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Objectives Materials and Methods Results Conclusions Lumbar spine surgery is a common procedure for treating disabling spine‐related pain. In recent decades, both the number and cost of spine surgeries have increased despite technological advances and modification in surgical technique. For those patients that have continued uncontrolled back and/or lower extremity pain following lumbar spine surgery, spinal cord stimulation (SCS) has emerged as a viable treatment option. However, the impact of lumbar spine surgical history remains largely unstudied. Specifically, the current study considers the impact of number of prior lumbar spine surgeries on pain relief outcomes following SCS implantation.We queried the electronic medical record of five separate pain practices for all patients who have undergone a SCS implant between January 1, 2017, and March 1, 2020. Inclusion criteria consisted of any patients with an SCS implant who underwent a prior lumbar spine surgery. The primary outcome was the mean calculated percentage pain relief in patients based on number of prior lumbar spine surgeries.There was a total of 1974 total SCS implant cases identified across five separate pain clinics. There was no difference in mean calculated pain relief in patients with one prior spine surgery versus those with two or more prior spine surgeries (28.2% vs. 25.8%, adjusted β‐coefficient –3.1, 95% CI –8.9 to 2.7, p = 0.290). Similarly, when analyzing number of spine surgeries as a continuous variable, there was no association between number of spine surgeries and calculated pain relief (adjusted β‐coefficient –1.5, 95% CI –4.0 to 1.1, p = 0.257). Additionally, after patients were stratified based on waveform, there was no association between number of prior lumbar spine surgeries (analyzed both as a categorical and continuous variable) and calculated percentage pain relief.This multicentered retrospective study found that there was no significant difference in pain scores in individuals who received SCS following one or more lumbar spine surgeries. Additionally, the waveform of the SCS device had no statistically significant impact on post‐operative pain scores following one or more lumbar spine surgeries. [ABSTRACT FROM AUTHOR]

Background: Spinal cord stimulation (SCS) is a cost‐effective option for treating refractory persistent spinal pain syndrome type‐2 (PSPS‐2). For patients with extensive spine instrumentation including the thoraco‐lumbar junction, percutaneous placement of SCS leads is usually not an option being paddle leads typically implanted anterograde. Paddle lead placement will be particularly challenging in more complex cases when the instrumentation covers the targeted level. To overcome this barrier, we studied using a retrograde approach to reach the sweet spot, facilitate the placement, and reduce associated risks. Objectives: To study the use of retrograde SCS paddle as a placement method to optimize the spinal cord target and reduce the risks of conventional placement in complex cases. Study Design: Case series and technical note. Methods: We present three cases of thoracic retrograde SCS paddle lead placement cases, detailing patient selection, operative technique, and outcome. All the cases had extensive instrumentation to the thoraco‐lumbar spine, and one had additional spinal canal stenosis. The surgical procedure entailed a retrograde midthoracic inter‐laminar approach, flavectomy, and caudal placement of the paddle lead with intraoperative neurophysiologic monitoring (IONM) guidance for functional midline determination. Results: All the cases had a successful lead placement over the sweet spot without complications. The same approach was used to decompress a focal spinal stenosis in one case. One case had significantly improved pain and hence underwent a pulse generator implant. The other cases had non‐satisfactory pain control and were explanted. Limitations: These case description could guide technical procedural steps, however, a larger number of such cases would be needed to describe further technical nuances. Conclusions: We demonstrated that placing SCS paddle leads via retrograde midthoracic approach with IONM guidance is safe. This procedure should be an option for SCS paddle implants in patients with posterior spinal fusion encompassing the intended targeted spinal stimulation level. [ABSTRACT FROM AUTHOR]

Background: Failed back surgery syndrome (FBSS) is a constellation of conditions occurring after spine surgeries, characterized by the presence of persistent or recurring low back pain that has a significant impact on patients' quality of life. Neuromodulation in the form of Spinal Cord Stimulation (SCS) is considered an indispensable treatment modality in the management of certain chronic pain conditions and it is showing good results for improvement in pain scores and functional capacity of the FBSS patients. Objectives: To assess the change in pain scores, quality of life, and opioid medication intake as an outcome of neuromodulation procedures performed on patients diagnosed with failed back surgery syndrome, and to detect the post‐procedure complications. Methods: A prospective observational study was conducted at two university hospitals in Egypt and the U.S.A. during the period from September 2019 to August 2021 for patients who underwent spinal cord stimulation procedures for FBSS with follow‐up period of at least 1 year. Patients who are 18 years old or older diagnosed with FBSS for more than 6 months and treated with spinal cord stimulation with successful trials during this time frame were included in the study. Results: Thirty‐four patients were included in this study who had successful SCS trials and underwent permanent implantation of SCS devices with post‐procedure follow‐up period of 12 months. Patients showed a median pain numerical rating scale (NRS) of 7/10 at baseline with a median NRS of 4/10 through the follow‐up period. Basic mobility and daily activity scores assessed by activity measure of post‐acute care (AM‐PAC) showed significant improvement from the mean of 16.87 ± 2.74 at baseline to a mean of 19.97 ± 2.93 through follow‐up. In addition, there was a reduction in opioid medication usage. Post‐procedure complications was of low percentage with the most detected were battery dysfunction in 7 patients and pocket pain in 6 patients. Reoperation was needed in 13 patients with 4 needed just revision and 9 patients required a complete removal of the device. Conclusion: Spinal cord stimulation is an effective modality of treatment for cases of failed back surgery syndrome with a statistically significant reduction in pain scores and a significant improvement in quality of life. Also, it achieves a recognizable reduction in opioid analgesic medications, with a reliable safety profile as detected with the recorded post‐procedure complications. However, randomized controlled trials with more patients and long‐term follow‐up are highly recommended. [ABSTRACT FROM AUTHOR]

Objectives: Chronic pain has a substantial negative impact on work‐related outcomes, which underlines the importance of interventions to reduce the burden. Spinal cord stimulation (SCS) efficiently relieves pain in specific chronic pain syndromes and is recommended for treating failed back surgery syndrome (FBSS) or post‐surgical chronic back pain that is refractory to other treatments. To examine the impact of SCS in patients with FBSS on the return to work (RTW), we determined the RTW rate and the factors positively associated with the RTW. Materials and Methods: Among 106 patients with FBSS who benefitted from SCS at a single institution in France between September 1999 and March 2010, we retrospectively included 59 who had stopped work at the time of SCS because of disability or sick leave and evaluated the RTW (rate and predictors, estimating odds ratios [ORs] and 95% confidence intervals [CIs]). Results: The mean (SD) post‐surgery follow‐up for the 59 patients (34 men; mean [SD] age 46.9 [7.4] years) was 7.5 (3.6) years (range 5–15). The RTW rate was 30.5%, with a median [IQR] recovery time of 5.5 months [3–8.5]. RTW was improved with functional improvement evolution (OR 1.1, 95% CI [1.01–1.1], p = 0.02) and was reduced with unemployment > 3 years (OR 0.1, 95% CI [0.01–0.7], p = 0.02). Conclusions: Our protocol for SCS for patients with FBSS, including a strict selection of patients and a multidisciplinary approach, led to good results, especially for the RTW. RTW should be a therapeutic goal, directly affecting indirect costs related to FBSS. [ABSTRACT FROM AUTHOR]

Introduction: Traditional spinal cord stimulation (t‐SCS) has been used to treat chronic pain for over 50 years. However, up to 30% of patients undergo explant, with the main indication being loss of efficacy (LoE), and few alternative treatment options exist for these patients. Strategies to mitigate LoE commonly include conversion to another type of SCS (termed 'salvage' or 'rescue'). This review summarizes the existing literature concerning the efficacy and safety of 10 kHz SCS as a salvage therapy. Methods: We searched PubMed, the Cochrane Library, ClinicalTrials.gov, and other sources between January 2009 and April 2021. Records were retained if the authors reported clinical outcomes with a minimum of ≥ 3 months of follow‐up in patients implanted with a Senza® 10 kHz SCS system in an effort to treat t‐SCS LoE. Results: Ten articles were eligible for inclusion, reporting 3 prospective studies and 7 retrospective reviews. In the single study that salvaged patients without a repeat trial prior to surgery, 81% of patients were responders (≥ 50% pain relief from baseline), with mean pain relief of 60%. Among repeat‐trial studies, the responder rate ranged from 46% to 80%, and mean pain relief from 47% to 68%. No unanticipated therapy‐related safety issues were reported among the included articles. Conclusion: Preliminary data suggest that chronic back and/or leg pain patients with t‐SCS LoE can experience improved and durable pain relief after conversion to 10 kHz SCS. However, additional research is needed to define predictors of success and establish whether salvage without a repeat trial is a viable conversion method. [ABSTRACT FROM AUTHOR]

Introduction: Dorsal root ganglion stimulation (DRG‐S) has recently emerged as a novel therapy in neuromodulation that demonstrated a higher rate of success than spinal cord stimulation (SCS) in a prospective, head‐to‐head randomized comparative trial to treat complex regional pain syndrome (CRPS) and causalgia. In contrast to SCS, DRG‐S also shows promise in treating conditions that are not purely neuropathic such as axial low back pain, which has a prominent nociplastic pain component. It is not known to what extent the effectiveness of DRG‐S for such indications is due to effective treatment of the neuropathic pain component versus the effects of DRG‐S on mechanical pain. Although rarely studied, reporting outcomes of DRG‐S to treat predominantly mechanical/nociceptive pain may help point toward expanding the utility of this therapy. Here, we present five cases of refractory mechanical pain treated with DRG‐S. Methods: A retrospective analysis of all patients who underwent a successful DRG‐S trial and implant between September 2017 and September 2021 at our institute was performed. Patients who had intractable joint pain without strong evidence of neuropathic pain were included in this case series. The Budapest criteria for CRPS, the Douleur Neuropathique 4 Questions (DN4) survey, or a definable nerve injury were used to determine the presence of neuropathic pain. Baseline assessments for pain (Numeric Rating Scale [NRS]), function (Oswestry Disability Index [ODI]), quality of life (EuroQol‐5 Dimension [EQ‐5D]), and other applicable joint surveys were extracted from pre‐trial baseline and follow‐up appointments. Results: Five patients were identified and included. Patient diagnoses consisted of refractory joint pain of the hip, knee, or ankle. Mean NRS pain scores improved by 74% from 9.2 at baseline to 2.4 at the last follow‐up (mean = 28 months post‐implant). From baseline to the last follow‐up, mean ODI scores improved by 65% from 66 to 23 and EQ‐5D scores more than doubled from an average of 0.371 to 0.797. Conclusion: This clinical report illustrates the potential utility DRG‐S has in treating pain that clinically presents as predominantly refractory mechanical joint pain without a significant neuropathic component. The physiological reasons for our observations may be that DRG‐S is able to directly influence the conduction of nociceptive signaling at the DRG and within the spinal cord. Further investigations are warranted to determine if DRG‐S is a potential treatment option for chronic mechanical pain. [ABSTRACT FROM AUTHOR]

The article offers information on the effectiveness of spinal cord stimulation (SCS) in treating Failed Back Surgery Syndrome (FBSS), showing significant improvements in pain reduction and quality of life (QoL) for patients. Topics include the impact of FBSS on QoL and psychological behavior, the variability in FBSS incidence, and the lack of clear consensus on its management.

Introduction: Dorsal root ganglion stimulation (DRG‐S) is a relatively new neuromodulation modality. Therefore, data on long‐term device explantation rates is limited. This investigation aimed to assess DRG‐S device explantation rates at long‐term follow‐up. Methods: We retrospectively reviewed individuals implanted with DRG‐S in four pain centers from different continuous periods between April 2016 to September 2020. We recorded patient demographics, diagnoses, duration to explantation or last follow‐up, treatment complications, and failure etiologies. Results: A total of 249 patients with 756 leads and a mean 27‐month follow‐up were included. The mean age was 55 ± 15 years; 148 (63%) were female. Leading diagnoses were CRPS (n = 106, 43%), followed by FBSS (n = 64, 26%), and non‐surgical low back pain (n = 23, 9%). The explantation rate was ~2% per year (n = 10 total). At explantation, the average time from implantation was 13 ± 10 months. Six patients were explanted for inadequate pain relief. Two patients were explanted due to device‐related complications. One patient was explanted secondary to infection and subsequently reimplanted. Five explanted patients experienced a therapy‐related complication before eventual explantation: one transient post‐procedural neuritis and pocket site pain, one lead fracture, two lead migrations, and one experienced a fracture, a migration, and pocket site pain. Discussion: This large retrospective study of DRG‐S revealed a low therapy‐termination rate. The rate of infection leading to explantation was objectively very low at 0.4%. The leading cause of explantation was inadequate pain relief. Explanted patients often had a therapy‐related complication. Therefore, minimizing adverse treatment events may reduce ultimate explantation rates. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

The article discusses a study by Dauriac-Le Masson et al., examining the efficacy of spinal cord stimulation (SCS) in facilitating the return to work (RTW) for patients with failed back surgery syndrome (FBSS). Topics include the study's focus on patients with failed back surgery syndrome (FBSS), the significant impact of chronic pain on disability and work capability, and the positive correlation observed between spinal cord stimulation (SCS).

Introduction: Spinal cord stimulation (SCS) is effective for patients with failed back surgery syndrome (FBSS). SCS improves their pain, as well as their functionality and health‐related quality of life. Different waveforms for SCS have emerged that show improvement in small prospective studies. Analysis of real‐world data shows the clinical implementation and the effect of different waveforms in SCS. Methods: A real‐world analysis was performed of 208 patients with FBSS who were treated over 3 years. Stimulators with tonic, burst, high‐density, and 10‐kHz high‐frequency (HF10) waveforms were implanted in patients with FBSS who had predominant pain in the back, legs, or both back and legs. Pain as measured by the VAS, functional disability as measured by the Oswestry Disability Index (ODI), and health‐related quality of life as measured by the 3‐level EuroQol 5‐Dimension (EQ5D‐3L) questionnaire were determined at baseline and for outcome assessment. Results: SCS is effective for patients with FBSS. This analysis showed a change in baseline VAS score from 8.0 to 4.7 (P < 0.0001) at 24 months. The EQ5D‐3L score improved from 0.29 to 0.49 (P < 0.0001) at 24 months. The ODI score improved from 54% to 42% (P < 0.0001) at 24 months. The unanticipated explantation rate was only 1.6%. Conclusion: This study of SCS showed significant long‐term improvement in pain, disability, and quality of life in a large dataset of patients with FBSS. Strict selection procedures and a strong opioid policy contributed to the high success rate and low unanticipated explantation rate. There was no difference in pain reduction between tonic and HF10 stimulation. Further investigation is necessary to detect any difference between other waveforms of SCS. [ABSTRACT FROM AUTHOR]

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 < 0.001). Conclusions: Our study suggests that socioeconomic disparities may exist in the utilization of SCS among hospitalized patients with CRPS I and FBSS the United States. However, confirming these data from other administrative databases, in the outpatient setting, may shed more insight. [ABSTRACT FROM AUTHOR]

Introduction: The effectiveness of spinal cord stimulation (SCS) as pain‐relieving treatment for failed back surgery syndrome (FBSS) has already been demonstrated. However, potential structural and functional brain alterations resulting from subsensory SCS are less clear. The aim of this study was to test structural volumetric changes in a priori chosen regions of interest related to chronic pain after 1 month and 3 months of high‐frequency SCS in patients with FBSS. Methods: Eleven patients with FBSS who were scheduled for SCS device implantation were included in this study. All patients underwent a magnetic resonance imaging protocol before SCS device implantation 1 and 3 months after high‐frequency SCS. Pain intensity, pain catastrophizing, and sleep quality were also measured. Regions‐of‐interest voxel‐based morphometry was used to explore grey matter volumetric changes over time. Additionally, volumetric changes were correlated with changes in pain intensity, catastrophizing, and sleep quality. Results: Significant decreases were found in volume in the left and right hippocampus over time. More specifically, a significant difference was revealed between volumes before SCS implantation and after 3 months of SCS. Repeated‐measures correlations revealed a significant positive correlation between volumetric changes in the left hippocampus and changes in back pain score over time and between volumetric changes in the right hippocampus and changes in back pain score over time. Conclusion: In patients with FBSS, high‐frequency SCS influences structural brain regions over time. The volume of the hippocampus was decreased bilaterally after 3 months of high‐frequency SCS with a positive correlation with back pain intensity. [ABSTRACT FROM AUTHOR]

Objective: To identify variables that influence pain reduction following peripheral nerve field stimulation (PNFS) in order to identify a potential responder profile. Methods: Exploratory univariate and multivariate (random forest) analyses were performed separately on 2 randomized controlled trials and a registry; all included patients with chronic back pain, mainly failed back surgery syndrome. An international expert panel judged the clinical relevance of variables to identify responders by consensus. Results: Variables identified that may help predict PNFS success in patients with back pain include patient and pain characteristics (age, time since onset of pain and spinal surgery, pain medication history, position and size of pain area, pain severity, mixed nociceptive/neuropathic pain, health‐related quality of life, depression, functional disability, and leg pain status), implant procedure variables (the number and position of leads, paresthesia coverage, and amount of pain relief during the trial), and programming (number of programs, cathodes, and anodes; pulse rate; pulse width; and percentage of device usage). Conclusions: While these analyses are exploratory and restricted to a limited sample size, they suggest variables that may play a role in predicting a therapeutic response. These results, however, are informative only and should be cautiously interpreted. Future research to validate the variables in a clinical study is needed. [ABSTRACT FROM AUTHOR]

Background: Stimulation of the dorsal root ganglion (DRG‐S) has been shown to be an efficacious treatment option for refractory neuropathic pain syndromes. However, placement of the percutaneous leads for trial implantation can be challenging in patients with prior spinal surgical interventions resulting in anatomical changes and adhesions. Methods: This technical report describes the transgrade placement of DRG‐S leads in 4 patients with back pain surgery histories in whom secondary to specific anatomical pathologies the traditional anterograde placement of DRG‐S leads was not feasible. Results: We used a transgrade placement approach, entering superior and contralateral to the target level of placement, resulting in uncomplicated and effective placement of DRG‐S leads. Conclusions: Transgrade lead placement for DRG‐S may be an efficacious alternative to traditional anterograde DRG lead placement in cases where interlaminar access below the level of the DRG is not available, or desirable. Further studies are needed to clarify the safety and applicability of this approach. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Introduction: Pain associated with chronic pancreatitis is often difficult to treat. On many occasions, interventional techniques may be necessary. In recent years, spinal cord stimulation techniques have been used successfully in the treatment of these patients. However, only the use of traditional tonic stimulation based on paresthesias has been published for this purpose. Spinal cord burst stimulation has been shown to be more effective than tonic stimulation, especially in failed back surgery syndrome. Case description: We present the case of an 82‐year‐old patient with incoercible pain related to chronic pancreatitis for the preceding 5 years. She had shown good short‐term results with lidocaine‐cortisone blocks and celiac plexus radiofrequency. After a failed trial period with low‐frequency conventional tonic stimulation, she was successfully treated with burst stimulation. Results: A sustained pain score reduction of over 50% on the visual analogue scale was seen, as were a decrease in opioid consumption and a high degree of satisfaction with the therapy by our patient. [ABSTRACT FROM AUTHOR]

Introduction: Surgical lumbar discectomy is a commonly performed routine spinal procedure that is usually undertaken to alleviate lumbar radicular symptoms caused by a herniated intervertebral disc. Surgical lumbar discectomy can also lead to chronic postsurgical leg and/or back pain (failed back surgery syndrome [FBSS]), a condition that can be refractory to conventional medical management. Early clinical results on the use of dorsal root ganglion (DRG) stimulation for FBSS have supported the use of this treatment alternative. Methods: A multicenter, single‐arm, observational cohort study enrolled patients who had chronic pain following surgical lumbar discectomy, had failed conservative treatments, and reported pain intensity of at least 6 out of 10 in the primary region of pain. Data were collected on pain, quality of life, disability, and mood at baseline and through 12 months. Results: Thirteen patients underwent a trial of DRG stimulation; 11 (84.6%; 95% confidence interval = 57.8% to 95.7%) had good outcomes and underwent permanent device placement. Pain was reduced from a score of 8.64 (±0.92) at baseline to 2.40 (±2.38; n = 9) after 12 months of treatment, a 72.05% average reduction (P < 0.001). Similar improvements were observed across the secondary clinical measures, and safety data were in line with published rates. Discussion: These results suggest that DRG stimulation induces pain relief in subjects diagnosed with FBSS. These reductions in pain were also associated with improvements in quality of life and disability. Additional prospective studies are warranted to further investigate this potential application of DRG stimulation, as well as to optimize patient selection, lead placement, and programming strategies. [ABSTRACT FROM AUTHOR]

Spinal cord stimulation (SCS) is a minimally invasive therapy used for the treatment of chronic neuropathic pain. SCS is a safe and effective alternative to medications such as opioids, and multiple randomized controlled studies have demonstrated efficacy for difficult‐to‐treat neuropathic conditions such as failed back surgery syndrome. Conventional SCS is believed mediate pain relief via activation of dorsal column Aβ fibers, resulting in variable effects on sensory and pain thresholds, and measurable alterations in higher order cortical processing. Although potentiation of inhibition, as suggested by Wall and Melzack's gate control theory, continues to be the leading explanatory model, other segmental and supraspinal mechanisms have been described. Novel, non‐standard, stimulation waveforms such as high‐frequency and burst have been shown in some studies to be clinically superior to conventional SCS, however their mechanisms of action remain to be determined. Additional studies are needed, both mechanistic and clinical, to better understand optimal stimulation strategies for different neuropathic conditions, improve patient selection and optimize efficacy. [ABSTRACT FROM AUTHOR]

Abstract: Background and Aims: Persistent low back pain after initially successful surgery that is not attributed to structural deficits is called failed back surgery syndrome (FBSS). When conservative and minimal invasive therapy fail, the recommended treatment is spinal cord stimulation (SCS). Because epidural fibrosis can be a contributing factor in the majority of FBSS patients, lumbosacral epiduroscopic lysis of adhesions may be considered as a less invasive alternative treatment option. We hypothesized that the use of epiduroscopic lysis of adhesions could reduce the need for SCS. Methods: A pilot study was performed in 35 consecutive patients with FBSS who underwent epiduroscopic lysis of adhesions. SCS was considered if epiduroscopic lysis of adhesions gave less than 50% global perceived effect (GPE) improvement after 15 months of follow‐up. The GPE was measured 1 week and 6 months after the procedure. Results: Over a period of 69 months, 35 patients were included. After 15 months of follow‐up, 43% of patients required SCS. Eight of the 15 patients who reported no short‐term improvement needed SCS; those patients had severe epidural fibrosis. One week after epiduroscopic lysis of adhesions, 34%, 23%, and 43% of patients reported GPE improvement of > 50%, 20% to 50%, and < 20%, respectively. After 6 months, 5 patients were lost to follow‐up, and 30%, 17%, and 16% of patients reported improvement of > 50%, 20% to 50%, and < 20%, respectively. Conclusions: In this pilot study we observed a reduced need for SCS when lumbosacral epiduroscopic lysis of adhesions was used for patients with FBSS and magnetic resonance imaging–proven adhesions. These observations justify the evaluation of both treatment options in a prospective observational trial. [ABSTRACT FROM AUTHOR]

Abstract: Background: Spinal cord stimulation (SCS) is an effective therapy to reduce pain in patients who suffer from failed back surgery syndrome (FBSS). In order to inform patients optimally prior to this therapy, knowing their expectations is crucial. Methods: Thirteen patients suffering from FBSS and scheduled for SCS were interviewed using a semistructured protocol. Patients were interviewed either at home or at their treating hospital. Data from these interviews were analyzed using directed content analysis. In addition to the qualitative interviews, an adjusted Brief Pain Inventory questionnaire was used to quantify expectations. Results: The expectations of patients with regard to SCS could be subdivided into 13 categories, which could be grouped into 6 general themes: (1) physical well‐being, (2) social well‐being, (3) material well‐being, (4) emotional well‐being, (5) development and activity, and (6) constraints of the procedure of SCS. These findings confirm patients’ expectations about the improvement of their quality of life by SCS for FBSS. This indicates that assessing pain relief is not enough to adequately evaluate the effects of SCS. The small diversity within the studied population and the lack of patient‐to‐patient education are 2 possible limitations of this study. Conclusions: To improve education for patients prior to SCS surgery and to evaluate the effects of SCS, a multidimensional approach needs to be implemented. Possible disadvantages of SCS need to be discussed prior to the treatment. [ABSTRACT FROM AUTHOR]

Abstract: Introduction: Chronic low back pain affects millions of people worldwide and can arise through a variety of clinical origins. In the case of failed back surgery syndrome (FBSS), previous surgical procedures can contribute to low back pain that is often unresponsive to intervention. Although spinal cord stimulation (SCS) can be an effective treatment modality, it does not provide sufficient pain relief for some intractable cases. Recently, alternative neuromodulation options have been developed, including dorsal root ganglion (DRG) stimulation. The objective of this report is to further investigate these clinical observations. Methods: Twelve patients with significant chronic discogenic low back pain due to FBSS were included. All subjects underwent implantation of DRG stimulation systems that had at least 1 lead placed at L2 or L3. Subjects’ pain ratings, mood, and quality of life were tracked prospectively for up to 12 months. Results: More than half of subjects reported 50% or better pain relief in the low back, and the average low back pain relief was 45.5% at 12 months. Concomitant reductions in overall pain, leg pain, pain interference, mood, and quality of life were also found. Discussion: For the studied population, DRG stimulation at the L2–L3 levels was effective at relieving low back pain. These reductions in pain were associated with improvements in quality of life. Thus, DRG stimulation at these levels may be effective for low back pain by recruiting both segmental and nonsegmental neural pathways that are not otherwise accessible via traditional SCS. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Introduction Spinal cord stimulators ( SCS) are used to treat various chronic pain states. Establishing patient outcomes in terms of pain control, opioid medication use, and overall satisfaction is vital in maintaining SCS's role in clinical practice. Methods All patients who underwent SCS implantation between January 2001 and December 2011 at a tertiary academic pain medicine center were included if he or she underwent permanent cervical or thoracolumbar dorsal column SCS implantation and age was 18 or greater. For the 199 patients who met inclusion criteria, data were collected retrospectively. Preimplant information included indication for implantation, Numeric Rating Scale ( NRS) score, and dose in oral morphine equivalents ( OME). Postimplant NRS score was recorded at 6 months and 1 year. OME requirement and patient satisfaction were determined at 1 year postimplantation. Results This data set showed an overall decrease in OME requirements and NRS scores at both 6 months and 1 year. These differences were statistically significant ( P < 0.01) compared to preimplantation values. Additionally, 84.27% of patients were satisfied with their implants at 1 year. Patient outcomes were analyzed further in respect to implant indication; groups included failed back surgery syndrome ( FBSS), complex regional pain syndrome ( CRPS), angina, and other. For all groups, there were statistically significant ( P < 0.01) decreases in NRS scores at 6 months and 1 year. In the FBSS and CRPS groups, statistically significant ( P < 0.02) decreases in OME usage existed. Conclusion Retrospective review of patients with spinal cord stimulators revealed OME reduction at 1 year for those patients in the FBSS and CRPS groups; patient satisfaction at 1 year and NRS score reduction at 6 months and 1 year were statistically significant for all groups. [ABSTRACT FROM AUTHOR]

Introduction Many studies have demonstrated the efficacy and the medical/economic value of epidural spinal cord stimulation for the treatment of 'failed back surgery syndrome' ( FBSS). However, the back pain component of FBSS has been recalcitrant. Recent clinical trials have suggested that multicolumn surgically implanted leads combined with enhanced programming capabilities in the newer implantable pulse generators demonstrate the ability to treat the back pain component of FBSS. The objective of our present international multicentre study is to prospectively evaluate these findings in a larger population. Methods We conducted a prospective, nonrandomized, observational study on 76 patients with refractory FBSS, consecutively implanted with multicolumn spinal cord stimulation ( SCS) between 2008 and 2011 in three neurosurgical pain management centers (Poitiers, France; Montréal, Canada; and Regina, Canada). The primary objective of this study was to prospectively analyze the effect of multicolumn lead programming on paresthesia coverage for the back pain region in these patients. The secondary objective was to assess the analgesic efficacy of this technique on the global and back pain components. Results Paresthesia could be induced in the lower extremities in the majority of patients with at least one of the configurations tested. Bilateral low back paresthesia was induced in 53.5% of patients, while unilateral low back paresthesia was induced in 78.9% of patients. Multicolumn configurations were statistically more effective than monocolumn configurations for all anatomic regions studied. At 6 months, 75.4% of patients receiving multicolumn stimulation ( n = 57) obtained at least a 30% improvement of the back pain VAS score, while 42.1% of patients obtained at least a 50% improvement of the back pain VAS score. Conclusion This study confirms the hypothesis that multicolumn SCS should be considered as an important tool in the treatment of radicular and axial pain in FBSS patients. The efficacy of this modality is based on a rigorous patient selection process, access to new generation lead technologies, but most importantly an algorithmic programming approach for optimal stimulation and electrical field shaping. With over 40 million potential programming combinations associated with 16 contact leads to achieve paresthesia coverage, optimal stimulation is often missed as either the patient or the clinician become exhausted or overwhelmed during the course of therapy programming and optimization session. [ABSTRACT FROM AUTHOR]

Introduction Ziconotide is an intrathecally administered nonopioid analgesic for the treatment of severe chronic pain. Previous reports have noted rhabdomyolysis in patients receiving ziconotide during the initial single-shot trial or due to concurrent medical problems. We present a case of an acute rhabdomyolysis following an intrathecal bolus injection of ziconotide on a patient who had long-term exposure to the drug. Case Report The patient suffered from chronic neuropathic pain with diagnosis of failed back surgery syndrome and received intrathecal ziconotide for 2 years. Moderate side effects resulting from dose escalation led to a discontinuation of the drug. The pump medication was changed to morphine, which failed to provide adequate analgesia even with dose titration. A single intrathecal bolus of ziconotide, as an adjunctive therapy, resulted in good pain control. Two months later, the patient received a second ziconotide injection. Sixteen hours after the injection, she presented to local emergency center with nausea, vomiting, diarrhea, and myalgia. She had significantly increased CK levels and was admitted for intravenous hydration and close observation. Her serum CK level peaked at 4940 IU/L. The patient was discharged on hospital day 3 with a CK level of 808 IU/L. Her symptoms resolved without renal impairment. Discussion The clinical scenario described is a case of acute rhabdomyolysis from an intrathecal bolus injection of ziconotide in a patient with prior long-term exposure to the drug. The decrease in CK levels coincided well with the average half-life of ziconotide; however, the rhabdomyolysis may have been potentiated by hypokalemia. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Patients who suffer from the condition known as failed back surgery syndrome ( FBSS) present to the offices of physicians, surgeons, and pain specialists alike in overwhelming numbers. This condition has been defined as persistent back and/or leg pain despite having completed spinal surgery. As lumbar surgery continues to grow in prevalence, so will the number patients suffering from FBSS. It is important for physicians treating this population to expand their knowledge of FBSS etiologies and appropriate diagnostic imaging modalities, combined with confirmatory diagnostic injections, and proper technique for interventional pain procedures. In doing so, the physician may adequately be prepared to manage these complex cases in the future, ideally with the support of stronger evidence. Management begins with a systematic evaluation of common FBSS etiologies such as new-onset stenosis, recurrent herniated nucleus pulposus ( HNP), epidural fibrosis, pseudarthrosis, and others. History and physical may be supplemented by imaging including X-ray, magnetic resonance imaging, or computed tomography myelography. Certain diagnoses may be confirmed with diagnostic procedures such as intra-articular injections, medial branch blocks, or transforaminal nerve root blocks. Once an etiology is determined, a multidisciplinary approach to treatment is most effective. This includes exercise or physical therapy, psychological counseling, medication, and interventional procedures. The most invasive treatment option, short of revision surgery, is spinal cord stimulation. This intervention has a number of studies demonstrating its efficacy and cost-effectiveness in this population. Finally, revision surgery may be used when indicated such as with progressive neurological impairment or with issues regarding previous surgical instrumentation. [ABSTRACT FROM AUTHOR]

Appropriate patient selection and minimizing complications are critical for successful spinal cord stimulation (SCS) therapy in managing intractable pain. We thus reviewed electronic medical records of 707 consecutive cases of patients who received SCS therapy in the Cleveland Clinic from 2000 to 2005 with an emphasis on indications and complications. SCS was used to treat complex regional pain syndrome (CRPS) (345 cases), failed back surgery syndrome (235 cases), peripheral vascular disease (20 cases), visceral pain in the chest, abdomen, and pelvis (37 cases), and peripheral neuropathy (70 cases). CRPS and failed back surgery syndrome accounted for 82% of the cases. The implant-to-trial ratio was 75% on average, with the highest for CRPS type 2 (83%) and the lowest for peripheral vascular diseases (65%). The only documented complication associated with SCS trials was lead migration in 5 of 707 patients (0.7%). There were no permanent neurological deficits or deaths as a result of SCS implant or its complications. Hardware-related complications were common (38%) and included lead migration (22.6%), lead connection failure (9.5%), and lead breakage (6%). Revisions or replacements were required in these cases. Biologically related complications included pain at the generator site (12%) and clinical infection (4.5%; 2.5% with positive culture). The rates of infection varied among the different diagnoses with the highest in failed back surgery syndrome (6.3%). Patients with diabetes had an infection rate of 9%, over the 4% in non-diabetics. Infections were managed successfully with explantation and antibiotic therapy without permanent sequela. [ABSTRACT FROM AUTHOR]

Failed back surgery syndrome (FBSS) has been reported to account for up to 40% of patients with chronic low back pain. Epidural fibrosis may be responsible for up to 30% of all cases of FBSS. Perineural fibrosis can interfere with cerebrospinal fluid-mediated nutrition, rendering the nerve root hyperesthetic and hypersensitive to compression. Traditionally, steroid injection has been used to treat low back pain and radiculopathy. The addition of hyaluronidase to the injectate has been reported to reduce the degree of fibrosis. To evaluate the role of hyaluronidase when added to fluoroscopically guided caudal steroid and hypertonic saline in patients with FBSS. Thirty-eight patients with back pain because of FBSS were studied. Twenty patients received fluoroscopically guided caudal epidural steroid, local anesthetic, and hypertonic saline in combination (group 1), and 18 patients received fluoroscopically guided caudal epidural steroid, hypertonic saline, local anesthetic, and hyaluronidase (group 2). Patients were asked to rate their pain using a verbal scale of 0 to 4 (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = extremely severe). Lumbar spine range of motion and opioid intake were measured. Significant improvement in short-term pain relief was noted in both groups, while significant long-term pain relief was only achieved in group 2 patients. The addition of hyaluronidase to fluoroscopically guided caudal epidural steroid and hypertonic saline combination improved long-term pain relief in patients with FBSS. [ABSTRACT FROM AUTHOR]

With the recent technological advances, neurostimulation has provided new hope for millions of patients with debilitating chronic pain conditions that respond poorly to other therapies. Outcome research demonstrated that patients with failed back surgery syndrome and complex regional pain syndromes benefit significantly from neurostimulation in pain reduction, functional capacity, and quality of life. Increasing clinical evidence supports the use of neurostimulation in post-herpetic neuralgia, peripheral neuropathy, occipital neuralgia, and other neuropathic pain conditions. Strong clinical evidences indicate that neurostimulation offers less invasive and more effective therapies for many patients with ischemic pain caused by cardiovascular and peripheral vascular diseases. A growing body of literature supports neurostimulation for visceral pain in general and interstitial cystitis in particular. As a basic principle, patient selection for the appropriate neurostimulation modalities is essential for safe, efficacious, and cost-effective applications of this therapy. Research with more vigorous designs is needed to establish evidence-based applications of neuromodulation therapy in emerging indications of pain management. [ABSTRACT FROM AUTHOR]

Objective: This case report describes an ultrasound approach to the transversus abdominis plane (TAP) local anesthetic block. This block induces sensory blockade in the lower half of the abdomen where the pulse generator or the infusion pump is to be housed in a subcutaneous pocket, and therefore provides an alternate to general anesthesia or administration of high-dose local anesthetics. Case Report: We report two cases of neuromodulation procedures—implantation of an internal morphine pump for severe somatic pain refractory to other therapies and placement of a double-stimulator generator for dorsal column stimulation in a patient diagnosed with postoperative failed-back syndrome. We successfully used ultrasound-guided TAP block to achieve ipsilateral sensory block of dermatomes T9-L1 in the context of a monitored anesthesia care multimodal approach. Conclusion: TAP block can be a potentially useful substitute to general anesthesia or local anesthesia for the pocket formation in neuromodulation techniques, and it provides adequate anesthesia of the abdominal wall. This block is potentially an important addition to the monitored anesthesia care protocol. [ABSTRACT FROM AUTHOR]

Background: Epidural fibrosis has been implicated in the etiology of persistent pain after back surgery (Failed Back Surgery Syndrome [FBSS]). Using spinal endoscopy to view the lumbosacral epidural cavity, the incidence, severity, and appearance of epidural fibrosis was evaluated in patients with FBSS. Methods: A prospective cohort observational study using epidural endoscopy was done involving 78 patients with persistent pain after back surgery. Patients were evaluated prospectively for the presence of epidural fibrosis and fibrosis was rated using a 4-level grading system based on appearance and resistance to epiduroscope advancement. The incidence of fibrosis detected by epiduroscopy vs. the incidence as reported in magnetic resonance imaging (MRI) studies for the same patients were compared. Results: As diagnosed with epiduroscopy, 83.3% of all patients with persistent pain after back surgery had severe (grade 3 or 4) epidural fibrosis, while 91.0% had significant (grade 2, 3, or 4) fibrosis. In patients who had undergone more extensive surgery, severe fibrosis was present in 91.1% and significant fibrosis in 95.6%. Using MRI, epidural fibrosis was diagnosed only in 16.1% of these patients. All patients with severe epidural fibrosis had a filling defect on epidurography. Concordant pain was present in 84.3% of patients and depended on the severity of fibrosis. Results were statistically evaluated using analysis of frequencies and t-test. P < 0.05 was considered statistically significant. Conclusions: Epiduroscopy demonstrates that the prevalence of severe epidural fibrosis after FBSS is substantially higher than is generally reported in MRI evaluations. Severe epidural fibrosis is an underlying pathology in most patients with FBSS. [ABSTRACT FROM AUTHOR]

Background: Neuropathic pain commonly affects the back and legs and is associated with severe disability and psychological illness. It is unclear how patients with predominantly neuropathic pain due to failed back surgery syndrome (FBSS) compare with patients with other chronic pain conditions. Aims: To present data on characteristics associated with FBSS patients compared with those with complex regional pain syndrome, rheumatoid and osteoarthritis, and fibromyalgia. Methods: The PROCESS (Prospective Randomized Controlled Multicenter Trial of the Effectiveness of Spinal Cord Stimulation, ISRCTN 77527324) trial randomized 100 patients to spinal cord stimulation ( n = 52) plus conventional medical management (CMM) or CMM alone ( n = 48). Baseline patient parameters included age, sex, time since last surgery, employment status, pain location and severity (visual analogue scale), health-related quality of life (HRQoL), level of disability, medication, and nondrug therapies. Reference population data was drawn from the literature. Results: At baseline, patients in the PROCESS study had a similar age and gender profile compared with other conditions. PROCESS patients suffered from greater leg pain and had lower HRQoL. PROCESS patients treatment cost was higher and they commonly took opioids, while antidepressants and nonsteroidal anti-inflammatory drugs were more often used for other conditions. Prior to baseline, 87% of patients had tried at least 4 different treatment modalities. Conclusions: Patients suffering from chronic pain of neuropathic origin following FBSS often fail to obtain adequate relief with conventional therapies (eg, medication, nondrug therapies) and suffer greater pain and lower HRQoL compared with patients with other chronic pain conditions. Neuropathic FBSS patients may require alternative and possibly more (cost-) effective treatments, which should be considered earlier in their therapeutic management. [ABSTRACT FROM AUTHOR]