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

The introduction of the term Persistent Spinal Pain Syndrome (PSPS-T1/2), replacing the older term Failed Back Surgery Syndrome (FBSS), has significantly influenced our approach to diagnosing and treating post-surgical spinal pain. This comprehensive review discusses this change and its effects on patient care. Various diagnostic methods are employed to elucidate the underlying causes of back pain, and this information is critical in guiding treatment decisions. The management of PSPS-T1/2 involves both causative treatments, which directly address the root cause of pain, and symptomatic treatments, which focus on managing the symptoms of pain and improving overall function. The importance of a multidisciplinary and holistic approach is emphasized in the treatment of PSPS-T1/2. This approach is patient-centered and treatment plans are customized to individual patient needs and circumstances. The review concludes with a reflection on the impact of the new PSPS nomenclature on the perception and management of post-surgical spinal pain.

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

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

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.

Application of the novel Nalu™ Neurostimulation System for peripheral nerve stimulation.

Peripheral nerve stimulation is an established treatment modality for chronic neuropathic pain. Over the last decade, with the advent of innovative devices and delivery platforms, peripheral nerve stimulation has evolved from invasive open surgeries to image-guided, minimally invasive percutaneous procedures. The authors hereby present a novel device, the Nalu™ Neurostimulation System (Nalu Medical, CA, USA), which has established its advantages in providing predictable and reliable peripheral nerve stimulation therapy for chronic neuropathic pain management. This novel device is effective in treating chronic pain conditions such as post-herniorrhaphy pain syndrome, intercostal neuralgia, post-laminectomy syndrome, and complex regional pain syndrome and holds great promise for the treatment of peripheral neuropathic pain.

Chronic nerve pain is a debilitating condition that can affect quality of life and functioning. The Nalu™ Neurostimulation System (Nalu Medical, CA, USA) provides long-term pain relief without medications. There are numerous devices currently available that can be utilized to block pain signals using small wires. This system is unique because the wires placed over affected nerves are powered by an external battery that does not require permanent surgical implantation. Pain after hernia surgery, back surgery, hip surgery and knee surgery, as well as nerve pain can be effectively managed by this system.

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.

The Added Value of Intraoperative Hypnosis during Spinal Cord Stimulation Lead Implantation under Awake Anesthesia in Patients Presenting with Refractory Chronic Pain.

To improve pain relief for refractory pain condition, spinal cord stimulation (SCS) needs to target the dedicated neuronal fibers within the dorsal columns. Intraoperative feedback from the patient can optimize lead placement but requires "awake surgery", allowing interaction between patient and surgeon. This can produce negative effects like anxiety and stress. To better manage these aspects, we propose to combine intraoperative hypnosis with awake anesthesia. Seventy-four patients (35 females, 22-80 years) presenting with chronic refractory pain, were offered intraoperative hypnosis during awake SCS lead implantation. Interactive conversational hypnosis was used as well as interactive touch, which was enhanced during painful moments during the lead intraoperative programming. All patients participated actively during the intraoperative testing which helped to optimize the lead positioning. They kept an extremely positive memory of the surgery and of the hypnotic experience, despite some painful moments. Pain could be reduced in these patients by using interactions and touch, which works on Gate Control modulation. Positive memory was reinforced by congratulations to create self-confidence and to induce positive expectations, which could reinforce the Diffuse Noxious Inhibitory Controls at the spinal level. Cooperation was improved because the patient was actively participating and thus, much more alert when feedback was required. Combining intraoperative hypnosis with awake anesthesia appears helpful for SCS lead implantation. It enhances patient cooperation, allows optimization of lead positioning, and leads to better pain control, positive and resourceful memory.

Multimodal exercises integrated with cognitive-behavioural therapy improve disability of patients with failed back surgery syndrome: a randomized controlled trial with one-year follow-up.

PURPOSE: To evaluate the effect of multimodal exercises integrated with cognitive-behavioural therapy on disability, pain, and quality of life in patients suffering from failed back surgery syndrome (FBSS), and to appraise its extent in the long term. METHODS: By means of a parallel-group superiority-controlled trial, 150 outpatients were randomly assigned to a 10-week individual-based multimodal programme of task-oriented exercises integrated with cognitive-behavioural therapy (experimental group, 75 patients) or individual-based general physiotherapy (control group, 75 patients). Before treatment, 10 weeks later (post-treatment), and 12 months after the end of treatment, the Oswestry Disability Index (primary outcome), the Tampa Scale for Kinesiophobia, the Pain Catastrophising Scale, a pain intensity numerical rating scale and the Short-Form Health Survey were evaluated. Linear mixed model analysis for repeated measures was carried out for each outcome measure. RESULTS: Significant group (p < 0.001), time (p < 0.001), and time-by-group interaction (p < 0.001) effects were found for all outcome measures. Concerning disability, between-group differences (95% confidential interval) in favour of the experimental group of -9 (-10.7; -7.3) after training and of -13.2 (-14.7; -11.7) at follow-up were found. Also, kinesiophobia, catastrophising and pain showed significant between-group differences of 9, 12.5 and 1.7 points, respectively. CONCLUSION: The multimodal intervention proposed was superior to general physiotherapy in reducing disability, kinesiophobia, catastrophising, and enhancing the quality of life of patients with FBSS. The effects were reinforced one year after the programme ended.IMPLICATIONS FOR REHABILITATIONMultimodal exercises integrated with cognitive-behavioural therapy induced significant improvements in disability, pain, kinesiophobia, catastrophising, and quality of life of subjects with Failed Back Surgery Syndrome.A well-integrated rehabilitative team which contributes towards reaching intervention goals is advised.Physiotherapists should adopt task-oriented exercises to promote an earlier return to common activities of disabled patients.Psychologists should explain how to modify useless beliefs and support adequate behaviours, in order to produce constructive attitudes towards perceived disability.

Efficacy of electroacupuncture in patients with failed back surgery syndrome: study protocol for a randomized controlled trial.

BACKGROUND: Persistent pain following back surgery called failed back surgery syndrome remains a major treatment challenge. The aim of this study is to evaluate the efficacy and safety of electroacupuncture on relieving back pain in FBSS patients. METHODS/DESIGN: This is a randomized, single-blind, single-site, placebo-controlled trial. A total of 144 eligible FBSS patients will be randomly assigned to the electroacupuncture, manual acupuncture, or sham acupuncture group in a 1:1:1 ratio. Each group will receive 2 treatment sessions per week for 12 weeks. The primary outcome will be low back pain intensity based on the 11-point numerical rating scale (NRS). The secondary outcomes include Oswestry Disability Index (ODI) questionnaire, Beck Depression Inventory-II (BDI-II), Pittsburgh Sleep Quality Index (PSQI), and analgesic consumption. All clinical outcomes will be collected at baseline, during the treatment phase (at 8 and 12 weeks), and at the 16-, 24- and 36-week follow-ups. All data will be analyzed based on the intention-to-treat principle and adverse events will be assessed during the trial. DISCUSSION: This pilot randomized controlled trial will evaluate the efficacy of electroacupuncture for treating failed back surgery syndrome. The outcomes will determine whether electroacupuncture is efficacious in relieving low back pain as well as improving the quality of life in failed back surgery syndrome patients. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2000040144 . Registered on 22 November 2020.

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.

Cognitive functional therapy (CFT) compared with core training exercise (CTE) in patients with failed back surgery syndrome (FBSS): A study protocol for a randomized controlled trial.

OBJECTIVE: This study aims to investigate the efficacy of cognitive functional therapy (CFT) compared to core training exercise (CTE) on pain and specific disability of patients with failed back surgery syndrome (FBSS). DESIGN: This will be a randomized controlled clinical trial of two groups with blinded evaluators. SETTING: The study will be conducted at the Federal University of Santa Catarina (UFSC) and a private clinic in Florianópolis, SC, Brazil. PARTICIPANTS: A total of 80 participants, of both sexes, with FBSS. INTERVENTION: Subjects will be randomized into two groups: one group receiving CFT or CTE. Individuals will be assisted once a week, for a maximum period of 12 weeks, with four being the minimum number of visits and 12 being the maximum number of visits. MEASUREMENTS: The primary outcomes will be pain and specific disability. CONCLUSIONS: This is the first study investigating whether CFT is efficacious for patients with FBSS and chronic low back pain. The study's sample size was calculated to detect the effect of clinically relevant treatment with a low risk of bias. This clinical trial was designed to be able to reproduce an approach as a physiotherapist trained in CFT would do. That is, in a pragmatic way, increasing the significance of this study. CTE comprises a strategy widely used by physiotherapists to treat low back pain. Given that the scientific evidence of its efficacy for pain management is limited, the findings of this study will assist physiotherapists in their clinical decision-making.

Effectiveness of Epiduroscopy for Patients with Failed Back Surgery Syndrome: A Systematic Review and Meta-analysis.

INTRODUCTION: Low-back or leg pain in patients suffering from failed back surgery syndrome (FBSS) is often severe, having a major impact on functionality and quality of life. Despite conservative and surgical treatments, pain can be persistent. An alternative treatment option is epiduroscopy, a minimally invasive procedure based on mechanical adhesiolysis of epidural fibrosis. As epidural fibrosis is speculated to be a major contributor in the pathophysiologic process of FBSS, this review evaluates the effectiveness of epiduroscopy in FBSS patients. METHODS AND MATERIALS: A systematic literature search was performed in PubMed, Embase, and Cochrane databases. Critical appraisal was performed using validated tools. Meta-analysis was performed using generic inverse variance analysis. RESULTS: From the 286 identified articles, nine studies were included. The visual analogue scale (VAS) average was 7.6 at baseline, 4.5 at 6, and 4.3 at 12 months. The Oswestry Disability Index (ODI) average was 61.7% at baseline, 42.8% at 6, and 46.9% at 12 months. An average of 49% of patients experienced significant pain relief at 6 and 37% at 12 months. Meta-analysis showed a pooled VAS mean difference of 3.4 (2.6 to 4.1; 95% confidence interval [CI]) and 2.8 (1.6 to 4.0; 95% CI) and pooled ODI mean difference of 19.4% (12.5 to 26.4%; 95% CI) and 19.8% (13.8 to 25.9%; 95% CI) at 6 and 12 months, respectively. CONCLUSION: Current literature demonstrates a clinically relevant reduction in pain and disability scores at 6 to 12 months after mechanical adhesiolysis in FBSS patients. The quality of evidence is moderate, and the level of recommendation is weak. Practitioners should consider the benefits of epiduroscopy after weighing the risks for individual patients with FBSS.

High-dose spinal cord stimulation for patients with failed back surgery syndrome: a multicenter effectiveness and prediction study.

ABSTRACT: The use of high-dose spinal cord stimulation (HD-SCS) has increased drastically during the past few years, with positive results. However, there remains a deficit of real-world data of the effectiveness of HD-SCS. Therefore, the primary aim was to evaluate the effectiveness of HD-SCS in patients with failed back surgery syndrome (FBSS). The second aim was to develop a prediction model for a holistic responder. One hundred ninety-four patients were recruited to a multicenter real-world registry. Self-reporting outcome variables were evaluated at baseline (before SCS) and at 1, 3, and 12 months of HD-SCS implant. Outcome measures were the mean pain intensity over time, sleep quality, disability, health-related quality of life, and medication use. Besides the effectiveness, logistic regression and decision tree analysis were performed to define a holistic responder (pain intensity reduction, medication reduction, Oswestry disability index reduction, and EQ5D improvement) after 12 months of HD-SCS. Of 185 FBSS patients who underwent a baseline visit, 75.13% had a successful HD trial. At 12 months, 92 patients were still receiving HD-SCS. Both low back and leg pain significantly decreased at 12 months. All outcome measures revealed a significant time-dependent effect from baseline to 12 months. Holistic responders could be predicted with a sensitivity and specificity of 90%. Clinically significant and sustained pain relief over a period of 12 months was achieved with HD-SCS in patients with FBSS. In addition, HD-SCS also achieved an improvement in sleep quality, functionality, and a decrease in pain medication.

Experiences From the Patient Perspective on Spinal Cord Stimulation for Failed Back Surgery Syndrome: A Qualitatively Driven Mixed Method Analysis.

INTRODUCTION: When neither pharmacological therapies nor alternative interventions provide sufficient pain relief, spinal cord stimulation (SCS) can be used to treat Failed Back Surgery Syndrome (FBSS). Although it seems reasonable that quality of life (QoL)- and psychosocial-related factors contribute to the outcome of SCS since pain is a multidimensional experience, few qualitative studies have explored the expectations of SCS and experiences on SCS to treat FBSS from the patient perspective. OBJECTIVES: The aim of this study was to qualitatively and quantitatively map the FBSS patients' experiences with SCS and the effects of SCS on low back pain caused by FBSS. MATERIALS AND METHODS: A qualitative study with in-depth semi-structured interviews, assisted by the Brief Pain Inventory (BPI)-questionnaire. RESULTS: Seven themes regarding patients' experiences, subdivided into 15 categories, were identified, including an understudied theme within this field of research, Spiritual Well-Being. "Acceptance" and "coping" emerged as pre-eminent motifs throughout these themes. Moreover, the realization of patients' expectations were variable throughout the presented themes. According to the BPI Questionnaire, four out of 13 patients (31%) had significant pain relief (≥50%). Seven out of 13 (54%) reported a ≥50% increase regarding enjoyment of life. CONCLUSION: Multiple QoL- and psychosocial-related themes are related to SCS-outcomes. In order to improve SCS-outcomes for both short- and long-term, these themes should be implemented as a multidimensional approach, both prior to implantation as during follow-up.