Neuromodulation With Burst and Tonic Stimulation Decreases Opioid Consumption: A Post Hoc Analysis of the Success Using Neuromodulation With BURST (SUNBURST) Randomized Controlled Trial

ObjectivesThe SUNBURST study was a prospective, multicenter, randomized crossover trial of a single device delivering burst and tonic spinal cord stimulation (SCS) for chronic trunk and/or limb pain. We performed a post hoc analysis of opioid consumption at baseline and after device implantation.Materials and MethodsAfter implantation, 100 patients were randomized to one mode (tonic or burst) for 12 weeks, and the other mode for the subsequent 12 weeks. After the crossover period (24 weeks), patients chose their preferred mode and were assessed for one year. We analyzed 69 patients who took opioid medication at baseline. The primary endpoint was opioid consumption in morphine milligram equivalents (MMEs) at baseline and 12 months postimplantation. Subgroup analysis included opioid consumption based on Center for Disease Control markers (<50, 50–90, 90–120, >120 MME/day) and stimulation mode preference.ResultsOpioid consumption at 12 months was lower compared to baseline (53.94 vs. 79.19 MME, MD −25.25, 95% CI −43.77 to 6.73, p = 0.008). By 12 months, 11 of 69 patients (15.9%) discontinued all opioid (p = 0.001). Based on CDC dose markers, the proportion of patients taking >120 MME/day decreased by 61.7% at 12 months postintervention compared to baseline (p = 0.043). Forty-five of 69 patients (65.2%) preferred burst SCS while 15 of 69 patients (21.7%) preferred tonic SCS (p < 0.001).ConclusionA device delivering tonic and burst SCS was associated with decreased opioid consumption after 12 months in patients with chronic trunk and/or limb pain. The proportion of patients reporting the highest opioid intake (>120 MME/day) decreased to a lower CDC dose category by 61.7%, carrying important implications for those at highest risk for opioid-related substance use disorder, overdose, and death.     

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

ObjectivesHigh-dose spinal cord stimulation (HD-SCS) revealed positive results for obtaining pain relief in patients with failed back surgery syndrome (FBSS). However, it is less clear whether HD-SCS also is able to reduce pain medication use. The aim of this registry-based cohort study is to explore the impact of HD-SCS on pain medication use in FBSS patients.Materials and MethodsData from the Discover registry was used in which the effectiveness of HD-SCS was explored in neurostimulation-naïve FBSS patients as well as in rescue patients. All neurostimulation-naïve FBSS patients positively responded to a four-week SCS trial period in which at least 50% pain relief and 50% medication reduction were obtained. Medication use was measured with the Medication Quantification Scale III (MQS) in 259 patients at baseline and at 1, 3, and 12 months of HD-SCS. Additionally, defined daily doses (DDD) and morphine milligram equivalents (MME) were calculated as well.ResultsOne hundred thirty patients reached the visit at 12 months. In neurostimulation-naïve patients, a statistically significant decrease in MQS (χ² = 62.92, p < 0.001), DDD (χ² = 11.47, p = 0.009), and MME (χ² = 21.55, p < 0.001) was found. In rescue patients, no statistically significant improvements were found. In both patient groups, statistically significant reductions in the proportion of patients on high-risk MME doses ≥90 were found over time. At the intraindividual level, positive correlations were found between MSQ scores and pain intensity for back (r = 0.56, r = 0.31, p < 0.001) and leg pain (r = 0.61, r = 0.22, p < 0.001) in neurostimulation-naïve and rescue patients, respectively.ConclusionsRegistry data on HD-SCS in FBSS patients revealed a statistically significant and sustained decrease in pain medication use, not only on opioids, but also on anti-neuropathic agents in neurostimulation-naïve patients, who positively responded to an SCS trial period with at least 50% pain relief and 50% pain medication decrease, but not in rescue patients.     

1.2 kHz High-Frequency Stimulation as a Rescue Therapy in Patients With Chronic Pain Refractory to Conventional Spinal Cord Stimulation

ObjectivesWe aimed to investigate the efficacy of new subperception stimulation paradigms including 1.2 kHz-high-frequency stimulation (HFS) and advanced-HFS field-shaping algorithm (dorsal horn HFS [DHHFS]) in refractory cases which initially benefited from conventional spinal cord stimulation (SCS) and lost the effect throughout time.Materials and MethodsIn the context of a rescue-therapy, patients underwent externalization of the implanted SCS-leads and were tested with multiple combinations of new SCS paradigms. Pain intensity was analyzed using the numeric rating scale (NRS), and data were collected preoperatively and at multiple postoperative follow-ups.ResultsThirty-seven patients underwent externalization of the leads. Mean preoperative NRS-score was 8.1/10 points (SD ± 0.9) for the ON-stimulation period. Patients received a combination of either tonic, burst and 1.2 kHz-HFS, or burst and 1.2 kHz-HFS, DHHFS, or 1.2 kHz-HFS and DHHFS, or 1.2 kHz-HFS alone. The mean postoperative NRS-score after the testing-phase was 3.8/10 points (SD ± 2.5), showing a 48.0% mean reduction (p < 0.001). In total, 29 patients reported a significant reduction above 50% in NRS-scores and therefore were reimplanted with new generators that could deliver the new paradigms. Eight patients underwent full SCS-system explantation. The patients who continued with the new paradigms (n = 29) reported mean NRS-scores of 3.5/10 points (SD ± 1.7) 12 months postoperatively, still showing a significant reduction of 43.3% when compared to preoperative scores (p < 0.001).ConclusionRescue-therapy with combination of multiple waveforms, including tonic, burst, 1.2 kHz-HFS, and DHHFS, was associated with a significant pain relief in patients with failed conventional SCS. This approach is a safe and efficient and should be considered before explantation of the SCS-system.     

Comparison of Spinal Cord Stimulation Outcomes Between Preoperative Opioid Users and Nonusers: A Cohort Study of 467 Patients

ObjectivesSpinal cord stimulation (SCS) is a surgical treatment modality reserved for a subset of patients with neuropathic pain in which conventional pharmacologic treatment has proven insufficient. Previous studies have suggested a possible negative relationship between opioid use at referral and subsequent success of SCS therapy. The aim of this cohort study was to investigate whether preoperative opioid use was associated with inferior SCS outcomes.Materials and MethodsData were obtained from the Danish Neurizon Neuromodulation Database and comprised preoperative registrations of analgesic use, postoperative Patients’ Global Impression of Change (PGIC) ratings, pre- and postoperative pain intensity scores (Numeric Rating Scale), and detailed surgical data. Patients were dichotomized according to preoperative opioid use (users vs nonusers) with subsequent assessment of the latest PGIC rating, reduction in pain intensity, and current treatment status (implanted/explanted). In addition, daily preoperative opioid dosages were quantified in oral morphine equivalents (OME) and correlated to the treatment outcomes.ResultsA total of 467 patients were included; 296 consumed opioids before SCS implantation (median 80 OME/d). Preoperative opioid use was not associated with the latest PGIC rating, reduction in pain intensity (30% or 50%), or risk of undergoing explantation (median follow-up = 3.0 years). Likewise, preoperative median OME per day of opioid users was not correlated with any of the defined outcomes.ConclusionsPreoperative opioid usage did not predict the outcome of SCS therapy in a large cohort of patients permanently implanted with an SCS system. The results do not support withholding otherwise well-indicated SCS therapy in patients with chronic neuropathic pain conditions based merely on preoperative opioid usage.     

Opioid use and spinal cord stimulation therapy: The long game

Spinal cord stimulation (SCS) has been considered as an alternative therapy to reduce opioid requirements in certain chronic pain disorders. However, information on long-term opioid consumption patterns and their impact on SCS device explantation is lacking. We conducted a retrospective study of 45 patients to characterize long-term patterns of opioid usage after SCS implantation. Daily morphine equivalent dosage (MED) increased, decreased, and remained the same in 40%, 40%, and 20% of patients at 1-year follow-up, respectively. Twelve (27%) underwent explantation due to treatment failure at a median of 18 months after implantation. Pre-operative opioid status (naïve vs. active use) was not associated with explantation (18% vs. 29%, p = 0.699) and neither was the daily MED change status (i.e. increased, decreased, unchanged) at 1-year (p = 0.499, 1.000, 0.735, respectively). Following explantation, reduction in the daily MED was seen in 92% of patients with dosages falling below pre-operative baseline in nine. Among the opioid naïve patients, 55% were on opioids at last follow-up (average 32.4 ± 14.6 months). Our results indicate that daily opioid consumption does not decrease in most patients 1-year after SCS implantation. Furthermore, post-operative evaluation beyond 1-year is necessary to assess the efficacy and durability of SCS therapy as well as its impact on opioid requirement. Lastly, rigorous patient selection and pre-operative risk assessment for misuse and dependence are paramount to improving outcome after SCS implantation.     

Subcutaneous Stimulation as an Additional Therapy to Spinal Cord Stimulation for the Treatment of Lower Limb Pain and/or Back Pain: A Feasibility Study

Objective: The objective of this study was to demonstrate the efficacy of subcutaneous stimulation (SubQ) as an additional therapy in patients with failed back surgery syndrome (FBSS) with chronic refractory pain, for whom spinal cord stimulation (SCS) was unsuccessful in treating low back pain. Study Design: Case series. Materials and Methods: FBSS patients with chronic limb and/or low back pain whose conventional therapies had failed received a combination of SCS (8‐contact Octad lead) and/or SubQ (4‐contact Quad Plus lead(s)). Initially leads were placed in the epidural space for SCS for a trial stimulation to assess response to suppression of limb and low back pain. Where SCS alone was insufficient in treating lower back pain, leads were placed superficially in the subcutaneous tissue of the lower back, directly in the middle of the pain area. A pulse generator was implanted if patients reported more than 50% pain relief during the trial period. Pain intensity for limb and lower back pain was scored separately, using visual analog scale (VAS). Pain and Quebec Back Pain Disability Scale (QBPDS) after 12‐month treatment were compared with pain and QBPDS at baseline. Results: Eleven FBSS patients, five male and six female (age: 51 ± 8 years; mean ± SD), in whom SCS alone was insufficient in treating lower back pain, were included. In nine cases, SubQ was used in combination with SCS to treat chronic lower back and lower extremity pain. In two cases only SubQ was used to treat lower back pain. SCS significantly reduced limb pain after 12 months (VAS_bl: 62 ± 14 vs. VAS_12m: 20 ± 11; p= 0.001, N= 8). SubQ stimulation significantly reduced low back pain after 12 months (VAS_bl: 62 ± 13.0 vs. VAS_12m: 32 ± 16; p= 0.0002, N= 10). Overall pain medication was reduced by more than 70%. QBPDS improved from 61 ± 15 to 49 ± 12 (p= 0.046, N= 10). Furthermore, we observed that two patients returned to work. Conclusion: SubQ may be an effective additional treatment for chronic low back pain in patients with FBSS for whom SCS alone is insufficient in alleviating their pain symptoms.     

Detoxification of Neuromodulation-Eligible Patients by a Standardized Protocol: A Retrospective Pilot Study

ObjectivesPatients eligible for spinal cord stimulation (SCS) generally experience excruciating pain, requiring more opioid consumption, which is usually an indication for SCS implantation. After final implantation, SCS has the ability to stabilize or decrease opioid usage in half of the patients. In this study, opioids were actively eliminated prior to implantation of any neuromodulation device with a standardized detoxification protocol. This pilot study aims to explore the feasibility, effectiveness, and safety of this opioid detoxification protocol prior to neuromodulation techniques.Materials and MethodsIn this retrospective pilot study, 70 patients who were taking opioids and who were eligible for neuromodulation techniques underwent the detoxification program. A combined in- and out-patient clinic protocol was applied, whereby clonidine was the main component of both parts of the program. A multidisciplinary team with pain physicians and psychologists was responsible for performing this detoxification program. Safety and feasibility were systematically recorded during the hospitalization.ResultsNo serious safety issues were reported. At the start of the program, patients reported a mild sedative effect of clonidine. Additionally, most patients presented mild symptoms of opioid withdrawal, which were partially countered by the sedative effect of clonidine. Both patients and the medical staff found this protocol feasible in clinical practice. Concerning the effectiveness, a statistically significant decrease in median morphine milligram equivalents (MMEs) was found with an MME of 175 (Q1–Q3: 118.1–240) at baseline, and at the last available follow-up visit the MME was 0 (Q1–Q3: 0–16.88).ConclusionsThis standardized detoxification program has proven its effectiveness, safety, and feasibility in this single-center experience pilot study in patients eligible for neuromodulation techniques.     

Dorsal Root Ganglion Stimulation as a Salvage Therapy Following Failed Spinal Cord Stimulation

IntroductionSpinal cord stimulation (SCS) can provide long-term pain relief for various chronic pain conditions, but some patients have no relief with trial stimulation or lose efficacy over time. To “salvage” relief in patients who do not respond or have lost efficacy, alternative stimulation paradigms or anatomical targets can be considered. Dorsal root ganglion stimulation (DRG-S) has a different mechanism of action and anatomical target than SCS.ObjectivesWe assessed DRG-S salvage therapy outcomes in patients who did not respond to SCS or had lost SCS efficacy.Materials and MethodsWe retrospectively included consecutive patients from 2016 to 2020 who were salvaged with DRG-S after failed SCS trials (<50% pain reduction) or who had lost efficacy after permanent SCS. We compared numerical rating scale (NRS) pain, Oswestry disability index (ODI), health-related quality of life (EuroQol five-dimensions five-level), and oral morphine equivalent (OME) opioid requirements before DRG-S salvage and at patients’ last follow-up.ResultsA total of 60 patients who had failed SCS were salvaged with DRG-S. The mean age was 56 ± 12 years, and the most common diagnoses were complex regional pain syndrome (n = 24) and failed back surgery syndrome (n = 24). The most common failed modalities included tonic (n = 32), Burst (n = 18), and high-frequency (n = 10) SCS. The median follow-up duration of salvage DRG-S was 34 months. With DRG-S, NRS decreased (8.7 ± 1.2 to 3.8 ± 2.1), and OME declined (median 23 mg to median 15 mg), whereas EuroQol 5D scores increased (0.40 ± 0.15 to 0.71 ± 0.15), and ODI improved (64 ± 14% to 31 ± 18%) (all p < 0.05).ConclusionsDRG-S can be used in patients with chronic pain who have previously failed to receive persistent benefit from SCS.     

Surgical Paddle Electrode Implantation as a Rescue Therapy to Failed Percutaneous Leads in Failed Back Surgery Syndrome Patients

IntroductionSpinal cord stimulation (SCS) to treat failed back surgery syndrome (FBSS) can be provided with either percutaneously or surgically implanted electrodes. Percutaneous electrodes are considered the first choice in many pain practices, but surgical paddle electrodes can also be indicated if a percutaneous electrode fails to retain sufficient pain relief or if percutaneous implantation is considered unachievable. Although the current efficacy of surgical paddle electrodes has been based mainly upon pain intensity scores, the evidence on surgical paddle electrodes as a rescue to failed percutaneous electrodes remains even more scarce.ObjectiveThis study aimed to evaluate the safety and clinical effectiveness of rescue surgical paddle electrodes in FBSS patients, multidimensionally.Materials and MethodsThe occurrence of complications, pain intensity scores, psychosocial-related questionnaires, and medication intake were collected. Subsequently, a Quality-of-Life Index (QLI) was calculated. A clinically relevant effect was obtained if the minimal clinically important difference regarding pain intensity was reached.ResultsA total of 25 patients were included in the study. The pain intensity scores were significantly reduced (p < 0.001), and clinically relevant reductions occurred during short-term (0–6 months), mid-term (1–3 years), and long-term follow-up (≥4 years). The structural morphine usage and QLI were significantly decreased at short-term follow-up (p = 0.038 and p = 0.036, respectively). Six complications occurred in five patients, of which, four concerned hardware-related problems and two were of biological origin.ConclusionSCS utilizing a surgical paddle electrode as a salvage treatment to failed conventional percutaneous cylindrical lead SCS can be practiced safely and effectively to treat FBSS. Because of potentially improved clinical effectiveness and cost-effectiveness resulting from fewer reoperations, a SCS treatment algorithm may benefit from expediting surgical paddle electrodes.     

Initiation of Intrathecal Drug Delivery Dramatically Reduces Systemic Opioid Use in Patients With Advanced Cancer

ObjectivesPain is common in cancer, affecting more than 70% of patients with advanced disease. Intrathecal drug delivery systems (IDDS) are a well-established treatment for patients with refractory cancer pain, improving pain control and reducing associated side effects. To date, details of systemic opioid use before and after IDDS implant have not been reported.Materials and MethodsWe conducted a retrospective review of patients at Huntsman Cancer Institute-University of Utah treated with IDDS for cancer pain from May 2014 to May 2018. Oral, transdermal, and parenteral opioid use before IDDS implant was compared to use 30 days postoperatively.ResultsA total of 173 patients were included, 93% with stage IV disease. The pre-implant median daily oral morphine equivalent (OME) was 240 mg (interquartile range 130–390, range 0–2616 mg). OME doses >200 mg/day were required by 57% of patients, and >500 mg OME by 19% of patients. The post-implant median OME was 0 mg (interquartile range 0–0, range 0–480 mg) and 82.6% of patients discontinued systemic opioids completely. 11.0% of patients used <100 mg OME, and only 1.7% of patients used >200 mg OME. Mean OME decreased by 94% following IDDS implant (p < 0.0001) and all patients who continued to use systemic opioids required a lower OME compared to pre-implant.ConclusionsIn the largest cohort of patients with advanced cancer and refractory pain treated with IDDS, implantation was associated with a dramatic reduction in systemic opioid use 30 days postoperatively, with a large majority of patients discontinuing systemic opioids. Those patients that continued systemic opioids utilized significantly lower doses as compared to their pre-implant dose.     

Pain Catastrophizing Does Not Predict Spinal Cord Stimulation Outcomes: A Cohort Study of 259 Patients With Long‐Term Follow‐Up

ObjectiveSpinal cord stimulation (SCS) is an important treatment modality used to treat chronic neuropathic pain. However, reported success rates of 26%-70% entail an increased focus on patient selection. An area of core interest is psychological evaluation, often using scales such as the Pain Catastrophizing Scale (PCS). The aim of this study was to assess the relation between baseline PCS scores obtained before implantation and SCS outcomes defined as (1) Rating on Patients’ Global Impression of Change scale (PGIC), (2) Pain relief on the Numeric Rating Scale (NRS), (3) Cessation of pain medication, and (4) Risk of permanent explantation.Materials and MethodsUsing records from the Neurizon Neuromodulation Database, we performed a multicenter open cohort study of 259 permanently implanted SCS patients. Follow-up ranged from six months to nine years (median = three years). For each of the defined SCS outcomes, patients were grouped according to their latest follow-up registration. Subsequently, we used a one-way ANOVA and exact t-tests to compare mean baseline PCS scores between groups.ResultsNo difference in mean baseline PCS scores was found between PGIC groups. Baseline PCS scores was not associated with the probability of obtaining 30% or 50% pain relief on latest registration. Baseline PCS scores of patients able to cease all usage of tricyclic antidepressants, antiepileptics, or opioids during SCS treatment did not differ from baseline scores of continuous users. We found no association between baseline PCS scores and risk of permanent explantation.ConclusionThis study did not demonstrate any associations between baseline PCS scores and SCS outcomes.     

Spinal Cord Stimulation in the Treatment of Cancer Pain: A Retrospective Review

ObjectivesSpinal cord stimulation (SCS) involves electrical stimulation of the dorsal spinal cord to disrupt the transmission of ascending pain signals. SCS has been used successfully to manage a variety of chronic pain conditions, but its efficacy in the treatment of pain syndromes in patients with cancer has not been established because most studies have involved a limited number of patients. The purpose of this study was to assess the efficacy of SCS in a large group of patients with cancer.Materials and MethodsA retrospective review was performed for all patients who had SCS trials and implants placed at Memorial Sloan Kettering Cancer Center between 2003 and 2021. Patients were divided into groups based on whether their pain could be directly attributed to cancer or its treatment (cancer dependent, n = 51) and those who had incidental pain unrelated to cancer (cancer independent, n = 22). The cancer-dependent group was further subdivided into those whose pain was directly related to primary tumor invasion or metastasis (cancer related, n = 26) and those whose pain was a result of cancer treatment such as chemotherapy or surgery (treatment related, n = 25). The primary outcomes were changes in pain scores and daily oral morphine equivalents (OMEs) before intervention to one year after implant. Secondary measures included the SCS trial success rate, change in pain scores immediately after the SCS trial, and change in pain scores immediately after the SCS implant.ResultsMost patients in the cancer-dependent pain group (59%) and the cancer-independent pain group (68%) had successful SCS trials and subsequently went on to have SCS implants placed. The patients with cancer-dependent pain as a whole had median reduction of 1.5 points (or 23%) on a 10-point pain score immediately after implant (p = 0.001), with the effect diminishing to a median reduction of 1 point (or 15%) by one year after implant (p = 0.027). The cancer-dependent pain groups did not have a significant reduction in daily OMEs, following implantation (p = 0.30), but the cancer-independent group did have a significant reduction (p = 0.01).ConclusionsSCS can be considered as a treatment modality for patients with cancer whose pain is not adequately controlled with medical therapy or by less invasive interventions.     

The Link Between Spinal Cord Stimulation and the Parasympathetic Nervous System in Patients With Failed Back Surgery Syndrome

ObjectivesIn patients with chronic pain, a relative lower parasympathetic activity is suggested based on heart rate variability measurements. It is hypothesized that spinal cord stimulation (SCS) is able to influence the autonomic nervous system. The aim of this study is to further explore the influence of SCS on the autonomic nervous system by evaluating whether SCS is able to influence skin conductance, blood volume pulse, heart rate, and respiration rate.Materials and MethodsTwenty-eight patients with Failed Back Surgery Syndrome (FBSS), who are being treated with SCS, took part in this multicenter study. Skin conductance and cardiorespiratory parameters (blood volume pulse, heart rate, and respiration rate) were measured during on and off states of SCS. Paired statistics were performed on a 5-min recording segment for all parameters.ResultsSCS significantly decreased back and leg pain intensity scores in patients with FBSS. Skin conductance level and blood volume pulse were not altered between on and off states of SCS. Heart rate and respiration rate significantly decreased when SCS was activated.ConclusionsParameters that are regulated by the sympathetic nervous system were not significantly different between SCS on and off states, leading to the hypothesis that SCS is capable of restoring the dysregulation of the autonomic nervous system by primarily increasing the activity of the parasympathetic system in patients with FBSS.     

Factors Contributing to Spinal Cord Stimulation Outcomes for Chronic Pain

ObjectiveSpinal cord stimulation (SCS) has been shown to be a safe and effective therapy for patients with chronic pain. However, some patients do not obtain or maintain adequate pain relief after SCS. The goal of this study was to identify factors that affect patient outcome with regard to SCS.Materials and MethodsA retrospective analysis of electronic medical records at a single site was performed. Records for 181 patients who received SCS implants from 2014 through 2016 were collected with follow-up data captured up to August 2019. Patient outcome was measured by device explantation and patient benefit from the SCS. Study parameters included demographic characteristics, history of pain, SCS implant characteristics, and postimplantation events.ResultsAn earlier diagnosis of radiculopathy was associated with an increased risk of poor benefit (relative risk [RR], 1.81; 95% CI, 1.19–2.74; p = 0.008). Postimplantation falls were associated with an increased risk of poor benefit (RR, 2.17; 95% CI, 1.48–3.17; p = 0.009). Device manufacturer was associated with both patient benefit and explantation. Device 2 was associated with a reduced risk of poor benefit (RR, 0.52; 95% CI, 0.32–0.85; p = 0.009). Device 4 was associated with an increased risk of poor benefit (RR, 1.71; 95% CI, 1.14–2.55; p = 0.02) and increased risk of device explantation (RR, 2.69; 95% CI, 1.2–6.02; p = 0.03).ConclusionsPatient outcome was associated with diagnosis, postimplantation falls, and device manufacturer. Further investigation is recommended to confirm associations through prospective studies that can more accurately quantify patient outcome over longer periods.     

Impact of Long-Term Evoked Compound Action Potential Controlled Closed-Loop Spinal Cord Stimulation on Sleep Quality in Patients With Chronic Pain: An EVOKE Randomized Controlled Trial Study Subanalysis

ObjectiveSpinal cord stimulation (SCS) is considered an effective interventional nonpharmacologic treatment option for several chronic pain conditions. Here we present the effects of the novel evoked compound action potential (ECAP) controlled closed-loop (ECAP-CL) SCS system on long-term sleep quality outcomes from the EVOKE study.Materials and MethodsThe EVOKE study is a double-blind, randomized, controlled clinical trial conducted at 13 sites in the United States (N = 134 patients). The clinical trial utilized SCS to manage chronic pain and compared novel ECAP-CL technology to open-loop SCS. Additionally, sleep quality data was collected using the Pittsburgh Sleep Quality Index (PSQI) at baseline and all study visits.ResultsThe mean PSQI global score for ECAP-CL patients at baseline was 14.0 (n = 62; ± 0.5, SD 3.8), indicating poor sleep quality. Clinically meaningful and statistically significant reductions (p < 0.001) in the global PSQI scores were noted at 12 months (n = 55; 5.7 ± 0.6, SD 4.2). A total of 76.4% of ECAP-CL patients met or exceeded Minimal Clinically Important Difference from baseline in PSQI at 12 months. Additionally, 30.9% of ECAP-CL patients achieved “good sleep quality” scores (PSQI ≤ 5), and 29.1% achieved sleep quality remission. “Normative” sleep scores were observed in 29.6% of ECAP-CL patients at 12 months, and these scores were better than the US general population. Additionally, ECAP-CL patients achieved statistically significant changes from baseline (p < 0.01) across all seven subcomponent scores of PSQI at 12 months.ConclusionsECAP-CL SCS elicits consistent neural activation of the target leading to less variability in long-term therapy delivery. In the EVOKE study, this resulted in ECAP-CL patients demonstrating clinically superior and sustained pain relief. Results from this study provide new evidence of long-term improvement in sleep quality and quantity in patients with chronic pain resulting from the use of this novel ECAP-CL SCS technology.Clinical Trail RegistrationThe Clinicaltrials.gov registration number for the study is NCT02924129.     

Paresthesia-Based Versus High-Frequency Spinal Cord Stimulation: A Retrospective,Real-World,Single-Center Comparison

ObjectiveSpinal cord stimulation (SCS) has become a common treatment modality for chronic pain of various etiologies. Over the past two decades, significant technological evolution has occurred in the SCS space, and this includes high-frequency (10 kHz) stimulation. Level I evidence exists reporting superiority of 10 kHz SCS over traditional SCS, however, conflicting reports have been published. The primary objective was to report site-collected real-world patient reported percentage improvement in pain scale (PR-PIPS) with traditional SCS and 10 kHz SCS from a single, academic medical center.Materials and MethodsThis study was a single-center retrospective review to determine PR-PIPS of traditional SCS and 10 kHz SCS in those patients implanted for at least 12 months. Data were collected by two independent physicians not involved with the implant surgery to minimize bias in the data collection process. PR-PIPS and other clinical variables were abstracted either via chart review or via phone call for patients who were at least 12 months post-implant at the last clinical follow-up.ResultsA total of 163 implanted patients (traditional stimulation n = 85; high-frequency stimulation n = 78) were identified. Twenty-two explants (traditional stimulation n = 10; high-frequency stimulation n = 12) were performed (13.5%). Seventy-five total remaining SCS implants utilizing traditional stimulation and 66 total remaining SCS implants utilizing high-frequency stimulation were included. There was no difference in PR-PIPS between traditional stimulation (50.6% ± 30.1%) and high-frequency stimulation (47.6% ± 31.5%) in the adjusted linear regression model in a variety of implant indications (p = 0.399). There was no difference in frequency of patient categorization into various thresholds of percentage pain relief based on type of stimulation. The most common reasons for explant were loss of efficacy (50.0%) and infection (40.0%) in the traditional cohort, and loss of efficacy (58.3%) in the high-frequency cohort.ConclusionsThis study adds further evidence to the published literature that successful long-term results can be achieved with SCS. Our retrospective analysis did not find a statistically significant difference in PR-PIPS between traditional stimulation and high-frequency stimulation in a variety of indications over an average follow-up of nearly two years. Notably, there were statistically significant differences in treatment indications and primary sites of pain between the two patient cohorts, and this should be considered when interpreting the results.     

Does Fibromyalgia Affect the Outcomes of Spinal Cord Stimulation: An 11-Year,Multicenter, Retrospective Matched Cohort Study

BackgroundFibromyalgia is a prevalent disorder manifesting with widespread musculoskeletal pain and central sensitization, as well as fatigue, sleep issues, psychologic distress, and poor quality of life. Patients with fibromyalgia also may be diagnosed with other painful conditions amenable to treatment with spinal cord stimulation (SCS), although it is unclear how these patients respond to SCS compared with patients without fibromyalgia.Materials and MethodsWe performed an 11-year, multicenter, retrospective matched cohort study comparing SCS-treated patients with fibromyalgia and those without fibromyalgia. The primary outcome was comparison in mean calculated percentage pain relief between cohorts at six months after SCS implantation. Secondary outcomes included comparison of patient satisfaction between six and 12 months after SCS implantation, and percentage of patients reporting opioid intake and neuropathic medication intake at six months and 12 months after SCS implantation. Adjusted regression analysis was performed to make comparisons while adjusting for age, sex, body mass index, Charlson comorbidity index, preoperative opioid intake, and preoperative neuropathic medication intake.ResultsOf 90 patients with fibromyalgia who underwent SCS trial, 18 patients (20%) failed their SCS trial and did not proceed toward implantation. Sixty-eight patients with fibromyalgia were matched to 141 patients in the control cohort based on age, sex, Charlson comorbidity index, and the American Society of Anesthesiologists physical status score. At six months after SCS implantation, there was no statistical difference in calculated percentage change in pain intensity between the fibromyalgia cohort (46.6 ± 29.0) and the control cohort (50.9 ± 32.8; β, ?18.4; 95% CI, ?44.3 to 7.6; p = 0.157). At baseline, a greater percentage of patients in the fibromyalgia cohort reported preoperative opioid intake (51.5% vs 22.7%, p < 0.001) and preoperative neuropathic medication intake (67.6% vs 15.6%, p < 0.001). However, there was no difference between cohorts in the percentage of patients taking opioid or neuropathic medications at six months and 12 months after SCS implantation. Similarly, there was no difference between cohorts in the percentage of patients reporting satisfaction between six and 12 months.ConclusionPatients with fibromyalgia who received a diagnosis approved for treatment with SCS may expect similar post–SCS-implantation pain relief, overall satisfaction, and analgesic use rate to those of patients without fibromyalgia.     

Implantable Pulse Generator Site May Be Associated With Spinal Cord Stimulation Revision Surgeries

BackgroundThe use of implantable pulse generators (IPG) for spinal cord stimulation (SCS) in patients with chronic pain has been well established. Although IPG-related complications have been reported on, the association between IPG site and SCS complications has not been well studied.ObjectiveTo investigate whether IPG placement site in buttock or flank is associated with SCS complications and, hence, revision surgeries.MethodA retrospective cohort study was performed that included 330 patients (52% female) treated at a single institution who underwent permanent implantation of an SCS system between 2014 and 2018. Patients ranged between 20 and 94 years of age (mean: 57.54 ± 13.25). Statistical analyses were conducted using IBM SPSS Statistics. Tests included independent samples t test, chi-square test, Mann–Whitney U test, Spearman’s rank correlation coefficient, and logistic regression.ResultsThere was a total of 93 revision surgeries (rate of 28%), where 71 out of 330 patients (rate of 21.5%) had had at least one revision surgery. Univariate tests demonstrated a significant association between IPG site and revision surgeries (p = 0.028 [chi-square test] and p = 0.031 [Mann–Whitney U test]); however, multivariate logistic regression demonstrated that neither IPG site was more likely than the other to require revision surgeries (p = 0.286).ConclusionAlthough this study found a significant association between IPG site and revision surgeries, the effect of IPG site was not found to be predictive. The IPG site likely influences whether a patient will require revision surgery, but further investigation is required to establish this association.     

Pain and Interoceptive Awareness Outcomes of Chronic Pain Patients With Spinal Cord Stimulation

ObjectivesMeditation has been shown to improve outcomes for chronic pain by increasing patients’ awareness of their own bodies. Some patients have an innate ability to leverage their mind–body connection, and this interoceptive awareness may aid them in garnering pain relief. We explored whether spinal cord stimulation (SCS) patients with greater innate awareness had better outcomes.Materials and MethodsWe contacted 30 thoracic SCS patients with baseline and postoperative pain, psychological, and disability outcomes to complete the Multidimensional Assessment of Interoceptive Awareness (MAIA) survey. MAIA distinguishes between beneficial and maladaptive aspects of the perception of body sensations via six positive subscales (noticing, attention regulation, emotional awareness, self-regulation, body listening, and trusting) and two negative subscales (not distracting, not worrying). MAIA subscales and positive/negative groups were correlated with percentage change in Numerical Rating Scale (NRS), Oswestry Disability Index (ODI), Beck’s Depression Inventory (BDI), Pain Catastrophizing Scale (PCS), and McGill Pain Questionnaire (MPQ).ResultsPatients included 14 males/16 females with a mean age of 58. At a mean follow-up of 14.13 months (range 6–26), NRS, ODI, BDI, PCS, and MPQ showed improvements. Positive traits correlated with improvements in pain (MAIA-self regulation with NRS-worst [p = 0.018], NRS-least [p = 0.042], NRS-average [p = 0.006], NRS-current [p = 0.001]; MAIA-body listening with MPQ-total [p = 0.016] and MPQ-sensory [p = 0.026]). Improvement in PCS-total was associated with higher scores in noticing (p = 0.002), attention regulation (p = 0.017), emotional awareness (p = 0.039), and trusting (p = 0.047). PCS-rumination correlated with MAIA-positive total (p = 0.012). In contrast, better attention regulation signified less improvement in ODI (p = 0.043) and MPQ affective (p = 0.026).ConclusionsHigher interoceptive awareness in SCS patients correlated with greater improvement following the procedure, particularly with regards to pain relief and pain catastrophizing. These findings suggest that patients with better mind–body connections may achieve greater pain relief following SCS in this patient population, thereby aiding providers in determining who may benefit from this intervention.