Spinal Cord Stimulation in Failed Back Surgery Syndrome: An Integrative Review of Quantitative and Qualitative Studies.

BACKGROUND: Spinal cord stimulation (SCS) is an established therapy of failed back surgery syndrome (FBSS), although the effects on daily functioning, quality of life (QoL), and patients' expectations, experiences, and satisfaction remain elusive. The current integrative review aimed to summarize the overall effects of SCS in patients with FBSS on pain relief, health-related QoL, and daily activities. MATERIALS AND METHODS: PubMed, CINAHL, Embase, ClinicalTrials.gov, gray literature, and reference lists of relevant articles were searched for additional papers. All included studies were assessed for risk of bias using the Mixed Methods Appraisal Tool. Following the methods of Whittemore and Knafl, an integrative review and a meta-analysis were performed. RESULTS: In total, 16 articles were included; 11 articles presented quantitative outcomes, and five articles presented qualitative data. Lower back pain, leg pain, overall pain, Oswestry Disability Index, EuroQol Five Dimensions Health Questionnaire three-level/five-level, and the physical component score of Short Form Health Survey (SF-36) significantly improved during all follow-up moments. Only the mental component score of the SF-36 did not significantly improve, compared with baseline. Heterogeneity was diversely present among the studies. Patients' expectations and goals were disparate, although patients seemed to desire a return to their pre-FBSS state. Experiences with regard to the outcomes showed that patients largely recuperated after SCS, although limitations were still present. Patients also expressed inconvenience with regard to the trial period, implantation location, and recharging of the implantable pulse generator. CONCLUSIONS: SCS showed beneficial effects on different domains of life in patients with FBSS. The quantitative analyses suggest an overall improvement in most domains, although patients' experiences show that limitations in daily life and living with the SCS system persist. Multiple extensive preoperative counseling sessions and discussions with patients are deemed necessary to improve patient satisfaction and meet their expectations. Shared decision-making and provision of complete information are key factors for success.

Can dogs and cats really help our spinal cord stimulation patients?

OBJECTIVES: Pet ownership has been shown to decrease morbidity and mortality in several aspects of health but has not been studied in chronic pain patients. We evaluate whether subjects who underwent spinal cord stimulation (SCS) and own a pet have improved outcomes compared to non-pet owners. METHODS: After obtaining IRB approval, we re-contacted 38 subjects who underwent SCS surgery with preoperative and 1-year postoperative data on Numerical Rating Scale (NRS), McGill Pain Questionnaire (MPQ), Oswestry Disability Index (ODI), Beck Depression Inventory (BDI), and Pain Catastrophizing scale (PCS). We examined influence of pets and pet ownership-specific behaviors on improvement in SCS outcomes. RESULTS: Patients included 24 males/14 females with a mean age of 59.9 ± 11.5 years. At mean follow-up of 12.2 months (range 10-14), there were improvements in NRS, ODI, BDI, PCS and MPQ. Twenty subjects owned pets and 18 did not; all believed pet ownership could improve health. Pet owners improved more on NRS-right now (p = 0.05) and BDI (p = 0.05), and were more satisfied with SCS (p = 0.04). No significant improvement was seen in ODI, MPQ, or PCS. However, PCS did improve in pet owners who exercised their pet (PCS-total, p < 0.01; PCS-helplessness, p < 0.01; PCS-rumination, p = 0.05; PCS-magnification, p = 0.02). CONCLUSIONS: We provide preliminary evidence that pet ownership is associated with improved pain, depression and SCS satisfaction. Exercising with a pet also appears to be beneficial in limiting pain catastrophizing. Pets show promise as a novel means to improve patient SCS outcomes.

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.

Views of patients suffering from Failed Back Surgery Syndrome on their health and their ability to adapt to daily life and self-management: A qualitative exploration.

BACKGROUND: The clinical outcomes of Spinal Cord Stimulation (SCS) therapy in patients with a Failed Back Surgery Syndrome (FBSS) is mostly done by standardized pain and quality of life measurements instruments and hardly account for personal feelings and needs as a basis for a patient-centred approach and shared decision making. OBJECTIVES: The objective of this study is to explore perspectives on personal health and quality of life (QoL) in FBSS patients concerning their physical-, psychological and spiritual well-being prior to receiving an SCS system. METHODS: We performed face-to-face, semi-structured, in-depth interviews to obtain descriptive and detailed data on personal health, guided by the Web diagram of Positive Health (Huber et al.) and a topic list. The following main topics were assessed qualitatively: 1) Bodily functioning, 2) Mental function and perception 3) Spiritual dimension, 4) Quality of life, 5) Social and societal participation and 6) Daily functioning. RESULTS: Seventeen FBSS patients (eight male, nine female) were included from April-November 2019 at the department of pain medicine in the Albert Schweitzer Hospital in the Netherlands. Median age 49 years; range 28 to 67 years, and patients underwent between one and five lumbar surgical operations. The duration of their chronic pain was between four and 22 years. After analyzing the interviews, three themes emerged: 1) dealing with chronic pain, 2) the current situation regarding aspects of positive health, and 3) future perspectives on health and quality of life. These themes arose from eleven categories and a hundred ninety codes. CONCLUSION: This qualitative study explored FBSS patients 'views on their health and the ability to adapt to daily life having complex chronic pain, and showed that patients experienced shortcomings in daily life within the six dimensions of the Web diagram of Positive Health before the SCS implant.

Effects of Scrambler Therapy in Patients with Failed Back Surgery Syndromes and Factors Associated with Depression Affecting Pain before and after the Therapy.

Objectives: To report the effects of scrambler therapy in patients diagnosed with failed back surgery syndromes and to analyze the factors affecting pain before and after the therapy. Methods: This study included 26 patients (12 males and 14 females). The Oswestry Disability Index (ODI) and Brief Pain Inventory (BPI) before and after scrambler therapy, Beck Depression Inventory (BDI) score before therapy, and residual pain after therapy were assessed. The changes in the ODI, BPI, and residual pain before and after the therapy were analyzed using the Wilcoxon signed rank test. Spearman correlation analysis and Fisher's exact test were used to confirm the correlation between BDI and other factors. Multiple regression analysis was used to identify independent factors predicting residual pain, posttherapy ODI, and posttherapy BPI. Results: The ODI changed from 25.69 ± 7.98 to 21.80 ± 9.41 (p < 0.05), and the BPI changed from 68.96 ± 18.00 to 61.62 ± 20.27 after scrambler therapy (p < 0.05). In addition, residual pain changed from 100 to 76.15 (p < 0.05). The BDI was negatively correlated with the duration of scrambler therapy and positively correlated with the initial OPD and BPI. In multiple regression analysis, residual pain was significantly correlated with the BDI (p < 0.05). Conclusion: Scrambler therapy can be used to change the total scores of the ODI and BPI after 5 sessions of treatment. Also, residual pain was significantly related to the BDI. Clinical significance of depression severity on pain should be further investigated via prospective studies.

[A retrospective investigation of the efficiency of transforaminal anterior epidural steroid injections in patients with low back pain and the effects of interventional pain therapy on quality of life]. / Bel agrili hastalarda transforaminal anterior epidural steroid enjeksiyonunun etkinliginin ve girisimsel tedavinin yasam kalitesine etkisinin retrospektif arastirilmasi.

OBJECTIVES: The aim of this retrospective study was to evaluate the efficacy of transforaminal anterior epidural steroid and local anesthetic injections (TAESE) and the effects on quality of life in patients with low back pain. METHODS: The study patients (n=191) were divided into 3 groups: disc herniation (DH), failed back surgery (FBS), and spinal stenosis (SS). A visual analog scale (VAS) and verbal pain scale (VPS) were used to assess patient pain. Scores were measured before treatment (VAS 0), in the first month of application (VAS 1), 3 months (VAS 3), and 6 months (VAS 6). Patient quality of life was examined using the 36-Item Short Form Health Survey (SF-36). RESULTS: In all 3 groups, there was a statistically significant reduction in pain compared with the VAS 0 score at 1, 3, and 6 months (p<0.001). The reduction in VAS/VPS was greatest in the DH group, followed by the FBS and SS groups, respectively. All of the parameters of the SF-36 measurement were lower in the SS patients compared with the DH patients. The quality of life score was lowest in the SS patients, though the physical health and social functioning scores were lowest in the FBS group. CONCLUSION: TAESE is effective and can be safely performed in patients who have low back pain due to DH, FBS, or SS. The quality of life result was less successful in SS patients, particularly in the parameter of physical role limitations.

Long-Term Effect of Peripheral Nerve Field Stimulation as Add-On Therapy to Spinal Cord Stimulation to Treat Low Back Pain in Failed Back Surgery Syndrome Patients: A 12-Month Follow-Up of a Randomized Controlled Study.

OBJECTIVE: Different approaches in neuromodulation have been used to treat chronic low back pain in failed back surgery syndrome (FBSS) patients. We previously randomized 52 FBSS patients to be treated with spinal cord stimulation (SCS) and additional peripheral nerve field stimulation (PNFS) or SCS alone. At three months, we found a significant reduction of back pain in the PNFS-SCS group compared to the SCS group. In the subsequent open phase part of the study, all patients received optimal SCS and PNFS simultaneously. Here, we present the 12-month follow-up data on back and leg pain. MATERIALS AND METHODS: Data regarding back and leg pain, function, quality of life, patient satisfaction, anxiety and depression, and use of medication were collected by analyzing patients' questionnaires at 12 months and compared with data collected at baseline. Data were analyzed using multilevel regression models. RESULTS: A combined group of 50 subjects completed the 12-month follow-up. Back pain, measured on a 100-mm visual analog scale (VAS), significantly decreased over this period by 30.0 mm (95% CI: [-37.7/-22.4]; p < 0.001), while leg pain decreased by 43.7 mm (95% CI: [-51.5/-36.2]; p < 0.001). We observed statistically significant improvement in almost all secondary outcome measurements. CONCLUSIONS: At 12-month follow-up, PNFS in addition to SCS continues to provide a statistically significant and clinically relevant relief of low back pain in FBSS patients in whom SCS alone is effective for relief of leg pain only.

An Exploration of the Experiences and Educational Needs of Patients With Failed Back Surgery Syndrome Receiving Spinal Cord Stimulation.

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

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.

Use of a Psychological Evaluation Tool as a Predictor of Spinal Cord Stimulation Outcomes.

INTRODUCTION: Preoperative work-up for spinal cord stimulation (SCS) includes a psychological assessment; however, no one psychological factor has correlated with poor outcomes across studies. We developed a Psychological Evaluation Tool for Spinal Cord Stimulation Candidacy (PETSCSC), which includes all factors in the literature found to correlate with outcomes. In this study, we examine whether PETSCSC correlates with postoperative outcomes. METHODS: Patients undergoing SCS were prospectively enrolled in this study. PETSCSC scores were obtained preoperatively. Numeric rating scale (NRS), global impression of change (GIC), pain catastrophizing scale (PCS), McGill pain questionnaire (MPQ), Oswestry disability index (ODI), and Beck Depression Inventory were assessed preoperatively and postoperatively. Outcomes were correlated with PETSCSC scores. RESULTS: Thirty-four SCS patients had a mean follow-up of 9.88 ± 2.91 months. At latest follow-up, we observed significant improvement in NRS, PCS, MPQ, and ODI. Total PETSCSC score exhibited significant correlation with GIC (p = 0.026, r = 0.380) and improvement in PCS total (p = 0.041, r = 0.351), and MPQ affective (p = 0.002, r = 0.517) scores. The PETSCSC emotive subset significantly correlated with GIC (p = 0.020, r = 0.395). The PETSCSC depression subset significantly correlated with improvement in PCS rumination (p = 0.009, r = 0.439), PCS helplessness (p = 0.021, r = 0.393), PCS total (p = 0.021, r = 0.394), and MPQ affective (p = 0.002, r = 0.501). The PETSCSC therapy subset significantly correlated with improvement in MPQ sensory (p = 0.026, r = -0.381) and MPQ affective (p < 0.001, r = 0.583). DISCUSSION: PETSCSC scores and subscores demonstrate significant correlation with pain outcomes used in assessment of SCS efficacy. Higher PETSCSC scores correlate with greater improvement in GIC, MPQ affective, and PCS scores. Stratification of these patients based on PETSCSC total and subset scores could help with prognostication.

Effect of Pain Neuroscience Education Combined With Cognition-Targeted Motor Control Training on Chronic Spinal Pain: A Randomized Clinical Trial.

Importance: Effective treatments for chronic spinal pain are essential to reduce the related high personal and socioeconomic costs. Objective: To compare pain neuroscience education combined with cognition-targeted motor control training with current best-evidence physiotherapy for reducing pain and improving functionality, gray matter morphologic features, and pain cognitions in individuals with chronic spinal pain. Design, Setting, and Participants: Multicenter randomized clinical trial conducted from January 1, 2014, to January 30, 2017, among 120 patients with chronic nonspecific spinal pain in 2 outpatient hospitals with follow-up at 3, 6, and 12 months. Interventions: Participants were randomized into an experimental group (combined pain neuroscience education and cognition-targeted motor control training) and a control group (combining education on back and neck pain and general exercise therapy). Main Outcomes and Measures: Primary outcomes were pain (pressure pain thresholds, numeric rating scale, and central sensitization inventory) and function (pain disability index and mental health and physical health). Results: There were 22 men and 38 women in the experimental group (mean [SD] age, 39.9 [12.0] years) and 25 men and 35 women in the control group (mean [SD] age, 40.5 [12.9] years). Participants in the experimental group experienced reduced pain (small to medium effect sizes): higher pressure pain thresholds at primary test site at 3 months (estimated marginal [EM] mean, 0.971; 95% CI, -0.028 to 1.970) and reduced central sensitization inventory scores at 6 months (EM mean, -5.684; 95% CI, -10.589 to -0.780) and 12 months (EM mean, -6.053; 95% CI, -10.781 to -1.324). They also experienced improved function (small to medium effect sizes): significant and clinically relevant reduction of disability at 3 months (EM mean, -5.113; 95% CI, -9.994 to -0.232), 6 months (EM mean, -6.351; 95% CI, -11.153 to -1.550), and 12 months (EM mean, -5.779; 95% CI, -10.340 to -1.217); better mental health at 6 months (EM mean, 36.496; 95% CI, 7.998-64.995); and better physical health at 3 months (EM mean, 39.263; 95% CI, 9.644-66.882), 6 months (EM mean, 53.007; 95% CI, 23.805-82.209), and 12 months (EM mean, 32.208; 95% CI, 2.402-62.014). Conclusions and Relevance: Pain neuroscience education combined with cognition-targeted motor control training appears to be more effective than current best-evidence physiotherapy for improving pain, symptoms of central sensitization, disability, mental and physical functioning, and pain cognitions in individuals with chronic spinal pain. Significant clinical improvements without detectable changes in brain gray matter morphologic features calls into question the relevance of brain gray matter alterations in this population. Trial Registration: clinicaltrials.gov Identifier: NCT02098005.

Benefits in pain perception, ability function and health-related quality of life in patients with failed back surgery syndrome undergoing spinal cord stimulation in a clinical practice setting.

BACKGROUND: Failed back surgery syndrome (FBSS) represents one main cause of chronic neuropathic or mixed pain, functional disability and reduced Health Related Quality of Life (HRQoL). Spinal Cord Stimulation (SCS) can be a value for money option to treat patients refractory to conventional medical management (CMM). We estimated from real-world data: 1) the amount of reduced levels of HRQoL of target patients compared to general population, 2) the relationship between pain intensity, functional disability, and overall HRQoL, and 3) the improvement of patients' health from SCS intervention, and 4) we give some insights and make some suggestions on the selection of a battery of patients' reported health instruments for use in routine clinical practice. METHODS: At recruitment (before SCS) and every 6 months for 2 years after SCS a battery of questionnaires/tests were completed: the generic EQ-5D and SF-36 for HRQoL, the specific Numerical Rating Scale (NRS) to measure pain intensity, and Oswestry Disability Index (ODI) to measure functional disability. We conducted multilevel regression analyses to investigate the association of HRQoL with the NRS and ODI indexes; multiple regression analyses to compare EQ-5D data with those of the general population adjusted for age, sex and education, and statistical tests to compare the changes of HRQoL, NRS and ODI estimates at baseline with those measured during the follow-up. RESULTS: Eighty patients (40% male, mean age = 58 years) participated. HRQoL was significantly worse in the patients than in the corresponding general population. Pain, functional disability and HRQoL significantly related each other during follow-up, Significant improvements (p < 0.001) in pain intensity, functional capability and HRQoL were reached after 6 months from SCS and generally remained stable during follow-up. Specific instruments provided detailed information on disability and pain, while generic instruments assessed the overall HRQoL and allowed a comparison with the general population's one. CONCLUSIONS: SCS + CMM treatment reaches a statistically significant and probably a clinically relevant improvement in pain perception, functional disability and HRQoL in patients with FBSS refractory to CMM. An appropriate selection of instruments for use in clinical practice is crucial for a routine assessment of health perception in patients, aimed to guide decisions for optimal treatment.

Spinal Cord Stimulation for the Treatment of Failed Neck Surgery Syndrome: Outcome of a Prospective Case Series.

OBJECTIVES: Spinal cord stimulation (SCS) is an accepted, cost-effective treatment option for a variety of chronic pain syndromes, including failed back surgery syndrome (FBSS). The application of SCS in the cervical spine, particularly for pain after cervical spine surgery, has been drawn into question in recent years by payers due to a purported lack of clinical evidence. To challenge this claim, we analyzed data from a prospective registry to support the use of SCS in the cervical spine for pain after spine surgery. MATERIALS AND METHODS: Data from the EMPOWER and PAIN registries were analyzed on patients diagnosed with pain after neck surgery (C-FBSS) for the following outcomes: patient reported percent pain relief (PRPR), pain disability index (PDI), quality of life (QoL), and satisfaction at 3-, 6-, and 12-month post-implantation. Statistical analysis was provided for all measures. RESULTS: Fifteen patients with C-FBSS were successfully implanted with SCS leads in the cervical spine. PRPR was 65.2%, 62.4%, and 71.9% at 3-, 6-, and 12-month post-implantation, respectively. PDI scores were significantly reduced from baseline (51.21-23.70 at 12 months, p = 0.001). At one-year post-implantation, the average overall QoL was reported to be improved/greatly improved and patient satisfaction was rated satisfied/greatly satisfied. CONCLUSIONS: For many, the application of SCS in the neck for pain after surgery is based on the obvious similarities to FBSS or anecdotal experience rather than published data. The data contained herein suggest SCS for C-FBSS is an effective therapy that improves QoL and patient satisfaction, as well as decreasing pain and PDI. The use of successful application of neurostimulation as a therapy has largely been predicated on the principles of patient selection, implantation technique, and stimulation parameters. As such, SCS would appear to be an appropriate and valid treatment for C-FBSS that requires further study and investigation to make additional recommendations.

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.

Temperament and Character Profile in Failed Back Surgery Syndrome: A Cross-Sectional Clinical Study.

AIM: Some psychometric properties may predict the development of failed back surgery syndrome (FBSS). The aim of this study was to determine the pain, disability, and depression severity in patients diagnosed with FBSS, and to determine the temperament and character subgroups in comparison with control group. MATERIAL AND METHODS: Thirty-eight patients diagnosed with FBSS, and 35 patients with favourable outcome after lumbar spinal surgery were included to the study. Pain intensity, disability, depression scores, temperament and character profile were determined by the visual analogue scale (VAS), Roland Morris Disability Index, Beck Depression Inventory, and Temperament and Character Inventory. RESULTS: Pain intensity, disability, and depression scores were higher in the FBSS group (p < 0.001). There were no significant differences between temperament and character subgroups between study groups except one of the temperament subgroup, reward dependence (p=0.05). There was a negative correlation between self-directedness and leg pain severity in the FBSS group (p=0.01, r=-0.400). CONCLUSION: No significant differences were found between the FBSS and control groups with respect to temperament and character profile but FBSS was the cause of severe pain, disability, and higher depression scores. This group of patients must therefore be evaluated psychiatrically and should also be subjected to a clinical examination, and they should be managed using a multidisciplinary approach.

Are fibromyalgia and failed back surgery syndromes actually "functional somatic syndromes" in terms of their symptomatological, familial and psychological characteristics? A comparative study with chronic medical illness and healthy controls.

OBJECTIVES: The aim of this study was to investigate whether Fibromyalgia and Failed Back Surgery Syndromes (FMS-FBSS) may be evaluated under the single heading of Functional Somatic Syndromes (FSS) with respect to their symptomatological characteristics such as intensity, frequency, age of onset, duration, painful areas, fear of pain, and pain coping styles; familial characteristics such as family history of chronic medical illness, psychopathology and pain; and psychological characteristics such as manner of dealing with pain, fear of pain, alexithymia, symptom interpretation, somatosensory amplification and depression. METHODS: The study comprised 150 individuals, separated into 3 groups; The FSS Group comprised 47 patients who were referred to the Physical Medicine and Rehabilitation Clinic at Istanbul University's Faculty of Medicine with FMS (n=35) and FBSS (n=12), the healthy control group (HC Group) comprised 47 individuals, and the chronic medical illness control group (CMIC Group) was made up of 56 individuals. Turkish versions of the Toronto Alexithymia Scale, Symptom Attribution Inventory, Somatosensory Amplification Scale and Beck Depression Inventory, along with a semi-structured form questioning general health, pain and demographics were administered to all participants. RESULTS: FMS and FBSS participants (FSS Group) did not differ as a function of the major familial, symptomatological and clinical features considered in this study. Additionally, this group significantly differed from the HC and CMIC Groups with respect to almost all these features. CONCLUSION: This study is Important Insofar as it simultaneously evaluated FMS and FBSS groups in the presence of a control group. The results suggest that FMS and FBSS, currently treated as two different diagnostic categories in general medical practice, may be evaluated under the single heading of FSS.

Cost-Effectiveness and Cost-Utility Analysis of Spinal Cord Stimulation in Patients With Failed Back Surgery Syndrome: Results From the PRECISE Study.

OBJECTIVE: To assess the cost-effectiveness and cost-utility of Spinal Cord Stimulation (SCS) in patients with failed back surgery syndrome (FBSS) refractory to conventional medical management (CMM). MATERIALS AND METHODS: We conducted an observational, multicenter, longitudinal ambispective study, where patients with predominant leg pain refractory to CMM expecting to receive SCS+CMM were recruited in 9 Italian centers and followed up to 24 months after SCS. We collected data on clinical status (pain intensity, disability), Health-Related Quality-of-Life (HRQoL) and on direct and indirect costs before (pre-SCS) and after (post-SCS) the SCS intervention. Costs were quantified in € 2009, adopting the National Health Service's (NHS), patient and societal perspectives. Benefits and costs pre-SCS versus post-SCS were compared to estimate the incremental cost-effectiveness and cost utility ratios. RESULTS: 80 patients (40% male, mean age 58 years) were recruited. Between baseline and 24 months post-SCS, clinical outcomes and HRQoL significantly improved. The EQ-5D utility index increased from 0.421 to 0.630 (p < 0.0001). Statistically significant improvement was first observed six months post-SCS. Societal costs increased from €6600 (pre-SCS) to €13,200 (post-SCS) per patient per year. Accordingly, the cost-utility acceptability curve suggested that if decision makers' willingness to pay per Quality-Adjusted-Life-Years (QALYs) was €60,000, SCS implantation would be cost-effective in 80% and 85% of cases, according to the NHS's and societal point of views, respectively. CONCLUSIONS: Our results suggest that in clinical practice, SCS+CMM treatment of FBSS patients refractory to CMM provides good value for money. Further research is encouraged in the form of larger, long-term studies.

Optimal medical, rehabilitation and behavioral management in the setting of failed back surgery syndrome.

INTRODUCTION: Failed back surgery syndrome (FBSS) constitutes a constellation of symptoms grouped together and attributed to prior surgical intervention. Clinicians often poorly understand the heterogeneity of this condition combined with the etiological factors responsible for its development. Therefore, it would follow that an algorithmic treatment approach to patients diagnosed with this syndrome might pose challenges. The clinical work-up of the patient involves history, examination and appropriate diagnostic imaging as well as behavioral assessment. MATERIALS AND METHODS: We sought to conduct a narrative review of the available literature focused on the medical, rehabilitative and behavioral treatment of FBSS. To that end, we conducted a literature search using PubMed (through March 2013). We focused on studies published over the last 20years. Only English language articles were included. Search terms included "failed back surgery syndrome", "FBSS", "failed back syndrome", and "post-laminectomy syndrome". Studies included in our review focused on randomized controlled trials (RCTs), prospective cohort studies, and case series (retrospective and prospective). Studies were organized by intervention (e.g. medical management, physical therapy and rehabilitation, and psychosocial) and presented to emphasize the quality of evidence (e.g. RCTs, prospective studies, etc.). CONCLUSION: Overall, the literature provides very limited guidance on the comprehensive management of patients suffering from FBSS. There are rehabilitative interventions and behavioral protocols that demonstrate promise. Pathways based on medication management remain difficult to clearly define.

Patient selection for spinal cord stimulators: mental health perspective.

Research has shown that psychosocial factors can predict poor outcome for spinal cord stimulation (SCS) for patients with chronic pain, substantiating the need for standardized assessment techniques to incorporate psychosocial factors in patient selection. Presurgical psychological assessment is often required for SCS. Best practices include clinical interviews by psychologists and use of standardized measures of psychosocial risk factors. Psychologists should assess mental health and social risk factors, as well as an individual's understanding of SCS and expectations for pain relief, while consulting with physicians to support a multidisciplinary based patient selection. In addition, psychologists take part in preparing patients who were initially deemed unsuitable for SCS by providing recommendations and potential access to clinical care addressing psychological issues in chronic pain. Barriers to presurgical psychological assessments include limited access to skilled psychologists and issues with feasibility and appropriateness of standardized measures, and further work is needed to improve standardized methodology.

Default mode network functional connectivity altered in failed back surgery syndrome.

UNLABELLED: The purpose of this study was to identify alterations in the default mode network of failed back surgery syndrome patients as compared to healthy subjects. Resting state functional magnetic resonance imaging was conducted at 3 Tesla and data were analyzed with an independent component analysis. Results indicate an overall reduced functional connectivity of the default mode network and recruitment of additional pain modulation brain regions, including dorsolateral prefrontal cortex, insula, and additional sensory motor integration brain regions, including precentral and postcentral gyri, for failed back surgery syndrome patients. PERSPECTIVE: This article presents alterations in the default mode network of chronic low back pain patients with failed back surgery syndrome as compared to healthy participants.