Treatment Options for Failed Back Surgery Syndrome Patients With Refractory Chronic Pain: An Evidence Based Approach.

STUDY DESIGN: A significant number of lumbar postsurgical patients continue to suffer persistent pain and limited function and are termed to have "Failed back surgery syndrome" (FBSS). This review evaluates clinical trial data for the treatment of FBSS patients.

OBJECTIVE: Using an evidence-based approach to evaluate FBSS treatments will assist clinicians in choosing the most effective options for FBSS patients. Furthermore, reducing the utilization of less effective therapies may result in substantial financial savings for this patient population.

SUMMARY OF BACKGROUND DATA: Treatments for FBSS may be generally categorized as physical therapy and exercise, medications, interventional procedures, neuromodulation, and reoperation. Careful review and classification of the level of evidence available for each category of treatment for FBSS patients will help guide clinical decision-making.

METHODS: A literature review was performed for FBSS treatments. The publications were arranged hierarchically according to the North American Spine Society's guidelines as randomized controlled trials (RCTs), prospective studies, retrospective chart, and systematic reviews. Book chapters, nonsystematic reviews, and expert opinions were excluded. The review focused on studies with at least 20 FBSS patients and 6-month follow-up.

RESULTS: Evidence is weak for medications and reoperation, but strong for active exercise and interventional procedures such as adhesiolysis. The strongest evidence for long-term treatment is for spinal cord stimulation (SCS), showing favorable Level I RCT results compared with conventional medical management and reoperation. In addition, high-frequency SCS at 10 kHz has demonstrated superiority over traditional, low-frequency SCS for treating low back and leg pain in a recent Level I RCT.

CONCLUSION: Clinicians may increasingly utilize levels of evidence during their evaluation of each FBSS patient to render the best therapeutic plan, likely resulting in improved long-term pain control and reducing costs by avoiding less effective modalities. New directions in SCS show promising results for the treatment of FBSS.

LEVEL OF EVIDENCE: 1.