High-dose spinal cord stimulation for patients with failed back surgery syndrome: a multicenter effectiveness and prediction study

Abstract

The use of high-dose spinal cord stimulation (HD-SCS) has increased drastically during the past few years, with positive results. However, there remains a deficit of real-world data of the effectiveness of HD-SCS. Therefore, the primary aim was to evaluate the effectiveness of HD-SCS in patients with failed back surgery syndrome (FBSS). The second aim was to develop a prediction model for a holistic responder. One hundred ninety-four patients were recruited to a multicenter real-world registry. Self-reporting outcome variables were evaluated at baseline (before SCS) and at 1, 3, and 12 months of HD-SCS implant. Outcome measures were the mean pain intensity over time, sleep quality, disability, health-related quality of life, and medication use. Besides the effectiveness, logistic regression and decision tree analysis were performed to define a holistic responder (pain intensity reduction, medication reduction, Oswestry disability index reduction, and EQ5D improvement) after 12 months of HD-SCS. Of 185 FBSS patients who underwent a baseline visit, 75.13% had a successful HD trial. At 12 months, 92 patients were still receiving HD-SCS. Both low back and leg pain significantly decreased at 12 months. All outcome measures revealed a significant time-dependent effect from baseline to 12 months. Holistic responders could be predicted with a sensitivity and specificity of 90%. Clinically significant and sustained pain relief over a period of 12 months was achieved with HD-SCS in patients with FBSS. In addition, HD-SCS also achieved an improvement in sleep quality, functionality, and a decrease in pain medication.

Predicting the Response of High Frequency Spinal Cord Stimulation in Patients with Failed Back Surgery Syndrome: A Retrospective Study with Machine Learning Techniques

“…Previous research already revealed that achieving functional goals is more important to patient satisfaction than obtaining reduction in self-reported pain [ 25 ]. Rather recently, the focus has shifted towards functioning instead of only focusing on pain relief, with multidimensional outcome measures such as holistic responders [ 26 ] or composite scores [ 27 ]. Another important issue in light of the ongoing opioid epidemic is the reduction in medication use.…”

High-Dose Spinal Cord Stimulation Reduces Long-Term Pain Medication Use in Patients With Failed Back Surgery Syndrome Who Obtained at Least 50% Pain Intensity and Medication Reduction During a Trial Period: A Registry-Based Cohort Study

“…“High density in spinal cord stimulation: virtual expert registry” (10) investigated the effectiveness, safety, and feasibility of HD‐SCS in a population of FBSS with chronic back and leg pain. In this registry, the investigated study population consisted of neurostimulation‐naïve “new patients” (11) and “rescue patients,” the latter defined as patients in whom the initial effectiveness of conventional SCS is lost over time (12). The aim of the current study was to investigate the impact of HD‐SCS on pain medication use, not only on opioid use, but also on other types of pain medication, measured by the Medication Quantification Scale III (MQS).…”

A Call to Action Toward Optimizing the Electrical Dose Received by Neural Targets in Spinal Cord Stimulation Therapy for Neuropathic Pain

“…Highdensity or high-dose SCS, in which longer pulse widths and/or higher frequencies are used, has also shown clinical utility. [11][12][13][14] Beyond just programming parameter changes, devices that target novel anatomical structures, such as the dorsal root ganglion, have been approved by regulatory bodies all over the world. 15,16 Multiple detailed reviews have been published on putative mechanisms of action specific to these various approaches.…”