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Fifty-five new Nd isotope analyses are presented for plutonic orthogneisses from the Grimsthorpe domain in the marble-rich segment of the Grenvillian Central Metasedimentary Belt (CMB) to test the back-arc aulacogen model for its origin. Nd isotope analyses from the Weslemkoon batholith, Elzevir batholith, Lingham Lake complex, and Canniff tonalite are used to probe the crustal formation age of their source rocks. Despite its concentric foliation, the Weslemkoon batholith displays a complex geochemical pattern consisting of several northeast-trending domains with older TDM ages, surrounded by juvenile crustal material. The new Nd isotope results, coupled with geochemistry for the Weslemkoon and Elzevir batholiths, depict the fragmentation of a block of old crust that formed a screen between en echelon segments of a mid-Mesoproterozoic back-arc rift zone. The isotope boundaries identified within the Weslemkoon batholith delineate magma pulses sampling two distinct sources, interpreted as Laurentian basement and juvenile basaltic underplate. Underplating could be attributed to slab rollback under the pre-Grenvillian continental margin arc. The intensification of rift-related magmatism in the CMB is demonstrated by its bimodal petrological character. A modern analogue for the tectonic context of the CMB is the Gulf of California, where subduction-related magmatism has transitioned to rift-related magmatism. However, the Gulf of California exhibits more transcurrent motion than is evidenced by the geometry of the CMB rift. A geometrical analogue for the break-up of the Elzevir block between two rift segments is provided by the Danakil block of the Red Sea, which is currently undergoing similar tectonic fragmentation.

Variations of the peripheral nerve plexuses are important to those clinicians who diagnose and treat patients with pathology of their parts. During routine dissection, a postfixed lumbosacral plexus with a furcal nerve arising from L5, not L4, was discovered. In addition, the case was found to have a split L5 ventral ramus. Such a variation might become clinically significant during clinical presentations of radiculopathy. With a better understanding of the fucal nerve variation presented here, along with previously documented variations, the diagnostic and treatment procedures for atypical radiculopathy can be refined, reducing the rates of nerve injury and failed back surgery.

Purpose: This study was done to investigate factors related to quality of life of patients with failed back surgery syndrome.Methods: One hundred and eighty four patients were recruited from a hospital pain clinic. Data were collected from March 12 to April 9, 2018 using structured questionnaires which included questions about quality of life, hope, and family support. Data analysis was done with descriptive statistics, independent t-test, one-way ANOVA, Pearson's correlation coefficient, and stepwise multiple regression analysis with SPSS version 25.0.Results: The factors related to quality of life were hope, family support, and frequency of pain. These three factors accounted for 53.1% of the total variance in quality of life.Conclusion: In order to increase quality of life of patients with failed back surgery syndrome, it is necessary to design intervention programs that effectively manage hope, family support, and frequency of pain.

OBJECTIVES: High-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 METHODS: Data 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. RESULTS: One hundred thirty patients reached thevisit at 12 months. In neurostimulation-naïve patients, a statistically significant decrease in MQS (χ2 = 62.92, p

Failed back surgery syndrome (FBSS), as described by Follett and Dirks is the least desirable situation for any patient dealing with pain in the lumbar region. Not a syndrome in itself, but rather a syntagm, the term FBSS is generally coined to describe unsuccessful surgical results despite correct surgery. Failed Back Surgery Syndrome is an emerging public health problem throughout the World, which has the unfortunate end-results of generating liability, disability and last but not least, heavy psychological and economical tolls. This paper acts as a brief literature review and tries to summarize available data regarding FBSS epidemiology, prevention and treatment. At the same time, the authors wish to offer neurosurgeons and spine surgeons a relevant starting point on how to handle this emerging public healthcare problem and how to help minimize its impact.

To date, failed back surgery syndrome (FBSS) remains a therapy-refractory clinical condition after spinal surgery. The antiadhesion membrane is applied to prevent FBSS by isolating fibrosis; however, the inflammation stimulated by the foreign body and surgical trauma needs to be further resolved simultaneously. Therefore, we developed new electrospun polycaprolactone (PCL) fibrous membranes loaded with celecoxib (CEL) to prevent fibrosis and inflammation associated with FBSS. The CEL-loaded PCL fibers were randomly distributed, and the drug was released over two weeks. Fluorescence micrographs revealed that the fibroblasts proliferated less on the PCL-CEL fibrous membranes than in the PCL group and the blank control. In the rat laminectomy model after 4 weeks, magnetic resonance imaging of epidural fibrosis was least in the PCL-CEL group. Expression of COX-2 and PGE2 was lower in the PCL-CEL group. It concluded that the CEL-loaded PCL membrane could reduce fibrosis and inflammation in a rat model of FBSS via COX-2/PGE2 signaling pathways.

To evaluate the effect of multimodal exercises integrated with cognitive-behavioural therapy on disability, pain, and quality of life in patients suffering from failed back surgery syndrome (FBSS), and to appraise its extent in the long term. By means of a parallel-group superiority-controlled trial, 150 outpatients were randomly assigned to a 10-week individual-based multimodal programme of task-oriented exercises integrated with cognitive-behavioural therapy (experimental group, 75 patients) or individual-based general physiotherapy (control group, 75 patients). Before treatment, 10 weeks later (post-treatment), and 12 months after the end of treatment, the Oswestry Disability Index (primary outcome), the Tampa Scale for Kinesiophobia, the Pain Catastrophising Scale, a pain intensity numerical rating scale and the Short-Form Health Survey were evaluated. Linear mixed model analysis for repeated measures was carried out for each outcome measure. Significant group (p < 0.001), time (p < 0.001), and time-by-group interaction (p < 0.001) effects were found for all outcome measures. Concerning disability, between-group differences (95% confidential interval) in favour of the experimental group of −9 (−10.7; −7.3) after training and of −13.2 (−14.7; −11.7) at follow-up were found. Also, kinesiophobia, catastrophising and pain showed significant between-group differences of 9, 12.5 and 1.7 points, respectively. The multimodal intervention proposed was superior to general physiotherapy in reducing disability, kinesiophobia, catastrophising, and enhancing the quality of life of patients with FBSS. The effects were reinforced one year after the programme ended.IMPLICATIONS FOR REHABILITATIONMultimodal exercises integrated with cognitive-behavioural therapy induced significant improvements in disability, pain, kinesiophobia, catastrophising, and quality of life of subjects with Failed Back Surgery Syndrome.A well-integrated rehabilitative team which contributes towards reaching intervention goals is advised.Physiotherapists should adopt task-oriented exercises to promote an earlier return to common activities of disabled patients.Psychologists should explain how to modify useless beliefs and support adequate behaviours, in order to produce constructive attitudes towards perceived disability. Multimodal exercises integrated with cognitive-behavioural therapy induced significant improvements in disability, pain, kinesiophobia, catastrophising, and quality of life of subjects with Failed Back Surgery Syndrome. A well-integrated rehabilitative team which contributes towards reaching intervention goals is advised. Physiotherapists should adopt task-oriented exercises to promote an earlier return to common activities of disabled patients. Psychologists should explain how to modify useless beliefs and support adequate behaviours, in order to produce constructive attitudes towards perceived disability.

Introduction Low‐back or leg pain in patients suffering from failed back surgery syndrome (FBSS) is often severe, having a major impact on functionality and quality of life. Despite conservative and surgical treatments, pain can be persistent. An alternative treatment option is epiduroscopy, a minimally invasive procedure based on mechanical adhesiolysis of epidural fibrosis. As epidural fibrosis is speculated to be a major contributor in the pathophysiologic process of FBSS, this review evaluates the effectiveness of epiduroscopy in FBSS patients. Methods and materials A systematic literature search was performed in PubMed, Embase, and Cochrane databases. Critical appraisal was performed using validated tools. Meta‐analysis was performed using generic inverse variance analysis. Results From the 286 identified articles, nine studies were included. The visual analogue scale (VAS) average was 7.6 at baseline, 4.5 at 6, and 4.3 at 12 months. The Oswestry Disability Index (ODI) average was 61.7% at baseline, 42.8% at 6, and 46.9% at 12 months. An average of 49% of patients experienced significant pain relief at 6 and 37% at 12 months. Meta‐analysis showed a pooled VAS mean difference of 3.4 (2.6 to 4.1; 95% confidence interval [CI]) and 2.8 (1.6 to 4.0; 95% CI) and pooled ODI mean difference of 19.4% (12.5 to 26.4%; 95% CI) and 19.8% (13.8 to 25.9%; 95% CI) at 6 and 12 months, respectively. Conclusion Current literature demonstrates a clinically relevant reduction in pain and disability scores at 6 to 12 months after mechanical adhesiolysis in FBSS patients. The quality of evidence is moderate, and the level of recommendation is weak. Practitioners should consider the benefits of epiduroscopy after weighing the risks for individual patients with FBSS.

Introduction Persistent back/and or leg pain is a common outcome after spinal surgery (otherwise known as failed back surgery syndrome [FBSS]). Studies have shown that spinal cord stimulation (SCS) at 10 kHz provides effective analgesia in FBSS patients with both back and leg pain symptoms and in those with predominant back pain. This study is the first to evaluate the therapy in FBSS patients with predominant leg pain. Methods The safety and efficacy of 10 kHz SCS was evaluated in an uncontrolled, open‐label, prospective study of FBSS patients with predominant leg pain in the Netherlands. Follow‐ups were performed at 1, 3, 6, and 12 months post implantation. Results Sixty out of 68 patients (88%) experienced sufficient pain relief during a stimulation trial. Of these, 58 proceeded to permanent implantation of a 10 kHz SCS system. After 12 months of treatment, 80% of patients experienced ≥ 50% reduction in baseline leg pain, and a similar proportion (76%) experienced ≥ 50% reduction in baseline back pain. At least two‐thirds of patients were also leg pain and back pain remitters (visual analog scale [VAS] ≤ 2.5 cm). The therapy was also associated with a general improvement in patients’ quality of life, as measured by secondary outcomes including disability, perception of health improvement, mental well‐being, and satisfaction. A positive impact on opioid consumption was also observed. Conclusions Consistent with previous findings, 10 kHz SCS for the treatment of FBSS patients with predominant radicular symptoms is safe and effective and is associated with improved quality of life.

Background Persistent or recurring radicular pain after lumbar surgery is a clinical condition of failed back surgery syndrome (FBSS) that seriously affects the life quality of patients. Conventional medication and physiotherapy do not fully relieve this pain. A simpler, safer, and less invasive option is lumbar selective nerve root block or paravertebral block. Here, we share our experience regarding lumbar paravertebral block for a patient with FBSS, which successfully alleviated radicular pain after lumbar surgery. Case presentation An 80-year-old man with left lower limb radicular pain diagnosed as L4-5, L5-S1 intervertebral disc protrusion, spinal canal stenosis, and degenerative scoliosis underwent lumbar surgery. Four months after surgery, he experienced left lower limb radicular pain. After designing the puncture route based on X-ray film, we performed a combined ultrasound-guided L4 and L5 paravertebral block. With his improved pain control, his functional status and ability to perform daily activities also markedly improved. Conclusion Real-time ultrasound-guided lumbar paravertebral block performed with a pre-designed route on X-ray film can provide a simple and safe way to relieve radicular pain in FBSS.

Background Spinal cord stimulation (SCS) is a neuromodulation process to treat neuropathic pain, initially developed on tonic paresthesia-based stimulation. In the last decade, 3 major paresthesia-free SCSs have emerged. Several studies show their superiority over tonic stimulation. Objective We summarize the data on SCS efficacy and patients' preferences. Methods We selected studies from the last decade to clarify whether the different paresthesia-free SCSs are superior to tonic or not and for which SCS the patient has a preference. Study selection was focused on a failed back surgery syndrome predominant population. Results SCS is an effective way to treat intractable neuropathic pain of the limbs and back, compared with conventional medical management and reoperation. Paresthesia-free SCSs as burst, high-density, and 10-kHz frequency are equal to tonic SCS in some studies and superior in most. Analysis of patients' preferences shows a clear trend toward paresthesia-free SCS. Conclusions Recent studies show superiority of paresthesia-free SCS compared with tonic SCS and those results are corroborated by analysis of patients' preferences. Taking these data into account should motivate physicians to opt for multimodal capable devices before implanting SCS.

Every year, the number of operations on the lumbar spine with the use of various spinal fusion techniques increases, which leads to an increase in the number of cases in the long-term period of surgical treatment, the formation of pathology of the adjacent segment (ASP), which is part of the structure of the failed back surgery syndrome (FBSS). It is known that the pathology of the adjacent segment is a general term and covers two concepts: the degeneration of the adjacent segment (ASDeg) and the disease of the adjacent segment (ASDis). ASDeg is represented by radiographic changes occurring in the adjacent spinal motion segments during spinal surgery with spinal fusion, and ASDis refers to the clinical symptoms that develop during radiographic changes in these segments. With the pathology of an adjacent segment, clinically significant degenerative changes in it are not always formed. If these X-ray changes are formed and correlate with clinical and neurological manifestations, then surgical treatment is indicated. This pathology can be treated with repeated surgical intervention, which this article demonstrate with the clinical example of surgical treatment of the adjacent segment of the spine during fusion.

Background: Epidural fibrosis (EF) is one of the leading causes of post lumbar surgery syndrome (PLSS). Although there are studies in the literature suggesting that lumbar epidural steroid injections are an effective method in the pain management of PLSS caused by EF, no study is available comparing the effectiveness and safety of caudal and transforaminal approaches. Objectives: To investigate the efficacy of caudal epidural steroid injection (CESI) versus transforaminal epidural steroid injection (TFESI) in patients with PLSS. Study Design: A prospective, randomized, assessor-blind study. Setting: Interventional pain management center at a tertiary care center. Methods: Patients with low back and radicular pain related to EF following single-level lumbar discectomy were included. The patients were randomly divided into 2 groups: a CESI group and a TFESI group. All patients were assessed before the procedure (baseline) and at one hour, 3 weeks, and 3 months after the procedure using the Numeric Rating Scale (NRS-11) and at baseline, 3 weeks, and 3 months using the modified Oswestry Disability Index (mODI). Treatment success was defined as a ≥ 50% decrease in the NRS-11 scores compared to baseline. Results: A total of 56 patients (n = 26 CESI group; n = 30 TFESI group) were included. NRS-11 and mODI scores showed a significant decline in both groups at all follow-ups (P < 0.001). At 3 weeks, the improvement in the mODI scores was significantly higher in the TFESI group (P = 0.020). In all follow-ups, the NRS-11 scores were similar between the groups. At 3 weeks, the rates of patients with a ≥ 50% decrease in NRS-11 scores were 53.8% and 60% in the CESI group and TFESI group, respectively, while these rates were 30% and 26.7%, respectively, at 3 months. Limitations: This study had no placebo-control group and a relatively short follow-up. Conclusion: Both CESI and TFESI are effective and safe methods in the treatment of PLSS caused by EF following lumbar discectomy. These methods can reduce pain and disability. Although both methods have similar treatment success rates, TFESI seems to be a more effective treatment method in reducing disability at 3-week follow-up. Keywords: Post lumbar surgery syndrome, failed back surgery syndrome, post laminectomy syndrome, epidural fibrosis, epidural steroid injections, transforaminal, caudal, radiculopathy, back pain

Objective Spinal cord stimulation (SCS) is an effective treatment in failed back surgery syndrome (FBSS). We studied the effect of preimplantation opioid use on SCS outcome and the effect of SCS on opioid use during a two‐year follow‐up period. Materials and methods The study cohort included 211 consecutive FBSS patients who underwent an SCS trial from January 1997 to March 2014. Participants were divided into groups, which were as follows: 1) SCS trial only (n = 47), 2) successful SCS (implanted and in use throughout the two‐year follow‐up period, n = 131), and 3) unsuccessful SCS (implanted but later explanted or revised due to inadequate pain relief, n = 29). Patients who underwent explantation for other reasons (n = 4) were excluded. Opioid purchase data from January 1995 to March 2016 were retrieved from national registries. Results Higher preimplantation opioid doses associated with unsuccessful SCS (ROC: AUC = 0.66, p = 0.009), with 35 morphine milligram equivalents (MME)/day as the optimal cutoff value. All opioids were discontinued in 23% of patients with successful SCS, but in none of the patients with unsuccessful SCS (p = 0.004). Strong opioids were discontinued in 39% of patients with successful SCS, but in none of the patients with unsuccessful SCS (p = 0.04). Mean opioid dose escalated from 18 ± 4 MME/day to 36 ± 6 MME/day with successful SCS and from 22 ± 8 MME/day to 82 ± 21 MME/day with unsuccessful SCS (p

Study Design: Retrospective Cohort Study. Objectives: Spinal surgery site infection and chronic implant infection are possible causes for ongoing pain, implant loosening, and failed back surgery syndrome. Evidence of chronic infection was found in 29.1% of revision cases but is also found in a considerable number of degenerative cases without prior surgery. Infection mechanisms and possible clinical correlations are unclear. Methods: Retrospective analysis of standardized surgery site screening (swab, tissue samples, implant sonication) in 181 cases without clinical evidence of preoperative surgery site infection. Results: Screening results of cases without prior spinal surgery (n = 49, 10.2% positive) were compared to cases with prior spine surgery without implant placement (e.g. micro discectomy) (n = 21, 23.8% positive), revision cases following singular spinal fusion (n = 73, 23.2% positive), and cases with multiple revisions (n = 38, 50.0% positive). Propionibacterium spp. detection rate increased to 80% in positive cases with multiple revisions. Implants in place during revision surgery had a significantly higher infection rate (32.4%) compared to no implant (14.2%, p = 0.007). Positive cases had a significantly higher pain level prior to surgery compared to negative cases ( p = 0.019). Laboratory parameters had no predictive value. Logistic regression revealed that previous spinal surgeries (odds ratio [OR] 1.38 per operation, p < 0.001) and male sex (OR 1.15, p = 0.028) were independent predictive factors for infection. Conclusions: Previous spinal surgery is a risk factor for chronic surgery site infection, leading to chronic pain, implant loosening, and revision. The presence of Propionibacterium spp. was correlated with chronic implant loosening and was more likely with cumulative surgeries.

The opioid epidemic challenges current attitudes toward pain management and necessitates the reexamination of the World Health Organization (WHO) 3-step analgesic ladder, introduced in 1986 for cancer pain management. Surgical treatment of pain is a logical extension of the original guideline, which is often absent in conversations with patients about treatment options for their pain and consequentially underutilized. However, with concerns growing regarding opioid use, a shift in the stepwise approach of the WHO analgesic ladder in an age of developing technology and surgical offerings could have profound implications for patients and public health. Surgical interventions potentially provide a long-term, cost-effective management strategy to reduce opioid use. This review canvasses surgical options, highlights literature on failed back surgery syndrome and spinal cord stimulation and reconsiders the current ladder approach to pain management.

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

Study Design: Retrospective study. Objective: Multiple studies have shown that osteoporotic patients are at an increased risk for medical and surgical complications, making optimal management of these patients challenging. The purpose of this study was to determine the relationship between patient age and the likelihood of surgical complications, mortality, and 30-day readmission rates following surgery for osteoporotic vertebral compression fractures (OVCFs). Methods: A retrospective analysis of the American College of Surgeons National Surgery Quality Improvement Project (ACS-NSQIP) database from 2007 to 2014 identified 1979 patients who met inclusion criteria. A multivariate logistic regression analysis was conducted to calculate odds ratios (OR), with corresponding P values and 95% confidence intervals, of the relationship between age (treated as a continuous variable) and perioperative mortality, surgical complications, and 30-day readmission rates. Results: Younger patients were statistically more likely to endure a minor (OR = 0.98; P = .002) or major complication (OR = 0.97; P = .009). The older a patient was, on the other hand, the higher the likelihood that patient would be readmitted within 30 days of surgery (OR =1.02; P = .004). Mortality within the 30-day perioperative period was not statistically correlated with age. Conclusions: The impact of age on adverse outcomes following surgery for OVCF is mixed. While younger patients are more likely to endure complications, older patients are more likely to be readmitted within 30 days following surgery. Patient age showed no correlation with mortality rates. In the setting of surgical treatment for an OVCF, a patient’s age can help determine the risk of complications and the rate of readmission following intervention.

Objective Spinal cord stimulation (SCS) is a recommended treatment method for patients afflicted by failed back surgery syndrome (FBSS). Although SCS is shown to be clinically effective, not many patients return to work (RTW). The aim of this study is to assess the RTW rate of these patients. Materials and methods We prospectively evaluated 102 patients with FBSS, managed by low frequency SCS at a single institution in Poland. RTW rate was the main endpoint in the study. Additionally, we browsed the first 300 records in Google and extracted the suggested RTW time post-SCS implantation. Results Mean follow-up was 8.5 years. 79.4% of patients were actively working at the baseline. Fifteen patients were sick leave benefit claimants (15/81; 18.5%) and six were permanently disabled (6/81; 7.4%). In the follow-up, 40 did not change their work status. Only 2 of 21 patients resumed work and the total RTW rate was 9.5%. On the other hand, 38 of 81 patients (46.9%), who actively worked before SCS, gained disability status. Out of entire group, 20.6% (21 of 102) were not working at the baseline and 55.9% (57 of 102) were not working in the follow-up. Neither factor influenced RTW rate. In the second stage of the study, internet data search yielded a mean RTW time of 6.1 weeks. Conclusions Unlike the well-analyzed effectiveness of SCS, RTW remains an underutilized outcome measure. The RTW rate in our series was the second lowest in the reviewed literature. We demonstrated that half of the patients with an implanted SCS either did not resume their work or left their job.

Study Design: Case studies. Objectives: To demonstrate that muscle generated pain (MGP) may be a cause of pain in patients who have undergone minimally invasive spine surgery (MISS). Methods: A physical examination including electrical stimulation of putative pain generating muscles to identify the presence of lowered thresholds for depolarization of muscle nociceptors, and an examination of strength and flexibility of key muscles in the upper and lower body, may identify multiple etiologies of MGP. Treatment of identified muscles consisted of muscle/tendon injections to identified sensitized muscles followed by exercises incorporating relaxation limbering and stretching. Results: Postsurgical pain was eliminated and mobility restored in both presented cases replicating success in prior published studies. Conclusions: Understanding the pathophysiological mechanisms of muscle pain may facilitate the evaluation and treatment of MGP in MISS patients diagnosed with failed back surgery syndrome.

OBJECTIVES: Spinal cord stimulation (SCS) is considered an effective pain-relieving treatment for patients with Failed Back Surgery Syndrome (FBSS). Despite the clinical effectiveness, it is unknown whether the altered functional connectivity in such patients, as compared to healthy persons, can be influenced by SCS. Therefore, the goal of this study is to evaluate whether brain connectivity assessed by EEG differs between baseline and SCS in patients with FBSS. MATERIALS AND METHODS: Eight patients with FBSS underwent a resting-state EEG protocol before SCS, 1.5 months and 2.5 months after receiving SCS. At each frequency band, power spectrums were compared for no SCS, conventional (CON) SCS and High Dose (HD) SCS. Functional connectivity, with the aid of eConnectome was also calculated. RESULTS: Significant differences in the average power density spectrum over the whole scalp were observed between no SCS, CON SCS and HD SCS in delta, theta and beta frequency bands (p < 0.01). The average power spectrum for CON SCS was significantly lower than the average power spectrum for HD SCS. Marked increases in strength of the information flow between electrode pair FC3-TP9 in the beta frequency band (p = 0.006) were found in favor of HD SCS. CONCLUSIONS: The differences in power spectrum and connectivity between the three conditions lead to the hypothesis that HD SCS differs from CON SCS on average power spectrum, suggesting that HD SCS may have a higher contribution on the excitatory bottom-up pathway.

New waveforms have changed the field of Spinal Cord Stimulation (SCS) to optimize therapy outcomes, among which is High-Dose SCS (HD-SCS). Missing observations are often encountered when conducting clinical trials in this field. In this study, different approaches with varying assumptions were constructed to evaluate how conclusions may be influenced by these assumptions. The aim is to perform a tipping point sensitivity analysis to evaluate the influence of missing data on the overall conclusion regarding the effectiveness of HD-SCS on disability. Data from the Discover study were used, in which 185 patients with Failed Back Surgery Syndrome were included. Disability was evaluated before SCS and after 1, 3 and 12 months of HD-SCS. During the second, third and fourth visit, data from 130, 114 and 90 patients were available, respectively. HD-SCS resulted in a significant decrease in disability scores based on the analysis of observed data and with multiple imputations. The tipping point sensitivity analysis revealed that the shift parameter was 17. Thus, the conclusion concerning the time effect under a "missing at random" mechanism is robust when the shift parameter for the disability score is 17. From a clinical point of view, a shift of 17 points on disability is not very plausible. Therefore we tend to consider the conclusions drawn under "missing at random" as being robust. In this manuscript, data of the Discover study was used. Discover was funded by Medtronic Europe Sárl that provided an independent research grant. Medtronic was not involved in the collection and analysis of the data or in the writing of the article.

The adjacent segment syndrome is defined as the changes in the adjacent structures of an operated spinal level that produce symptoms of pain and disability, which worsen the quality of life of a patient. Pain management specialists must be aware of these biomechanical changes brought by spinal surgeries, as well as of the symptoms associated with pain after surgery, to reach an appropriate diagnosis and provide an adequate treatment. Specialized pain literature contains few reports on specific management of patients using the terms "adjacent segment syndrome, degeneration or disease;" most of the literature comes from surgical journals. It is necessary to perform studies with a population sample comprising patients with adjacent segment syndrome after spinal surgery, since almost all treatments applied in this group are extrapolated from those used in patients with pain originating in the same area but who have not previously undergone spine surgery. Therefore, we consider necessary for pain physicians to understand the underlying biomechanics, promote the diagnosis of this condition, and analyze possible treatments in patients with adjacent segment disease to alleviate their pain and improve their quality of life.

Failed back surgery syndrome (FBSS) is a stigmatizing and misleading term, and in many cases surgery is not relevant to the development, persistence, worsening or recurrence of the symptoms. An international panel recently proposed the notion of Persistent spinal pain syndrome (PSPS) as the preferred option to replace FBSS. The new label avoids ambiguity and inappropriately-implied causation. PSPS type 1 applies when there was no spinal surgery; type 2 applies when surgery had occurred. PSPS is therefore broader than FBSS but more accurate.

Objective: Pain researchers demonstrated that pain intensity is not the most reliable measure of the success of chronic-pain treatment. Several research groups have proposed "core outcome domains", such as measurements of disability, to assess the effect of an intervention in pain patients. Up till now, studies investigating the relation between pain intensity and disability in patients treated with spinal cord stimulation (SCS) are lacking. Therefore, the current objective is to examine which pain-reporting strategy, routinely used in pain research, associates best with the degree of disability in these patients.Methods: Eighty-one failed back surgery syndrome patients (37 males and 44 females, mean age 54.6 years), treated with high-dose spinal cord stimulation (HD-SCS) are recruited. Pain intensity was scored on an 11-point numerical rating scale (NRS) for leg and back pain, while disability was assessed with the Oswestry disability index (ODI). The association between both variables was investigated with Spearman's correlation and Cramér's V.Results: Significant correlations (p

Elena Rojo,1 Concepción Pérez Hernández,1 Noelia Sánchez Martínez,1 A César Margarit,2 Tania Blanco Arias,3 Manuel Muñoz Martínez,1 Carlos Crespo,4 Dolores Ochoa Mazarro1 1Pain Unit, La Princesa University Hospital, Madrid, Spain; 2Pain Unit, General University Hospital of Alicante, Alicante, Comunitat Valenciana, Spain; 3Pain Unit, Anderson Clinic, Madrid, Spain; 4Axentiva Solutions, Barcelona, SpainCorrespondence: Concepción Pérez HernándezPain Unit, La Princesa University Hospital, Calle Diego de León, 62, Madrid, 28006, SpainTel +34 915 20 23 75Fax +34 914 02 11 69Email concha.phte@gmail.comPurpose: Failed 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 Methods: Patient-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.Results: After 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.Conclusion: SCS is a cost-effective treatment for FBSS compared to CMM alone based on real-world evidence.Keywords: cost-effectiveness analysis, failed back surgery syndrome, modelling study, real-world evidence, spinal cord stimulation