BACKGROUND: Failed back surgery syndrome is common in the United States. Management of post lumbar surgery syndrome with multiple modalities includes interventional techniques, resulting in moderate improvement, leaving a proportion of patients in intractable pain. The systematic reviews of long-term benefits and risks of spinal cord stimulation (SCS) for patients with failed back surgery syndrome showed limited to moderate evidence and cost effectiveness. However, with the exponential increase in surgery in the United States, spinal cord implants are also increasing. Thus, the discussion continues with claims of lack of evidence on one hand and escalating increases in utilization on the other hand.
STUDY DESIGN: A systematic review of SCS in patients with failed back surgery syndrome.
OBJECTIVES: This systematic review is undertaken to examine the evidence from randomized controlled trials (RCTs) and observational studies to evaluate the effectiveness of SCS in post lumbar surgery syndrome and to demonstrate clinical and cost effectiveness.
METHODS: Review of the literature was performed according to the Cochrane Musculoskeletal Review Group Criteria as utilized for interventional techniques for randomized trials and the Agency for Healthcare Research and Quality (AHRQ) criteria for observational studies.
The 5 levels of evidence were classified as Level I, II, or III with 3 subcategories in Level II based on the quality of evidence developed by the U.S. Preventive Services Task Force (USPSTF).
Data sources included relevant literature of the English language identified through searches of PubMed and EMBASE from 1966 to December 2008, and manual searches of bibliographies of known primary and review articles.
OUTCOME MEASURES: The primary outcome measure was pain relief (short-term relief </= one-year and long-term > one-year). Secondary outcome measures of improvement in functional status, psychological status, return to work, and reduction in opioid intake were utilized.
RESULTS: The indicated evidence is Level II-1 or II-2 for long-term relief in managing patients with failed back surgery syndrome.
LIMITATIONS: The limitations of this review included the paucity and heterogeneity of the literature.
CONCLUSION: This systematic review evaluating the effectiveness of SCS in relieving chronic intractable pain of failed back surgery syndrome indicated the evidence to be Level II-1 or II-2 for clinical use on a long-term basis.