Optimizing the Management and Outcomes of Failed Back Surgery Syndrome: A Consensus Statement on Definition and Outlines for Patient Assessment.

Failed back surgery syndrome (FBSS) is a controversial term for identifying patients affected by new, recurrent, or persistent pain in the low back and/or legs following spinal surgery. The lack of a comprehensive standardized care pathway compromises the appropriate management of FBSS patients, which is associated with a heavy financial burden. An international panel of spine surgeons, neurosurgeons, and pain specialists with a particular interest in FBSS established the chronic back and leg pain (CBLP) network with the aim of addressing the challenges and barriers in the clinical management of FBSS patients by building a common transdisciplinary vision. Based on literature reviews, additional input from clinical expertise of multiple professional disciplines, and consensus among its members, the network attempted to provide recommendations on the management of patients with FBSS utilizing a multidisciplinary team (MDT) approach. The presentation of this work has been divided in two separate parts to enhance its clarity. This first paper, in favour of selecting appropriate validated tools to improve the FBSS patient assessment, focuses on FBSS taxonomy and its clinical implications for evaluation. Concise recommendations for assessment, treatment, and outcome evaluation using a MDT approach would be an important resource for specialists and nonspecialist clinicians who manage patients with FBSS, to improve decision-making, reduce variation in practice, and optimize treatment outcomes in this difficult-to-treat population.

Cost effectiveness of a novel 10 kHz high-frequency spinal cord stimulation system in patients with failed back surgery syndrome (FBSS).

OBJECTIVES: Spinal cord stimulation (SCS) is an effective method of relieving chronic intractable pain, and one of its key indications is failed back surgery syndrome (FBSS). The objective of the current study was to evaluate the cost effectiveness of 10 kHz high-frequency SCS (HF10 SCS) compared to conventional medical management (CMM), reoperation, and traditional nonrechargeable (TNR-SCS) and rechargeable SCS (TR-SCS). METHODS: A health economic model of SCS in the United Kingdom was reproduced in the perspective of the health care system to simulate costs and quality adjusted life years (QALYs) over 15 years. In the model, both a decision tree and the Markov model were used to describe the health outcomes of the evaluated therapies. RESULTS: HF10 SCS therapy showed a favorable incremental cost-effectiveness ratio (ICER) of £3,153 per QALY gained as compared to CMM and established dominance (less costly, more QALYs) compared to TNR-SCS (£8,802 per QALY vs. CMM) and TR-SCS (£5,101 per QALY vs. CMM). CONCLUSION: This first analysis of the cost effectiveness of HF10 SCS suggests that it is more cost effective and provides a greater number of QALYs than both TNR-SCS and TR-SCS.

Spinal cord stimulation for complex regional pain syndrome: a systematic review of the clinical and cost-effectiveness literature and assessment of prognostic factors.

OBJECTIVE: To review the clinical and cost-effectiveness of spinal cord stimulation (SCS) in the management of patients with complex regional pain syndrome (CRPS) and identify the potential predictors of SCS outcome. DESIGN: Systematic review of the literature and meta-regression. METHODS: Electronic databases were searched for controlled and uncontrolled studies and economic evaluations relating to the use of SCS in patients with either CRPS type I or II. RESULTS: One randomised controlled trial, 25 case series and one cost-effectiveness study were included. In the randomised controlled trial in type I CRPS patients, SCS therapy lead to a reduction in pain intensity at 24 months of follow-up (mean change in VAS score -2.0), whereas pain was unchanged in the control group (mean change in VAS score 0.0) (p<0.001). In the case series studies, 67% (95% CI 51%, 84%) of type I and type II CRPS patients implanted with SCS reported pain relief of at least 50% over a median follow-up period of 33 months. No statistically significant predictors of pain relief with SCS were observed in multivariate meta-regression analysis across studies. An economic analysis based on the randomised controlled trial showed a lifetime cost saving of approximately 58,470 (60,800 US dollars) with SCS plus physical therapy compared with physical therapy alone. The mean cost per quality-adjusted life-year at 12-month follow-up was 22,580 (23,480 US dollars). CONCLUSIONS: SCS appears to be an effective therapy in the management of patients with CRPS type I (Level A evidence) and type II (Level D evidence). Moreover, there is evidence to demonstrate that SCS is a cost-effective treatment for CRPS type I.

The cost effectiveness of spinal cord stimulation in the treatment of pain: a systematic review of the literature.

In this systematic review, we identified and evaluated studies of the cost effectiveness of spinal cord stimulation (SCS) for the treatment of chronic pain. Published reports were identified from a systematic search of a number of general medical electronic databases (Medline, CINAHL, and EMBASE), and specialist economic databases (NHS Centre for Reviews and Dissemination Economic Evaluation Database, and Health Economics Evaluation Database). Reference lists of retrieved reports were also searched, and contact was made with experts in the field. Of the 99 abstracts identified, 14 studies were considered to meet the inclusion criteria of the review. We found that across a range of medical indications, the initial healthcare acquisition costs of SCS implantation are consistently offset by a reduction in post-implant healthcare resource demand and costs. Further research is required to formally examine the cost effectiveness of SCS.