Search

To investigate the presence of altered central pain processing in patients with failed back surgery syndrome (FBSS) using quantitative sensory testing (QST).This study included 34 patients with FBSS, 102 patients post-lumbar surgery without low back pain (LBP), and 102 healthy subjects. All subjects underwent both pressure pain threshold (PPT) and conditioned pain modulation (CPM) in both local and remote pain-free areas, as well as temporal summation (TS) in a remote pain-free area. All patient subjects were assessed using the Pain Catastrophizing Scale (PCS), Beck Anxiety Inventory (BAI), Beck Depression Index (BDI), Numeric rating pain scale (NRS) and Oswestry Disability Index (ODI).Compared with both control groups, FBSS patients showed a reduction in both PPT and CPM in both tested areas, along with increased TS in a pain-free area (P 0.05). Furthermore, the patients with FBSS had a significantly higher prevalence of anxiety, depression and pain catastrophizing thoughts than the patient controls (P 0.05). In the FBSS patients, there was a significant correlation between LBP at rest and both CPM and TS in the pain-free areas, and QST measurements were also associated with the ODI, PCS and BAI (P 0.05).These findings support the existence of augmented central pain processing in patients with FBSS, which may be caused by dysfunction of endogenous pain facilitation and inhibition. This central amplification of pain may contribute to both LBP intensity and disability in FBSS patients. Therefore, treatment efforts should take into account functional alterations in the central nervous system of FBSS patients.

Approximately one in five adults in the United States experiences chronic pain. Over the last 50 years, spinal cord stimulation has become increasingly recognized as a minimally invasive, efficacious treatment modality for the management of chronic pain. The authors report a case study of a 46-year-old female in the first documented spinal cord stimulation simultaneously targeting intractable neuropathic and visceral pain caused by post-laminectomy syndrome and chronic pancreatitis, respectively. This case study demonstrates near-total relief of the patient's neuropathic low back/leg pain and visceral epigastric pain, showing evidence of potential clinical usefulness for spinal cord stimulation as a treatment option in patients who present with a combination of visceral and somatic pain symptoms.Lay abstract Approximately one in five adults in the United States experiences chronic pain. Over the last 50 years, a treatment for chronic pain referred to as spinal cord stimulation has become a promising alternative to back surgery and may minimize the need for strong opioid pain medications. The authors report a case study of a 46-year-old female patient who suffered from chronic pain following back surgery as well as persistent pain from chronic pancreatitis. This case study demonstrates the use of spinal cord stimulation to provide near-total relief of the patient's low back/leg pain and pain from visceral inflammatory symptoms.

Purpose The purpose of this study was to outline the feasibility of continuous epidural analgesia in the treatment of failed back surgery syndrome (FBSS) or spinal stenosis. Methods We queried our prospective collected institutional database to include all consecutive patients, who underwent continuous epidural analgesia with accompanying intensive physiotherapeutic exercise within a timeframe of 4 years. Patients suffered from FBSS or spinal stenosis; protocolled continuous epidural analgesia was planned for 4 days within the framework of an inpatient multimodal pain therapy concept. The instillation technique of the epidural catheter, the capability to attend in accompanying physiotherapy, and the peri-interventional complications were evaluated. Results 153 patients with an average age of 57.4 years (± 11.9) were enrolled in this study. 105 patients suffered from FBSS and 48 patients had spinal stenosis. Overall, 148 patients (96.7%) reported the pain reduction and were able to perform daily intensified physiotherapeutic exercise. There were no serious adverse events, neither infection nor bleeding, no cardiopulmonary complication or permanent neurological deficits. The most common side effect was neurological impairment, such as numbness, dysesthesia, or weakness of the lower limbs with complete regression after flow rate adjustment. Patients with FBSS were more likely to develop dysesthesia (p = 0.007). Conclusions Continuous epidural analgesia is feasible in patients with FBSS or spinal stenosis. This treatment enables extensive physiotherapeutic treatment even in patients with severe pain conditions and can be considered as an alternative to epidural injections. An increased complication rate in comparison to short-term perioperative or perinatal application was not observed.

Failed back surgery syndrome (FBSS) is a general term for persistent postoperative back pain with or without accompanying radicular pain. FBSS may present as chronic facet joint pain.We introduced full endoscopic lumbar rhizotomy for patients suffering from facet joint pain due to FBSS. Facet joint block was introduced into the facet joint to determine whether pain improved after the injection.With full endoscopic lumbar rhizotomy, the surgeon can identify the regions involved more clearly and directly. Although it is an invasive procedure, it provides a more effective and safe treatment for patients with FBSS-related facet joint pain.

Spinal 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.This study aimed to evaluate the safety and clinical effectiveness of rescue surgical paddle electrodes in FBSS patients, multidimensionally.The 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.A 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.SCS 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.

(1) Background: Various procedures were performed on patients with persistent spinal pain syndrome (PSPS), but the clinical effect and safety were insufficient. The study was to examine the effects of auricular acupressure (AA) on low back pain, neuropathy, and sleep in patients on PSPS. (2) Methods: This was a randomized, single-blind, placebo-controlled study conducted from 1 March 2022 to 31 July 2022. The participants who had at least one lumbar surgery were randomly assigned to either the experimental group (n = 26) or the placebo control group (n = 25). All participants received 6 weeks of AA intervention. To validate the effects of the intervention, pressure pain thresholds (PPT), the Visual Analogue Scale (VAS), douleur neuropathique 4 (DN4) questions, the Pittsburgh Sleep Quality Index (PSQI), and actigraphy with a Fitbit Alta were conducted. The data were analyzed with SPSS/WIN ver. 27.0, using a t-test and repeated-measures ANOVA. (3) Results: The findings showed that there were significant differences in pain (back VAS p = 0.003, leg VAS p = 0.002, PPT p = 0.008), neuropathy (DN4 p = 0.034), and sleep actigraphy (sleep efficiency p = 0.038, number of awake p = 0.001, deep sleep stage p = 0.017). (4) Conclusions: We conclude that AA is an effective, safe, cost-effective, non-invasive nursing intervention that can improve pain, neuropathy, and sleep in patients on PSPS.

Introduction: Epidural steroid injections are a preferred interventional pain treatment for patients with low back pain. Our aim was to investigate the effectiveness of epidural steroid injections treatment in elderly patients and to examine the effect of patients’ diagnosis on the treatment success. Materials and Methods: Patients over the age of 65 who underwent epidural injections between January 2020 and January 2022 were retrospectively screened. The patients were divided into three groups according to their diagnosis: disc herniation, spinal stenosis, and failed back surgery syndrome. Numeric rating scale scores of all patients before the procedure, at three weeks, and at three months were noted. Results: A total of 234 patients were included in the study. Of these, 89 had disc herniation, 98 had spinal stenosis, and 47 had a history of failed back surgery. There were no significant differences between the groups in terms of age, gender, symptom duration, pre-procedural pain score, medical treatment, radiation dose, and procedure duration. Although a significant improvement was detected in pain scores at all follow-ups in all groups, these scores were found to be significantly lower in the disc herniation group than the spinal stenosis and failed back surgery groups at the three-week and month follow-ups. Conclusions: Epidural steroid injections has been found to be effective in back pain in elderly. In addition, elderly patients with disc herniation had a better response to treatment than those with spinal stenosis and failed back surgery. Further prospective and long-term follow-up studies are needed to support these results. Keywords: Aged; Low Back Pain; Injections, Epidural; Spinal Stenosis; Failed Back Surgery Syndrome.

Diagnosis and stratification of chronic pain patients is difficult due to a lack of sensitive biomarkers for altered nociceptive and pain processing. Recent developments enabled to preferentially stimulate epidermal nerve fibers and simultaneously quantify the psychophysical detection probability and neurophysiological EEG responses. In this work, we study whether using one or a combination of both outcome measures could aid in the observation of altered nociceptive processing in chronic pain. A set of features was extracted from data from a total of 66 measurements on 16 failed back surgery syndrome patients and 17 healthy controls. We assessed how well each feature discriminates both groups. Subsequently, we used a random forest classifier to study whether psychophysical features, EEG features or a combination can improve the classification accuracy. It was found that a classification accuracy of 0.77 can be achieved with psychophysical features, while a classification accuracy of 0.65 was achieved using only EEG features.Clinical Relevance-This study shows which combined features of nociceptive detection behavior and evoked EEG responses are most sensitive and specific to altered nociception in failed back surgery syndrome.

Background For patients with therapy-refractory persistent spinal pain syndrome type II (PSPS-T2), spinal cord stimulation (SCS) may serve as an effective minimally invasive treatment. Despite the evidence that SCS can improve return to work (RTW), only 9.5 to 14% of patients implanted with SCS are effectively capable of returning to work. Thus, it seems that current post-operative interventions are not effective for achieving RTW after SCS implantation in clinical practice. The current objective is to examine whether a personalised biopsychosocial rehabilitation programme specifically targeting RTW alters the work ability in PSPS-T2 patients after SCS implantation compared to usual care. Methods A two-arm, parallel-group multicentre randomised controlled trial will be conducted including 112 patients who will be randomised (1:1) to either (a) a personalised biopsychosocial RTW rehabilitation programme of 14 weeks or (b) a usual care arm, both with a follow-up period until 12 months after the intervention. The primary outcome is work ability. The secondary outcomes are work status and participation, pain intensity, health-related quality of life, physical activity and functional disability, functional capacities, sleep quality, kinesiophobia, self-management, anxiety, depression and healthcare expenditure. Discussion Within the OPERA project, we propose a multidisciplinary personalised biopsychosocial rehabilitation programme specifically targeting RTW for patients implanted with SCS, to tackle the high socio-economic burden of patients that are not re-entering the labour market. The awareness is growing that the burden of PSPS-T2 on our society is expected to increase over time due to the annual increase of spinal surgeries. However, innovative and methodologically rigorous trials exploring the potential to decrease the socio-economic burden when patients initiate a trajectory with SCS are essentially lacking. Trial registration ClinicalTrials.gov NCT05269212. Registered on 7 March 2022.

While spinal cord stimulation (SCS) is a well-established therapy to address refractory persistent spinal pain syndrome after spinal surgery (PSPS-T2), its lack of spatial selectivity and reported discomfort due to positional effects can be considered as significant limitations. As alternatives, new waveforms, such as burst stimulation and different spatial neural targets, such as dorsal root ganglion stimulation (DRGS), have shown promising results. Comparisons between DRGS and standard SCS, or their combination, have never been studied on the same patients. “BOOST DRG” is the first prospective, randomized, double-blinded, crossover study to compare SCS vs. DRGS vs. SCS+DRGS. Sixty-six PSPS-T2 patients will be recruited internationally in three centers. Before crossing over, patients will receive each stimulation modality for 1 month, using tonic conventional stimulation. After 3 months, stimulation will consist in switching to burst for 1 month, and patients will choose which modality/waveform they receive and will then be reassessed at 6 and 12 months. In addition to our primary outcome based on pain rating, this study is designed to assess quality of life, functional disability, psychological distress, pain surface coverage, global impression of change, medication quantification, adverse events, brain functional imaging and electroencephalography, with the objective being to provide a multidimensional insight based on composite pain assessment.

Background Non-invasive painless signaling therapy (NPST) is an electro-cutaneous treatment that converts endogenous pain information into synthetic non-pain information. This study explored whether pain improvement by NPST in failed back surgery syndrome (FBSS) patients is related to cerebral modulation. Methods Electroencephalography (EEG) analysis was performed in 11 patients with FBSS. Subjects received daily NPST for 5 days. Before the first treatment, patients completed the Brief Pain Inventory (BPI) and Beck Depression Inventory and underwent baseline EEG. After the final treatment, they responded again to the BPI, reported the percent pain improvement (PPI), and then underwent post-treatment EEG. If the PPI grade was zero, they were assigned to the ineffective group, while all others were assigned to the effective group. We used standardized low-resolution brain electromagnetic tomography (sLORETA) to explore the EEG current-source distribution (CSD) associated with pain improvement by NPST. Results The 11 participants had a median age of 67.0 years, and 63.6% were female. The sLORETA images revealed a beta-2 CSD increment in 12 voxels of the right anterior cingulate gyrus (ACG) and the right medial frontal area. The point of maximal CSD changes was in the right ACG. The alpha band CSD increased in 2 voxels of the left transverse gyrus. Conclusions Pain improvement by NPST in FBSS patients was associated with increased cerebral activity, mainly in the right ACG. The change in afferent information induced by NPST seems to be associated with cerebral pain perception.

The risk of spinal cord damage after Spinal Cord Stimulator (SCS) implant is a very rare event. In our case report, the patient was affected by a progressively worsening spinal stenosis due to SCS compression.The authors describe a progressive paraparesis in a 58-year-old woman with a long history of back pain and multiple spine surgeries. Computed tomography (CT) outlined vertebral canal stenosis corresponding to an electrode array implanted in T9. A posterior T8-T10 spinal cord decompression with explanation of the SCS device was performed and a partial neurological improvement was observed immediately postoperative.Spinal cord stimulation has been used since 1967 for the treatment of refractory chronic pain, particularly failed back surgery syndrome (FBSS) and complex regional pain syndrome (CRPS). Still, the mechanism underlying its function is not completely clear. Moreover, complications are mainly related to implant dysfunction and the risk of direct and indirect spinal cord compression is described as exceptional in the literature. Our aim is to describe the case SCS device spinal cord direct compression and its surgical treatment.

Honghui Feng,1 Patrick Doherty,1 Anand Rotte2 1Lawrence and Memorial Hospital, Yale New Haven Healthcare, New London, CT, USA; 2Nevro Corp., Redwood City, CA, USACorrespondence: Honghui Feng Email fenghonghui@yahoo.comBackground: Chronic pain is frequently treated with opioid analgesics, but there is limited evidence for efficacy for chronic use of opioids and the drugs pose significant risks to patients’ physical and mental health. Spinal cord stimulation delivered at a frequency of 10,000 Hertz (10 kHz SCS) is a minimally invasive therapy with demonstrated efficacy and safety in treating chronic pain that has also been associated with decreased opioid use.Objective: To evaluate opioid reduction and pain relief in real-world cohort.Study Design: Retrospective review.Setting: Single center.Patients and Methods: Consecutive patients who were implanted with 10 kHz SCS devices from December 1, 2015, to June 30, 2020 for the treatment of chronic pain in the trunk or lower limbs were included. Changes in opioid use following 10 kHz SCS treatment were extracted from electronic medical records, and patient-reported pain relief, improvement in function and sleep were extracted from manufacturer’s database. Responder rate was defined as the proportion of patients with at least 50% pain relief. Anonymised results from descriptive analysis of the data are reported.Results: At last follow-up (median 21.4 months), mean daily opioid dose fell by 48.4 morphine milligram equivalents (MME), and fewer patients used opioids. Mean pain relief in these patients was 57% ± 4%, and responder rate was 68% at last recorded follow-up. Interestingly, pain relief (66%) and responder rate (86%) were higher in patients with 1 year or more. Finally, 50% of patients reported improved sleep, and 73% reported improvement in function at last recorded follow-up after treatment with 10 kHz SCS.Conclusion: These results support 10 kHz SCS as a safe and effective treatment of chronic pain in real-world patients with secondary benefits to opioid consumption and measures of patients’ quality of life.Keywords: spinal cord stimulation, chronic pain, opioid analgesics, failed back surgery syndrome

BACKGROUND Spinal cord stimulation (SCS) is an effective treatment in failed back surgery syndrome (FBSS). The effect of neuropathic pain medication use on SCS outcome is poorly understood. OBJECTIVE To study the effect of gabapentinoid use on SCS outcome measured by trial success, explantation rate and opioid dose reduction during a 2-yr follow-up. METHODS The study cohort included 203 consecutive FBSS patients who underwent SCS in a single tertiary center during January 1997 to March 2014. Purchase data of gabapentinoids, opioids, tricyclic antidepressants, serotonin and noradrenaline reuptake inhibitors, and benzodiazepines during January 1995 to March 2016 were retrieved from national registries. RESULTS In multivariate Cox regression analysis, patients using gabapentinoids had significantly fewer explantations during the 2-yr follow-up (hazard ratio [HR] 0.2, 95% CI 0.04-0.81, P = .03). In contrast, patients with opioid use of >40 morphine milligram equivalent before implantation had significantly more explantations (HR 6.7, 95% CI 2.5-18, P 50% dose reduction. This indicates that patients with SCS could benefit from concomitant use of gabapentinoids. Prospective randomized trials are warranted to verify this hypothesis.

Objective To describe outcomes of awake transforaminal endoscopic surgical treatment for patients presenting with lumbar radiculopathy after laminectomy. Methods Awake endoscopic decompression surgery was performed on 538 patients over a 5-year period (2014–2019). Transforaminal endoscopic discectomy and foraminotomy was performed in 128 patients who had previously undergone laminectomy surgery. Results At 2-year follow-up, preoperative visual analog scale score for leg pain improved from 7.0 ± 1.4 to 2.0 ± 1.3 and Oswestry Disability Index score improved from 41.4% ± 11.9% to 12.4% ± 11.9% in 118 patients. During the 2-year follow-up period, 10 patients (7.8%) required repeat surgery at the treated level. Conclusions The results of a minimally invasive awake endoscopic procedure are presented for the treatment of lumbar radiculopathy after lumbar laminectomy in a series of patients.

Peripheral nerve stimulation is an established treatment modality for chronic neuropathic pain. Over the last decade, with the advent of innovative devices and delivery platforms, peripheral nerve stimulation has evolved from invasive open surgeries to image-guided, minimally invasive percutaneous procedures. The authors hereby present a novel device, the Nalu™ Neurostimulation System (Nalu Medical, CA, USA), which has established its advantages in providing predictable and reliable peripheral nerve stimulation therapy for chronic neuropathic pain management. This novel device is effective in treating chronic pain conditions such as post-herniorrhaphy pain syndrome, intercostal neuralgia, post-laminectomy syndrome, and complex regional pain syndrome and holds great promise for the treatment of peripheral neuropathic pain.Chronic nerve pain is a debilitating condition that can affect quality of life and functioning. The Nalu™ Neurostimulation System (Nalu Medical, CA, USA) provides long-term pain relief without medications. There are numerous devices currently available that can be utilized to block pain signals using small wires. This system is unique because the wires placed over affected nerves are powered by an external battery that does not require permanent surgical implantation. Pain after hernia surgery, back surgery, hip surgery and knee surgery, as well as nerve pain can be effectively managed by this system.

Spinal cord stimulation (SCS) is an effective treatment for failed back surgery syndrome (FBSS). In patients with FBSS, opioids have often been initiated, even before SCS is trialed.We studied the effect of retirement on opioid use in patients with chronic pain after failed back surgery.A retrospective study design.The study was conducted at Kuopio University Hospital.The study group consisted of all 230 patients with SCS trialed or implanted for FBSS at Kuopio University Hospital Neurosurgery from January 1, 1996 through December 31, 2014. All purchases of prescribed opioids and their daily defined doses, as well as data on working ability, were obtained from the Social Insurance Institution. Patients were divided into 3 groups: SCS trial only, SCS implanted permanently, and SCS implanted but later explanted. We analyzed the differences in opioid use among these groups 2 years before and 2 years after the start of their disability pension (DP).During the follow-up period, a total of 60 patients received a DP. One year before DP, the majority of patients used opioids (n = 43, 72%), and throughout the one-year follow-up after retirement, the number of users increased slightly (n = 46, 77%). In the permanently implanted SCS group, the number of strong opioid users decreased after retirement. Most patients used a moderate dose (0.1-10.5 morphine milligram equivalent/d). Retirement appeared to interrupt dose escalation in all groups, but doses increased further as the follow-up continued.No structured questionnaires were used in this study. Also, many underlying factors contributing to chronic pain were missing.DP did not reduce the use of opioids in patients with FBSS. Opioid doses were lower and dose escalation less steep with continuous SCS therapy.

Neuromodulation is an expanding area of pain medicine that incorporates an array of non-invasive, minimally invasive, and surgical electrical therapies. In this Series paper, we focus on spinal cord stimulation (SCS) therapies discussed within the framework of other invasive, minimally invasive, and non-invasive neuromodulation therapies. These therapies include deep brain and motor cortex stimulation, peripheral nerve stimulation, and the non-invasive treatments of repetitive transcranial magnetic stimulation, transcranial direct current stimulation, and transcutaneous electrical nerve stimulation. SCS methods with electrical variables that differ from traditional SCS have been approved. Although methods devoid of paraesthesias (eg, high frequency) should theoretically allow for placebo-controlled trials, few have been done. There is low-to-moderate quality evidence that SCS is superior to reoperation or conventional medical management for failed back surgery syndrome, and conflicting evidence as to the superiority of traditional SCS over sham stimulation or between different SCS modalities. Peripheral nerve stimulation technologies have also undergone rapid development and become less invasive, including many that are placed percutaneously. There is low-to-moderate quality evidence that peripheral nerve stimulation is effective for neuropathic pain in an extremity, low quality evidence that it is effective for back pain with or without leg pain, and conflicting evidence that it can prevent migraines. In the USA and many areas in Europe, deep brain and motor cortex stimulation are not approved for chronic pain, but are used off-label for refractory cases. Overall, there is mixed evidence supporting brain stimulation, with most sham-controlled trials yielding negative findings. Regarding non-invasive modalities, there is moderate quality evidence that repetitive transcranial magnetic stimulation does not provide meaningful benefit for chronic pain in general, but conflicting evidence regarding pain relief for neuropathic pain and headaches. For transcranial direct current stimulation, there is low-quality evidence supporting its benefit for chronic pain, but conflicting evidence regarding a small treatment effect for neuropathic pain and headaches. For transcutaneous electrical nerve stimulation, there is low-quality evidence that it is superior to sham or no treatment for neuropathic pain, but conflicting evidence for non-neuropathic pain. Future research should focus on better evaluating the short-term and long-term effectiveness of all neuromodulation modalities and whether they decrease health-care use, and on refining selection criteria and treatment variables.

Objectives Heart rate variability recordings have the potential to examine the role of the autonomic nervous system. Several wearable devices are nowadays readily available. Up until now, no studies explored whether a wearable device is able to reliably measure a treatment response in chronic pain patients. Therefore, the aim of this study is to evaluate the reliability of a Polar V800 (Polar Electro Oy, Finland) wearable device to accurately measure RR intervals in patients with failed back surgery syndrome (FBSS) during spinal cord stimulation (SCS), as compared with an eMotion 2-lead ECG recording. Materials and methods Twenty-two patients diagnosed with FBSS and treated with SCS participated in this study. HRV was measured with a 2-lead ECG registration tool and a Polar V800 during on and off state of SCS. Intraclass correlation coefficients, correlations, limits of agreement, Cronbach's α, and effect sizes were calculated. Results Analysis based on the recordings from the ECG and wearable device revealed the same HRV parameters (except for the time-frequency domain) to capture the treatment response of SCS. Parameters that are relevant for measuring the SCS treatment response have strong correlations (r ≥ .82), good ICC values (ICC ≥0.82), acceptable consistency (α ≥ .9), and limited bias. Conclusions Similar pre- to posttreatment changes were revealed between a wearable device and 2-lead ECG with reliable HRV estimates for parameters that are able to capture the treatment changes. This suggests that a wearable heart rate monitor might be a reliable wearable tool for the detection of pre- to post treatment changes of SCS, in patients with FBSS.

Study Design: Systematic Review. Objectives: To review the literature surrounding the cost-effectiveness of implanting spinal cord stimulators for failed back surgery syndrome. Methods: A systematic review was conducted inclusive of all publications in the Medline database and Cochrane CENTRAL trials register within the last 10 years (English language only) assessing the cost-effectiveness of Spinal Cord Stimulator device implantation (SCSdi) in patients with previous lumbar fusion surgery. Results: The majority of reviewed publications that analyzed cost-effectiveness of SCSdi compared to conventional medical management (CMM) or re-operation in patients with failed back surgery syndrome (FBSS) showed an overall increase in direct medical costs; these increased costs were found in nearly all cases to be offset by significant improvements in patient quality of life. The cost required to achieve these increases in quality adjusted life years (QALY) falls well below $25 000/QALY, a conservative estimate of willingness to pay. Conclusions: The data suggest that SCSdi provides both superior outcomes and a lower incremental cost: effectiveness ratio (ICER) compared to CMM and/or re-operation in patients with FBSS. These findings are in spite of the fact that the majority of studies reviewed were agnostic to the type of device or innervation utilized in SCSdi. Newer devices utilizing burst or higher frequency stimulation have demonstrated their superiority over traditional SCSdi via randomized clinical trials and may provide lower ICERs.

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

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.

Objective Generator site pain is a relatively common phenomenon in patients undergoing spinal cord stimulation (SCS) that complicates management and effective pain relief. This pain may be managed conservatively, with repositioning of the battery and, in some cases, with explant. Here we explore our experience with management of generator site pain (“pocket pain”) in a large single-center study. Methods All SCS permanent implants and implantable pulse generator (IPG) placements over 9 years were reviewed. Of 785 cases, we identified 43 patients with pocket pain (5.5%). Demographics and treatments of the pocket pain cohort were analyzed. Results The mean age (± SEM) of the pocket pain cohort was 46.86 ± 1.06, and there were 10/33 males/females. Females were overrepresented in pocket pain cohort (76.7%) when compared with the total SCS cohort (59.0%) (X2 = 5.93, P = 0.015). Diagnosis included failed back surgery syndrome (51.2%), complex regional pain syndrome (23.3%), and chronic neuropathic pain (25.5%). No patients improved with conservative therapy. All patients either went on to revision (n = 23) or explant (n = 20). Time from initial surgery to development of pocket pain was 7.5 months (range: 0.3–88) and from pocket pain to revision surgery was 4.5 months (range: 0.4–26). In addition, significantly more pocket pain patients (65.1%) had workers’ compensation (WC) insurance compared with patients without pocket pain (24.9%) (X2 = 33.3, P Conclusion In our institutional experience, pocket pain was inadequately managed with conservative treatments. Being female and having SCS filed under WC increased risk of pocket pain. Future work will explore the nuances in device placement based on body shape and manual activity responsibilities.

Spinal cord stimulation (SCS) is an established therapy for chronic neuropathic pain and most frequently utilised for Failed Back Surgery Syndrome (FBSS). BurstDR™ also known as DeRidder Burst-SCS, a novel waveform, has demonstrated superiority to conventional tonic stimulation of the thoracic spine in FBSS. There are case reports of an improvement in multidimensional pain outcomes using DeRidder Burst-SCS in the cervical spine for chronic neck and cervical radicular pain. The safety and efficacy of cervical DeRidder Burst-SCS stimulation still however remain undetermined. This is a prospective, multicentre feasibility trial evaluating the safety and therapeutic efficacy of DeRidder Burst-SCS stimulation for the treatment of chronic intractable neck pain with or without radiation to the arm, shoulder, and upper back. After baseline evaluation, subjects will undergo an SCS trial using the Abbott Invisible Trial system according to standard clinical procedures. During the trial phase, SCS leads will be implanted in the cervical epidural space. At the end of the SCS trial, subjects experiencing at least 50% pain relief will be considered for permanent implant. Pain intensity, medication usage, and other multidimensional pain outcomes will be collected. The timing of these will be at baseline, end of the SCS trial and at 3-, 6-, and 12-month visits. Incidence of adverse events will be collected throughout the study duration. The results of this feasibility study will validate the efficacy and safety of DeRidder Burst-SCS stimulation in the cervical spine. The results obtained in this study will potentially be used to generate a level 1 evidence-based study with formal statistical hypotheses testing. www.clinicaltrials.gov Identifier: NCT03159169.

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.

Danxu Ma,1 Huili Li,1 Rong Shi,1 Yinan Yang,1 Haoda Liu,2 Xiaodong Ge1 1Department of Anesthesiology, Beijing Chaoyang Hospital, Capital Medical University, Beijing, People’s Republic of China; 2Department of Anesthesiology, Beijing Huairou Maternal and Child Health Care Hospital, Beijing, People’s Republic of ChinaCorrespondence: Xiaodong GeDepartment of Anesthesiology, Beijing Chaoyang Hospital, Capital Medical University, No. 8, Gongtinan Road, Chaoyang District, Beijing 100020, People’s Republic of ChinaEmail xiaodongge2005@163.comBackground: 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.Keywords: lumbar paravertebral block, failed back surgery syndrome, ultrasound-guided, pre-designed route

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.

Background With the growing number of traditional posterior open surgery, the incidence of failed back surgery syndrome (FBSS) increases gradually. We aimed to investigate the incidence and risk factors for FBSS following open posterior lumbar surgery for degenerative lumbar disease (DLD). Method A multivariable regression analysis was performed for 333 consecutive patients to identify potential risk factors for FBSS. Clinical outcomes were evaluated by the validated North American Spine Society (NASS) Questionnaire and numerical rating scale (NRS) for pain. Demographics, diagnostic characteristics, surgical data, radiographic parameters for each patient were analyzed. Result 16.8% of the included patients were classified as FBSS. Univariate analysis showed that age, hypertension, symptom location, intermittent claudication, preoperative pain NRS-leg, HIZ, Modic changes (MCs), surgical strategy and postoperative rehabilitation were related to FBSS. Multivariable logistic regression analysis demonstrated that preoperative NRS-leg (OR:0.80, 95%CI:0.71–0.91, P = 0.001), hypertension (OR: 2.22, 95%CI: 1.10–4.51, P = 0.027), intermittent claudication with waking distance > 100 m (OR: 4.07, 95%CI: 1.75–9.47, P = 0.001) and waking distance ≤ 100 m (OR: 12.43, 95%CI: 5.54–27.92, P P P P = 0.024) were risk factors for FBSS. Conclusion Open posterior lumbar surgery is an effective treatment for DLD which provides pain reduction and lumbar curve improvement with a considerable satisfaction rate. Lower preoperative NRS-leg, hypertension, intermittent claudication, HIZ, MCs and postoperative rehabilitation are risk factors for FBSS, which can serve as a tool for clinicians to identify at-risk population and provide more effective management to mitigate the doctor-patient contradictions and further occupation of medical resources.

Failed back surgery syndrome (FBSS) is a significant cause of lumbar disability and is associated with severe patient morbidity. As the etiology of FBSS is not completely elucidated, the risk factors and evaluation of patients with FBSS remains challenging. Our analysis of a wide variety of operation types, clinical setting, and their correlation to FBSS seeks to allow fellow clinicians to be aware of the potential risk factors that leads to this devastating diagnosis.Data were obtained for patients undergoing anterior lumbar fusion, posterior lumbar fusion, or decompression procedures from January 2010 to December 2017 from the Mariner insurance database. Rates of FBSS at six- and twelve-months post-surgery were determined for patients undergoing single/multilevel procedures according to place of service, and approach/procedure type.From 2010 to 2017, 102,047 patients underwent lumbar fusion or decompression surgery (54% decompression procedures, 36% posterior fusions, and 8.9% anterior fusions).5.4% of patients were diagnosed with FBSS within six months of the index procedure, and 8.4% were diagnosed with FBSS within twelve months. FBSS was higher in the inpatient (6.0%) vs. outpatient (4.3%) cohort. Among the surgical techniques, multi-level procedures had significantly higher rates of FBSS than single-level procedures, the highest being 10% in multi-level inpatient decompression procedures (p 0.05).The highest rates of FBSS occurred in in the elderly (age group 70-74), for those patients whose index procedure was received in an inpatient setting, as well as for those receiving a multi-level surgery.

Electrode migration is one of the most common complication of Spinal Cord Stimulation (SCS). Usually the lead migrates cranio-caudally or laterally and in the vast majority of cases occurs during the first few months after implantation. One method of preventing lead migration is the use of open-surgical insertion of paddle electrodes.51-year old woman was admitted for a revision of postoperative wound after implantation of Spinal Cord Stimulator, which was inserted 4 years earlier due to Failed Back Surgery Syndrome (FBSS). Two years after surgery the patient reported severe pain at the site of electrode implantation. After removal of scar tissue pulling on electrode wires the symptoms subsided. In the following months impaired healing of the postoperative wound was observed. For a long time, the patient would not consent to removal of SCS hardware because of good therapeutic effect. When she was finally admitted for surgery, radiological examination demonstrated significant electrode migration out of the vertebral canal. Surgery was performed to remove all of the hardware.In this case, electrode migration out of the vertebral canal resulted from prolonged infection of SCS hardware. The importance of an infection prevention in neuromodulation procedures should be highlighted. According to our best knowledge, this is the first presented case of paddle type electrode extraspinal migration.

Failed back surgery syndrome (FBSS) is a complex and multifaceted condition associated with significant disability and morbidity. The purpose of this study was to investigate the association between FBSS with new incidences of mental health disorders.Our cohort included patients diagnosed with FBSS within 12 months of a posterior fusion, laminectomy, or discectomy, identified using The International Classification of Disease, both Ninth and Tenth Revisions (ICD-9 and ICD-10). In the next step, both non-FBSS and FBSS-diagnosed patients were queried for the diagnosis of first-time occurrence of mental health disorders. The incidence of new mental health disorders was determined within 12-months following FBSS diagnosis.FBSS patients were significantly at greater risk than non-FBSS patients of developing all included mental health pathologies: Depression: OR 1.9, 95% CI 1.8-2.0, p 0.0001); Anxiety: OR 1.5, 95% CI 1.4-1.6, p 0.0001; Sleep Disorder: OR 1.9, 95% CI 1.7-2.0, p 0.0001; Bipolar Disorder: OR 1.7, 95% CI 1.5-2.0 p 0.0001; PTSD: OR 1.5, 95% CI 1.3-1.8, p 0.0001; Panic Disorder: OR 1.8, 95% CI 1.5-2.1, p 0.0001; Suicidal Disorder: OR 1.7 95% CI 1.4-2.0, p 0.0001, ADHD: OR 1.3, 95% CI 1.0-1.5, p = 0.0367.In the current study, patients diagnosed with FBSS were at a significantly greater risk of developing mental health pathologies. While other studies have suggested pre-surgical psychological support and treatment, the current results suggest that a post-operative psychologic care may also be warranted. By identifying potential psychosocial unforeseen obstacles that occur in patients diagnosed with FBSS, more precise treatment pathways can be developed leading to improved patient outcomes.

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

Leonardo Kapural,1 Dawood Sayed,2 Brian Kim,2 Caroline Harstroem,1 James Deering1 1Carolinas Pain Institute, Winston-Salem, NC 27103, USA; 2Department of Anesthesiology, University of Kansas, Kansas City, KS, USACorrespondence: Leonardo Kapural Email lkapuralmd@gmail.comBackground and Objectives: A randomized clinical trial demonstrated that 10 kHz SCS (10kHz-SCS) therapy is superior to traditional low-frequency SCS (LF-SCS) at 12- and 24-month clinical follow-ups and led to Food and Drug Administration (FDA) approval of the therapy. The results of the study led our practices to trial 10kHz-SCS in patients who had not maintained pain relief with LF-SCS therapy. Here, we report a large set of data from two clinical sites to assess if 10kHz-SCS is an effective salvage modality when LF-SCS fails.Methods: We conducted a retrospective chart review of 120 patients across two clinical sites who had LF-SCS implants and were salvaged with 10kHz-SCS.Results: Data were analyzed from 105 patients between 28 and 90 years old (median 60) with chronic pain for 13.6 years. The mean duration of LF-SCS therapy was 4.66± 3.9 years. The average Visual Analog Scale (VAS) decreased from 8.30± 1.4 (median of 8) cm to 3.32± 2.0 (median of 3) cm at 12 months and 3.36± 2.0 (median of 3) cm at the most recent clinic visit (p< 0.001) following salvage therapy. Pain relief of 50% or more was obtained in 85 out of 105 (81%) patients. Opioid usage decreased from 60.3± 77.1 mg to 32.1± 44.0 mg MSO4 equivalents (p = 0.001) at 12 months after salvage therapy.Conclusion: Eighty-one percent of patient cases reviewed, where LF-SCS had failed, achieved > 50% pain relief with 10kHz-SCS, and almost all exhibited some clinical improvement. Therefore, 10kHz-SCS should be considered an appropriate option to rescue failed LF-SCS.Keywords: spinal cord stimulation, high-frequency 10 kHz spinal cord stimulation, low-frequency spinal cord stimulation, neuromodulation, lower back pain, lumbosacral radiculopathy, post-laminectomy syndrome, failed back surgery syndrome

Objective Despite the clinical effectiveness of Spinal Cord Stimulation (SCS), potential structural brain modifications have not been explored. Our aim was to identify structural volumetric changes during subsensory SCS, in patients with Failed Back Surgery Syndrome (FBSS). Methods In this cohort study, twenty-two FBSS patients underwent a magnetic resonance imaging protocol before SCS and 3 months after SCS. Clinical parameters were correlated with volumetric changes, calculated with voxel-based morphometry. Results After 3 months, a significant volume decrease was found in the inferior frontal gyrus, precuneus, cerebellar posterior lobe and middle temporal gyrus. Significant increases were found in the inferior temporal gyrus, precentral gyrus and the middle frontal gyrus after SCS. Additionally, significant increases in volume of superior frontal and parietal white matter and a significant decrease in volume of white matter underlying the premotor/middle frontal gyrus were revealed after SCS. A significant correlation was highlighted between white matter volume underlying premotor/middle frontal gyrus and leg pain relief. Conclusions This study revealed for the first time that SCS is able to induce volumetric changes in gray and white matter, suggesting the reversibility of brain alterations after chronic pain treatment. Significance Volumetric brain alterations are observable after 3 months of subsensory SCS in FBSS patients.

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

Objective The use of multicolumn-lead spinal cord stimulation (SCS) to control back pain (BP) and leg pain (LP) in patients with failed back surgery syndrome (FBSS) in the short term and mid-term has been well documented. Our study investigated whether SCS remained efficient after 72 months. Methods In an observational, single-center study, we assessed SCS efficacy in 62 patients with FBSS patients. BP, LP, and magnitude of daily activity limitation (DAL) were graded using a 0–10 visual analog scale (VAS) preoperatively and at 2, 6, 12, 24, 36, and 72 months after SCS implantation. Sleep quality, use of medications, and complications were also recorded. Results Of the 62 patients, 15 with complete follow-up data available were still using their SCS device at 72 months (SCS+). For these patients, the VAS scores for BP, LP, and DAL had changed from a median of 9 (interquartile range [IQR], 8.5–10), 7 (IQR, 6–8), and 8 (IQR, 8–9) preoperatively to a median of 4 (IQR, 3–4.5), 3 (IQR, 1.5–3.5), and 3 (IQR, 2–4) at 72 months. Their quality of sleep and analgesic medication consumption had also improved. In a subset of patients no longer using the SCS device after 72 months (SCS−), the VAS scores for BP, LP, and DAL, quality of sleep, and medication consumption were comparable to those for the SCS+ group. The SCS− group was less satisfied with the technique and were less professionally active than were the SCS+ group. Conclusions The SCS device provides sustained beneficial effects on BP, LP, DAL, sleep, and medication consumption in patients with FBSS still using it at 72 months postoperatively. Further studies are needed to identify the factors of adherence to the technique and the chances of success compared with the natural evolution of FBSS.

Objectives This study aims to evaluate whether ultrasound (US)- guided facet joint injection reduces pain and improves mobility in patients with failed back surgery syndrome (FBSS). Patients and methods This retrospective study included 27 patients (8 males, 19 females; mean age 43.6±11.5 years; range, 31 to 54 years) who underwent US-guided facet injections for FBSS between January 2017 and January 2019. Patients’ medial records were assessed. Pain rating scores were evaluated with the Numeric Rating Scale (NRS). Functional status was assessed with Oswestry Disability Index (ODI) version 2.0. Lumbar flexion degree was noted. After injection (lidocaine-betamethasone mixture), patients were reevaluated at first and sixth months. The study data were analyzed with Wilcoxon signed-rank test. Results Successful facet joint injections were achieved without any complications in all patients. The median duration of time after surgery was 7.8±1.3 months. Mean duration of pain was 6.7±5.7 months. There was a significant decrease in NRS values between baseline and sixth month comparison (7.0 at baseline and 6.0 at sixth month, p=0.006). Baseline-first month and first-sixth months comparisons were not significant (p=0.165 and p=0.106, respectively). For ODI, no significant change was observed between baseline-first month, first-sixth months, and baseline-sixth month comparisons (p=0.109, p=0.857, and p=0.095, respectively). For lumbar flexion, all comparisons resulted in significant increase (50.0° for baseline, 60.0° at first month, and 70.0° at sixth month; p

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.

OBJECTIVES Spinal cord stimulation (SCS) therapies are used in the management of patients with complex regional pain syndrome I (CRPS I) and failed back surgery syndrome (FBSS). The purpose of this study was to investigate the racial and health insurance inequalities with SCS therapy in patients with chronic pain who had CRPS I and FBSS. METHODS Patients with chronic pain who had a discharge diagnosis of FBSS and CRPS I were identified using the National Inpatient Sample database. Our primary outcome was defined as the history of SCS utilization by race/ethnicity, income quartile, and insurance status. Multivariable logistic regression was used to determine the variables associated with utilization of SCS therapy. RESULTS Between 2011 and 2015, 40,858 patients who were hospitalized with a primary diagnosis of FBSS and/or CRPS I were identified. Of these patients, 1,082 (2.7%) had a history of SCS therapy. Multivariable regression analysis revealed that compared to White patients, Black and Hispanic patients had higher odds of having SCS therapy (Black patients: odds ratio [OR] = 1.41; 95% confidence interval [CI], 1.12 to 1.77; P = 0.003; Hispanic patients: OR = 1.41; 95% CI, 1.10 to 1.81; P = 0.007). Patients with private insurance had significantly higher odds of having SCS therapy compared with those with Medicare (OR = 1.24; 95% CI, 1.08 to 1.43; P = 0.003). Compared to patients with Medicare, Medicaid patients had lower odds of having SCS therapy (OR = 0.50; 95% CI, 0.36 to 0.70; P

The OBJECTIVE was to improve the results of surgical treatment of patients with discogenic radiculopathy by preoperative neuropsychological examination of patients with an increased risk of unsatisfactory outcome of the operation.METHODS AND MATERIALS. Neuropsychological status of 77 patients with discogenic radiculopathy in the preoperative period was studied. For this purpose, we assessed the intensity of pain, levels of personal and situational anxiety and the presence and severity of depression. The obtained data were compared with postoperative results of quality of life assessment for the main parameters, which include the level of pain and adaptation to daily activities.RESULTS. Data from neuropsychological tests were revealed, the presence of which in patients with discogenic pain syndrome suggests the risk of an unsatisfactory assessment of the operation performed by the patient. According to the long-term results of neurosurgical treatment, patients were divided into three groups: 1 – with a good result; 2 – patients with a number of preserved complaints, who rated the result of the operation as satisfactory; 3 – unsatisfactory outcome. In patients with unsatisfactory results of surgical treatment of discogenic radiculopathies with pain syndrome, patterns of psychological indices were found that were significantly associated with the outcome of treatment.CONCLUSION. Conducting a neuropsychological examination prior to surgery with the identification of predictors of chronic discogenic pain and patient dissatisfaction with the results of treatment can influence the surgical tactics and optimize the process of further treatment.

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.

Introduction In the PROMISE study, a multinational randomized controlled trial (RCT) of the effectiveness of spinal cord stimulation (SCS) with multicolumn surgical leads as a treatment of low back pain, clinicians followed their usual practice. An early, unplanned safety analysis revealed that the infection rate in Belgium (5/23), where trial duration was a median 21.5 days, was significantly higher than the 1/64 rate observed in the other study countries (median 5.8 days, p 10 days was 24.1% vs. 1.4% for subjects trialed ≤10 days (p

Background Facioscapulohumeral muscular dystrophy (FSHD) is a rare condition affecting 1/20,000 persons and the third most common muscular dystrophy condition, with an autosomal dominant pattern of inheritance characterized by progressive muscular weakness primarily involving the face, shoulder girdle, and upper arm. The condition is associated with atrophic musculature of the trunk and core leading to difficulties with gait, posture, and function. FSHD leaves as many as 20% of patients wheelchair-bound and most commonly presents with low back, neck, and shoulder pain. Case Description We present the case of a patient with FSHD who underwent multiple spinal fusion surgeries without relief in her back pain. Imaging studies serve to highlight the extent of paraspinal muscle atrophy and provides the basis for a discussion on the preoperative factors that may predict patients most likely to benefit from surgery. We then provide a brief review of the literature on the role of paraspinal muscle atrophy in back pain. Conclusions This case adds to our understanding of the surgical management of patients with FSHD and patients with atrophic core musculature as a whole.

Objective Presently, there is only limited evidence about the cost-effectiveness of peripheral nerve field stimulation (PNFS) and no evidence to date on the cost-effectiveness of PNFS as an add-on therapy to spinal cord stimulation (SCS). In a multicenter randomized controlled trial, PNFS as add-on therapy to SCS demonstrated clinical effectiveness in treating chronic low back pain in failed back surgery syndrome (FBSS) patients. We report here the cost-effectiveness of PNFS as additional therapy. Materials and Methods Cost-effectiveness analysis was performed from a health-care perspective using the general principles of cost-utility analysis, using empirical data from our multicenter randomized controlled trial on the effectiveness of hybrid SCS + PNFS on low back pain in FBSS patients, who were back pain non-responders to initial SCS-therapy, over a time-horizon of three months. Outcome measures were costs and quality-adjusted life-years (QALYs). Cost and QALYs were integrated using the net monetary benefit (NMB). Differences in costs, effects, and NMB were analyzed using multilevel regression. Uncertainty surrounding the NMB was presented by cost-effectiveness acceptability curves. Results A total of 52 patients implanted with both SCS and PNFS, randomly assigned to a group with PNFS either activated or inactive, completed the controlled part of the study. With mean total costs for the SCS + active PNFS group of euro1813.86 (SD euro109.78) versus euro1103.64 (SD euro123.43) for the SCS + inactive PNFS group at three months, we found an incremental cost-utility ratio of euro25.311 per QALY gained and a probability being cost-effective of more than 80% given a willingness to pay for a QALY of about euro40.000. Conclusions From a Dutch national health-care context, when the willingness to pay threshold is up to 60.000 Euros per QALY, PNFS as an add-on therapy to SCS for the treatment of low back pain in FBSS patients has a high probability of being cost-effective.

BACKGROUND AND OBJECTIVE We evaluated the effect of caudal epidural pulsed radiofrequency stimulation in patients with chronic lumbosacral radicular pain due to postlumbar surgery syndrome who were unresponsive to at least two epidural steroid injections through the interlaminar, transforaminal, or caudal route. METHODS We recruited 25 patients with chronic persistent radicular pain in one or both legs (⩾ 4 on the Numeric Rating Scale [NRS]) despite spinal surgery. They were unresponsive to at least two epidural steroid injections. We retrospectively conducted this study. Electrode needles were placed into the epidural space (S2-3 intervertebral level) through the sacral hiatus, and pulsed radiofrequency stimulation was administered. The outcomes were evaluated using the NRS scores for radicular pain before treatment and 1-3 months after treatment. Successful pain relief was defined as a ⩾ 50% reduction in the scores at 3 months after treatment. RESULTS The pain scores changed significantly over time (p< 0.001): pretreatment, 4.9 ± 0.9; 1 month, 3.6 ± 1.4; 2 months, 3.8 ± 1.4; and 3 months, 3.9 ± 1.4. At 1, 2, and 3 months after pulsed radiofrequency (PRF) procedure, the NRS scores were significantly reduced compared with the scores before the treatment. Eight patients (32%) reported successful pain relief at 3 months after treatment. CONCLUSIONS Although only 32% of the patients with postlumbar surgery syndrome showed successful pain relief after treatment, the result is encouraging because we recruited only patients unresponsive to repeated epidural steroid injections.

Chronic severe pain results in a detrimental effect on the patient's quality of life. Such patients have to take a large number of medications, including opioids, often without satisfactory effect, sometimes leading to medication abuse and the pain worsening. Spinal cord stimulation (SCS) is one of the most effective technologies that, unlike other interventional pain treatment methods, achieves long-term results in patients suffering from chronic neuropathic pain. The first described mode of SCS was a conventional tonic stimulation, but now the novel modalities (high-frequency and burst), techniques (dorsal root ganglia stimulations), and technical development (wireless and implantable pulse generator-free systems) of SCS are becoming more popular. The improvement of SCS systems, their miniaturization, and the appearance of new mechanisms for anchoring electrodes results in a significant reduction in the rate of complications and revision surgeries, and the appearance of new waves of stimulation allows not only to avoid the phenomenon of addiction, but also to improve the long-term results of chronic SCS. The purpose of this review is to describe the current condition of SCS and up-to-date technical advances.