Effect of spinal cord stimulation on quality of life and opioid consumption in patients with failed back surgery syndrome.

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.

MR Neurography of Lumbosacral Plexus: Incremental Value Over XR, CT, and MRI of L Spine With Improved Outcomes in Patients With Radiculopathy and Failed Back Surgery Syndrome.

BACKGROUND: Lower back pain is often evaluated using magnetic resonance imaging (MRI) and conventional imaging, which provide incomplete information about the etiology of pain and lead to less than optimal management. HYPOTHESIS: MR neurography (MRN) of the lumbosacral (LS) plexus renders a more accurate diagnosis, alters the management strategy, and clinical outcomes of radiculopathy or failed back surgery Syndrome (FBSS) patients when compared to the conventional imaging modalities. STUDY TYPE: Retrospective, cross-sectional. POPULATION: A total of 356 patients (mean age 65.8 ± 12.3; 48.9% female) from single university hospital over 6 years with MRN of LS plexus were included from a cohort of 14,775 total patients with lumbar spine MR imaging. ASSESSMENT: Conventional imaging obtained before and after MRN of LS plexus was reevaluated and categorized into three levels based on extent of imaging findings' correlation to presenting clinical symptoms (contributory levels). Clinical notes were reviewed for changes in ordering provider's recommended management and subsequent patients' symptom level pre-MRN to post-MRN. FIELD STRENGTH/SEQUENCE: A 5 T and 3.0 T. T1-weighted (T1W), T2-weighted (T2W), short T1 inversion recovery (STIR), T1 turbo spin echo (T1 TSE), T2 spectral attenuated inversion recovery (T2 SPAIR). STATISTICAL TESTS: Chi-squared test. Statistical significance was set at P < 0.05. RESULTS: A total of 356 total patients (174 females) with mean age ± SD was 65.8 ± 12.3 years, 4.2% of patients imaged with lumbar spine MRI. Definitely contributory studies among X-rays, computed tomography, MRI, and MRN were 3 of the 129 (2.3%), 3 of the 48 (6.2%), 35 of the 184 (19.0%), and 283 of the 356 (79.8%), respectively. Pre-MRN vs. post-MRN led to change in recommendation in 219 of the 356 (61.5%) patients and 71 of the 99 (71.7%) patients had improved symptoms. CONCLUSION: MRN of the LS plexus can provide more corroborative image findings for symptom correlation compared to other imaging modalities for accurate diagnosis, effects patient management and leads to positive clinical outcomes in a small subset of patients with radiculopathy or FBSS. EVIDENCE LEVEL: 4 TECHNICAL EFFICACY: Stage 5.

Severity of spinal degeneration does not affect the pain reduction under continuous epidural analgesia.

PURPOSE: To outline clinical effectiveness of continuous epidural analgesia (CEA) in patients with failed back surgery syndrome (FBSS) or lumbar spinal stenosis (LSS) depending on severity of spinal degeneration. METHODS: In this retrospective cohort study, all patients with FBSS or LSS who underwent CEA within an inpatient rehabilitation program were evaluated. The pain reduction was measured by VAS on an hourly basis. Substantial pain reduction was defined as a minimal clinically important difference (MCID) > 50%. Severity of spinal degeneration, side effects and patient-specific characteristics were documented. RESULT: We included a total of 148 patients with 105 patients suffering from FBSS and 48 with LSS. The average pain reduction was - 37.6 ± 19.2 in FBSS and - 38.1 ± 17.8 in LSS group (p < .001 and p < .001, respectively). In the FBSS group, sensory deficits (p = .047) and numbness (p = .002), and in the LSS group, a severe disability measured by ODI (38.2 ± 15.4 vs. 57.3 ± 11.3, p < .001) significantly contributed to a worse outcome. The severity of the spinal degeneration and psychological disorders did not affect the pain reduction in terms of MCID. CONCLUSIONS: This study provides new evidence about CEA in the treatment of FBSS and LSS. CEA provides a significant pain reduction even under intensified physiotherapeutic exercising in patients with severe spinal degeneration and a broad variety of secondary diagnoses. Neurologic deficits in case of FBSS and severe disability in case of LSS may be risk factors for less favorable outcome.

Spinal Cord Stimulation Meets Them All: An Effective Treatment for Different Pain Conditions. Our Experience and Literature Review.

IntroductionSpinal Cord Stimulation (SCS) is an emerging minimally invasive technique which uses neuromodulation to manage different forms of intractable pain. SCS is a well-established option for the treatment of various pain conditions, and nowadays, indications are ever increasing.Materials and MethodsIn this study, we present our case series of 49 patients who underwent SCS at our Institution for the treatment of pain from different etiologies, and discuss our 10-year experience in SCS. For the purpose of this study, we also performed a systematic review of current indications and new perspectives in SCS.ResultsAmong our case series, patients were differentiated into two groups upon prior spinal surgery: patients who had undergone prior spinal surgery for back pain were defined as the "FBSS (failed back surgery syndrome) group," instead patient suffering from different types of pain but who had never undergone surgery were defined as the "naive group." As regards clinical response to SCS, 20 patients out of 36 (55.56%) were classified as responders in the FBSS group; in the "naïve" group, 10 patients out of 13 (76.92%) were classified as responders. Among the "not responders" group, several patients suffered from infections.Of the recent literature about SCS, 2124 records were screened and 37 studies were finally included in the qualitative synthesis for our systematic review.DiscussionIn case of FBSS, surgical revision is often associated with a high morbidity and corresponding low rates of success. Unfortunately, patients affected by chronic pain often become refractory to conservative treatments. Spinal Cord Stimulation (SCS) is nowadays considered as an effective therapy for several chronic and neuropathic pain conditions, such as failed back surgery syndrome. As regards the economic impact of SCS, implantation of an SCS system results in short-term costs increase, but the annual cumulative costs decrease during the following years after implantation, when compared to the costs of conventional management. Beyond the application for the treatment of FBSS, SCS has also been used for the treatment of other types of chronic non-oncological pain such as neuropathic pain and chronic back pain ineligible for surgical intervention. This evidence paved the way to establishing the potential role of SCS also for the treatment of oncological pain. However, the effectiveness and relative safety of SCS for cancer-related pain has not yet been adequately established.ConclusionsSpinal Cord Stimulation is a well-established treatment option in for FBSS. Beyond that, SCS has also been used for the treatment of "naive" patients, suffering from other types of chronic, both oncological and non-oncological, medical-refractory pain such as neuropathic pain and chronic back pain ineligible for surgical intervention.

Subcutaneous Stimulation as Add-on Therapy to Spinal Cord Stimulation in Patients With Persistent Spinal Pain Syndrome Significantly Increases the Total Electrical Charge per Second: Aspects on Stimulation Parameters and Energy Requirements of the Implanted Neurostimulators.

OBJECTIVE: In our previous multicenter randomized controlled trial, we demonstrated the clinical effectiveness of peripheral nerve field stimulation (PNFS) as add-on therapy to spinal cord stimulation (SCS) for the treatment of chronic back pain in patients with persistent spinal pain syndrome (PSPS) or failed back surgery syndrome (FBSS). To our knowledge, no previous study has investigated the effect of PNFS as an add-on to SCS on the energy consumption of the implanted neurostimulators. Therefore, in this study, we compared the specific stimulation parameters and energy requirements of a previously unreported group of patients with only SCS with those of a group of patients with SCS and add-on PNFS. We also investigated differences that might explain the need for PNFS in the treatment of chronic low back pain. MATERIALS AND METHODS: We analyzed 75 patients with complete sets of stimulation parameters, with 21 patients in the SCS-only group and 54 patients in the SCS + PNFS group. Outcome measures were average visual analog scale score, SCS parameters (voltage, frequency, and pulse width), SCS charge per second, and total charge per second. We analyzed baseline characteristics and differences between and within groups over time. RESULTS: Both groups had comparable patient characteristics at baseline and showed a significant decrease in back and leg pain. SCS charge per second did not significantly differ between the groups at baseline or at 12 months. The total charge per second was significantly higher in the active SCS + PNFS group than in the SCS-only group at baseline; in the SCS + PNFS group, this persisted for up to 12 months, and the SCS charge per second and total charge per second increased significantly over time. CONCLUSIONS: Our results show that add-on PNFS increases the total charge per second compared with SCS alone, as expected. However, further research is needed because our results do not directly explain why some patients require add-on PNFS to treat low back pain.

A Feasibility Study Exploring Measures of Autonomic Function in Patients With Failed Back Surgery Syndrome Undergoing Spinal Cord Stimulation.

OBJECTIVES: Failed back surgery syndrome (FBSS) is associated with impaired autonomic tone, characterized by sympathetic prevalence and vagal withdrawal. Although spinal cord stimulation (SCS) alleviates pain in FBSS, there is limited research investigating how SCS affects measures of autonomic function. This was a prospective, open-label, feasibility study exploring measures of autonomic function in patients with FBSS receiving SCS therapy. MATERIALS AND METHODS: A total of 14 patients with FBSS were recruited for baseline measurements and underwent a trial of 10-kHz SCS. There were three failed trials, resulting in the remaining 11 participants receiving a fully implanted 10-kHz SCS system. One participant requested an explant, resulting in ten participants completing both baseline and follow-up (three to six months after SCS implant) measurements. Autonomic function was assessed using time- and frequency-domain heart rate variability (HRV), baroreceptor reflex sensitivity (BRS), and muscle sympathetic nerve activity (MSNA) using microneurography. Because this was a feasibility study, most of the analysis was descriptive. However, paired t-tests and Wilcoxon signed-rank tests tested for differences between baseline and follow-up. RESULTS: In the whole (N = 14) and final (N = 10) samples, there was between-participant variation in baseline and follow-up measures. This, combined with a small sample, likely contributed to finding no statistically significant differences in any of the measures between baseline and follow-up. However, plotting baseline and follow-up scores for individual participants revealed that those who showed increases in MSNA frequency, square root of the mean of the squared differences between adjacent RR intervals (RMSSD), percentage of the number of RR intervals >50 ms (pRR50), total power, and up BRS between baseline and follow-up had distinct clustering of baseline values compared with those who showed decreases in these measures. CONCLUSIONS: Findings from this feasibility study will aid with informing hypotheses for future research. A key aspect that should be considered in future research concerns exploring the role of baseline measures of autonomic function in influencing change in autonomic function with SCS therapy.

Long-Term Outcome in Patients With Spinal Cord Stimulation for Failed Back Surgery Syndrome: A 20-Year Audit of a Single Center.

STUDY DESIGN: This is a retrospective, observational study. INTRODUCTION: Spinal cord stimulation (SCS) has found its application in chronic pain treatment, with failed back surgery syndrome (FBSS) as one of the most important indications. However, to date, little is known about the long-term effectiveness of the treatment. The aim of this study is to analyze retrospectively the long-term outcomes of SCS treatment in a single multidisciplinary pain center on predominant radicular pain, using devices of a single manufacturer. MATERIALS AND METHODS: Patient data on overall patient satisfaction, pain intensity, and adverse events were retrospectively collected in our clinical practice between January 1998 and January 2018, for 191 patients who received a permanent SCS implant. Secondary health measures included the influence of opioid and nicotine use on pain reduction after therapy. RESULTS: The trial-to-implant ratio was 93.6%. At a mean follow-up of 10.6 years, 78.5% of the patients were satisfied with the treatment outcome, with a significant pain reduction of an average three points on a Numeric Rating Scale. Opioid and nicotine usage did not have a significant link with the pain reduction one year after the treatment. Furthermore, devices had an average battery lifespan of 8.4 years. A total of 248 revisions were recorded. A total of 24 patients (11.7%) acquired an infection; 7 of 204 patients had an infection during the trial period, 2 of 191 patients had an infection in the first postoperative year, and 15 of 191 patients had an infection after the first year. The average time to infection, if not in the first year, was 10.1 years. CONCLUSIONS: A successful long-term outcome regarding pain relief in patients with predominant radicular pain due to FBSS is established with SCS therapy.

Short-Term Health Care Costs of High-Frequency Spinal Cord Stimulation for the Treatment of Postsurgical Persistent Spinal Pain Syndrome.

OBJECTIVE: High-frequency spinal cord stimulation (HF-SCS) is a treatment option for postsurgical persistent spinal pain syndrome (type 2 PSPS). We aimed to determine the health care costs associated with this therapy in a nationwide cohort. MATERIALS AND METHODS: IBM Marketscan® Research Databases were used to identify patients who underwent HF-SCS implantation from 2016 to 2019. Inclusion criteria included prior spine surgery or diagnoses of PSPS or postlaminectomy pain syndrome any time within the two years before implantation. Inpatient and outpatient service costs, medication costs, and out-of-pocket costs were collected six months before implantation (baseline) and one, three, and six months after implantation. The six-month explant rate was calculated. Costs were compared between baseline and six months after implant via Wilcoxon sign rank test. RESULTS: In total, 332 patients were included. At baseline, patients incurred median total costs of $15,393 (Q1: $9,266, Q3: $26,216), whereas the postimplant median total costs excluding device acquisition were $727 (Q1: $309, Q3: $1,765) at one month, $2,840 (Q1: $1,170, Q3: $6,026) at three months, and $6,380 (Q1: $2,805, Q3: $12,637) at six months. The average total cost was reduced from $21,410 (SD $21,230) from baseline to $14,312 (SD $25,687) at six months after implant for an average reduction of $7,237 (95% CI = $3212-$10,777, p < 0.001). The median device acquisition costs were $42,937 (Q1: $30,102, Q3: $65,880). The explant rate within six months was 3.4% (8/234). CONCLUSIONS: HF-SCS for PSPS was associated with significant decreases in total health care costs and offsets acquisition costs within 2.4 years. With the rising incidence of PSPS, it will be critical to use clinically effective and cost-efficient therapies for treatment.

Functional Connectivity Magnetic Resonance Imaging Sequences in Patients With Postsurgical Persistent Spinal Pain Syndrome Type 2 With Implanted Spinal Cord Stimulation Systems: A Safety, Feasibility, and Validity Study.

BACKGROUND: Chronic pain has been associated with alterations in brain connectivity, both within networks (regional) and between networks (cross-network connectivity). Functional connectivity (FC) data on chronic back pain are limited and based on heterogeneous pain populations. Patients with postsurgical persistent spinal pain syndrome (PSPS) type 2 are good candidates for spinal cord stimulation (SCS) therapy. We hypothesize that 1) FC magnetic resonance imaging (fcMRI) scans can be safely obtained in patients with PSPS type 2 with implanted therapeutic SCS devices and that 2) their cross-network connectivity patterns are altered and involve emotion and reward/aversion functions. MATERIALS AND METHODS: Resting-state (RS) fcMRI (rsfcMRI) scans were obtained from nine patients with PSPS type 2 implanted with therapeutic SCS systems and 13 age-matched controls. Seven RS networks were analyzed, including the striatum. RESULTS: Cross-network FC sequences were safely obtained on a 3T MRI scanner in all nine patients with PSPS type 2 with implanted SCS systems. FC patterns involving emotion/reward brain circuitry were altered as compared with controls. Patients with a history of constant neuropathic pain, experiencing longer therapeutic effects of SCS, had fewer alterations in their connectivity patterns. CONCLUSIONS: To our knowledge, this is the first report of altered cross-network FC involving emotion/reward brain circuitry in a homogeneous population of patients with chronic pain with fully implanted SCS systems, on a 3T MRI scanner. All rsfcMRI studies were safe and well tolerated by all nine patients, with no detectable effects on the implanted devices.

Spinal Cord Stimulation-Naïve Patients vs Patients With Failed Previous Experiences With Standard Spinal Cord Stimulation: Two Distinct Entities or One Population?

INTRODUCTION: Nowadays, the success of spinal cord stimulation (SCS) is evaluated separately in patients who have previous experiences with standard SCS and in SCS-naïve patients. Nevertheless, it is yet to be evaluated whether both patient groups are effectively distinct patient groups. Therefore, the aims of this study are twofold: 1) Are there clusters in the data to distinguish between both patient groups? 2) Can we discriminate both patient groups based on routinely collected clinical parameters? MATERIALS AND METHODS: Baseline data from the Discover study were used, in which 263 patients with persistent spinal pain syndrome type 2 were included (185 neurostimulation-naïve patients and 78 patients with previous SCS experience). Pain intensity scores for low back and leg pain, functional disability, medication use, and health-related quality of life utility scores were used in the analysis. Model-based clustering was performed on standardized data. Discriminant analysis was performed with linear and quadratic discriminant analysis, with leave-one-out cross-validation to evaluate model performance. RESULTS: Model-based clustering revealed two different clusters in the data. None of the clusters clearly separated SCS-naïve patients from patients with previous SCS experience. Linear discriminant analysis resulted in a leave-one-out cross-validation error rate of 30.0% to discriminate between both patient groups, based on routinely collected clinical parameters. CONCLUSIONS: Clustering analysis did not result in clusters that separate SCS-naïve patients from patients with previous SCS experience. This may suggest that both patient groups should not be considered as two different patient groups when comparing them on routine clinical parameters, with potentially profound implications for research and clinical settings. CLINICAL TRIAL REGISTRATION: The Clinicaltrials.gov registration number for the Discover study is NCT02787265.

Exceptional Cases of Spinal Cord Stimulation for the Treatment of Refractory Cancer-Related Pain.

OBJECTIVES: Cancer pain has traditionally been managed with opioids, adjuvant medications, and interventions including injections, neural blockade, and intrathecal pump (ITP). Spinal cord stimulation (SCS), although increasingly used for conditions such as failed back surgery syndrome and complex regional pain syndrome, is not currently recommended for cancer pain. However, patients with cancer-related pain have demonstrated benefit with SCS. We sought to better characterize these patients and the benefit of SCS in exceptional cases of refractory pain secondary to progression of disease or evolving treatment-related complications. MATERIALS AND METHODS: This was a single-center, retrospective case series at a tertiary cancer center. Adults ≥18 years old with active cancer and evolving pain secondary to disease progression or treatment, whose symptoms were refractory to systemic opioids, and who underwent SCS trial followed by percutaneous implantation between 2016 and 2021 were included. Descriptive statistics included mean, SD, median, and interquartile range (IQR). RESULTS: Eight patients met the inclusion criteria. The average age at SCS trial was 60.0 (SD: ±11.6) years, and 50% were men. Compared with baseline, the median (IQR) change in pain score by numeric rating scale (NRS) after trial was -3 (2). At an average of 14 days after implant, the median (IQR) change in NRS and daily oral morphine equivalents were -2 (3.5) and -126 mg (1095 mg), respectively. At a median of 63 days after implant, the corresponding values were -3 (0.75) and -96 mg (711 mg). There was no significant change in adjuvant therapies after SCS implantation at follow-up. Six patients were discharged within two days after implantation. Two patients were readmitted for pain control within the follow-up period. CONCLUSIONS: In patients with cancer-related pain, SCS may significantly relieve pain, reduce systemic daily opioid consumption, and potentially decrease hospital length of stay and readmission for pain control. It may be appropriate to consider an SCS trial before ITP in select cases of cancer-related pain.

Failed Back Surgery Syndrome: No Longer a Surgeon's Defeat-A Narrative Review.

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.

Spinal cord stimulation and return to work of patients with failed back surgery syndrome.

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.

Neuromodulation for chronic pain.

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

Effect of Previous Caudal Block to Predict Successful Outcome after Adhesiolysis using a Steerable Catheter in Lumbar Failed Back Surgery Syndrome: A Retrospective Study.

Adhesiolysis is minimally invasive and commonly used for pain associated with adhesion after lumbar spine surgery. Caudal epidural block may be used for radiating pain due to failed back surgery syndrome. We evaluated the predictive value of response to caudal block performed prior to adhesiolysis in failed back surgery syndrome. Between January 1, 2013 and June 30, 2020, 150 patients with failed back surgery syndrome were treated with adhesiolysis using a steerable catheter at the pain clinic of a tertiary hospital after failed conservative treatment (including caudal block). Patient demographics, pain duration, and lumbar magnetic resonance imaging findings were examined. Response to previous caudal block was determined as a binary result (yes or no). Patients were followed up 3 months after adhesiolysis. Successful outcome was defined as a ≥2-point reduction in the numeric rating scale scores for radicular pain 3 months after adhesiolysis, evident in 81/150 (46%) patients. Multivariable logistic regression analysis revealed that caudal block response was an independent predictor of successful adhesiolysis (odds ratio = 4.403; p = 0.015). Response to prior caudal block is a positive predictor of successful adhesiolysis.

Onset of mental disorders in patients who developed failed back surgery syndrome.

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

Risk factors for failed back surgery syndrome following open posterior lumbar surgery for degenerative lumbar disease.

BACKGROUND: With the growing number of traditional posterior open surgery, the incidence of failed back surgery syndrome (FBSS) increases gradually. We aimed to investigate the incidence and risk factors for FBSS following open posterior lumbar surgery for degenerative lumbar disease (DLD). METHOD: A multivariable regression analysis was performed for 333 consecutive patients to identify potential risk factors for FBSS. Clinical outcomes were evaluated by the validated North American Spine Society (NASS) Questionnaire and numerical rating scale (NRS) for pain. Demographics, diagnostic characteristics, surgical data, radiographic parameters for each patient were analyzed. RESULT: 16.8% of the included patients were classified as FBSS. Univariate analysis showed that age, hypertension, symptom location, intermittent claudication, preoperative pain NRS-leg, HIZ, Modic changes (MCs), surgical strategy and postoperative rehabilitation were related to FBSS. Multivariable logistic regression analysis demonstrated that preoperative NRS-leg (OR:0.80, 95%CI:0.71-0.91, P = 0.001), hypertension (OR: 2.22, 95%CI: 1.10-4.51, P = 0.027), intermittent claudication with waking distance > 100 m (OR: 4.07, 95%CI: 1.75-9.47, P = 0.001) and waking distance ≤ 100 m (OR: 12.43, 95%CI: 5.54-27.92, P < 0.001), HIZ (OR: 8.26, 95%CI: 4.00-17.04, P < 0.001), MCs (OR: 3.41, 95%CI: 1.73-6.71, P < 0.001), postoperative rehabilitation (OR: 2.63, 95%CI: 1.13-6.12, P = 0.024) were risk factors for FBSS. CONCLUSION: Open posterior lumbar surgery is an effective treatment for DLD which provides pain reduction and lumbar curve improvement with a considerable satisfaction rate. Lower preoperative NRS-leg, hypertension, intermittent claudication, HIZ, MCs and postoperative rehabilitation are risk factors for FBSS, which can serve as a tool for clinicians to identify at-risk population and provide more effective management to mitigate the doctor-patient contradictions and further occupation of medical resources.

Genetic variants of interleukin 1B and 6 are associated with clinical outcome of surgically treated lumbar degenerative disc disease.

BACKGROUND: Successfully surgically treating degenerative disc diseases can be challenging to the spine surgeons, the long-term outcome relies on both the physical and mental status of the patient before and after treatment. Numerous studies underlined the role of inflammatory cytokines - like interleukin 1B and 6 - in the development of chronic diseases such as failed back surgery syndrome (FBSS) and major depressive disorder (MDD) which alter the outcome after spinal surgery. Our aim was to evaluate the associations of IL6 and IL1B gene polymorphisms with the long-term outcome of degenerative lumbar spine surgeries. METHODS: An international genetical database (GENODISC) was combined with our institute's clinical database to create a large pool with long term follow up data. Altogether 431 patient's data were analysed. Patient reported outcome measures and surgical outcome was investigated in association with IL1B and IL6 SNPs with the help of 'SNPassoc' R genome wide association package. RESULTS: Interleukin 1B variants analysis confirmed association with improvement of pain after surgery on individual SNP level and on haplotype level, moreover relationship with patient reported outcome and preoperative level of depression was found on individual SNP level. IL6 variants were associated with preoperative depression, somatization and with subsequent surgery. CONCLUSION: Understanding the complexity of spinal surgery patients' long-term well-being is crucial in effectively treating chronic debilitating somatic diseases and the associated mental illnesses. Further studies should investigate more comprehensively the linkage of chronic physical and mental illnesses focusing on their simultaneous treatment.

How I do it? Full endoscopic lumbar rhizotomy for chronic facet joint pain due to failed back surgery syndrome.

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

Effect of Spinal Cord Burst Stimulation vs Placebo Stimulation on Disability in Patients With Chronic Radicular Pain After Lumbar Spine Surgery: A Randomized Clinical Trial.

Importance: The use of spinal cord stimulation for chronic pain after lumbar spine surgery is increasing, yet rigorous evidence of its efficacy is lacking. Objective: To investigate the efficacy of spinal cord burst stimulation, which involves the placement of an implantable pulse generator connected to electrodes with leads that travel into the epidural space posterior to the spinal cord dorsal columns, in patients with chronic radiculopathy after surgery for degenerative lumbar spine disorders. Design, Setting, and Participants: This placebo-controlled, crossover, randomized clinical trial in 50 patients was conducted at St Olavs University Hospital in Norway, with study enrollment from September 5, 2018, through April 28, 2021. The date of final follow-up was May 20, 2022. Interventions: Patients underwent two 3-month periods with spinal cord burst stimulation and two 3-month periods with placebo stimulation in a randomized order. Burst stimulation consisted of closely spaced, high-frequency electrical stimuli delivered to the spinal cord. The stimulus consisted of a 40-Hz burst mode of constant-current stimuli with 4 spikes per burst and an amplitude corresponding to 50% to 70% of the paresthesia perception threshold. Main Outcomes and Measures: The primary outcome was difference in change from baseline in the self-reported Oswestry Disability Index (ODI; range, 0 points [no disability] to 100 points [maximum disability]; the minimal clinically important difference was 10 points) score between periods with burst stimulation and placebo stimulation. The secondary outcomes were leg and back pain, quality of life, physical activity levels, and adverse events. Results: Among 50 patients who were randomized (mean age, 52.2 [SD, 9.9] years; 27 [54%] were women), 47 (94%) had at least 1 follow-up ODI score and 42 (84%) completed all stimulation randomization periods and ODI measurements. The mean ODI score at baseline was 44.7 points and the mean changes in ODI score were -10.6 points for the burst stimulation periods and -9.3 points for the placebo stimulation periods, resulting in a mean between-group difference of -1.3 points (95% CI, -3.9 to 1.3 points; P = .32). None of the prespecified secondary outcomes showed a significant difference. Nine patients (18%) experienced adverse events, including 4 (8%) who required surgical revision of the implanted system. Conclusions and Relevance: Among patients with chronic radicular pain after lumbar spine surgery, spinal cord burst stimulation, compared with placebo stimulation, after placement of a spinal cord stimulator resulted in no significant difference in the change from baseline in self-reported back pain-related disability. Trial Registration: ClinicalTrials.gov Identifier: NCT03546738.