Spinal Cord Stimulation Outcomes Research Articles

Evaluation of thoracic sympathetic ganglion block as a predictor for response to ketamine infusion therapy and spinal cord stimulation in patients with chronic upper extremity pain.

To investigate the predictive value of thoracic sympathetic ganglion block (TSGB) in response to ketamine infusion therapy (KIT) and spinal-cord stimulation (SCS) in patients with chronic upper-extremity pain including complex regional pain syndrome (CRPS). Retrospective. Tertiary hospital single-center. Patients who underwent TSGB receiving KIT or SCS within a 3-year window. Positive TSGB outcomes were defined as ≥ 2 0-10 Numerical Rating Scale (NRS) score reduction at 2 weeks post-procedure. Positive KIT and SCS outcomes were determined by ≥ 2 NRS score reduction at 2-4 weeks post-KIT and ≥4 NRS score reduction at 2-4 weeks post-SCS implantation, respectively. Among 207 patients who underwent TSGB, 38 received KIT and 34 underwent SCS implantation within 3 years post-TSGB; 33 patients receiving KIT and 32 patients receiving SCS were included. Among 33 patients who received KIT, 60.6% (n = 20) reported a ≥ 2 0-10 NRS pain-score reduction. Positive response to TSGB occurred in 70.0% (n = 14) KIT responders, significantly higher than that in 30.8% (n = 4) KIT non-responders. Multivariable analysis revealed a positive association between positive responses to TSGB and KIT (OR 7.004, 95% CI 1.26-39.02). Among 32 patients who underwent SCS implantation, 68.8% (n = 22) experienced short-term effectiveness. Positive response to TSGB was significantly higher in SCS responders (45.5%, n = 10) than in non-responders (0.0%). However, there were no associations between pain reduction post-TSGB and that post-KIT or post-SCS. A positive response to TSGB is a potential predictor for positive KIT and SCS outcomes among patients with chronic upper-extremity pain, including CRPS.

Comparison of the efficacy of spinal cord stimulation and dorsal root ganglion stimulation in the treatment of painful diabetic peripheral neuropathy: a prospective, cohort-controlled study.

The aim of this study was to compare the clinical outcomes of spinal cord stimulation (SCS) and dorsal root ganglion stimulation (DRG-S) in the treatment of painful diabetic peripheral neuropathy (PDPN). In this prospective cohort study, 55 patients received dorsal column spinal cord stimulation (SCS group) and 51 patients received dorsal root spinal cord stimulation (DRG-S group). The primary outcome was a Numerical Rating Scale (NRS) remission rate of ≥50%, and secondary outcomes included the effects of SCS and DRG-S on quality of life scores (EQ-5D-3L), nerve conduction velocity, and HbA1c, respectively. The percentage of NRS remission rate ≥ 50% at 6 months was 80.43 vs. 79.55%, OR (95% CI): 1.06 (0.38-2.97) in the SCS and DRG-S groups, respectively, and the percentage of VAS remission rate ≥ 50% at 12 months was 79.07 vs. 80.95%, OR (95% CI): 0.89 (0.31-2.58). Compared with baseline, there were significant improvements in EQ-5D and EQ-VAS at 6 and 12 months (p < 0.05), but there was no difference in improvement between the SCS and DRG-S groups (p > 0.05). Nerve conduction velocities of the common peroneal, peroneal, superficial peroneal, and tibial nerves were significantly improved at 6 and 12 months compared with the preoperative period in both the SCS and PND groups (p < 0.05). However, at 6 and 12 months, there was no difference in HbA1c between the two groups (p > 0.05). Both SCS and DRG-S significantly improved pain, quality of life, and lower extremity nerve conduction velocity in patients with PDPN, and there was no difference between the two treatments at 12 months.

Clinical outcomes of spinal cord stimulation in patients with intractable leg pain in Japan.

Neuromodulation through spinal cord stimulation (SCS) is a therapeutic option for relieving leg pain and improving the chances of limb salvage in patients with intractable chronic limb-threatening ischemia (CLTI); however, there is no consensus on its indications. The aim of this study was to assess the clinical outcomes of SCS in patients with intractable leg pain caused by various diseases treated in the department of cardiovascular medicine in Japan. This was a retrospective study of patients who underwent SCS for pain management. Patients were considered eligible for the therapy if they met the following criteria: (1) intractable leg pain (numerical rating scale [NRS] score of 10), (2) no revascularization option, and (3) no septicemia. Twenty patients (mean age: 77 years; men/women: 11/9) were included in this study. The NRS score of the patients significantly reduced from 10 ± 0 before procedure to 4 ± 3 at discharge (p < 0.001). The clinical response rate of the entire cohort was 65% (13/20) at 17 ± 14 months after implantation; however, patients with intractable CLTI showed a low response rate (45%), whereas those with subacute limb ischemia showed a high response rate (100%). A multivariable regression analysis showed that hemoglobin level was significantly associated with treatment response, even after adjusting for age and sex (p = 0.026). The area under the receiver operating characteristic curve for the correlation between hemoglobin level (cutoff, 11.4 g/dL) and clinical response to SCS was 0.824 (0.619-1). SCS can reduce clinical symptoms in majority of patients with intractable leg pain. Although implantation of an SCS device has been shown to improve microvascular perfusion insufficiency, the correlation between hemoglobin level and the clinical effect of SCS indicates that a preserved microcirculatory vascular bed is essential for the therapy to be effective.

A single-center real-world review of 10 kHz high-frequency spinal cord stimulation outcomes for treatment of chronic pain

ObjectiveTo compare pragmatic real-world 10-kHz high-frequency spinal cord stimulation (HF-SCS) outcomes at a single academic center to the industry-sponsored SENZA-RCT and Stauss et al. study. MethodsThis single-center retrospective study included patients with refractory back or limb pain trialed and/or permanently implanted with the Nevro HF-SCS system from 2016 to 2021. Demographic and outcome data were obtained from the electronic medical record (EMR) and real-world global database maintained by Nevro Corp. Data obtained from the global database were confirmed using the EMR. Main outcome measures included positive responder status (≥50% patient-reported percentage pain reduction (PRPPR)), improvement in function, improvement in sleep, and reduction in pain medication usage. Comparison groups included patient outcomes from the SENZA-RCT and Stauss et al. study. ResultsPatients (N = 147) trialed with HF-SCS were reviewed, with data available for 137. Positive trialed patient responder rate (≥50% PRPPR) was 77% (106/137, 95CI 70–84%) vs. 87% (1393/1607, 95CI 85–89%) Stauss et al. vs. 93% (90/97, 95CI 88–98%) SENZA-RCT HF-SCS. At the last available follow-up, positive implanted patient responder rate was 73% (58/80, 95CI 63–82%) vs. 78% (254/326, 95CI 73–82%) Stauss et al. vs. 79% (71/90, 95CI 70–87%) SENZA-RCT HF-SCS. Sixty-seven percent (59/88, 95CI 57–77%) reported improved function vs. 72% (787/1088, 95CI 70–75%) Stauss et al.; 45% (31/69, 95CI 33–57%) reported improved sleep vs. 68% (693/1020, 95CI 65–71%) Stauss et al. and 16% (9/56, 95CI 6–26%) reported decrease in medication use vs. 32% (342/1070, 95CI 29–35%) Stauss et al. ConclusionPatient responder rates in this retrospective pragmatic real-world study of HF-SCS are consistent with previous industry-sponsored studies. However, improvements in quality-of-life measures and reduction in medication usage were not as robust as reported in industry-sponsored studies. The findings of this non-industry-sponsored, independent study of HF-SCS complement those of previously published studies by reporting patient outcomes collected in the absence of industry sponsorship.

ID: 206203 Management Pathway and Outcomes of Spinal Cord Stimulation for Patients With Spine Deformities

Spinal column deformities such as kyphosis or rotoscoliosis are typically managed surgically with major spinal deformity correction procedures, which are associated with substantial immediate and delayed complication rates. In some patients, associated medical co-morbidity may preclude a deformity correction procedure.

ID: 215548 Clinical Efficacy of Patient-Adapted Stimulation for SCS Therapy in Patients With Persistent Spinal Pain Syndrome

In patients with chronic axial back pain, results of spinal cord stimulation are still heterogeneous regrading comparable therapeutic response between systems and stimulation paradigms used. New patient-adapted stimulation seems to lead to a clinically significant pain reduction in this commonly low-responder patient population. We therefore examined the efficacy of two types of patients adapted stimulation on pain intensity in patients with persistent spinal pain (PSP).

ID: 211994 Efficacy, Safety, and Functional Outcomes of Multiphase SCS in Subjects With Chronic Pain: BENEFIT-02 Study

Novel multiphase spinal cord stimulation (SCS) is designed to disperse a less concentrated electrical stimulus more broadly across the target pain area.1 The goal of the BENEFIT-02 clinical study was to evaluate the efficacy including functional outcomes, and safety associated with multiphase stimulation.

Painful Peripheral Neuropathies of the Lower Limbs and/or Lower Extremities Treated with Spinal Cord Stimulation: A Systematic Review with Narrative Synthesis.

Painful peripheral neuropathy (PPN) is a debilitating condition with varied etiologies. Spinal cord stimulation (SCS) is increasingly used when conservative treatments fail to provide adequate pain relief. Few published reviews have examined SCS outcomes in all forms of PPN. We conducted a systematic review of SCS in PPN. The PubMed database was searched up to February 7th, 2022, for peer-reviewed studies of SCS that enrolled PPN patients with pain symptoms in their lower limbs and/or lower extremities. We assessed the quality of randomized controlled trial (RCT) evidence using the Cochrane risk of bias tool. Data were tabulated and presented narratively. Twenty eligible studies documented SCS treatment in PPN patients, including 10 kHz SCS, traditional low-frequency SCS (t-SCS), dorsal root ganglion stimulation (DRGS), and burst SCS. In total, 451 patients received a permanent implant (10 kHz SCS, n=267; t-SCS, n=147; DRGS, n=25; burst SCS, n=12). Approximately 88% of implanted patients had painful diabetic neuropathy (PDN). Overall, we found clinically meaningful pain relief (≥30%) with all SCS modalities. Among the studies, RCTs supported the use of 10 kHz SCS and t-SCS to treat PDN, with 10 kHz SCS providing a higher reduction in pain (76%) than t-SCS (38-55%). Pain relief with 10 kHz SCS and DRGS in other PPN etiologies ranged from 42-81%. In addition, 66-71% of PDN patients and 38% of nondiabetic PPN patients experienced neurological improvement with 10 kHz SCS. Our review found clinically meaningful pain relief in PPN patients after SCS treatment. RCT evidence supported the use of 10 kHz SCS and t-SCS in the diabetic neuropathy subpopulation, with more robust pain relief evident with 10 kHz SCS. Outcomes in other PPN etiologies were also promising for 10 kHz SCS. In addition, a majority of PDN patients experienced neurological improvement with 10 kHz SCS, as did a notable subset of nondiabetic PPN patients.

Clinical practice patterns of opioid prescribing by physicians -performing percutaneous spinal cord stimulation trials and implants.

Spinal cord stimulation (SCS) is an effective therapy for neuropathic pain. Outcomes of SCS may be influenced by peri-implant opioid management; however, to date, standard practices of opioid management in this scenario remain undefined and unreported. A survey inquiring SCS management practices in the peri-implant period was sent to the members of the Spine Intervention Society and the American Society of Regional Anesthesia. The results of three questions pertaining to peri-implant opioid management are presented here. For each of the three questions examined, there were between 181 and 195 responses. Among respondents, 40 percent encouraged reduction of opioids prior to SCS trial, and 17 percent mandated reduction. After a SCS trial, 87 percent of respondents did not provide any additional opioids for periprocedure pain. After implant, the majority of respondents provided 1-7 days of opioids for post-operative pain. Based upon survey results and current literature, it is advisable to recommend or attempt opioid reduction before SCS and to not provide additional opioid for post-operative pain after trial lead insertion. Routine prescribing for the pain of the SCS implant beyond 7 days is not favored.

Long-term Safety of Spinal Cord Stimulation Systems in A Prospective, Global Registry of Patients With Chronic Pain

Aim: The availability of long-term (>2years) safety outcomes of spinal cord stimulation (SCS) remains limited. We evaluated safety in a global SCS registry for chronic pain. Methods: Participants were prospectively enrolled globally at 79 implanting centers and followed out to 3yearsafter device implantation. Results: Of 1881 participants enrolled, 1289 received a permanent SCS implant(1776completed trial). The annualized rate of device explant was 3.5% (all causes), and 1.1% due to inadequate pain relief. Total incidence of device explantation >3years was 7.6% (n=98). Of these, 32subjects (2.5%) indicated inadequate pain relief as cause for removal. Implantsite infection (11 events) was the most common device-related serious adverse event(<1%). Conclusion: This prospective, global, real-world study demonstrates a high-level of safety for SCS with low rate of explant/serious adverse events. Clinical Trial Registration: NCT01719055 (ClinicalTrials.gov).

Holistic Treatment Response: An International Expert Panel Definition and Criteria for a New Paradigm in the Assessment of Clinical Outcomes of Spinal Cord Stimulation

BackgroundTreatment response to spinal cord stimulation (SCS) is focused on the magnitude of effects on pain intensity. However, chronic pain is a multidimensional condition that may affect individuals in different ways and as such it seems reductionist to evaluate treatment response based solely on a unidimensional measure such as pain intensity. AimThe aim of this article is to add to a framework started by IMMPACT for assessing the wider health impact of treatment with SCS for people with chronic pain, a ”holistic treatment response”. DiscussionSeveral aspects need consideration in the assessment of a holistic treatment response. SCS device data and how it relates to patient outcomes, is essential to improve the understanding of the different types of SCS, improve patient selection, long-term clinical outcomes, and reproducibility of findings. The outcomes to include in the evaluation of a holistic treatment response need to consider clinical relevance for patients and clinicians. Assessment of the holistic response combines two key concepts of patient assessment: (1) patients level of baseline (pre-treatment) unmet need across a range of health domains; (2) demonstration of patient-relevant improvements in these health domains with treatment. The minimal clinical important difference (MCID) is an established approach to reflect changes after a clinical intervention that are meaningful for the patient and can be used to identify treatment response to each individual domain. A holistic treatment response needs to account for MCIDs in all domains of importance for which the patient presents dysfunctional scores pre-treatment. The number of domains included in a holistic treatment response may vary and should be considered on an individual basis. Physiologic confirmation of therapy delivery and utilisation should be included as part of the evaluation of a holistic treatment response and is essential to advance the field of SCS and increase transparency and reproducibility of the findings.

Improved Spinal Cord Stimulation Outcomes and Pain Relief Using Novel Fast-Acting Sub-Perception Therapy

Improved Spinal Cord Stimulation Outcomes and Pain Relief Using Novel Fast-Acting Sub-Perception Therapy

Outcome of Spinal Cord Stimulation for Complex Regional Pain Syndrome (CRPS): Real

Complex Regional Pain Syndrome (CRPS) is often refractory to conventional pain therapies. Spinal cord stimulation (SCS) has been proposed as an effective treatment for refractory CRPS. We present here analysis of data from patients with refractory CRPS who underwent SCS trials and implants from July 2017 to 28 February 2022 in our program.

Outcomes of Spinal Cord Stimulation: Real-Life Data From Patients With Peripheral Neuropathic Pain Syndromes

Peripheral neuropathic pain (PNP) is challenging to treat and pharmacotherapy often does not achieve adequate pain relief. Spinal cord stimulation (SCS) has been used to relive pain in patients with PNP with variable success rates. We present here data from our centre to evaluate the outcomes of SCS in patients with PNP.

Improved Spinal Cord Stimulation Outcomes and Pain Relief Using Novel Fast Acting Sub Perception Therapy

Fast-Acting Sub-Perception Therapy (FAST) is a new Spinal Cord Stimulation (SCS) method developed in part from knowledge gleaned in earlier studies that paresthesia can be exploited as a biomarker for precise targeting of sub-threshold-based neurostimulation (Metzger CS, et al. Exp Rev Med Dev. 2021).

O084 / #701 NEUROSTIMULATION IS AN EFFECTIVE TREATMENT OPTION FOR CHRONIC BACK PAIN REGARDLESS OF PRIOR SPINAL SURGERY: TRACK 3: NEUROSTIMULATION FOR BACK AND LEG PAIN

Low back pain (LBP) has been one of the leading causes of disability worldwide for the past 30 years. Spinal cord stimulation (SCS) is a minimally invasive and reversible therapy, demonstrating increasing efficacy for the treatment of chronic pain when used earlier in the treatment algorithm. Despite this, SCS is frequently considered a last-line therapy option, often following surgical intervention. Here, we assess the outcomes of passive recharge burst SCS in surgically naïve subjects and those with persisting pain post-surgery.

O086 / #882 OBJECTIVE LONG-TERM DATA RECORDING OF DAILY ACTIVITY LEVELS IN PATIENTS WITH FAILED BACK SURGERY SYNDROME TREATED WITH SPINAL CORD STIMULATION: TRACK 3: NEUROSTIMULATION FOR BACK AND LEG PAIN

Data derived from patient questionnaires on how chronic pain affects individuals' daily life and activity levels are inherently subjective. This study aims to: 1) Assess activity levels in patients treated with spinal cord stimulation (SCS) utilizing an existing, neurostimulator-based data diary which continuously stores hourly data of seven different body positions, including upright and upright mobile; 2) Test the usefulness of this tool for objective evaluation of SCS outcomes and investigate how the data relates to the subjective experience of the patient.

Combining Awake Anesthesia with Minimal Invasive Surgery Optimizes Intraoperative Surgical Spinal Cord Stimulation Lead Placement.

Spinal cord stimulation (SCS) is an effective and validated treatment to address chronic refractory neuropathic pain in persistent spinal pain syndrome-type 2 (PSPS-T2) patients. Surgical SCS lead placement is traditionally performed under general anesthesia due to its invasiveness. In parallel, recent works have suggested that awake anesthesia (AA), consisting of target controlled intra-venous anesthesia (TCIVA), could be an interesting tool to optimize lead anatomical placement using patient intra-operative feedback. We hypothesized that combining AA with minimal invasive surgery (MIS) could improve SCS outcomes. The goal of this study was to evaluate SCS lead performance (defined by the area of pain adequately covered by paraesthesia generated via SCS), using an intraoperative objective quantitative mapping tool, and secondarily, to assess pain relief, functional improvement and change in quality of life with a composite score. We analyzed data from a prospective multicenter study (ESTIMET) to compare the outcomes of 115 patients implanted with MIS under AA (MISAA group) or general anesthesia (MISGA group), or by laminectomy under general anesthesia (LGA group). All in all, awake surgery appears to show significantly better performance than general anesthesia in terms of patient pain coverage (65% vs. 34–62%), pain surface (50–76% vs. 50–61%) and pain intensity (65% vs. 35–40%), as well as improved secondary outcomes (quality of life, functional disability and depression). One step further, our results suggest that MISAA combined with intra-operative hypnosis could potentialize patient intraoperative cooperation and could be proposed as a personalized package offered to PSPS-T2 patients eligible for SCS implantation in highly dedicated neuromodulation centers.

Factors associated with success of trial spinal cord stimulation in patients with chronic pain

Objective: Spinal cord stimulation (SCS) is a widely employed technique in treating chronic pain, however, it still fails in significantly reducing pain in one-out-of-three cases. Poor consensus exists on the most predictive factors of SCS outcomes. Although psychological criteria such as emotional stability are recommended for this treatment, it is not well understood if the perception of patients’ own health may impact the SCS success. Therefore, we retrospectively examine factors associated with the patient's subjective conditions, to investigate their relationship with SCS success. Methods: Before the implantation of an SCS trial per routine clinical decision-making, and independently from the implanted devices, patients treated in our clinical practice underwent an extensive evaluation of pain, disability, depression and the overall quality of life. In those patients with successful SCS trials, the pain level was also evaluated at the end of the trial period. Regression analyses were performed to investigate factors predicting successful trial stimulation. Results: Successful trial stimulation was effective in 15 patients (75%). Perceived disability, pain and general health resulted as independent predictive factors on SCS trial outcome. Further investigation showed perceived disability (i.e. Oswestry Disability Index) as a crucial factor, and ROC curve analysis identifies a cut-off of 38 as a predictive score of success. Conclusions: Although preliminary, these findings suggest that standardized scales examining the overall patients’ perceived health status, particularly the disability index may help shed light on predicting SCS trial success. Thus, it is argued the potential application of self-administered scales in SCS patients’ selection in routine clinical practice.

How Was It for You?: Patients’ Perception of Long-Term Outcomes of Spinal Cord Stimulation

Spinal Cord Stimulation (SCS) is often used for treating refractory neuropathic pain.1 Though validated instruments are used to collect data on pain and related domains in patients who receive SCS implants,2 there is little information on patients’ perception of the impact of SCS. This study was conducted with the goal of ascertaining outcomes of SCS as relevant to patients.