronic, Inc., Nevro Corp., and St. Jude Medical. Dr. Monis reported no conflict of interest. Dr. Poree holds stock options in Spinal Modulation. Dr. Deer is a consultant for Medtronic, Inc. and St. Jude Medical. Dr. Levy is an advisor and consultant for Medtronic, Inc. and St. Jude Medical.
- Issue published online: 4 AUG 2011
- Article first published online: 7 JUL 2011
- Received: February 4, 2011 Accepted: March 23, 2011
- continuum of care;
- failed back surgery syndrome;
- pain therapies;
- SAFE principles;
- spinal cord stimulation
Objective: In this paper we review the literature on failed back surgery syndrome (FBSS) and use principles of Safety, Appropriateness, Fiscal Neutrality, and Effectiveness (SAFE) to determine the appropriate place for spinal cord stimulation (SCS) for the treatment of FBSS.
Methods and Results: We analyzed the most recent literature regarding treatments of pain due to FBSS and used the SAFE principles to reprioritize pain treatments, particularly electrical stimulation therapies, for FBSS in a more appropriate, relevant, and up to date continuum of care.
Conclusions: Based on this review and analysis of the safety, appropriateness, cost-effectiveness, and efficacy of treatments for the pain of FBSS, relegating SCS to a last resort therapy is no longer justifiable. SCS should be considered before submitting a patient to either long-term systemic opioid therapy or repeat spinal surgery for chronic pain resulting from FBSS.