Spinal Cord Stimulation Group Research Articles

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.

351 Comparing SCS and Conventional Medical Management in Patients With No Prior Back Surgery (SOLIS RCT)

INTRODUCTION: Spinal Cord Stimulation (SCS) as a treatment for chronic pain has been historically designated for patients who have had at least one prior spinal surgery. Modern SCS devices though now offer more novel technological capabilities and neurostimulative approaches than older-generational SCS systems. METHODS: This is a prospective, multicenter, randomized controlled trial (RCT) that compares therapeutic effectiveness of SCS versus CMM only, in patients with chronic low back and/or leg pain with no prior spinal surgery (SOLIS, Clinicaltrials.gov: NCT04676022). Enrolled NSBP patients are randomized to SCS combined with CMM (SCS + CMM arm) or a CMM-only arm. Those receving SCS are implanted with a multimodal system capable of engaging multiple mechanisms of action (Wavewriter Systems, Boston Scientific). Key inclusion criteria include diagnosis of chronic low back pain, with or without leg pain, for =6 months, and documented care of chronic pain for =90 days. The primary endpoint is responder rate (=50% reduction in pain) with no increase in baseline opioid medications to treat pain at 3-months following treatment activation. RESULTS: The primary endpoint (p &lt; 0.0001) was met based on a prespecified cohort of 60 treatment-activated subjects. This analysis demonstrated that multimodal SCS combined with CMM was superior to CMM alone (p &lt; 0.0001) in treating NSBP patients at 3-months follow-up (SCS: 88% versus CMM: 8%). Additionally, a 27-point reduction in Oswestry Disability Index score (improvement in disability) was noted in the SCS group versus a 6-point reduction in the CMM group. CONCLUSIONS: The data obtained in this RCT demonstrates that utilization of multimodal SCS provides for superior outcomes when compared to use of CMM alone for treatment of NSBP.

Comparative Analysis of the Efficacy of Spinal Cord Stimulation and Traditional Debridement Care in the Treatment of Ischemic Diabetic Foot Ulcers: A Retrospective Cohort Study

BACKGROUND AND OBJECTIVES: Spinal cord stimulation (SCS) is an effective treatment for diabetic peripheral neuropathy. The purpose of this study was to investigate the effectiveness of SCS in the treatment of ischemic diabetic foot ulcers. METHODS: In this retrospective study, the SCS group comprised 102 patients with ischemic diabetic foot who were treated with SCS for foot ulcers and nonhealing wounds due to severe lower limb ischemia. The traditional debridement care (TDC) group comprised 104 patients with ischemic diabetic foot who received only TDC. Strict screening criteria were applied. The assignment of patients to either group depended solely on their willingness to be treated with SCS. Secondary end points were transcutaneous partial pressure of oxygen (PtcO2), ankle-brachial index (ABI), and color Doppler of the lower limb arteries in the feet at 6 months and 12 months after treatment. The primary end point was the amputation. RESULTS: The dorsal foot PtcO2 and ABI of the patients in the SCS group were significantly improved at 6 months and 12 months postoperation (P &lt; .05). The therapeutic efficacy was significantly better than that of the TDC group over the same period of time (P &lt; .05). The degree of vasodilation of the lower limb arteries (ie, femoral, popliteal, posterior tibial, and dorsalis pedis arteries) on color Doppler was higher in the SCS group than in the TDC group (P &lt; .05). The odds ratios for total amputation at 6 and 12 months postoperatively in the SCS group were 0.45 (95% CI, 0.19-1.08) and 0.17 (95% CI, 0.08-0.37), respectively, compared with the TDC group. CONCLUSION: SCS improved symptoms of lower limb ischemia in ischemic diabetic feet and reduced the rate of toe amputation by increasing PtcO2, ABI, and arterial vasodilation in the lower limbs.

Mechanisms by which spinal cord stimulation intervenes in atrial fibrillation: The involvement of the endothelin-1 and nerve growth factor/p75NTR pathways.

Can the spinal cord stimulation (SCS) regulate the autonomic nerves through the endothelin-1 (ET-1) and nerve growth factor (NGF)/p75NTR pathways and thus inhibit the occurrence of atrial fibrillation (AF)? In our research, 16 beagles were randomly divided into a rapid atrial pacing (RAP) group (n = 8) and a RAP + SCS group (n = 8), and the effective refractory period (ERP), ERP dispersion, AF induction rate, and AF vulnerability window (WOV) at baseline, 6 h of RAP, 6 h of RAP + SCS were measured. The atrial tissue was then taken for immunohistochemical analysis to determine the localization of ET-1, NGF, p75NTR, NF-kB p65, and other genes. Our results showed that SCS attenuated the shortening of ERP in all parts caused by RAP, and after 6 h of SCS, the probability of AF in dogs was reduced compared with that in the RAP group. Moreover, the expression of ET-1, NGF, and p75NTR in the atrial tissues of dogs in the RAP + SCS group was significantly increased, but the expression of NF-kB p65 was reduced. In conclusion, SCS promotes the positive remodeling of cardiac autonomic nerves by weakening NFκB p65-dependent pathways to interfere with the ET-1 and NGF/p75NTR pathways to resist the original negative remodeling and inhibit the occurrence of AF.

Evaluating the effect of spinal cord stimulation on patient with disorders of consciousness: A TMS-EEG study

ObjectiveThe application of spinal cord stimulation (SCS) in the treatment of disorders of consciousness (DOC) has attracted attention, but its effect on brain activity is still unknown. Transcranial magnetic stimulation combined with EEG (TMS-EEG) can measure cortical activity, which can evaluate the effect of SCS on DOC. MethodsWe record 20 DOC patients' CRS-R values and TMS-EEG data before and after one-session SCS (Pre-SCS and Post-SCS). 20 DOC patients including 10 patients with unresponsive wakefulness syndrome (UWS) and 10 patients with minimally conscious states (MCS). TMS evoked potential (TEP) was used to measure the changes of cortical activity in DOC patients between Pre-SCS and Post-SCS. Firstly, we used the global mean field potential (GMFP) and fast perturbational complexity index (PCIst) to compare the temporal changes of patients' cortical activity. Then, we obtained the frequency feature (natural frequency, NF) based on the TEP time-frequency analysis, and compared the changes of natural frequency between Pre-SCS and Post-SCS. Finally, the study explored the relationship between the patient's baseline CRS-R values and changes of TMS evoked cortical activity in time and frequency domains. ResultsAfter SCS, MCS and UWS groups almost have no changes of CRS-R values (MCS: 9.9 ± 1.52 at Pre-SCS, 10.2 ± 1.48 at Post-SCS; UWS: 5.6 ± 1.26 at Pre-SCS, 5.7 ± 1.34 at Post-SCS). MCS group showed significant increases of GMFP amplitude (around 100 ms and 300 ms) and PCIst values at Post-SCS (p < 0.05). UWS group had no significant changes (p > 0.05). Besides, SCS induced the significant increases of natural frequency for MCS group(p < 0.05), but not for UWS group. At last, the study found that all patient's baseline CRS-R values were significantly correlated with ΔPCIst (r = 0.67, p < 0.005), and ΔNF (r = 0.72, p < 0.001). ConclusionsSCS can modulate cortical activity of DOC patient, including temporal complexity and natural frequency. The changes of cortical activity caused by SCS are related to patients’ consciousness level. TMS-EEG can evaluate the effect of SCS on DOC patients.

Effect of stimulation intensity of a differential target multiplexed SCS program in an animal model of neuropathic pain.

Spinal cord stimulation (SCS) has been proven to be an effective treatment for patients suffering from intractable chronic neuropathic pain. Recent advances in the field include the utilization of programs that multiplex various signals to target different neural structures in the dorsal spinal cord associated with the painful area. Preclinical studies have been fundamental in understanding the mechanism by which this differential target multiplexed programming (DTMP) SCS approach works. Transcriptomic- and proteomic-based studies demonstrated that DTMP can modulate expression levels of genes and proteins involved in pain-related processes that have been affected by a neuropathic pain model. This work studied the effect of the intensity of DTMP signals on mechanical hypersensitivity and cell-specific transcriptomes. The spared nerve injury model (SNI) of neuropathic pain was induced in 20 animals which were 1:1 randomized into two SCS groups in which the intensity of the DTMP was adjusted to either 70% or 40% of the motor threshold (MT). SCS was applied continuously for 48 h via a quadripolar lead implanted in the dorsal epidural space of animals. Controls, which included a group of implanted SNI animals that received no SCS and a group of animals naive to the SNI, were assessed in parallel to the SCS groups. Mechanical hypersensitivity was assessed before SNI, before SCS, and at 48 h of SCS. At the end of SCS, the stimulated segment of the dorsal spinal cord was dissected and subjected to RNA sequencing to quantify expression levels in all experimental groups. Differential effects were assessed via fold-change comparisons of SCS and naive groups versus the no-SCS group for transcriptomes specific to neurons and glial cells. Standard statistical analyses were employed to assess significance of the comparisons (p < 0.05). SCS treatments provided significant improvement in mechanical sensitivity relative to no SCS treatment. However, the change in the intensity did not provide a significant difference in the improvement of mechanical sensitivity. DTMP regulated expression levels back toward those found in the naive group in the cell-specific transcriptomes analyzed. There were no significant differences related to the intensity of the stimulation in terms of the percentage of genes in each transcriptome in which expression levels were reversed toward the naive state. DTMP when applied at either 40% MT or 70% MT provided similar reduction of pain-like behavior in rats and similar effects in neuron- and glia-specific transcriptomes.

Spinal cord stimulation for low back pain.

Spinal cord stimulation for low back pain.

Is spinal cord stimulation useful in the long term? A commentary on Brill et al.

This journal recently published a paper by Brill et al., entitled ‘Short and long term effects of conventional spinal cord stimulation on chronic pain and health perceptions: a longitudinal controlled trial’. In fact, spinal cord stimulation (SCS) is considered a last-option technique to manage chronic refractory neuropathic pain, initially based on the gate control theory with subsequent other documented mechanisms of action. Even though pain relief assessment is highly subjective, objective SCS effects on clinical pain were well-documented years ago using nociceptive flexion reflexes-RIII (Garcia-Larrea et al., 1989), ruling out a possible paresthesia-based placebo effect of the procedure. While short-term pain relief following SCS is well documented, the long-term clinical SCS benefits remain questionable. Moreover, patients may develop tolerance to SCS, with loss of the therapeutic effect over time (Taccola et al., 2020). These issues can be tackled using a control group as a comparison, which is somewhat unethical, and/or a sham group which is unrealistic since conventional SCS induces paresthesiae. Very few studies considered the long-term effects of SCS on a large sample of patients. While the beneficial effect of SCS at 1 year on a large sample was clearly documented (EMP3OWER study, 401 patients; Rosenberg et al., 2016), longer beneficial effects have only been reported in very small series (Kumar et al., 2008). The recently published article in the European Journal of Pain concerns a study on 167 patients candidates for SCS followed for 28 weeks post-implantation (Brill et al., 2022). The authors used the patients whose SCS initial trial failed as a comparison group for the patients permanently implanted with SCS. They found no beneficial effects for the SCS group at the last follow-up compared to either the pre-operative status or the failed trial group. The results of this study are in contrast with those of most published data about the efficacy of SCS, and the strength of this series includes the absence of sponsorship by the devices' manufacturers, the number of patients (n = 167) and the test–retest study for the outcome measures—with clear cut-off values for a clinically significant difference. Notwithstanding these merits, the findings and conclusions of the study are to be interpreted with caution, since the study, although well conducted and interesting, carries limitations the reader must take into consideration. The comparison group used in this study is not typical and can induce bias in the comparison. Patients disappointed by the failure of the “last chance therapy” can either work psychologically on themselves and develop useful coping strategies, can successfully modify their other therapeutic approaches, or use illicit drugs and/or medications to overcome their suffering. Thus, they cannot be considered as a robust comparison group like a placebo/sham group. Of note, outcome measures did not include medication intake in the two groups; reporting this parameter is extremely important since a significant difference between the two groups would be in itself an objective marker of SCS efficacy. A third and important limitation is the absence of multivariate analysis, most probably because of the sample size, in order to investigate the influence of several factors like the device's manufacturer, the aetiology of the chronic pain and also the pain duration. The question that remains unanswered is why the findings of this study are in contradiction with most previously published data in the literature. One explanation might be that some studies exclude analysis of drop-out patients, but the probability that this alone explains the results appears very low. Given the generally good methodology followed in this paper, only the possible biases mentioned above, the patient population/selection process and/or the technique itself appear as potential explanations of the observed divergences with previous literature. In any case, the results are of potential importance and should prompt the development of other studies with a high level of evidence, which take into consideration the challenges of placebo/sham in this context, in order to document the real long-term effectiveness of SCS on pain relief in chronic refractory neuropathic pain.

P111. Spinal cord stimulators adversely affect outcomes in deformity surgery

P111. Spinal cord stimulators adversely affect outcomes in deformity surgery

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

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.

High-Frequency 10-kHz Spinal Cord Stimulation Improves Health-Related Quality of Life in Patients With Refractory Painful Diabetic Neuropathy: 12-Month Results From a Randomized Controlled Trial.

ObjectiveTo evaluate high-frequency (10-kHz) spinal cord stimulation (SCS) treatment in refractory painful diabetic neuropathy.Patients and MethodsA prospective, multicenter randomized controlled trial was conducted between Aug 28, 2017 and March 16, 2021, comparing conventional medical management (CMM) with 10-kHz SCS+CMM. The participants had hemoglobin A1c level of less than or equal to 10% and pain greater than or equal to 5 of 10 cm on visual analog scale, with painful diabetic neuropathy symptoms 12 months or more refractory to gabapentinoids and at least 1 other analgesic class. Assessments included measures of pain, neurologic function, and health-related quality of life (HRQoL) over 12 months with optional crossover at 6 months.ResultsThe participants were randomized 1:1 to CMM (n=103) or 10-kHz SCS+CMM (n=113). At 6 months, 77 of 95 (81%) CMM group participants opted for crossover, whereas none of the 10-kHz SCS group participants did so. At 12 months, the mean pain relief from baseline among participants implanted with 10-kHz SCS was 74.3% (95% CI, 70.1-78.5), and 121 of 142 (85%) participants were treatment responders (≥50% pain relief). Treatment with 10-kHz SCS improved HRQoL, including a mean improvement in the EuroQol 5-dimensional questionnaire index score of 0.136 (95% CI, 0.104-0.169). The participants also reported significantly less pain interference with sleep, mood, and daily activities. At 12 months, 131 of 142 (92%) participants were “satisfied” or “very satisfied” with the 10-kHz SCS treatment.ConclusionThe 10-kHz SCS treatment resulted in substantial pain relief and improvement in overall HRQoL 2.5- to 4.5-fold higher than the minimal clinically important difference. The outcomes were durable over 12 months and support 10-kHz SCS treatment in patients with refractory painful diabetic neuropathy.Trial registrationclincaltrials.gov Identifier: NCT03228420

High-frequency spinal cord stimulation in treatment of chronic limb-threatening ischemia (HEAL-SCS): short-term results of a randomized trial

Background. Critical limb ischemia is defined as persistent ischemic pain attributed to a variety of severely compromised blood flow to affected extremities. The treatment of non-reconstructable critical limb ischemia is still challenging; the amputation rate was 9.3%, and mortality rate was 23.2% within 24 months. Spinal cord stimulation (SCS) has become an alternative clinical practice for the treatment of intractable pain of the extremities.Aim. To determine whether high-frequency spinal cord stimulation (SCS) is better than low-frequency SCS for pain relief in chronic limb-threatening ischemia treatment.Methods. Throughout enrollment 56 patients were examined, of whom 6 rejected to participate in the study. The participants were randomly allocated to high-frequency (HF) or low frequency (LF)-SCS groups of 25 patients each by an external statistician, using an online tool. The patients were examined by a neurosurgeon and a vascular surgeon to assess pain intensity by visual analog scale, quality of life by short-form-36 health survey (SF-36), and functional status by walking impairment questionnaire in 3 and 12 months. Tissue perfusion by transcutaneous oxygen tension measurement was also measured in 12 months.Results. Intention-to-treat analysis demonstrated comparative advantage of HF-SCS over LF-SCS in 3 months with mean visual analog scale score 2.8 [95% CI, 2.4; 3.2] and 3.3 [95% CI, 3.0; 3.6] respectively (p = 0.031). Clinical superiority of HF-SCS persisted at 12 months follow up (p&lt;0.001). HF-SCS produces significantly greater pain relief by walking impairment questionnaire in 3 (p&lt;0.001) and 12 months (p = 0.009). Accordingly, general and mental health domains of SF-36 were significantly better in HF-SCS in 12 months. Despite a tendency toward better resting oxygen pressure in HF-SCS group, there was no intergroup difference by transcutaneous oxygen tension (p = 0.076).Conclusion. High-frequency spinal cord stimulation imposes better pain relief, life quality and functional activity in patients with chronic limb-threatening ischemia in short-term follow up.

Science, Medicine, and the Anesthesiologist

Science, Medicine, and the Anesthesiologist

IDF21-0081 Effect of High-Frequency 10 kHz Spinal Cord Stimulation in Painful Diabetic Neuropathy – A Randomized Controlled Trial

Background: The World Health Organization estimates 422 million persons with diabetes globally and approximately 20% with painful diabetic neuropathy (PDN). Current treatment options are ineffective for many patients; however, previous results suggest high-frequency (10kHz) spinal cord stimulation (SCS) relieves pain and may improve sensation in patients with refractory symptoms. Aim: Prospective, multicenter RCT to evaluate the effectiveness of 10 kHz SCS (Nevro Corp.) plus conventional medical management (CMM) compared with CMM alone for persons with refractory PDN. Method: Participants had PDN symptoms ≥12 months, lower limb pain ≥5 cm (10 cm visual analog scale), hemoglobin A1c ≤10%, and were randomized 1:1 between treatment arms. Outcomes included pain, neurological function, and quality of life over 12 months. Patients could opt to crossover to the alternative treatment at 6 months if they had insufficient pain relief (<50%), were dissatisfied, and their physician deemed it was medically appropriate. Results: Baseline characteristics were similar between groups. The mean age of participants was 60.8 years (SD 10.7) with mean hemoglobin A1c of 7.4% (SD 1.2%). Median duration of diabetes was 10.9 years (IQR 6.3-16.4) with median 5.6 years (IQR 3.0-10.1) of peripheral neuropathy symptoms. At 6 months, 82% of the CMM group crossed over to SCS treatment and none in the 10 kHz SCS group crossed over to CMM. In total, 154 patients underwent permanent SCS device implant; 5 (3.2%) were explanted, all due to infection. Participants originally randomized to 10 kHz SCS as well as those who crossed over demonstrated clear, sustained benefits in lower limb pain, pain interference with daily living, sleep quality, and improvement on neurological examination at 12-month follow-up (Table). TableData shown as mean (95% CI) or proportions.CMM Pre- and Post-crossover to 10 kHz SCS10 kHz SCSBaseline6 Months (CMM only)12 Months (6 mo CMM, 6 mo SCS)Baseline6 Months12 MonthsLower Limb Pain VAS17.2 cm (6.8-7.6 cm)7.4 cm (7.0-7.8 cm)2.0 cm (1.6-2.4 cm)7.6 cm (7.2-7.9 cm)1.7 cm (1.3-2.1 cm)1.7 cm (1.3-2.1 cm)Pain relief from baseline--6.7% (-15.0-1.7%)70.3% (63.4-77.1%)-76.3% (70.7-81.9%)77.1% (71.8-82.3%)Pain interference with mood & daily activities (BPI-DPN)25.9 (5.4-6.4)6.2 (5.6-6.8)2.1 (1.6-2.6)6.2 (5.8-6.7)2.2 (1.7-2.6)1.9 (1.5-2.3)Impact of pain on sleep VAS (PSQ-3)36.7 cm (6.1-7.2 cm)7.0 cm (6.3-7.6 cm)2.7 cm (2.0-3.3 cm)5.9 cm (5.4-6.5 cm)2.1 cm (1.6-2.5 cm)2.1 cm (1.6-2.6 cm)Participants with improvement on neurological examination-0/52 (0%)32/52 (62%)-43/73 (59%)52/76 (68%)110 cm visual analog scale. 2Brief Pain Inventory for Diabetic Peripheral Neuropathy questionnaire. 3Pain and Sleep Questionnaire Three-Item index. Open table in a new tab 110 cm visual analog scale. 2Brief Pain Inventory for Diabetic Peripheral Neuropathy questionnaire. 3Pain and Sleep Questionnaire Three-Item index. Discussion: This is the largest RCT to date of SCS management in PDN. Substantial improvements with high-frequency (10kHz) SCS were sustained over 12 months and support this treatment for PDN patients with refractory symptoms.

123 Long-Term High-Frequency (10 kHz) Spinal Cord Stimulation in Painful Diabetic Neuropathy - A Randomized Controlled Trial

INTRODUCTION: World Health Organization estimates 422 million people with diabetes globally and approximately 20% with painful diabetic neuropathy (PDN). Current treatment options are ineffective for many patients; however, previous results suggest high-frequency (10 kHz) spinal cord stimulation (SCS) relieves pain and may improve sensation in patients with refractory symptoms. METHODS: Randomization of 216 patients assigned 1:1 to 10 kHz SCS (Nevro Corp.) combined with conventional medical management (CMM) or CMM alone. Patients had PDN symptoms ≥12 months, lower limb pain ≥5 cm (10 cm visual analog scale), and hemoglobin A1c ≤10%. Outcomes include pain, interference with daily activities and sleep, and neurological examination. Patients could opt to crossover to the other treatment arm at 6 months. RESULTS: At 6 months, 86% of patients in the 10 kHz SCS group were responders with at least 50% pain relief. They reported reduced pain interference with daily activities and improvements in sleep. None of the patients in the 10 kHz SCS group chose to crossover to CMM at 6 months. Treatment benefits were sustained through 12 months. A majority of patients treated with 10 kHz SCS were noted to have improvement on neurological examination. Participants in the CMM group experienced no change in pain levels, pain interference with daily activities, or sleep quality over 6 months. Eighty-two percent opted to crossover to 10 kHz SCS at 6 months. Results post-crossover were similar to those in patients originally randomized to 10 kHz SCS: 84% responders as well as reduced pain interference with daily activities, improvements in sleep, and a majority with observed improvements on neurological examination. CONCLUSION: This is the largest RCT to-date of SCS management in PDN. Substantial improvements with high-frequency (10kHz) SCS were sustained over 12 months and support this treatment for PDN patients with refractory symptoms.

Association of Spinal Cord Stimulator Implantation With Persistent Opioid Use in Patients With Postlaminectomy Syndrome

The results of studies evaluating spinal cord stimulation (SCS) for postlaminectomy syndrome (PLS) have yielded mixed results. This has led to an increased emphasis on objective outcome measures such as opioid prescribing. To determine the association between SCS and long-term opioid therapy (LOT) for PLS. In this cohort study, adults with PLS were identified using the TriNetx Diamond Network and separated based on whether they underwent SCS. Patients were stratified according to baseline opioid use (opioid-naive or receiving LOT) and subsequent opioid therapy over the 12-month period ranging from 3 to 15 months post-SCS implantation or post-PLS index date. Statistical analysis was performed from June to December 2021. SCS. The main outcome was cessation of opioid use among patients receiving LOT or abstinence from opioids among opioid-naive patients. Opioid-naive patients were defined as those receiving at most 2 opioid prescriptions per year, and patients on LOT were those receiving at least 6 opioid prescriptions per year. Among 552 937 eligible patients treated between December 2015 and May 2021, 26 179 with PLS received an SCS implant. The median (IQR) patient age was 60 (51-69) years; 305 802 patients (55.3%) were female. Among those reporting racial identify (37.0% [204 758 patients]), 9.3% (18 971 patients) were African American, 0.3% (648 patients) were Asian, and 90.4% (185 139 patients) were White. Compared with those who did not receive an SCS, individuals who received an SCS were more likely to be using opioids preimplantation (mean [SD] prescriptions: 4.3 [8.5] vs 4.1 [9.3]; P < .001) but less likely to be using opioids after SCS implantation (mean [SD] prescriptions: 3.8 [8.2] vs 4.0 [9.4]; P = .006). In the 12-month study period, similar proportions in the SCS and no-SCS groups receiving baseline LOT remained on LOT (70.3% [n = 74 585] vs 69.2% [n = 3882], respectively; P = .10). In opioid-naive patients, SCS was associated with a small decreased likelihood of patients subsequently receiving LOT (7.6% vs 7.0%; difference, -0.6% [95% CI, -1.0% to -0.2%]; P = .003). In multivariable analysis, SCS was associated with an increased likelihood of not being on opioids in both opioid-naive (adjusted odds ratio [OR], 0.90 [95% CI, 0.85-0.96]; P < .001) and LOT patients (adjusted OR, 0.93 [95% CI, 0.88-0.99]; P = .02). White patients were significantly more likely to be diagnosed with PLS (ie, underwent surgery) (90.4% vs 85.2%; difference, 5.2% [95% CI, 5.1%-5.4%]; P < .001) and receive an SCS (93.7% vs 90.3%; difference, 3.4% [95% CI, 2.9% to 4.0%]; P < .001) than patients of other racial identities. These findings suggest that under real-life conditions, SCS was associated with small, clinically questionable associations with opioid discontinuation and not starting opioids in the context of PLS.

Real-World Cost-Effectiveness Analysis of Spinal Cord Stimulation vs Conventional Therapy in the Management of Failed Back Surgery Syndrome.

PurposeFailed back surgery syndrome (FBSS) causes disability and lowers health-related quality of life (HRQoL) for patients. Many patients become refractory to conventional medical management (CMM) and spinal cord stimulation (SCS) is advised. However, comparative cost-effectiveness research of both clinical approaches still lacks further evidence. This probabilistic cost-effectiveness analysis compares CMM versus SCS plus CMM in FBSS patients for a 5-year period in Spain.Patients and MethodsPatient-level data was obtained from a 2-year real-world study (SEFUDOCE) of adults diagnosed with FBSS who were treated with CMM or SCS. Incremental cost-effectiveness ratios (ICER) were estimated in terms of direct clinical cost and quality-adjusted life years (QALYs). Costs (€ for 2019) were estimated from the Spanish National Health Service (NHS) perspective. We applied a yearly discount rate of 3% to both costs and outcomes and performed a probabilistic sensitivity analysis using bootstrapping.ResultsAfter 2 years, the health-related quality of life measured by the EQ-5D displayed greater improvements for SCS patients (00.39) than for improved CMM patients (0.01). The proportion of SCS patients using medication fell substantially, particularly for opioids (−49%). In the statistical model projection, compared with the CMM group at year 5, the SCS group showed an incremental cost of € 15,406 for an incremental gain of 0.56 0.56 QALYs, for an ICER of € 27,330, below the €30,000 willingness-to-pay threshold for Spain. SCS had a 79% of probability of being cost-effective.ConclusionSCS is a cost-effective treatment for FBSS compared to CMM alone based on real-world evidence.

Science, Medicine, and the Anesthesiologist

Science, Medicine, and the Anesthesiologist

16-LB: Long-Term 10 kHz Spinal Cord Stimulation in Painful Diabetic Neuropathy: A Randomized Controlled Trial

Background: Seven million US adults are living with painful diabetic neuropathy (PDN) with current treatments ineffective for many. Recent RCT results demonstrate high-frequency (10 kHz) spinal cord stimulation (SCS) relieves pain and may improve sensation in patients with refractory symptoms.Methods: Prospective, multicenter RCT assigned 216 patients 1:1 to 10 kHz SCS (Nevro Corp.) plus conventional medical management (CMM) or CMM alone (NCT03228420). Patients had PDN symptoms ≥12 months, lower limb pain ≥5 cm (10 cm visual analog scale), and hemoglobin A1c ≤10%. Outcomes included pain, neurological function, and quality of life over 12 months. Patients could opt to crossover to the alternative treatment at 6 months.Results: Baseline characteristics were similar between groups. At 6 months, 82% of the CMM group crossed over to SCS treatment and none in the 10 kHz SCS group crossed over to CMM. In total, 154 patients underwent SCS implant; 5 (3.2%) were explanted for infection. At 12-month follow-up, there were clear, sustained benefits of 10 kHz SCS in lower limb pain, pain interference with daily living, sleep quality, and activity (Figure). Most patients treated with 10 kHz SCS also showed improvements on neurological examination.Conclusion: The largest RCT to date of SCS management of PDN demonstrates durable pain relief and improved quality of life over 12 months with high-frequency (10 kHz) SCS.View largeDownload slideView largeDownload slide DisclosureE. Petersen: Consultant; Self; Abbott, Medtronic, Nevro Corp., Research Support; Self; Neuros Medical, Inc., Nevro Corp., ReNeuron Group plc, Saluda, Stock/Shareholder; Self; SynerFuse. N. Mehta: Research Support; Self; Nevro Corp. P. W. Wu: None. C. Argoff: Consultant; Self; Nevro Corp., Vertex Pharmaceuticals Incorporated, Other Relationship; Self; Amgen Inc., Eli Lilly and Company, Teva Pharmaceutical Industries Ltd., Speaker’s Bureau; Self; AbbVie Inc. C. E. Nasr: Advisory Panel; Self; Nevro Corp. R. Taylor: Consultant; Self; Nevro Corp. Senza-pdn study group: n/a. J. Scowcroft: Research Support; Self; Boston Scientific Corporation, Nevro Corp. E. S. Brooks: Employee; Self; Nevro Corp. J. L. White: Advisory Panel; Self; Eli Lilly and Company, Nevro Corp. K. Amirdelfan: Advisory Panel; Self; Biotronik, Nevro Corp., Consultant; Self; Boston Scientific Corporation. M. Guirguis: Consultant; Self; Avanos medical, Nevro Corp. J. Xu: None. D. G. Patterson: Advisory Panel; Self; Advanced Infusion Systems (AIS), Spark Biomedical, Consultant; Self; Vivex Biologics, Other Relationship; Self; Abbott Laboratories, CornerLoc, Saluda, Vertos Medical Inc., Speaker’s Bureau; Self; AbbVie Inc., Amgen Inc., Lundbeck. V. Galan: None.FundingNevro Corp.

Effect of High-frequency (10-kHz) Spinal Cord Stimulation in Patients With Painful Diabetic Neuropathy

Many patients with diabetic peripheral neuropathy experience chronic pain and inadequate relief despite best available medical treatments. To determine whether 10-kHz spinal cord stimulation (SCS) improves outcomes for patients with refractory painful diabetic neuropathy (PDN). The prospective, multicenter, open-label SENZA-PDN randomized clinical trial compared conventional medical management (CMM) with 10-kHz SCS plus CMM. Participants with PDN for 1 year or more refractory to gabapentinoids and at least 1 other analgesic class, lower limb pain intensity of 5 cm or more on a 10-cm visual analogue scale (VAS), body mass index (calculated as weight in kilograms divided by height in meters squared) of 45 or less, hemoglobin A1c (HbA1c) of 10% or less, daily morphine equivalents of 120 mg or less, and medically appropriate for the procedure were recruited from clinic patient populations and digital advertising. Participants were enrolled from multiple sites across the US, including academic centers and community pain clinics, between August 2017 and August 2019 with 6-month follow-up and optional crossover at 6 months. Screening 430 patients resulted in 214 who were excluded or declined participation and 216 who were randomized. At 6-month follow-up, 187 patients were evaluated. Implanted medical device delivering 10-kHz SCS. The prespecified primary end point was percentage of participants with 50% pain relief or more on VAS without worsening of baseline neurological deficits at 3 months. Secondary end points were tested hierarchically, as prespecified in the analysis plan. Measures included pain VAS, neurological examination, health-related quality of life (EuroQol Five-Dimension questionnaire), and HbA1c over 6 months. Of 216 randomized patients, 136 (63.0%) were male, and the mean (SD) age was 60.8 (10.7) years. Additionally, the median (interquartile range) duration of diabetes and peripheral neuropathy were 10.9 (6.3-16.4) years and 5.6 (3.0-10.1) years, respectively. The primary end point assessed in the intention-to-treat population was met by 5 of 94 patients in the CMM group (5%) and 75 of 95 patients in the 10-kHz SCS plus CMM group (79%; difference, 73.6%; 95% CI, 64.2-83.0; P < .001). Infections requiring device explant occurred in 2 patients in the 10-kHz SCS plus CMM group (2%). For the CMM group, the mean pain VAS score was 7.0 cm (95% CI, 6.7-7.3) at baseline and 6.9 cm (95% CI, 6.5-7.3) at 6 months. For the 10-kHz SCS plus CMM group, the mean pain VAS score was 7.6 cm (95% CI, 7.3-7.9) at baseline and 1.7 cm (95% CI, 1.3-2.1) at 6 months. Investigators observed neurological examination improvements for 3 of 92 patients in the CMM group (3%) and 52 of 84 in the 10-kHz SCS plus CMM group (62%) at 6 months (difference, 58.6%; 95% CI, 47.6-69.6; P < .001). Substantial pain relief and improved health-related quality of life sustained over 6 months demonstrates 10-kHz SCS can safely and effectively treat patients with refractory PDN. ClincalTrials.gov Identifier: NCT03228420.