Evaluation of the Effect of Repetitive Transcranial Magnetic Stimulation of Motor Cortex on Failed Back Surgery Syndrome Pain Control in the Short Term.

BACKGROUND: This study aimed to evaluate the short-term efficacy of repetitive transcranial magnetic stimulation (rTMS) on the treatment of failed back surgery syndrome (FBSS). METHODS: In this prospective clinical trial study, 13 patients with FBSS were selected to undergo rTMS, including 5 sessions of stimulation of the primary motor cortex of 90 trains with a frequency of 10 Hz for 2 seconds and an intertrain interval of 20 seconds with a total pulse rate of 1800 per session. The time of each session was 30 minutes with an intensity of 80% of the motor threshold. The severity of pain before and after the intervention was measured by the short-form McGill Pain Questionnaire and visual analog scale (VAS). RESULTS: The mean of pain severity was 26.54 ± 6.78 and 14.92 ± 10.1 before and after rTMS, respectively. The severity of pain was significantly decreased after the intervention (p = 0.001). According to the McGill Pain Questionnaire, the severity of pain in the patients was decreased by 44.09 ± 27.32. The mean of the severity of pain according to VAS was 77.31 ± 16.66 before rTMS and 53.46 ± 22.49 after rTMS, which showed that pain intensity was significantly decreased after the intervention (p = 0.006). CONCLUSIONS: The use of rTMS of the primary motor cortex in patients who have undergone lumbosacral spine surgery and suffer from pain related to FBSS is associated with a significant reduction in the severity of pain. Because rTMS is a noninvasive treatment method, it can be used as a suitable treatment in these patients.

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.

Techniques for Safe Removal of Spinal Cord Stimulation Paddle Leads.

BACKGROUND: Spinal cord stimulation (SCS) is a safe neuromodulatory treatment used to treat failed back surgery syndrome, chronic neuropathic pain, and complex regional pain syndrome. Despite its efficacy, some patients fail to achieve pain relief and elect to undergo removal of SCS paddle leads. The safety and best practices of these procedures have not been defined. OBJECTIVE: In this article, we describe our technique and complication rate in a series of SCS paddle removals. METHODS: All patients who underwent SCS paddle removal at the Albany Medical Center between 2011 and 2020 were identified. Medical charts were reviewed for demographic data, operative technique, and incidence of complications within 30 days of the procedure. RESULTS: Thirty-two (91%) patients underwent a thoracic paddle removal, whereas 3 (9%) underwent a cervical paddle removal. All cases underwent preoperative imaging with computed tomography or MRI, and all cases were performed with neuromonitoring and fluoroscopy. The technique required for paddle removal depended on the extent of local scar formation and ranged from soft tissue dissection to additional laminectomy at an adjacent level. Cases took on average 2 ± 0.09 hours with 23.21 ± 4.29 cc blood loss. Two patients had superficial infections, which were cleared with 1 week of oral antibiotics. There were no other adverse events. CONCLUSION: Thirty-five patients successfully underwent paddle removal with the minor complications reported. In this article, we show that by using neuromonitoring, fluoroscopy, and the techniques described, SCS paddle removal can be performed with minimal risk.

Disability Pension Did Not Reduce Opioid Use Among Patients With Failed Back Surgery Syndrome Who Were Trialed and Implanted for Spinal Cord Stimulation.

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

Feasibility of continuous epidural analgesia in patients with failed back surgery syndrome and spinal stenosis.

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

Pathogenesis, etiology and treatment of failed back surgery syndrome.

Failed back surgery syndrome (FBSS) is associated with persistent lower back pain after and despite one or more surgical interventions. A number of factors underlie and maintain FBSS and successful management of pain chiefly depends on identifying them. Pharmacological, surgical, and non-surgical therapeutic measures are taken to treat the pain. Spinal cord stimulation and nerve stimulation have been widely practiced in this regard and enhanced pain reduction and patient satisfaction. In hernia and recurrent disc degeneration and sagittal imbalance, discectomy and/or fusion are indicated. The present review focuses on FBSS and its underlying components and on available treatment options.

The dimensions of "failed back surgery syndrome": what is behind a label?

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

Analysis of Spinopelvic Sagittal Balance and Persistent Low Back Pain (PLBP) for Degenerative Spondylolisthesis (DS) following Posterior Lumbar Interbody Fusion (PLIF).

Objective: To investigate the change of spinopelvic sagittal balance and clinical outcomes after posterior lumbar interbody fusion (PLIF) in patients with degenerative spondylolisthesis (DS), especially the relationship between sagittal spinopelvic parameters and persistent low back pain (PLBP). Methods: 107 patients who were diagnosed with DS and underwent PLIF in our department were enrolled retrospectively in the present study. Sagittal spinopelvic parameters including lumbar lordosis (LL), segmental lordosis (SL), height of the disc (HOD), sacral slope (SS), pelvic incidence (PI), and pelvic tilt (PT) were recorded pre- and postoperatively. Sagittal balance and clinical outcomes were compared between patients with and without PLBP. Pearson correlation was used to analyze the change of sagittal balance parameters and clinical functions. Logistic regression analysis was performed to examine the risk factors of PLBP. Results: It showed significant improvements of SL, HOD, and PT postoperatively. Both the Numeric Rating Scale (NRS) and Oswestry Disability Index (ODI) had significant improvement postoperatively. Change of PT and SL also differed observably between patients with and without PLBP. SL and PT were correlated with NRS and ODI, and insufficient restoration of PT was an independent factor for PLBP. Conclusion: The sagittal balance parameters and clinical outcomes can be improved markedly via PLIF for treating DS. Restoration of SL and PT was correlated with satisfactory outcomes, and adequate improvement of PT may have positive impact on reducing PLBP.

Incidence, diagnosis and management of sacroiliitis after spinal surgery: a systematic review of the literature.

The sacroiliac joint (SIJ) is a possible source of persistent or new onset pain after lumbar or lumbosacral fusion. The aim of this paper is to systematically review and analyze the available literature related to the incidence, diagnosis and management of sacroiliitis after spinal arthrodesis. The authors independently screened the titles and abstracts of all articles identified concerning sacroiliac joint pain after lumbar or lumbosacral fusion, to assess their suitability to the research focus. The average incidence of sacroiliitis after lumbar or lumbosacral arthrodesis was found to be 37 ± 28.48 (range 6-75), increasing directly to the number of fused segments involved, especially when the sacrum is included. The most accurate evaluation is the image-guided injection of anesthetic solutions in the joint. Surgery treatment may be considered when conservative therapy fails, with open surgery or with minimally invasive SIJ fusion. Although the risk of developing SIJ degeneration is unclear, the results indicate that pain and degeneration of SIJ develop more often in patients undergoing lumbosacral fusion regardless of the number of melting segments. The treatment of sacroiliitis appears to be independent of his etiology, with or without previous instrumentation on several levels.

Reducing the extent of facetectomy may decrease morbidity in failed back surgery syndrome.

BACKGROUND: Percutaneous transforaminal endoscopic discectomy (PTED) is widely used for the treatment of lumbar disc herniation. Facetectomy in PTED is necessary for accessing the intraspinal region and for decompressing the exiting nerve roots in patients who suffer from hypertrophy of the facet joints. However, this may increase morbidity in failed back surgery syndrome (FBSS) and has not been clearly elucidated. METHODS: A three-dimensional lumbosacral model was reconstructed and validated. And corresponding models after PTED with one-quarter and one-half excisions of the superior articular process were reconstructed. The maximum shear stress on the annulus in L5, von Mises stress of the facet cartilage, maximum principle capsular strain and deformation of the lumbosacral model were calculated using finite element methods. RESULTS: Calculated results show no significant differences in the complete model and the model with one-quarter excision of the superior articular process, but all biomechanical indexes have been deteriorated under most of the loading conditions tested in the model with one-half excision of the superior articular process. CONCLUSIONS: Less facetectomy is better because it may reduce the risk of biomechanical deterioration and consequently, that of FBSS.

Can quantitative sensory tests predict failed back surgery?: A prospective cohort study.

BACKGROUND: Failed back surgery syndrome (FBSS) is a pain condition refractory to therapy, and is characterised by persistent low back pain after spinal surgery. FBSS is associated with severe disability, low quality of life and high unemployment. We are currently unable to identify patients who are at risk of developing FBSS. Patients with chronic low back pain may display signs of central hypersensitivity as assessed by quantitative sensory tests (QST). This can contribute to the risk of developing persistent pain after surgery. OBJECTIVE: We tested the hypothesis that central hypersensitivity as assessed by QST predicts FBSS. DESIGN: Prospective cohort study. SETTING: Three tertiary care centres. PATIENTS: 141 patients scheduled for up to three segment spinal surgery for chronic low back pain (defined as at least 3 on a numerical rating scale on most days during the week and with a minimum duration of 3 months) due to degenerative changes. OUTCOMES: We defined FBSS as persistent pain, persistent disability or a composite outcome defined as either persistent pain or disability. The primary outcome was persistent pain 12 months after surgery. We applied 14 QST using electrical, pressure and temperature stimulation to predict FBSS and assessed the association of QST with FBSS in multivariable analyses adjusted for sociodemographic, psychological and clinical and surgery-related characteristics. RESULTS: None of the investigated 14 QST predicted FBSS, with 95% confidence intervals of crude and adjusted associations of all QST including one as a measure of no association. Results remained robust in all sensitivity and secondary analyses. CONCLUSION: The study indicates that assessment of altered central pain processing using current QST is unlikely to identify patients at risk of FBSS and is therefore unlikely to inform clinical decisions.

A Randomized Controlled Trial of Subcutaneous Nerve Stimulation for Back Pain Due to Failed Back Surgery Syndrome: The SubQStim Study.

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

Depression Increases the Rates of Neurological Complications and Failed Back Surgery Syndrome in Patients Undergoing Lumbar Spine Surgery.

STUDY DESIGN: This was a retrospective database study. OBJECTIVE: The aim of this study was to use a large sample to accurately determine risk factors and rates of neurological complications in patients undergoing commonly performed lumbar spine surgeries. SUMMARY OF BACKGROUND DATA: Damage to neurological structures and failed back surgery syndrome (FBSS) are among the most feared complications of lumbar spine surgery. Despite the large impact on quality of life these complications have, reported rates of neurological complications vary immensely, ranging from 0.46% to 24%. MATERIALS AND METHODS: Data were obtained for patients undergoing initial posterior lumbar interbody fusion, transforaminal lumbar interbody fusion, anterior lumbar interbody fusion, posterolateral fusion, discectomy, and laminectomy procedures from January 2007 to June 2015 covered by the nationwide insurance carrier Humana. Patient records were analyzed to determine rates of dural tear, damage to nervous tissue, cauda equina syndrome, neurogenic bowel/bladder, and FBSS following each procedure. Rates were determined for patients undergoing single/multilevel procedures, by age, and for patients with a previous diagnosis of depression to determine the influence these factors had on the risk of neurologic complications. RESULTS: Analysis of 70,581 patient records revealed a dural tear rate of 2.87%, damage to the nervous tissue of 1.47%, cauda equina syndrome of 0.75%, neurogenic bowel or bladder of 0.45%, and FBSS of 15.05% following lumbar spine surgery. The incidence of complications was highest for patients undergoing multilevel procedures and posterior fusion. Depression was a significant risk factor for FBSS (risk ratio, 1.74; P<0.0001), damage to nervous tissue (1.41; P<0.0001), and dural tear (1.15; P<0.0001), but had no impact on risk of cauda equina syndrome or neurogenic bowel or bladder. Increased age was associated with higher rates of dural tear and damage to nervous tissue. CONCLUSIONS: Patients with a history of depression are at significantly increased risk for neurologic complications following lumbar spine surgery and should be managed accordingly.