Real-world outcomes in spinal cord stimulation: predictors of reported effect and explantation using a comprehensive registry-based approach.

Introduction: Despite advancements in implanted hardware and development of novel stimulation paradigms in Spinal Cord Stimulation (SCS), real world evidence suggests a large variation in patient reported outcomes and a proportion of patients are later explanted due to loss of analgesia. Possible predictors for outcome have been explored in smaller short-term evaluations, but few clinically applicable robust measures for long term outcome have emerged. Methods: We performed a comprehensive retrospective study based on an assembled patient-level aggregated database from multiple local and national registries in Sweden. Variables associated with risk of explantation (due to insufficient analgesia) and analgesic effect was analyzed using a Cox regression analysis and an ordered logit regression model, respectively. Results: We found the accumulated risk of explantation due to loss of analgesia to be 10% and 21% at two and ten years follow up, respectively. The use of 10 kHz spinal cord stimulation (compared with Tonic waveform; p = 0.003), and being 60 years or older (reference 18-40 years; p = 0.003) were associated with an increased risk of explantation.At a mean follow up at 1 year, 48% of patients reported a pain intensity reduction from baseline of at least 30%. Secondary (p = 0.030) and post-secondary (p = 0.001) education (compared with primary education) was associated with an increased probability of successful patient reported outcomes. Conclusion: This study suggests that a higher educational level and being employed are associated with successful treatment outcome in patients with chronic pain treated with SCS in Sweden.

Impact of spinal cord stimulation on sick leave and disability pension in patients with chronic neuropathic pain: a real-world evidence study in Sweden.

ABSTRACT: Current research indicates that spinal cord stimulation (SCS) has a positive short-term impact on outcomes, such as quality of life, pain, and productivity in patients with chronic neuropathic pain. However, there is a need for studies on larger population samples. This study used data from Swedish national registers to analyze change and predictors of sick leave and disability pension 2 years before and after SCS treatment. Patients with SCS implanted between 2006 and 2017, and a reference group consisting of 5 individuals matched to each SCS patient without replacement with respect to age, sex, and region of residence, were included. A difference-in-difference approach was used to compare the average change (2 years after treatment vs 2 years before treatment) in net disability days and indirect cost related to disability days for the SCS group, compared with the average change for the reference group. The results showed that SCS treatment in Sweden is associated with a decrease of 21 disability days and consequent decrease in indirect cost of €4127 in working age patients. Large work loss prior to index date was also demonstrated (average 214 days before 1 year), indicating a significant burden on the patient, employers, and the society at large. The number of disability days varied considerably depending on age, sex, socioeconomic variables, and comorbidities; however, the effect of SCS seemed to have little association with patient characteristics. This economic benefit needs to be considered, as well as the clinical outcome, when evaluating the full societal value of SCS.

Cost and Health Outcomes Patterns in Patients Treated With Spinal Cord Stimulation Following Spine Surgery-A Register-Based Study.

OBJECTIVE: Spinal cord stimulation (SCS), a minimally invasive treatment option for long-term neuropathic pain, has been shown to be effective in patients with persisting neuropathic pain after spine surgery. However, little is known about the long-term cost and quality-of-life (QoL) patterns in SCS-treated patients. The aim is to describe the use of SCS, costs, pre-spine-surgery and post-spine-surgery QoL, and reported pain intensity, in patients who have undergone spine surgery and subsequent SCS implantation. The results will be related to outcome and cost in spine surgery patients in general. MATERIALS AND METHODS: A research database comprised from six Swedish national and regional registers, and the spine surgery quality-of-care register Swespine was utilized. Two cohorts were identified: all patients who had spine surgery (N = 73,765) and patients who had spine surgery and subsequent SCS implantation (N = 239). Costs were analyzed before and after spine surgery for both cohorts, as well as before and after SCS implantation for the second cohort. QoL was explored by estimating patient-reported outcome measures such as pain intensity, Oswestry Disability Index, and EuroQol-5Dimensions from spine surgery up to five years post-spine surgery. RESULTS: In spine surgery patients, mean QoL and pain intensity levels improved following surgery. Patients subsequently treated with SCS had lower reported QoL and higher costs before the initial spine surgery, and spine surgery did not lead to any substantial improvements, however, costs decreased following SCS implantation in these patients.

Burst Spinal Cord Stimulation: A Clinical Review.

OBJECTIVE: Clinical review on outcomes using burst spinal cord stimulation (SCS) in the treatment of chronic, intractable pain. DESIGN: Narrative clinical literature review conducted utilizing a priori search terms including key words for burst spinal cord stimulation. Synthesis and reporting of data from publications including an overview of comparative SCS outcomes. RESULTS: Burst SCS demonstrated greater pain relief over tonic stimulation in multiple studies, which included blinded, sham-controlled, randomized trials. Additionally, burst stimulation impacts multiple dimensions of pain, including somatic pain as well as emotional and psychological elements. Patient preference is weighted toward burst over tonic due to increased pain relief, a lack of paresthesias, and impression of change in condition. CONCLUSION: Burst SCS has been shown to be both statistically and clinically superior to tonic stimulation and may provide additional benefits through different mechanisms of action. Further high-quality controlled studies are warranted to not only elucidate the basic mechanisms of burst SCS but also address how this unique stimulation signature/pattern may more adequately handle the multiple affective dimensions of pain in varying patient populations.

Burst Spinal Cord Stimulation: A Systematic Review and Pooled Analysis of Real-World Evidence and Outcomes Data.

OBJECTIVE: This review provides a comprehensive assessment of the effectiveness of burst spinal cord stimulation (SCS). Ratings of pain intensity (visual analog scale or numeric rating scale) and patient-reported outcomes (PROs) on functional/psychometric domains such as depression (Beck Depression Index), catastrophizing (Pain Catastrophizing Scale), surveillance (Pain Vigilance and Attention Questionnaire), and others are addressed. DESIGN: Articles were identified and selected from the literature according to prospective, replicable methods. Effectiveness data-pain scores and PRO ratings-were weighted by study sample sizes and pooled. The effects of burst SCS were compared against values at baseline and with tonic SCS. For PROs, published population norms were used for comparison. RESULTS: Fifteen articles, with a combined sample size of 427, were included. Follow-up ranged from a few hours to two years. A variety of prospective designs were employed, including crossover studies, single-arm cohorts, and a randomized controlled trial, as well as retrospective case reports. The weighted pooled mean pain rating across articles at baseline was 76.7 (±27.4). With tonic SCS, this was reduced to 49.2 (±12.9), and with burst SCS it was further reduced to 36.7 (±11.6), a 12.5-point difference between tonic and burst values. Psychometric analyses of PROs noted preferential improvement with burst SCS. In addition, 65% of subjects stated a preference for burst SCS. CONCLUSIONS: In pooled analyses that incorporated all available published evidence, the improvement over baseline for burst SCS was shown to have a clinically important incremental benefit over tonic SCS. In addition, burst SCS may support resolution of the emotional or cognitive aspects of pain that are mediated by medial thalamo-cortical pathways. This study highlights the value in considering the entire knowledge base in therapeutic assessments as well as adopting a consistent set of outcome variables within neuromodulation. Burst SCS is a valuable intervention, providing both analgesia and psychometric benefits that warrant further thoughtful applications.