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The introduction of the term persistent spinal pain syndrome (PSPS), replacing the term failed back surgery syndrome (FBSS) has significantly changed diagnostic and treatment approaches of PSPS. There are multiple risk factors that may contribute to the development of PSPS. Accurately identifying individual risk factors is, therefore, crucial for patient-centered treatment planning. This article mainly focuses on patient-related psychosocial risk factors. Possibilities of evaluating these risk factors prior to spinal surgery in order to prevent PSPS from developing, as well as treatment options for established PSPS will be discussed., Competing Interests: Einhaltung ethischer Richtlinien. Interessenkonflikt: F. Schulz gibt an, dass kein Interessenkonflikt besteht. Für diesen Beitrag wurden von den Autor/-innen keine Studien an Menschen oder Tieren durchgeführt. Für die aufgeführten Studien gelten die jeweils dort angegebenen ethischen Richtlinien., (© 2024. The Author(s), under exclusive licence to Springer Medizin Verlag GmbH, ein Teil von Springer Nature.)

Introduction: Persistent Spinal Pain Syndrome (PSPS) refers to chronic axial pain and/or extremity pain. Two subtypes have been defined: PSPS-type 1 is chronic pain without previous spinal surgery and PSPS-type 2 is chronic pain, persisting after spine surgery, and is formerly known as Failed Back Surgery Syndrome (FBSS) or post-laminectomy syndrome. The etiology of PSPS-type 2 can be gleaned using elements from the patient history, physical examination, and additional medical imaging. Origins of persistent pain following spinal surgery may be categorized into an inappropriate procedure (eg a lumbar fusion at an incorrect level or for sacroiliac joint [SIJ] pain); technical failure (eg operation at non-affected levels, retained disk fragment, pseudoarthrosis), biomechanical sequelae of surgery (eg adjacent segment disease or SIJ pain after a fusion to the sacrum, muscle wasting, spinal instability); and complications (eg battered root syndrome, excessive epidural fibrosis, and arachnoiditis), or undetermined., Methods: The literature on the diagnosis and treatment of PSPS-type 2 was retrieved and summarized., Results: There is low-quality evidence for the efficacy of conservative treatments including exercise, rehabilitation, manipulation, and behavioral therapy, and very limited evidence for the pharmacological treatment of PSPS-type 2. Interventional treatments such as pulsed radiofrequency (PRF) of the dorsal root ganglia, epidural adhesiolysis, and spinal endoscopy (epiduroscopy) might be beneficial in patients with PSPS-type 2. Spinal cord stimulation (SCS) has been shown to be an effective treatment for chronic, intractable neuropathic limb pain, and possibly well-selected candidates with axial pain., Conclusions: The diagnosis of PSPS-type 2 is based on patient history, clinical examination, and medical imaging. Low-quality evidence exists for conservative interventions. Pulsed radiofrequency, adhesiolysis and SCS have a higher level of evidence with a high safety margin and should be considered as interventional treatment options when conservative treatment fails., (© 2024 The Authors. Pain Practice published by Wiley Periodicals LLC on behalf of World Institute of Pain.)

The introduction of the term Persistent Spinal Pain Syndrome (PSPS-T1/2), replacing the older term Failed Back Surgery Syndrome (FBSS), has significantly influenced our approach to diagnosing and treating post-surgical spinal pain. This comprehensive review discusses this change and its effects on patient care. Various diagnostic methods are employed to elucidate the underlying causes of back pain, and this information is critical in guiding treatment decisions. The management of PSPS-T1/2 involves both causative treatments, which directly address the root cause of pain, and symptomatic treatments, which focus on managing the symptoms of pain and improving overall function. The importance of a multidisciplinary and holistic approach is emphasized in the treatment of PSPS-T1/2. This approach is patient-centered and treatment plans are customized to individual patient needs and circumstances. The review concludes with a reflection on the impact of the new PSPS nomenclature on the perception and management of post-surgical spinal pain.

Objectives: Failed back surgery syndrome (FBSS) refers to a condition where symptoms such as low back pain, leg pain, and numbness persist or recur after lumbar surgery; it has been reported to occur in 10%-40% of patients who have undergone lumbar surgery. Spinal cord stimulation (SCS) has been reported useful for low back and leg pain due to FBSS. In this study, we studied the efficacy and safety of SCS for FBSS in older adults., Methods: Among FBSS patients who underwent an SCS trial between November 2017 and December 2020, those with at least 50% pain reduction during the trial phase who requested spinal cord stimulator implantation underwent implantation of a stimulator under local anesthesia. The patients were divided into two groups: patients aged <75 years (<75-year-old group) and patients aged ≥75 years (≥75-year-old group). The male/female ratio, symptom duration, operative duration, visual analog scale (VAS) scores before and after one year of surgery, responder rate (RR), complications one year after surgery, and stimulator removal rate were analyzed., Results: There were 27 cases in the <75-year-old group and 46 in the ≥75-year-old group, with no significant differences in male/female ratio, duration of pain, or operative time between the two groups. VAS scores for low back pain, leg pain, and overall pain one year after surgery were improved significantly from respective preoperative scores in both groups ( P < 0.001). There were no significant differences in low back pain VAS, leg pain VAS, overall pain VAS, RR, complications one year after surgery, or stimulator removal rate between the two groups., Conclusion: SCS reduced pain effectively in both <75-year-old and ≥75-year-old groups with no differences in complications. Therefore, spinal cord stimulator implantation was considered a viable option for FBSS treatment in older adults because it can be performed under local anesthesia and is associated with a low incidence of complications., Competing Interests: The authors declare that they have no conflicts of interest., (Copyright © 2023 Naoki Higashiyama et al.)

Introduction: Failed back surgery syndrome (FBSS) is defined as back pain which either persists after attempted surgical intervention or originates after a spine surgery. There is a high risk of perioperative morbidity and a high likelihood of extensive revision surgery in geriatric patients with FBSS or post-laminectomy foraminal stenosis., Methods: There is a need for less invasive methodologies for the treatment of FBSS, such as patient-tailored exercise training, with attention to the cost and special needs of the geriatric patients with FBSS. This commentary will provide some background regarding teleexercise (utilizing an internet-based platform for the provision of exercise-related care) for FBSS and will propose three exercises which are easy to administer over online-based platforms and can be the subject of future investigation., Results: Given the documented benefits of regular rehabilitative exercises for patients with FBSS, the high cost of face-to-face services, and the need for infection mitigation in the wake of the COVID-19 Pandemic, teleexercise may be a practical and cost-beneficial method of exercise delivery, especially for geriatric patients with limitations in mobility and access to care. It should be noted that, prescription of these exercises should be done after face-to-face evaluation by the physician and careful evaluation for any "red flag" symptoms., Conclusion: In this commentary, we will suggest three practical exercise training methodologies and discuss the benefits of teleexercise for geriatric patients with FBSS. Future research should aim to assess the efficacy of these exercises, especially when administered through telehealth platforms., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Alizadeh, Anastasio, Shariat, Bethell and Hassanzadeh.)

Objective: To investigate the presence of altered central pain processing in patients with failed back surgery syndrome (FBSS) using quantitative sensory testing (QST)., Methods: 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)., Results: 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)., Conclusion: 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., Competing Interests: Declaration of Competing Interest None of the authors have potential conflicts of interest to be disclosed. The authors alone are responsible for the content and writing of this paper., (Copyright © 2022 Elsevier Masson SAS. All rights reserved.)

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.

Objective: Spinal cord stimulation (SCS) targets structures of the dorsal column and dorsal horn of the spinal cord with electrical impulses, thereby, modulating pain perception. For chronic pain patients, e.g., in failed back surgery syndrome (FBSS), the aim is to achieve pain relief and enable patients to improve their quality of life., Indications: Failed back surgery syndrome, complex regional pain syndrome (CRPS) type I and II, therapy-refractory ischemic pain, neuropathic pain syndromes (e.g., phantom limb pain)., Contraindications: Identification of degenerative alterations as the cause of pain; untreated mental illness., Surgical Technique: A two-stage implantation technique is performed. Initially, after percutaneous implantation of epidural leads a trial period with stimulation by an external pulse generator is evaluated. Following verification of pain relief, a subcutaneous internal pulse generator is implanted., Follow-Up: Early mobilization and adjustment of stimulation parameters., Results: In all, 19 consecutive patients with FBSS were treated by high frequency SCS (HF-SCS) and included in a prospective prognostic study. In 18 patients, an internal pulse generator (IPG) for HF-SCS was permanently implanted. Therapy success was assessed using the Oswestry Disability Index (ODI), visual analogue pain scale (VAS) and painDetect questionnaire. Neuropathic pain of the legs versus the back (median values: VAS leg 71 mm, VAS back 69 mm) was dominant in the patients at a preoperative mean ODI of 63%. With HF-SCS therapy, a pronounced pain reduction was seen and persisted in the follow-up after 6 months (VAS leg 18 mm, VAS back 24 mm). The ODI showed an improvement to a mean of 24% after 6 months., (© 2021. Springer Medizin Verlag GmbH, ein Teil von Springer Nature.)

Objective: For many medical professionals dealing with patients with persistent pain following spine surgery, the term Failed back surgery syndrome (FBSS) as a diagnostic label is inadequate, misleading, and potentially troublesome. It misrepresents causation. Alternative terms have been suggested, but none has replaced FBSS. The International Association for the Study of Pain (IASP) published a revised classification of chronic pain, as part of the new International Classification of Diseases (ICD-11), which has been accepted by the World Health Organization (WHO). This includes the term Chronic pain after spinal surgery (CPSS), which is suggested as a replacement for FBSS., Methods: This article provides arguments and rationale for a replacement definition. In order to propose a broadly applicable yet more precise and clinically informative term, an international group of experts was established., Results: 14 candidate replacement terms were considered and ranked. The application of agreed criteria reduced this to a shortlist of four. A preferred option-Persistent spinal pain syndrome-was selected by a structured workshop and Delphi process. We provide rationale for using Persistent spinal pain syndrome and a schema for its incorporation into ICD-11. We propose the adoption of this term would strengthen the new ICD-11 classification., Conclusions: This project is important to those in the fields of pain management, spine surgery, and neuromodulation, as well as patients labeled with FBSS. Through a shift in perspective, it could facilitate the application of the new ICD-11 classification and allow clearer discussion among medical professionals, industry, funding organizations, academia, and the legal profession., (© The Author(s) 2021. Published by Oxford University Press on behalf of the Society for Molecular Biology and Evolution.)

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., (© 2019 International Neuromodulation Society.)

Background: The term failed back surgery syndrome (FBSS) has been criticized for being too unspecific and several studies have shown that a variety of conditions may underlie this label. The aims of the present study were to describe the specific symptoms and to investigate the primary and secondary underlying causes of FBSS in a contemporary series of patients who had lumbar spinal surgery before., Methods: We used a multilevel approach along three different axes defining symptomatic, morphological, and functional pathology dimensions., Results: Within the study period of 3 years, a total of 145 patients (74 f, 71 m, mean age 51a, range 32-82a) with the external diagnosis of FBSS were included. Disk surgery up to 4 times and surgery for spinal stenosis up to 3 times were the commonest index operations. Most often, the patients complained of low back pain (n = 126), pseudoradicular pain (n = 54), and neuropathic pain (n = 44). Imaging revealed osteochondrosis (n = 61), spondylarthrosis (n = 48), and spinal misalignment (n = 32) as the most frequent morphological changes. The majority of patients were assigned at least to two different symptomatic subcategories and morphological subcategories, respectively. According to these findings, one or more functional pathologies were assigned in 131/145 patients that subsequently enabled a specific treatment strategy., Conclusions: FBSS has become rather a vague and imprecisely used generic term. We suggest that it should be avoided in the future both with regard to its partially stigmatizing connotation and its inherent hindering to provide individualized medicine.

Objective: To study a role of central sensitization (CS) in patients with Failed Back Surgery Syndrome (FBSS) after decompression of the lumbar and/or sacral roots., Material and Methods: The study included three groups of patients: 1) early FBSS (e-FBSS, n =23), pain after surgery decreased, but continued to significantly bother the patient, or recurred in the first 6 months after surgery; 2) middle FBSS (m-FBSS, n =42), pain after surgery completely stopped, but recurred within 6-12 months; 3) late FBSS (l-FBSS, n =31), if pain relapse occurred more than 12 months later. Neurological status assessment, study of muscle trigger zones (MTZ), postoperative scar trigger zones (TZS), pain assessment according to the Visual Analogue Scale (VAS), CS assessment according to the Russian version of the Central Sensitization Inventory (CSI) were performed. Treatment included the following stages: stage 1 (non-steroidal anti-inflammatory drug (NSAID) meloxicam 15 mg 7 days); stage 2 (aminophenylbutyric acid hydrochloride (APAH) 250 mg 3 times a day 14 days); stage 3 (fluvoxamine 50 mg daily 8 weeks); stage 4 (MTZ and TZS treatment, fitness program). In addition to the previously described 96 patients, 15 patients (4 men and 11 women, aged 36-47 years) with FBSS and widespread pain, corresponding to the criteria for fibromyalgia ACTTION-APS Pain Taxonomy, who took only milnacipran 25-50 mg daily for two months (WSP-FBSS group), were studied., Results: At baseline, CSI and VAS are as follows: CSI=72.2±6.5; VAS=58.5±8.8 in the e-FBSS group; CSI=49.2±9.0; VAS=39.5±5.3 in the m-FBSS group; CSI=18.1±5.9; VAS=18.1±5.4 in the l-FBSS group. All patients have active MTZ and TZS. The differences between MTZ and TZS subgroups were in the reproduction of pain - the appearance of pain characteristic of the patient during stimulation (pressure) of the MTZ or TZS. In the e-FBSS group, there is the low efficacy of NSAIDs, the moderate efficacy of APAH, the high efficacy of fluvoxamine. In the m-FBSS group, the moderate efficacy of NSAIDs and APAH and the high efficacy of fluvoxamine are observed. In the l-FBSS group, there is the high efficacy of NSAIDs. In the WSP-FBSS group, VAS and CSI are 58.8±9.2 mm and 75.1±8.04, respectively, before treatment, 15.51±5.1 mm ( p =0.00032) and 25.6±8.2 ( p =0.0002), respectively, after 2 months of treatment., Conclusions: In patients with FBSS, MTZ and TZS should be treated taking into account CS. The study shows the efficacy of APAH, fluvoxamine and milnacipran in the presence of CS.

Background: Spinal cord stimulation for failed back surgery syndrome and chronic pain is a well-established treatment regimen today. Lead migration is the most common complication; mainly epidural caudal more than cranial electrode migration from the primary position is described repeatedly throughout the literature., Case Description: A 60-year-old male patient with failed back surgery syndrome was eligible for spinal cord stimulation. Surgery had been performed 4 weeks before readmission with proper lead positioning of both electrodes in the midline of the epidural space. The electrode fixation mechanism at L2/3 had to be revised and was replaced with multiple ligature fixations due to the patient's slim build. He presented to our outpatient clinic with thoracic right-sided pain matching T5 with signs of overstimulation of the paravertebral muscles. X-ray imaging revealed cranial migration of 1 lead to T4 and a right-sided extraspinal migration of the other lead along a spinal nerve in T5 exiting the neuroforamen and following beneath the corresponding rib dorsally. Revision surgery was performed using a thoracic paddle electrode., Conclusions: Lead migration remains a challenge in spinal cord stimulation regardless of the fixation method. Rare unusual migration patterns in addition to simple caudal or cranial migration might pose a challenge for revision surgery and thus might reduce overall treatment efficacy., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: While the evolution of technology provides new opportunities to manage chronic refractory pain using different waveform modalities of spinal cord stimulation in failed back surgery syndrome (FBSS), there is no randomized controlled trial available to compare the efficacy of these different stimulations waveforms to date. MULTIWAVE is a prospective, randomized, double-blinded, crossover trial study designed to compare the clinical efficacy of tonic conventional stimulation (TCS), burst stimulation (BURST) and high-frequency stimulation (HF) in FBSS patients over a 15-month period in SCS implanted patients., Methods/design: Twenty-eight patients will be recruited in the Poitiers University Hospital, in Niort and La Rochelle Hospitals in France. Eligible patients with post-operative low back and leg pain with an average visual analog scale (VAS) score ≥ 5 for low back pain are implanted and randomly assigned to one of the six arms (in a 1:1:1:1:1:1 ratio), where they receive a 3-month combination of TCS, BURST and HF including one treatment modality per month and varying the order of the modality received within the six possible combinations. Patients receiving intrathecal drug delivery, peripheral nerve stimulation and back resurgery related to the original back pain complaint and experimental therapies are excluded from this study. Patients included in the spinal cord stimulation group undergo trial stimulation, and they all receive a TCS treatment for 2 months, as the gold standard modality. Thereafter, patients are randomly assigned to one of the six arms for the total duration of 3-month crossover period. Then, patients choose their preferred stimulation modality (TCS, BURST, or HF) for the follow-up period of 12 months. Outcome assessments are performed at baseline (first implant), before randomization (2 months after baseline) and at 1, 2, 3, 6, 9 and 15 months post-randomization. Our primary outcome is the average global VAS of pain over 5-day pain diary period between baseline and after each period of stimulation. Additional outcomes include changes in leg and back pain intensity, functional disability, quality of life, psychological state, paraesthesia intensity perception, patient satisfaction and the number of adverse events., Discussion: Recruitment began in February 2017 and will continue through 2019., Trial Registration: Clinicaltrials.gov NCT03014583 . Registered on 9 January 2017.

Objectives: To investigate the long-term effect of high-dose spinal cord stimulation (HD-SCS) in patients with chronic refractory low back and leg pain due to failed back surgery syndrome (FBSS)., Study Design: Prospective case series; pilot study., Materials and Methods: Patients with chronic low back and leg pain (CBLP) due to failed back surgery syndrome (FBSS) were screened for SCS according to the Dutch Neuromodulation Society guidelines. Patients with a pain score of >50 (on a visual analogue scale from 0 to 100) for both low back and leg pain, were selected for participation in this study. During intraoperative screening one or two electrodes were implanted to ensure adequate paresthesia coverage of the back and leg pain area. During the 14 days trial period patients received two programs: a conventional or low-dose (LD) program with 30 Hz; 390 μsec and a high-dose (HD) program with 420 Hz, 400 μsec. They all started with LD-SCS and changed to HD-SCS after three days. If patients reported more than 50% pain relief with either program a rechargeable neurostimulator was implanted for permanent SCS. The scores for low back pain and leg pain were recorded separately. Other therapy related outcomes that were collected are pain medication use, Quebec back pain disability scale (QBPDS), patient satisfaction, employment status, stimulation settings, and adverse events. We present the 6- and 12-months results. Results are presented as mean ± SD., Results: Thirteen patients, nine females and four males (mean age: 49.7 ± 8.1 years), were included between July 2015 and March 2016. Eleven patients responded to SCS during the trial period and were implanted with a neurostimulator. Most patients preferred HD-SCS over LD-SCS and the overall use of HD-SCS increased over time. At 6 to 12 months follow-up, two patients discontinued the study. In one patient low back pain returned despite optimal stimulation settings. The second patient was neither satisfied with LD nor HD and had the system explanted. VAS Leg pain at baseline was 71.2 ± 33.8 and reduced to 25.7 ± 24.0 at 6 months and 23.4 ± 32.0 at 12 months. VAS Back pain at baseline was 66.7 ± 33.2 and reduced to 36.8 ± 41.6 at 6 months and 26.1 ± 33.2 at 12 months. Pain medication was significantly reduced and QBPDS improved from 59.2 ± 12.2 at baseline to 44.1 ± 13.7 at 12 months. Five patients returned to work and overall patient satisfaction at the end of the study was high., Conclusion: This pilot study shows promising results of offering HD-SCS in addition to LD-SCS for treatment of chronic back and leg pain in patients with failed back surgery syndrome., (© 2019 International Neuromodulation Society.)

Background: There is a dearth in our understanding of the factors that are predictive of successful spinal cord stimulator (SCS) trials and eventual conversion to permanent implants. Knowledge of these factors is important for appropriate patient selection and treatment optimization., Objectives: Although previous studies have explored factors predictive of trial success, few have examined the role of waveform in trial outcomes. This study sought to establish the relationship of neuraxial waveform and related measures to trial outcomes., Study Design: This study used a retrospective chart review design., Methods: Data were retrospectively collected on 174 patients undergoing SCS trials upon institutional review board approval of the study protocol. Indications for SCS were: complex regional pain syndrome, failed back surgery syndrome with radicular symptoms, peripheral neuropathy, and axial low back pain. Descriptive statistics and logistic regression analyses were used to assess the association of demographic and clinical variables with SCS trial outcomes., Results: The study population comprised 56% women, had a median age of 55 (interquartile range [IQR], 44-64), and 32 of 174 (18%) patients failed SCS trials. Individuals with successful trials (>= 50% pain relief) were significantly younger and had a median age of 54 years (IQR, 42-60) compared to those who failed SCS trials (median age 66 years; IQR, 50-76; P = .005). Adjusting for age, gender, number of leads, pain category, and diagnoses: surgical history (odds ratio [OR] = 4.4; 95% confidence interval [CI], 1.3-15.8) and paresthesia-based tonic-stimulation (OR = 10.3; 95% CI, 1.7-62.0), but not burst or high frequency, were significantly associated with successful trials. Of note, the number of leads (whether dual or single), pain duration, characteristics, and category (nociceptive vs neuropathic) were not significant factors. An interaction between surgical spine history and lower extremity pain was significantly associated with a positive trial (P = .005)., Limitations: This study was limited by its retrospective nature and focus on a patient population at a single major academic medical center., Conclusions: Paresthesia-based tonic stimulation, age, and surgical history have significant effects on SCS trials. Prospective and randomized controlled studies may provide deeper insights regarding impact on costs and overall outcomes.IRB Approval #: 2018P002216., Key Words: Pain duration, pain location, spinal cord stimulator trial, stimulator waveform, surgical history.

Objectives: The aim of this study was to determine if any of the factors recorded on a standard clinical history of a patient considered for spinal cord stimulation (SCS) would be associated with reduction or cessation of opioids following implantation., Design: Retrospective, single academic center., Methods: Patients included in the chart analysis underwent implantation of percutaneous SCS devices from 1999 to 2015 with follow-up until the end of September 2018. Patients who achieved at least an average of 50% pain reduction were included for analysis of daily opioid intake. Patients were then divided into 4 groups that included no opioid use, stable opioid daily dose, weaned opioid dose, and complete cessation of opioids. Statistical methods were used to analyze for associations between opioid intake after SCS insertion and usual elements of a clinical history, including adjuvant medications, numeric pain rating, past medical history, psychiatric illness, substance abuse, employment, and smoking history., Results: In a group of 261 patients who had undergone implantation, 214 met the criteria for analysis and had a median age of 50 years, with majority having the diagnoses of failed back surgery syndrome and complex regional pain syndrome. The only factor that was associated with complete cessation of opioid use was a median dose of 30 mg of morphine per day (P < 0.01) and was observed in 15% of subjects who used opioids preoperatively., Conclusion: The elimination of opioid dependence following initiation of SCS therapy is highly dependent on the daily dose., (© 2019 World Institute of Pain.)

Introduction: Postlaminectomy syndrome (PLS) or failed back surgery syndrome is a condition characterized by persistent pain following a back surgery. Degenerative processes may result in foraminal stenosis development over time, even after a successful surgery. Percutaneous endoscopic lumbar foraminotomy (PELF) offers a minimally invasive means of treating foraminal stenosis after a back surgery. The objective of this study was to evaluate the outcomes of PELF for foraminal stenosis with PLS in geriatric patients., Methods: Two-year follow-up data were collected from 21 consecutive patients aged 65 years or older (mean age, 72.4 years) who underwent PELF for foraminal stenosis with PLS. Transforaminal endoscopic foraminal decompression was performed under local anesthesia. Outcomes were assessed using visual analog scale pain score, Oswestry Disability Index, and modified Macnab criteria., Results: Mean visual analog scale for leg pain improved from 8.48 at baseline to 3.33 at 6 weeks, 2.10 at 1 year, and 2.19 at 2 years after PELF (P < 0.01). Mean Oswestry Disability Index improved from 67.29 at baseline to 30.69 at 6 weeks, 22.50 at 1 year, and 20.81 at 2 years after PELF (P < 0.01). Based on the modified Macnab criteria, excellent or good results were obtained in 81.0% of patients and symptomatic improvements were obtained in 95.2% of patients., Conclusions: The transforaminal endoscopic approach can provide a better access angle to achieve a sophisticated foraminal decompression with less facet and dural injury. Therefore, PELF under local anesthesia can be useful for PLS or postoperative foraminal stenosis in elderly patients., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Purpose: Patients with chronic low back pain, who do not respond to conservative treatment methods, generally undergo surgical revision operations, and sometimes an undesirable condition called failed back surgery syndrome (FBSS) may be inevitable. Hereby, dextrose is one of the regenerative methods that has gained popularity in the treatment of many musculoskeletal problems, and we aimed to present and evaluate the outcomes of 5% dextrose for the treatment of FBSS., Methods: It has been designed as a consecutive case series. A total of 79 patients with FBSS, who had minimum 6 months of symptoms and did not respond to 3 months of conservative methods between May 2014 and March 2016, participated in the study. Prolotherapy injections were applied in posterior and lateral approaches. Visual Analog Scale (VAS) and Oswestry Disability Index (ODI) were used for the pre- and post-treatment evaluations. Patient satisfaction was assessed with using a 5-point Likert scale by phone contacting., Results: There was statistically significant difference between repeated VAS and ODI measurements., Conclusions: These results may be the first step giving a lead to an undiscovered field. This treatment method should be kept in mind for FBSS patients before giving a decision of revision surgery. These slides can be retrieved under Electronic Supplementary Material.

Objectives: To compare the effectiveness of peripheral nerve stimulation utilizing a subcutaneous lead implant technique-subcutaneous nerve stimulation (SQS) plus optimized medical management (SQS + OMM arm) vs. optimized medical management alone (OMM arm) in patients with back pain due to failed back surgery syndrome., Patients and Methods: Patients were recruited from 21 centers, in Europe, Israel, and Australia. Eligible patients were randomized (1:1) to SQS + OMM or OMM arms. Those in the SQS arm were implanted with a neurostimulator and up to two subcutaneous percutaneous cylindrical leads in the area of pain. Patients were evaluated pre-randomization and at one, three, six, and nine months post-randomization. The primary endpoint was the proportion of subjects with a ≥50% reduction in back pain intensity ("responder") from baseline to nine months. Secondary outcomes included proportion of responders with a ≥50% reduction in back pain intensity at six months and ≥30% reduction at nine months, and the mean change from baseline in back pain intensity at six and nine months between the two arms., Results: Due to the slow rate of recruitment, the study was terminated early with 116 subjects randomized. A total of 33.9% (19/56, missing: n = 20 [36%]) of subjects in the SQS + OMM arm and 1.7% (1/60, missing: n = 24 [40%]) in the OMM arm were responders at Month 9 (p < 0.0001). Secondary objectives showed a significant difference in favor of SQS + OMM arm., Conclusion: The results indicate that the addition of SQS to OMM is more effective than OMM alone in relieving low back pain at up to nine months., (© 2018 The Authors. Neuromodulation: Technology at the Neural Interface published by Wiley Periodicals, Inc. on behalf of International Neuromodulation Society.)

Objective: To explore the experience of spinal cord stimulation (SCS) for patients with failed back surgery syndrome (FBSS)., Methods: Adults with FBSS referred for SCS underwent semistructured interviews at three time points: before their SCS trial, after the trial, and three months after receiving the SCS implant. The face-to-face interviews were audio recorded, transcribed verbatim and analyzed thematically., Results: Twelve adults (8 male, 4 female, aged 38-80 years, pain duration 1-26 years) were recruited. Six themes were identified; 1) What should I expect? 2) Varied outcomes, 3) Understanding pain and this new treatment, 4) Experiences of the SCS journey, 5) Getting used to the device, and 6) Finding out what I need to know. Participants' expectations were varied and the procedures were broadly viewed as minor surgery. Participants' expectations about SCS were not limited to pain relief and included reductions in medication, better sleep, and increased physical activity. Participants' understanding of pain and how SCS purports to work was limited. Throughout the process, practical challenges were identified such as the surgical wound management and battery recharging. Participants received information from multiple sources and identified a range of key information needs including a quick-start guide on how to operate the device and a list of dos and don'ts., Conclusions: Overall, participants' understanding of SCS was limited. The value participants placed on understanding of the process varied markedly. A list of practical informational needs has been identified. Bespoke, user-friendly, informational tools should be developed from this list to enhance the patient experience of SCS., (© 2018 International Neuromodulation Society.)

Objectives: Currently little objective evidence exists regarding the phenotype or somato-sensory profile of patients with Failed Back Surgery Syndrome (FBSS). The aim of this study is to characterize the somato-sensory profile of the patients with FBSS undergoing spinal cord stimulation (SCS)., Methods: A combined quantitative sensory test and questionnaire approach was used to characterize the somatosensory profiles of patients undergoing SCS., Results: Baseline somatosensory profiles were obtained from 23 patients and full three-month data was obtained from 19 patients. At baseline, there was a high prevalence (>50% prevalence of moderate to severe sensation) of burning, tingling, electric shock, numbness, and pressure pain sensitivity. None of the sensory symptoms were present at significant levels at three months following SCS. At baseline, 65% of patients had an inefficient conditioned pain modulation (CPM). Three months post-SCS, 95% of patients had an efficient CPM. All the patients who had an inefficient CPM at baseline had a successful implant at three months and their CPM became efficient in all but one patient. Only 50% of the patients with an efficient CPM at baseline, had a successful implant at three months post-SCS., Conclusion: Although very low numbers, we could demonstrate the somatosensory profiles of patients with FBSS undergoing SCS. Early indication may associate an efficient CPM profile having a higher chance of an unsuccessful implant at three months., (© 2018 International Neuromodulation Society.)

Background: To date, clinical pain research has typically used subjective questionnaires to assess effectiveness of treatment. However, in the near future, new technologies may provide us objective outcome measures as an alternative to self-report. The goal of this study is to compare subjective and objective sleep assessments in a population of failed back surgery syndrome (FBSS) patients, treated with spinal cord stimulation (SCS)., Methods: Twenty-two patients diagnosed with FBSS received SCS. Sleep data was collected at three time point: prior to SCS implantation (B), one month after SCS (T1), and two months after SCS (T2). Sleep data measured by actigraphy provided objective sleep data and were compared to Pittsburgh sleep quality index (PSQI) scores. Agreement between sleep parameters, total sleep time (TST), sleep efficiency (SE), and sleep onset latency (SOL), was examined., Results: Nineteen out of 22 patients completed the study. We identified significant differences between objective and subjective measurements for TST and SE at baseline and after two months of SCS, with patients underestimating both parameters on the PSQI in comparison to objective measurements. For SOL no significant differences were found, although patients subjectively overestimated SOL at B., Conclusion: The results about sleep measurements shown in this population of chronic pain patients, suggest that the subjective ratings scored worse than the objective measurements. Second, short-term SCS mainly seems to affect subjectively measured sleep parameters, especially SOL. This study shows the discrepancies between objective and subjective assessments in chronic pain research. Objective tools are indispensable for a correct assessment and treatment of sleep parameters. They are also playing a role as a biofeedback tool and are supporting the rehabilitation process., (© 2018 International Neuromodulation Society.)

Background: Spinal cord stimulation (SCS) is a well-known treatment in patients with failed back surgery syndrome (FBSS). Burst stimulation is a recently developed stimulation modality that seems to be superior to tonic stimulation., Methods: This observational multicenter study compared tonic and burst stimulation during a trial period in patients with FBSS or radiculopathy. All the patients enrolled underwent two weeks of tonic stimulation followed by another two weeks of BurstDR stimulation, without randomization. The primary outcome was the reduction of pain in the legs and back. Health-related quality of life (EQ-5D) and the pain catastrophizing scale (PCS) were assessed before and after the trial. Patients were reevaluated after 12 months., Results: We recruited 23 patients, 57% of whom had FBSS and 43% had radiculopathies. Five patients failed both the tonic and burst stimulation trials. While tonic stimulation reduced leg pain (p < 0.05), the burst mode added an extra pain reduction (ΔNRS 1.2 ± 1.5) (p < 0.01). No significant reduction in back pain was found (p 0.29). Pain on movement was reduced only by BurstDR (p < 0.01). Both stimulation modalities increased EQ-5D and reduced PCS from the baseline (p < 0.0001). At the end of the SCS trial phase, 26% patients chose tonic SCS, while 74% preferred burst. On 12-month follow-up examination, the benefits recorded at the end of the trial were maintained., Conclusions: Burst stimulation confers a greater reduction in leg pain intensity at rest and on movement. Reducing axial pain is still a challenge. Further studies are needed in order to provide each patient with the most appropriate stimulation paradigm., (© 2018 International Neuromodulation Society.)

Failed back surgery syndrome (FBSS) is a controversial term for identifying patients affected by new, recurrent, or persistent pain in the low back and/or legs following spinal surgery. The lack of a comprehensive standardized care pathway compromises the appropriate management of FBSS patients, which is associated with a heavy financial burden. An international panel of spine surgeons, neurosurgeons, and pain specialists with a particular interest in FBSS established the chronic back and leg pain (CBLP) network with the aim of addressing the challenges and barriers in the clinical management of FBSS patients by building a common transdisciplinary vision. Based on literature reviews, additional input from clinical expertise of multiple professional disciplines, and consensus among its members, the network attempted to provide recommendations on the management of patients with FBSS utilizing a multidisciplinary team (MDT) approach. The presentation of this work has been divided in two separate parts to enhance its clarity. This first paper, in favour of selecting appropriate validated tools to improve the FBSS patient assessment, focuses on FBSS taxonomy and its clinical implications for evaluation. Concise recommendations for assessment, treatment, and outcome evaluation using a MDT approach would be an important resource for specialists and nonspecialist clinicians who manage patients with FBSS, to improve decision-making, reduce variation in practice, and optimize treatment outcomes in this difficult-to-treat population.

Introduction: Spinal cord stimulation (SCS) devices are cost effective and improve function as well as quality of life. Despite the demonstrated benefits of SCS, some patients have the device explanted. We are interested in exploring the patient characteristics of those explanted., Methods: This is a retrospective chart review of neurostimulation patients who underwent explantation at 18 centers across the United States within the previous five years., Results: Data from 352 patients were collected and compiled. Failed Back Surgery syndrome was the most common diagnosis (38.9%; n = 136/350) and over half of the patients reported numerical rating scale (NRS) scores ≥8 prior to implant (64.3%; n = 207/322). All patients reported changes in NRS scores across time, with an initial decrease after implant followed by a pre-explant increase (F (2, 961) = 121.7, p < 0.001). The most common reason for device explant was lack or loss of efficacy (43.9%; 152/346) followed by complications (20.2%; 70/346). Eighteen percent (18%; 62/343) of patients were explanted by a different physician than the implanting one. Rechargeable devices were explanted at a median of 15 months, whereas primary cell device explants occurred at a median of 36 months (CI 01.434, 2.373; median endpoint time ratio = 2.40)., Discussion: Loss or lack of efficacy and complications with therapy represent the most frequent reasons for neurostimulation explantation. Of the devices that were explanted, therapy was terminated earlier when devices were rechargeable, when complications occurred, or when pain relief was not achieved or maintained. Furthermore, in nearly 20% of the cases, a different provider than the implanting physician performed device removal., Conclusions: SCS is largely a safe and efficacious strategy for treating select chronic refractory pain syndromes. Further prospective data and innovation are needed to improve patient selection, maintain SCS therapeutic efficacy and reduce the reasons that lead to device explant., (© 2017 International Neuromodulation Society.)

Study Design: A significant number of lumbar postsurgical patients continue to suffer persistent pain and limited function and are termed to have "Failed back surgery syndrome" (FBSS). This review evaluates clinical trial data for the treatment of FBSS patients., Objective: Using an evidence-based approach to evaluate FBSS treatments will assist clinicians in choosing the most effective options for FBSS patients. Furthermore, reducing the utilization of less effective therapies may result in substantial financial savings for this patient population., Summary of Background Data: Treatments for FBSS may be generally categorized as physical therapy and exercise, medications, interventional procedures, neuromodulation, and reoperation. Careful review and classification of the level of evidence available for each category of treatment for FBSS patients will help guide clinical decision-making., Methods: A literature review was performed for FBSS treatments. The publications were arranged hierarchically according to the North American Spine Society's guidelines as randomized controlled trials (RCTs), prospective studies, retrospective chart, and systematic reviews. Book chapters, nonsystematic reviews, and expert opinions were excluded. The review focused on studies with at least 20 FBSS patients and 6-month follow-up., Results: Evidence is weak for medications and reoperation, but strong for active exercise and interventional procedures such as adhesiolysis. The strongest evidence for long-term treatment is for spinal cord stimulation (SCS), showing favorable Level I RCT results compared with conventional medical management and reoperation. In addition, high-frequency SCS at 10 kHz has demonstrated superiority over traditional, low-frequency SCS for treating low back and leg pain in a recent Level I RCT., Conclusion: Clinicians may increasingly utilize levels of evidence during their evaluation of each FBSS patient to render the best therapeutic plan, likely resulting in improved long-term pain control and reducing costs by avoiding less effective modalities. New directions in SCS show promising results for the treatment of FBSS., Level of Evidence: 1.

Study Design: .: Prospective observational 1-year study., Objective: .: To determine minimum clinically important difference (MCID) and substantial clinical benefit (SCB) of outcome measures in failed back surgery syndrome (FBSS) patients, as these metrics enable assessment of whether and when an intervention produces clinically meaningful effects in a patient., Summary of Background Data: .: Several methods have been devised to quantify clinically important difference, but MCID and SCB for FBSS patients has yet to be determined., Methods: .: Patients with persisting/recurrent low back pain (LBP) and/or leg pain after lumbar surgery who completed 16 weeks of treatment (n = 105) at two hospitals in Korea from November 2011 to September 2014 were analyzed. Global perceived effect was used to determine receiver operating characteristic curves in visual analogue scale (VAS), Oswestry disability index (ODI), and short form-36 (SF-36) in an anchor-based approach., Results: .: MCIDs for ODI, LBP and leg pain VAS, physical component summary, mental health component summary (MCS), and overall health scores of SF-36 were 9.0, 22.5, 27.5, 10.2, 4.0, and 8.9, and SCBs were 15.0, 32.5, 37.0, 19.7, 19.3, and 21.1, respectively. MCID and SCB area under the curve was ≥0.8, and ≥0.7, respectively., Conclusion: .: LBP and leg pain VAS, ODI, and physical component summary of SF-36 may be used to measure responsiveness in FBSS patients., Level of Evidence: 3.

Objective: To evaluate the effectiveness and safety of percutaneous octapolar (8-contact) leads in spinal cord stimulation (SCS) treatment of failed back surgery syndrome (FBSS) patients who have not reached their therapy goals with other treatment interventions., Methods: Our prospective, multicenter, open-label, nonrandomized study included 93 patients ≥ 18 years of age suffering from chronic (≥ 6 months), intractable pain predominantly in the legs. Patients implanted with octapolar lead(s) and a neurostimulator after a successful test trial were followed for 12 months. Patients provided self-reported data on change in visual analog scale (VAS) score for leg pain (primary outcome) and low back pain, quality of life (EuroQol 5 dimensions [EQ-5D] index), sleep, medication use, and paresthesia coverage (secondary outcomes). Adverse events and preferred stimulation settings were documented., Results: Eighty-one (87%) patients had a successful SCS trial. Patients reported significantly improved leg pain relief; average VAS score was 72 ± 17 prior to SCS treatment and 32 ± 24 at 12 months (P < 0.001). Significant decrease in back pain (P < 0.001), improvement in quality of life (P < 0.001), and improvement in sleep (P < 0.05) was observed. Sixty-three percent and 40% of patients were responders (≥ 50% pain reduction) on leg and back pain, respectively, after 12 months. A decrease in medication use was seen for antidepressants and anticonvulsants. Eighty-eight percent of the patients managed with 1 or 2 programs for optimal effect and paresthesia coverage. Twenty-five SCS-related adverse events were registered in 22 patients (24%). Surgical revision due to lead displacement or dysfunction was needed in 6 (6%) of the patients., Conclusions: Use of percutaneous octapolar SCS leads gives significant long-term pain relief and improvement in quality of life and sleep in FBSS patients. The outcomes are better than reported on 4-contact leads and indicate that the progress in SCS technology that has taken place during the past decade correlates with therapy improvements., (© 2016 World Institute of Pain.)

We studied 8 patients with spinal cord stimulation (SCS) devices which had been previously implanted to treat neuropathic chronic pain secondary to Failed Back Surgery Syndrome. The aim of our study was to investigate the effects of SCS on posture and gait by means of clinical scales (Short Form Health Survey-36, Visual Analogue Scale for pain, and Hamilton Depression Rating Scale) and instrumented evaluation with 3D Gait Analysis using a stereophotogrammetric system. The latter was performed with the SCS device turned both OFF and ON. We recorded gait and posture using the Davis protocol and also trunk movement during flexion-extension on the sagittal plane, lateral bending on the frontal plane, and rotation on the transversal plane. During and 30 minutes after the stimulation, not only the clinical scales but also spatial-temporal gait parameters and trunk movements improved significantly. Improvement was not shown under stimulation-OFF conditions. Our preliminary data suggest that SCS has the potential to improve posture and gait and to provide a window of pain-free opportunity to optimize rehabilitation interventions.

Objectives: Test a miniaturized neurostimulator transforaminally placed at the dorsal root ganglion (DRG) and evaluate the device's safety and efficacy in treating failed back surgery syndrome (FBSS) low back pain., Design: Pilot, two-phase study., Subjects: Eleven subjects with chronic intractable neuropathic trunk and/or lower limbs pain were included., Methods: The system consisted of an implantable, miniaturized stimulator, provided by Stimwave Technologies (Freedom-4) and an external transmitter. Only one stimulator per subject was implanted unilaterally and transforaminally at L1 to L5 levels. During Phase 1 of the study, the stimulators were not anchored. In Phase 2, the stimulators were anchored. Subjects were treated during 45 days after which the stimulator was removed. Pain reduction, implant duration, and stimulator migration were registered., Results: Overall pain reduction was 59.9%, with only one device placed at one location, covering only a portion of the painful areas in the majority of the subjects. In Phase 1, the non-anchored stimulators migrated a mean of 8.80 mm and in Phase 2 a mean of 1.83 mm. Stimulator migration did not correlate with changes in pain relief. Mean time-to-implant duration was 10 minutes and no adverse events were reported during implant, follow-up period, or after explant., Conclusions: The pain reduction results indicate that the Freedom-4 spinal cord stimulation (SCS) Wireless System is a viable treatment of low back pain through stimulation of the DRG, and better overall pain reduction may be achieved by implanting multiple devices. With short percutaneous implant times and excellent safety profile, this new system may offer health cost savings., (© 2016 American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Failed back surgery syndrome (FBSS) is a frequent complication (15-40 %) of lumbar disc surgery and is rarely successfully treated by surgery with the exception of a re-prolapse associated with radicular pain. Multimodal pain treatment, however, is indicated by a lack of pathoanatomical correlates, unclear cause and psychosocial risk factors.This review describes a standardized non-operative treatment starting with broad interdisciplinary clarification by medical, psychological and physiotherapeutic means (assessment).If the conditions for multimodal pain therapy are met, the OPS 8‑918-procedure can be applied to avoid chronic developing pain. In doing so, the already issued quality standards and guidelines for documentation should be respected.

Unfortunately, 10-40 % of patients still experience pain after spinal surgery. There are many reasons for the patients' complaints. If no identifiable cause, such as a recurrent disc herniation, is visible, this is referred to as failed back surgery syndrome. However, this definition includes a variety of possible underlying causes of the pain, which result in just as many different therapeutic approaches. In addition to pharmacological, behavioral and physical therapy, also neuromodulation techniques can be offered; the best known method is spinal cord stimulation (SCS). The following article describes evidence-based studies with regard to the beneficial treatment of failed back surgery syndrome with conventional tonic SCS and new developments in spinal cord stimulation addressing the treatment of chronic refractory back pain.

Background: Post-nucleotomy syndrome includes all existing sequelae after surgical nucleotomy for the resection of a lumbar disc herniation, such as axial lumbar back pain and persisting radiculopathy., Objectives: To describe underlying pathologies and to determine operative treatment options., Materials and Methods: Extensive literature research was carried out on Medline., Results: Various devices and approaches have been developed in the last decades. Nonetheless, surgical and non-surgical therapy of post-nucleotomy syndrome remains complex and frequently fails., Conclusions: Better studies providing a better level of evidence for each sub-entity of post-nucleotomy syndrome are required.

Background: Intrathecal (IT) pumps have become a valuable tool in managing intractable non-cancer pain. The purpose of this study was to evaluate the efficacy of using a rigorous treatment algorithm for trialing and implanting IT pumps with hydromorphone and bupivacaine in managing a more homogeneous population of post-laminectomy syndrome or failed back surgery syndrome (FBSS) patients., Methods: This is a retrospective analysis of FBSS patients with chronic intractable back pain implanted with IT pumps delivering hydromorphone and bupivacaine., Results: A cohort of 57 (26 males, 31 females) consecutively implanted FBSS patients was analyzed. The average age at implant was 65.4 years. Average pain scores were 8.4 ± 0.2 (pre-implant), 4.9 ± 0.4 (6 months), 5.2 ± 0.5 (12 months), and 4.3 ± 0.5 (24 months). Average oral opioid doses in morphine equivalents were 56 ± 10 mg/day (pre-implant), 12.0 ± 3.5 mg/day (12 months), 15 ± 6 mg/day (24 months). Average IT hydromorphone doses were 79 ± 6.8 mcg/day (at implant), 184 ± 22 mcg/day (6 months), 329 ± 48 mcg/day (12 months), and 487 ± 80 mcg (24 months). IT hydromorphone dose escalation from baseline was 133% (6 months vs baseline), 78% (12 months vs 6 months), and 48% from 12 months to 24 months. Average IT bupivacaine doses were 5.8 ± 0.3 mg/day (implant), 9.5 ± 0.6 mg/day (6 months), 12.2 ± 0.7 mg/day (12 months), and 12.6 ± 0.9 mg/day (24 months)., Conclusion: IT hydromorphone and bupivacaine are effective in treating chronic pain of FBSS, as demonstrated by the reduction of pain intensity and oral opioid consumption. However, an IT dose escalation phenomenon was observed, although at a reduced rate compared with what had been previously reported in the literature. It is possible that the local anesthetic combination delivered via a patient-activaed bolus device is an important factor. Despite demonstrating effectiveness, the clinical utility of myPTM-optimized IT therapy remains limited by a lack of prospective, placebo-controlled trials and comparative effectiveness research., (© 2015 American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: Chronic low back pain (CLBP) is defined as pain that persists longer than 12 weeks and is often attributed to degenerative or traumatic conditions of the spine. Failed back surgery syndrome is a condition in which chronic pain persists after spinal surgery. Electrodiagnostic studies can be used to confirm the diagnosis of lumbosacral radiculopathy, but other diagnostic methods are often needed to assess sympathetic nervous system dysfunction., Objectives: The aim of this study was to investigate the affection of sympathetic skin response (SSR) in cases of chronic low back pain (LBP) and failed back surgery syndrome (FBSS) and to assess the association of SSR abnormalities with perceived functional disability and pain among these patients., Methodology: Twenty patients with CLBP and 10 patients with failed FBSS who fulfilled the inclusion criteria were recruited to the present study. All cases had back, leg, or back and leg pain of at least 3-month duration or following spinal surgery. The control group consists of 10 healthy participants matched in age and sex. Electrophysiologic nerve conduction studies and SSR recording were applied on the symptomatic and normal side in study cases and on both sides in the control group. Pain intensity was analyzed by the visual analogue scale (VAS) and perceived functional disability was assessed with the Oswestry disability index (ODI)., Conclusions: It was concluded that the sympathetic nervous system is affected in CLBP and FBSS patients with abnormalities in SSR and that the dysfunction of sympathetic nervous system may contribute to the intensity and chronicity of pain in these groups of patients. Moreover, a strong association was found between SSR and functional disabilities in these patients.

Objective: Pregabalin group (PGB) is an antiepileptic used to treat neuropathic pain. We evaluated analgesic efficacy and safety for postoperative/chronic pain, disability, and sleep quality in patients who underwent spine surgery administered with PGB, or not, during the presurgical and postsurgical periods., Design: Retrospective cohort study of 60 patients (two groups with 30 patients) with full information on 50 (29 with PGB and 21 without PGB). Ten patients were dismissed as information was lacking. The PGB group (P) (29 patients) received 75 mg/12 hours before surgery, 150 mg 10 hours after surgery, and 150 mg/12 hours 3 days after surgery. The control group (C; 21 patients) took no PGB., Methods: Neuropathic pain was assessed before surgery, and 2 and 6 months later using visual analog scales (VAS), DN4, disability (Oswestry), and sleep quality. No serious adverse events occurred with PGB., Results: The median VAS pain score at rest was lower in the PGB group at 2 months postsurgery (1 vs 2, P = 0.032), as was the median DN4 score (0 vs 3, P = 0.032) and the median Oswestry disability index (ODI: 12 vs 18, P = 0.001). At 6 months postsurgery, pain scores were also lower in the PGB group for VAS (0 vs 4, P = 0.001), DN4 score (0 vs 4, P = 0.001) and the ODI (10 vs 24, P = 0.001). Improvement in the functionality and sleep quality of the PGB group was noteworthy (P = 0.018)., Conclusions: PGB has analgesic/antihyperalgesic effects on postoperative neuropathic pain after surgery for lumbar disc hernia. Our findings show that this benefit increases with time.

This review provides current data on the failed back surgery syndrome (FBSS) of lumbar degenerative disease. The full range of complications forming this term is described. The data on the frequency and risk factors of various forms of FBSS are presented. General symptoms and diagnosis of the main FBSS forms are described. The questions of prevention and treatment of FBSS are considered.

Background: Chronic neuropathic pain has been recognized as contributing to a significant proportion of chronic pain globally. Among these, spinal pain is of significance with failed back surgery syndrome (FBSS), generating considerable expense for the health care systems with increasing prevalence and health impact., Objective: To assess the role and effectiveness of spinal cord stimulation (SCS) in chronic spinal pain., Study Design: A systematic review of randomized controlled trials (RCTs) of SCS in chronic spinal pain., Methods: The available literature on SCS was reviewed. The quality assessment criteria utilized were Cochrane review criteria to assess sources of risk of bias and Interventional Pain Management Techniques - Quality Appraisal of Reliability and Risk of Bias Assessment (IPM - QRB) criteria for randomized trials.The level of evidence was based on a best evidence synthesis with modified grading of qualitative evidence from Level I to Level V.Data sources included relevant literature published from 1966 through March 2015 that were identified through searches of PubMed and EMBASE, manual searches of the bibliographies of known primary and review articles, and all other sources., Outcome Measures: RCTs of efficacy with a minimum 12-month follow-up were considered for inclusion. For trials of adaptive stimulation, high frequency stimulation, and burst stimulation, shorter follow-up periods were considered., Results: Results showed 6 RCTs with 3 efficacy trials and 3 stimulation trials. There were also 2 cost effectiveness studies available. Based on a best evidence synthesis with 3 high quality RCTs, the evidence of efficacy for SCS in lumbar FBSS is Level I to II. The evidence for high frequency stimulation based on one high quality RCT is Level II to III. Based on a lack of high quality studies demonstrating the efficacy of adaptive stimulation or burst stimulation, evidence is limited for these 2 modalities., Limitations: The limitations of this systematic review continue to require future studies illustrating effectiveness and also the superiority of high frequency stimulation and potentially burst stimulation., Conclusion: There is significant (Level I to II) evidence of the efficacy of spinal cord stimulation in lumbar FBSS; whereas, there is moderate (Level II to III) evidence for high frequency stimulation; there is limited evidence for adaptive stimulation and burst stimulation.

Objective: Neuropathic pain screening tools have shown promise in identifying common neuropathic pain characteristics that derive from diverse etiologies (e.g., diabetic peripheral neuropathy, postherpetic neuralgia). However, no prior studies have specifically assessed whether these tools are capable of discerning the underlying pain mechanisms in the vast, heterogeneous group of patients diagnosed with failed back surgery syndrome (FBSS)., Design: In this clinical observational study, two tests for neuropathic pain characteristics, the Douleur Neuropathique en 4 (DN4) and Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) questionnaires, were performed on 43 subjects with FBSS. Subjects underwent physical or neurosensory exam components of the DN4 and LANSS in the region of most severe pain (e.g., axial low back or lower extremities). DN4 and LANSS scores were correlated with clinical history and neurologic exam, pain-related quality of life questionnaires, and compared to an independent assessment of pain distribution., Results: The presence of neuropathic characteristics, determined by the DN4 (62% sensitivity, 44% specificity), LANSS (38% sensitivity, 75% specificity; cut-offs of 4 and 12, respectively), or their combination (20% sensitivity, 58% specificity) was associated with higher pain intensity as measured by the visual analog scale (DN4 > 4, P = 0.001; LANSS ≥ 12, P = 0.042), modified Brief Pain Inventory-Short Form (DN4 > 4, P = 0.001; LANSS ≥ 12, P = 0.082), and Neuropathic Pain Symptom Inventory (DN4 > 4, P = 0.001; LANSS ≥ 12, P = 0.001), and greater pain-related functional impairment as measured by the Roland-Morris Disability Questionnaire (DN4 > 4, P = 0.006; LANSS ≥ 12, P = 0.018). The percentage of subjects characterized as neuropathic by the DN4 and LANSS lacked concordance (67.4 vs. 25.6), and the distribution of most severe symptoms (i.e., axial vs radicular) did not correlate with subjects determined to have neuropathic pain., Conclusions: Unlike other neuropathic syndromes, the neuropathic component of FBSS is less reliably identified by the LANSS and DN4., (Wiley Periodicals, Inc.)

Failed back surgery syndrome (FBSS) is defined as persistent pain more than 3 months after any form of spinal surgery. Due to its multifactorial origin, FBSS is often difficult to treat. In this context of failed back surgery, a very thorough assessment must be conducted concerning the site and characteristics of the pain (nociceptive or neuropathic), its mode of onset (presence or absence of pain-free intervals), and its impact on the patient's work and social life. Physical examination must exclude a non-spinal cause for the pain. MRI is the imaging modality of choice in this disease, but is often difficult to interpret, as MR signals are modified for 6 months after the operation. Scar tissue, which can be distinguished from recurrent disc hernia by its gadolinium enhancement, is present even in asymptomatic patients. After having eliminated infection and sacroiliac or posterior facet joint disease, the main aetiologies investigated are foraminal stenosis, degenerative disc disease, recurrent disc hernia, and non-union of spinal fusion; sometimes patients only experience persistent neuropathic pain. The treatment of failed back surgery syndrome with a predominant neuropathic component is based on the use of analgesics, especially antiepileptics, antidepressants or transcutaneous electrical stimulation. Epidural spinal infiltration should be considered as second-line treatment in view of the risk of serious neurological complications. Management must be based on a global, multidisciplinary approach with identification of any cognitive or behavioural disorders in combination with an appropriate functional rehabilitation programme., (Copyright © 2015 Elsevier Masson SAS. All rights reserved.)

Background: Failed back surgery syndrome is a complication of spine surgery that leads to chronic pain and disability, often with disastrous emotional consequences to the patient., Aim: To compare the profile of patients whose first surgery was performed in our hospital versus a group that underwent first spine surgery in a different centre., Methods: Retrospective study with 65 patients; 18 formed group I (first spine surgery performed in our institution), and 47 patients in group II (first surgery performed in another hospital). Background, demographic, clinical features and functional status were compared. In group I the majority of the cases had a previous diagnosis of lumbar stenosis (group I 44.4% vs group II 25.5% p = 0.22), whereas disk herniation was the main diagnosis in group II (group I 22.2% vs group II 61.7% p = 0.001). The main cause of the syndrome in group I was technical error during surgery (61.1%), while in group II this cause represented only 6.3% (p=.001). Among the patients of this latter group, misdiagnosis was highly prevalent (57.4%), against no cases in group I (p=.001). The preoperative functional status between both groups and their recovery in the immediate postoperative period was similar (p = 0.68)., Conclusions: This study suggests that the diagnostic and treatment standards are different between healthcare centres, specifically between academic centres vs. private practice., (Copyright © 2015 Academia Mexicana de Cirugía A.C. Published by Masson Doyma México S.A. All rights reserved.)

We sought to assess the extent to which pain relief in chronic back and leg pain (CBLP) following spinal cord stimulation (SCS) is influenced by patient-related factors, including pain location, and technology factors. A number of electronic databases were searched with citation searching of included papers and recent systematic reviews. All study designs were included. The primary outcome was pain relief following SCS, we also sought pain score (pre- and post-SCS). Multiple predictive factors were examined: location of pain, history of back surgery, initial level of pain, litigation/worker's compensation, age, gender, duration of pain, duration of follow-up, publication year, continent of data collection, study design, quality score, method of SCS lead implant, and type of SCS lead. Between-study association in predictive factors and pain relief were assessed by meta-regression. Seventy-four studies (N = 3,025 patients with CBLP) met the inclusion criteria; 63 reported data to allow inclusion in a quantitative analysis. Evidence of substantial statistical heterogeneity (P < 0.0001) in level of pain relief following SCS was noted. The mean level of pain relief across studies was 58% (95% CI: 53% to 64%, random effects) at an average follow-up of 24 months. Multivariable meta-regression analysis showed no predictive patient or technology factors. SCS was effective in reducing pain irrespective of the location of CBLP. This review supports SCS as an effective pain relieving treatment for CBLP with predominant leg pain with or without a prior history of back surgery. Randomized controlled trials need to confirm the effectiveness and cost-effectiveness of SCS in the CLBP population with predominant low back pain., (© 2013 The Authors Pain Practice Published by Wiley Periodicals, Inc. on behalf of World Institute of Pain.)

This article describes the costs and risk factors for failed back surgery syndrome and reviews the diagnosis and treatment strategies commonly used to address this syndrome. The purpose of this review is to describe some of the treatment pitfalls associated with these approaches from a physiatric perspective., (Copyright © 2014 Elsevier Inc. All rights reserved.)

This article reviews the imaging of lumbar spinal fusion and its major indications. The most common procedures are described for the purpose of allowing understanding of postoperative imaging. Imaging options are reviewed for preoperative workup, intraoperative guidance, and postoperative purposes. Examples of hardware integrity, fusion, and loosening are provided., (Copyright © 2014 Elsevier Inc. All rights reserved.)