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.

Assessment of efficacy of percutaneous epidural neuroplasty for lumbar stenosis and failed back surgery syndrome: effective and safe?

OBJECTIVE: Chronic, refractory low back and lower extremity pain is a common problem. There are many causes for persistent low back pain, including spinal stenosis (SS), disc herniation, facet disease, sacroiliac disease, adjacent segment disease, ligamentous disease, and failed back surgery syndrome (FBSS). FBSS and SS are common and often result in chronic, persistent pain and disability. After the failure of conservative treatments, percutaneous epidural neuroplasty (PEN) is often used in managing low back pain. PATIENTS AND METHODS: We retrospectively analyzed 117 patients who received PEN for FBSS and SS between January 2018 and January 2019. Clinical outcomes were assessed with the visual analogue scale (VAS) score and the Oswestry disability index (ODI). The follow-up period was 6 months. We aimed to evaluate the effectiveness of percutaneous epidural neuroplasty in managing chronic refractory low back and lower extremity pain secondary to FBSS and SS and to compare the differences between outcomes of SS and FBSS groups, before and after PEN. RESULTS: Mean VAS scores were 6.15 ± 1.25 preoperatively, 2.97 ± 1.5 after 1 month, 3.18 ± 1.65 after 3 months, and 3.83 ± 1.64 after 6 months of follow-up. Mean ODI scores were 49.91 ± 13.87 preoperatively, 30.19 ± 12.01 after 1 month, 31.61 ± 12.46 after 3 months, 34.58 ± 12.52 after 6 months of follow-up. CONCLUSIONS: Percutaneous epidural neuroplasty was shown to be a safe and effective treatment in managing refractory back/leg pain following FBSS and SS.

Spinal Cord Stimulation for Failed Back Surgery Syndrome: to Trial or Not to Trial?

Spinal cord stimulation (SCS) is a recommended therapy to treat failed back surgery syndrome (FBSS). A trial period is practiced to enhance patient selection. However, its fundamental evidence is limited, especially concerning long-term benefit and therapy safety. We compared the long-term (5.3 ± 4.0 years) clinical outcome and therapy safety of a trialed and nontrialed implantation strategy, including multidimensional variables and pain intensity fluctuations over time. A multicenter cohort analysis was performed in 2 comparable groups of FBSS patients. Regarding eligibility, patients had to be treated with SCS for at least 3 months. While the Trial group comprised patients who underwent an SCS implantation after a successful trial, the No-Trial group encompassed patients who underwent complete implantation within 1 session. The primary outcome measures were pain intensity scores and complications. The Trial and No-Trial groups consisted of 194 and 376 patients (N = 570), respectively. A statistically but not clinically significant difference in pain intensity (P = .003; effect = 0.506 (.172-.839)) was found in favor of the Trial group. No interaction between a time dependency effect and pain intensity was noted. Whereas trialed SCS patients were more likely to cease opioid usage (P = .003; OR = .509 (.326-.792)), patients in the No-Trial group endured fewer infections (P = .006; proportion difference = .43 (.007-.083)). Although the clinical relevance of our findings should be proven in future studies, this long-term real-world data study indicates that patient-centered assessments on whether an SCS trial should be performed have to be investigated. According to the current ambiguous evidence, SCS trials should be considered on a case-by-case basis. PERSPECTIVE: The currently available comparative evidence, together with our results, remains ambiguous on which SCS implantation strategy might be deemed superior. An SCS trial should be considered on a case-by-case basis, for which further investigation of its clinical utility in certain patient populations or character traits is warranted.

Altered central pain processing assessed by quantitative sensory testing in patients with failed back surgery syndrome.

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

Spinal cord stimulator medullary compression-a very rare SCS complication and surgical treatment.

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

Efficacy of Minimally Invasive Trans-Sacral Canal Plasty between Patients with and without Failed Back Surgery Syndrome.

Background and Objectives: Clinicians are required to manage a growing number of elderly patients with several medical comorbidities, and invasive surgical treatments are sometimes not advisable for these patients. The aim of this study was to evaluate the efficacy of minimally invasive intraspinal canal treatment, trans-sacral canal plasty (TSCP), for patients with and without failed back surgery syndrome (FBSS). Materials and Methods: A multicenter analysis was conducted. TSCP was performed in patients with chronic low back pain and leg pain due to lumbar spinal disorders. An adhesiolysis by TSCP was carried out, then a mixture of steroid and local anesthesia was injected. Visual Analog Scales (VAS) for low back pain and leg pain, and complications were evaluated. Results: A total of 271 patients with a minimum 6-month follow-up were enrolled. There were 80 patients who had a history of previous lumbar spinal surgery (F group), and 191 patients without previous lumbar spinal surgery (N group). There were no significant differences in sex and age between the two groups. VAS scores for low back pain (N group/F group) preoperatively, immediately postoperatively, and 1 month, 3 months and 6 months postoperatively, were 51/52 mm, 24/26 mm, 33/34 mm, 30/36 mm, and 30/36 mm, respectively. VAS scores for leg pain were 69/67 mm, 28/27 mm, 39/41 mm, 36/43 mm, and 32/40 mm, respectively. Both VAS scores for low back pain and leg pain were significantly decreased from baseline to final follow-up in both groups (p < 0.01). However, VAS scores for leg pain at 3 months and 6 months postoperatively were significantly higher in F group (p < 0.05). There were three catheter breakages (2/3 in F group), and one dural tear in F group. Conclusions: TSCP significantly reduced both VAS scores for low back and leg pain in patients with and without FBSS. However, co-existence of intractable epidural adhesion might be associated with less improvement in 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.

Neuromodulation in the treatment of postoperative epidural fibrosis: comparison of the extent of epidural fibrosis and the effect of stimulation.

The goal was to prove that when a cohort of patients is chosen precisely, dorsal column stimulation provides significant improvement to quality of life. We studied a cohort of 50 patients with the history of failed back surgery syndrome coupled with epidural fibrosis (EF). A percutaneous implantation technique was used in each of the 50 patients. The study group was composed of 20 women and 28 men aged 26-67 years (mean age 49). A prospective observational questionnaire-based study was used. According to the methods, Ross's classification was adjusted to four degrees of scar size for our study objective. Despite this adjustment, it was not possible to statistically evaluate our research, due to very similar results in Groups I, III and IV. Patients without epidural fibrosis were assigned to Group 0, and patients with EF of different ranges were assigned to Group 1. The mean change in visual analogue scale DeltaVAS after our division into Group 0 was 4.82; for Group 1 it was 6.13. Evaluation of EF and DeltaVAS correlation by paired t-test shows a statistically higher effect of spinal cord stimulation (SCS) in the epidural fibrosis group, compared to group 0 without postoperative epidural fibrosis (p=0.008). The extent of epidural fibrosis is an important factor for Failed back surgery syndrome (FBSS). FBSS is the basis for the existence of neuropathic pain after lumbar spinal surgery. There is clear evidence of a correlation between patients with epidural scar formation on MR scan and the effect of dorsal column stimulation.

Socioeconomic Disparities in the Utilization of Spinal Cord Stimulation Therapy in Patients with Chronic Pain.

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.

Long-term quality of life and work status after high-dose spinal cord stimulation in patients with failed back surgery syndrome: a secondary analysis of real-world data.

OBJECTIVE: In recent years, the use of high-dose spinal cord stimulation (HD-SCS) as a treatment option for patients with failed back surgery syndrome (FBSS) has drastically increased. However, to the authors' knowledge a thorough evaluation of health-related quality of life (HRQOL) and work status in these patients has not yet been performed. Moreover, it is unclear whether patients who are treated with HD-SCS can regain the same levels of HRQOL as the general population. Therefore, the aims of this study were to compare the HRQOL of patients who receive HD-SCS to HRQOL values in an age- and sex-adjusted population without FBSS and to evaluate work status in patients who are receiving HD-SCS. METHODS: HRQOL, measured with the 3-level EQ-5D (EQ-5D-3L), and work status were evaluated in 185 FBSS patients at baseline (i.e., before SCS) and at 1, 3, and 12 months of treatment with HD-SCS. Difference scores in utility values between patients and an age- and sex-adjusted normal population were calculated. One-sample Wilcoxon tests were used to assess the EQ-5D-3L difference scores. Mixed models were used to evaluate the evolution over time in EQ-5D-3L utility scores and EQ-5D visual analog scale (VAS) scores in patients and matched controls. Quality-adjusted life-years (QALYs) were calculated using the area under the curve method. RESULTS: An overall significant increase in EQ-5D-3L utility scores and EQ-5D VAS scores was found over time in the patient group. Wilcoxon tests indicated that the difference scores in utility values between patients and the normal population were significantly different from zero at all time points. The median incremental QALY after 12 months of HD-SCS was 0.228 (Q1-Q3: 0.005-0.487) in comparison to continued conservative treatment. At 12 months, 13.75% of patients resumed work. CONCLUSIONS: HD-SCS may lead to significantly increased HRQOL at 12 months in patients with FBSS. Despite the increase, reaching the HRQOL level of matched controls was not achieved. Only a limited number of patients were able to return to work. This finding indicates that specialized programs to enhance return to work may be beneficial for patients undergoing SCS.

A Regions of Interest Voxel-Based Morphometry Study of the Human Brain During High-Frequency Spinal Cord Stimulation in Patients With Failed Back Surgery Syndrome.

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.

Functional connectivity and structural analysis of trial spinal cord stimulation responders in failed back surgery syndrome.

BACKGROUND: Chronic pain has been associated with alterations in brain structure and function that appear dependent on pain phenotype. Functional connectivity (FC) data on chronic back pain (CBP) is limited and based on heterogeneous pain populations. We hypothesize that failed back surgery syndrome (FBSS) patients being considered for spinal cord stimulation (SCS) therapy have altered resting state (RS) FC cross-network patterns that 1) specifically involve emotion and reward/aversion functions and 2) are related to pain scores. METHODS: RS functional MRI (fMRI) scans were obtained for 10 FBSS patients who are being considered for but who have not yet undergone implantation of a permanent SCS device and 12 healthy age-matched controls. Seven RS networks were analyzed including the striatum (STM). The Wilcoxon signed-rank test evaluated differences in cross-network FC strength (FCS). Differences in periaqueductal grey (PAG) FC were assessed with seed-based analysis. RESULTS: Cross-network FCS was decreased (p<0.05) between the STM and all other networks in these FBSS patients. There was a negative linear relationship (R2 = 0.76, p<0.0022) between STMFCS index and pain scores. The PAG showed decreased FC with network elements and amygdala but increased FC with the sensorimotor cortex and cingulate gyrus. CONCLUSIONS: Decreased FC between STM and other RS networks in FBSS has not been previously reported. This STMFCS index may represent a more objective measure of chronic pain specific to FBSS which may help guide patient selection for SCS and subsequent management.

Randomized clinical trial comparing buprenorphine/naloxone and methadone for the treatment of patients with failed back surgery syndrome and opioid addiction.

Opioid analgesic consumption has led to an unprecedented epidemic of overdose death and opioid addiction in the US history. The treatment of chronic pain in patients with opioid addiction who receive prescriptions for opioid medications presents a clinical dilemma. Continuing opioid medication could result in hyperalgesia rendering opioids ineffective and results in iatrogenic therapeutic damage as evidenced by the worsening of addiction. Discontinuing opioid medications could result in severe pain and cravings that often leads the patient to the illicit market. This study compared methadone and buprenorphine/naloxone in patients with failed back surgery syndrome and opioid addiction. Nineteen participants were randomly assigned to methadone or buprenorphine/naloxone and were followed for 6 months. In an intent-to-treat analysis analgesia, craving, functioning, drug use, depression, and treatment retention were assessed monthly. It was planned to enroll 66 patients with failed back surgery syndrome and opioid addiction; however, enrollment was closed early due to suspected abuse of medications. Patients in both treatment conditions exhibited significantly improved 24-hour pain severity with up to 20% reduction of pain severity at the last follow-up (p < .05). However, patients receiving methadone reported significantly reduced current pain severity, whereas patients receiving buprenorphine/naloxone did not. Patients reported significantly improved functioning, fewer cravings, less opioid use, and depression (p < .05) across the treatment conditions. When given a choice between methadone and buprenorphine/naloxone, buprenorphine/naloxone is recommended due to its superior safety profile. Treatment with either needs to be monitored closely.

Spinal cord stimulation in a patient with multiple sclerosis and failed back surgery syndrome.

In the present article, we described a case of treating intractable pain from failed back surgery syndrome (FBSS) and multiple sclerosis (MS) after implantation of spinal cord stimulation (SCS) in a patient. We are reporting a case where SCS has been used for treating a patient with both FBSS and MS.

Dolor crónico post cirugía de columna lumbar: magnitud del problema y opciones terapéuticas / Chronic pain after lumbar spine surgery: magnitude of the problem and therapeutic options

El dolor crónico postoperatorio de cirugía de columna lumbar tiene una incidencia entre un 10-50 por ciento de los pacientes postoperados, siendo de difícil manejo. Se ha denominado síndrome de fracaso de cirugía espinal lumbar (FBSS) a aquellos pacientes que han sido beneficiarios de una cirugía del raquis lumbosacro y en quienes no se logra una mejoría de manera satisfactoria, presentando dolor crónico lumbar, siendo su incidencia de alrededor de un 20 por ciento, y debido a una mala evolución del proceso de recuperación que puede ocasionar fibrosis en el canal medular. Existen diversas alternativas terapéuticas para afrontar este problema, donde destacan el tratamiento farmacológico, medicina física y el abordaje intervencionista no quirúrgico y quirúrgico implementados últimamente, con el fin de disminuir de manera efectiva el dolor en este grupo de pacientes. Sin embargo, a pesar de las terapias combinadas, existe un grupo de pacientes que debe ser sometido a una nueva intervención quirúrgica con resultados poco promisorios.

Chronic postoperative pain of lumbar spine surgery has an incidence between 10-50 percent of postoperative patients, being difficult to manage. The Failed Back Surgery Syndrome (FBSS) has been referred to those patients who have been beneficiaries of lumbosacral spinal surgery and who do not achieve a satisfactory improvement, presenting chronic lumbar pain with an incidence around 20 percent and due to a poor evolution of the recovery process that can cause fibrosis in the medullary canal. There are several therapeutic alternatives to address this problem, which highlights the pharmacological treatment, physical medicine and the non-surgical and surgical intervention approach recently implemented, in order to effectively reduce pain in this group of patients. However, despite the combination therapies, there is a group of patients that must undergo a new surgical intervention with little promising results.

[The effect of various multimodal analgesia regimens during surgical treatment of patients with spinal stenosis on the rate of failed back surgery syndrome]. / Vliianie razlichnykh mul'timodal'nykh skhem analgezii pri khirurgicheskom lechenii patsientov so stenozom pozvonochnogo kanala na chastotu sindroma neudachnoi operatsii na pozvonochnike.

OBJECTIVE: To determine the effect of various methods of perioperative analgesia on the rate of failed back surgery syndrome in patients operated on for spinal stenosis. MATERIAL AND METHODS: A total of 122 patients were operated on for spinal stenosis in 2010-2016. The patients were assigned to groups according to the type of received analgesia: Group K (n=19) underwent analgesia on-demand. Patients in the PMA group (n=21) received preventive multimodal analgesia (PMA) with ketoprofen, paracetamol and morphine. Patients in the PMA+PG (n=20) and PMA+N (n=20) groups additionally received pregabalin and nefopam, respectively. Patients in the PMA+E group (n=22) received continuous epidural analgesia with a combination of ropivacaine and morphine. In patients in the PMA+I group (n=20), the wound was infiltrated with ropivacaine and ketorolac. RESULTS AND CONCLUSION: In Group K, analgesia was not adequate during five postoperative days. Analgesia with PMA resulted in significant pain reduction during three postoperative days compared to Group K. Wound infiltration in addition to PMA was followed by more significant pain relief during six postoperative hours (compared to the PMA group). Administration of pregabalin or nefopam, as well as epidural analgesia, did not improve quality of postoperative analgesia. Five to seven months after the surgery, 66% (57; 75%) of patients had low back and/or leg pain; 41% (32; 50%) of patients had leg pain. Among patients suffering from pain, 32-41% patients had the severe chronic pain syndrome that resulted in sleep disorder, disability and significant deterioration of quality of life. The rate of failed back surgery syndrome did not depend on the perioperative analgesia regimen.

Clinical insomnia and associated factors in failed back surgery syndrome: a retrospective cross-sectional study.

Background Insomnia frequently occurs to patients with persistent back pain. By worsening pain, mood, and physical functioning, insomnia could lead to the negative clinical consequences of patients with failed back surgery syndrome (FBSS). This retrospective and cross-sectional study aims to identify the risk factors associated with clinical insomnia in FBSS patients. Methods A total of 194 patients with FBSS, who met the study inclusion criteria, were included in this analysis. The Insomnia Severity Index (ISI) was utilized to ascertain the presence of clinical insomnia (ISI score ≥ 15). Logistic regression analysis evaluates patient demographic factors, clinical factors including prior surgical factors, and psychological factors to identify the risk factors of clinical insomnia in FBSS patients. Results After the persistent pain following lumbar spine surgery worsened, 63.4% of patients reported a change from mild to severe insomnia. In addition, 26.2% of patients met the criteria for clinically significant insomnia. In a multivariate logistic regression analysis, high pain intensity (odds ratio (OR) =2.742, 95% confidence interval (CI): 1.022 - 7.353, P=0.045), high pain catastrophizing (OR=4.185, 95% CI: 1.697 - 10.324, P=0.002), greater level of depression (OR =3.330, 95% CI: 1.127 - 9.837, P=0.030) were significantly associated with clinical insomnia. However, patient demographic factors and clinical factors including prior surgical factors were not significantly associated with clinical insomnia. Conclusions Insomnia should be addressed as a critical part of pain management in FBSS patients with these risk factors, especially in patients with high pain catastrophizing.

Evaluation of spinal cord stimulation on the symptoms of anxiety and depression and pain intensity in patients with failed back surgery syndrome.

BACKGROUND: Spinal cord stimulation (SCS) is now established as the primary treatment for failed back surgery syndrome (FBSS). Commonly, patients with chronic pain and FBSS often report symptoms of anxiety and depression resulting from this condition. These factors can modulate and amplify the pain experience, therefore, further challenging treatment success. AIMS: This study examined the efficacy of SCS on alleviating the symptoms of anxiety and depression associated with chronic pain as well as pain intensity in a group of patients with FBSS. METHODS: A convenience sample (n = 26) was selected for participation. Questionnaires [Hospital Anxiety and Depression Scale (HADS) and Brief Pain Inventory Short Form (BPI-SF)] were completed and examined pre and post spinal cord implant. RESULTS: Analysis of the data 1 year following SCS indicates that there was a statistical significant improvement in the symptoms of depression and anxiety reported as well as pain intensity in all participants (p < 0.001). Both anxiety and depression scores on the HADS were significantly lower compared to baseline (p < 0.001). Pain intensity scores decreased by ≥50% from baseline in all participants. Opioid analgesia was discontinued by 90% (n = 8) of participants. CONCLUSION: Whilst it is already recognised that SCS reduces pain in FBSS, this study demonstrated that it also reduced the symptoms of anxiety and depression with an associated reduction in opioid consumption.