For Failed Back Surgery Syndrome Research Articles

Difficult Single-Lead Spinal Cord Stimulator Trial for Failed Back Surgery Syndrome Salvages Treatment

BACKGROUND: Spinal cord stimulation (SCS) is a minimally invasive neuromodulation treatment modality primarily used for failed back surgery syndrome (FBSS), complex regional pain syndrome, and diabetic neuropathy. Specifically, when utilized for the treatment of FBSS, placement can be complicated by the excessive scarring, adhesions, and altered anatomy limiting the access to the epidural space and advancement of the leads. CASE REPORT: Our patient is a 58-year-old woman with a history of scoliosis and severe lumbar spinal stenosis who presented for trial of an SCS for FBSS. Given the refractory nature to medical and minimally invasive management, an SCS trial was performed. Unfortunately, due to the extensive fibrosis and adhesions in her epidural space, only a single lead could be placed but experienced pain relief. During the permanent SCS, 2 leads were successfully placed with the patient ultimately receiving > 50% pain relief. CONCLUSIONS: Here, we present a case of FBSS refractory to medical and minimally invasive management where a single SCS lead was placed during the trial, due to scarring and adhesions, and 2 leads during the permanent SCS procedure. Our case report suggests considering even the trial of a single-lead placement during an SCS trial in patients with an otherwise difficult anatomy, as the placement of the permanent lead offers greater access to the epidural space potentially allowing for the placement of a second lead and potentially salvaging the entire therapy. KEY WORDS: Spinal cord stimulator, spinal stenosis, single lead, failed back surgery syndrome

Case Series: Spinal Cord Stimulator Therapy Alleviates Neuropathic Pain in Patients with Failed Back Surgery Syndrome in the Setting of Spinal Cord Injury

BACKGROUND: Spinal cord stimulation (SCS) is a minimally invasive neuromodulation treatment modality primarily indicated for failed back surgery syndrome (FBSS). When FBSS occurs in the setting of spinal cord injury (SCI) it can often be refractory to treatment with opioids and anticonvulsants; in such cases, SCS has demonstrated promising results. Here, we present a case series of 2 patients with FBSS in the setting of SCI who received pain relief with SCS therapy. CASE REPORT: Our first patient is a 49-year-old man with a history of SCI (T10-11) with resulting paraplegia, who presented after failure of conservative management of his neuropathic abdominal and lumbar back pain with radiculopathy to the right groin. Our second patient is a 50-year-old man with a history of insulin-dependent diabetes mellitus, coronary artery disease, and thoracic arachnoid cyst excision, who presented for treatment of worsening intractable neuropathic pain in his thorax, abdomen, and midback. Both patients received SCS therapy with significant improvement in their neuropathic pain. CONCLUSION: By delivering targeted electrical stimulation to the spinal cord, SCS can improve the pain resulting from FBSS. Recent literature has highlighted the successful use of SCS in alleviating neuropathic pain following SCI; our case series further adds to the literature supporting the use of SCS in this pain setting. SCS continues to offer chronic pain physicians alternative, effective options for patients suffering from FBSS in the setting of SCI. KEY WORDS: Spinal cord stimulator, failed back surgery syndrome, spinal cord injury, neuropathy

ID: 206245 Relationship Between Prior Spine Surgeries and Outcomes Following Spinal Cord Stimulation: A Pooled Analysis

Lumbar spine surgery is a common procedure for treating disabling spine-related pain. Ten to 40% of patients undergoing lumbar spine surgery experience persistent pain following the operation. Spinal cord stimulation (SCS) is a treatment indicated for failed back surgery syndrome (FBSS) with or without radiculopathy. The purpose of this review is to retrospectively determine the average pain relief felt from SCS implants after one or more failed lumbar spine surgeries.

ID:16549 Interventional Fluoroscopic Sacroiliac Fusion in Patients With Failed Back Surgery Syndrome and Spinal Cord Stimulation

Sacroiliac Joint (SIJ) Pain accounts for approximately 30 % of LBP. Up to 43% of patients post lumbar fusion have SIJ Pain. The pathophysiology postulated due to increased mechanical load. Patients develop adjacent segment disease in the SIJ leading to pain and dysfunction and may need surgery after failed conservative management. This study explores the use of a sacroiliac fusion for failed back surgery syndrome (FBSS) and SIJ pain with failed neuromodulation using spinal cord stimulators (SCS).

Improved Pain Control with Combination Spinal Cord Stimulator Therapy Utilizing Sub-perception and Traditional Paresthesia Based Waveforms: A Pilot Study.

BackgroundChronic back and neck pain affects 20% of Americans. Spinal cord stimulation (SCS) is an effective therapy for otherwise refractory chronic pain. Traditional SCS relies on low-frequency stimulus in the 40 - 60 Hz range causing robust paresthesia in regions overlapping with painful dermatomes.ObjectivesThis study aims to determine the effect of superimposing sub-perception stimulation in patients who previously had good long-term relief with paresthesia.MethodsThis is a prospective observational trial examining patients who had previously been implanted with paresthesia based SCS for failed back surgery syndrome (FBSS) or complex regional pain syndrome (CRPS). These patients presented for implantable pulse generator (IPG) replacement based on battery depletion with an IPG capable of combined sub-perception and paresthesia based SCS therapy. Patients were assessed immediately following the exchange and four weeks later using a telephone survey. Their pain was assessed on each follow up using a Numerical Rating scale (NRS); the primary outcome was the change in NRS after four weeks from the exchange day. Secondary outcomes included paresthesia changes, which included the subjective quality of sensation generated, the overall subjective coverage of the painful region, subjective variation of coverage with positional changes, and global perception of the percentage improvement in pain.ResultsBased on our clinic registry, 30 patients were eligible for IPG exchange, 16 were consented for follow up and underwent an exchange, and 15 were available for follow up four weeks following. The average NRS decreased from 7.47 with traditional SCS to 4.5 with combination therapy. 80% of patients reported an improvement in the quality of paresthesia over traditional SCS therapy, and in most patients, this translated to significantly improved pain control.ConclusionsOur findings suggest improved pain relief in patients who had previously had good results with paresthesia based therapy and subsequently underwent IPG exchange to a device capable of delivering combined sub-perception stimulation. The mechanism of action is unclear though there may be an additive and/or synergistic effect of the two waveforms delivered. Larger studies with long-term follow-up are needed to elucidate the durability of pain relief and the precise mechanism by which combined subperception and paresthesia based SCS may improve overall patient outcomes.

Three-in-one procedure for failed spinal surgery improved pain, disability scores and serum inflammatory milieu: Three-years follow-up

ABSTRACT Background None of the various treatment modalities for failed back surgery syndrome (FBSS) is satisfactory. Aim of the study Comparison of subjective and laboratory outcomes of the 3-in-1 procedure to percutaneous screw and rod spinal fixation (PSRF) for FBSS patients determined at the end of Phase II of the study (3-year follow-up after surgery). Patients & Methods This is phase II (follow-up at 3 years) of patients undergoing 3-in-1 procedure (Group B) or PSRF (Group A) as regard pain and disability scores and cytokines levels. Results At phase of the study, pain and disability scores were still significantly lower in all patients with significantly lower scores in group B than in group A. In comparison to the results obtained at the end of Phase I, the 3-in-1 procedure provided better outcome than PSRF only and number of patients graded the outcome as excellent-to-good was significantly higher than in patients of group B than group A. At the end of both phases, serum inflammatory cytokines’ levels were significantly decreased and anti-inflammatory cytokines’ levels were significantly increased in all patients compared to preoperative levels with significant difference in favor of patients of group B. the percentages of change in pain and disability scores at end of Phase II were significantly correlated with the percentage of change of serum anti-inflammatory cytokines’ levels in both groups. Conclusion After 36 m after the 3-in-1 procedure pain scores were significantly decreased with improved disability scores and inflammatory milieu than in patients having FBSS only.

Effect of Spinal Cord Stimulation on Early Disability Pension in 198 Failed Back Surgery Syndrome Patients: Case-Control Study.

ABSTRACTBACKGROUNDSpinal cord stimulation (SCS) has proven to be a cost-effective treatment for failed back surgery syndrome (FBSS). However, the effect on patients’ working capability remains unclear.OBJECTIVETo evaluate the impact of SCS on working capability and to identify the factors behind permanent disability in FBSS patients.METHODSThe study group consisted of 198 working-age patients with SCS trialed or implanted for FBSS in a single center between 1996 and 2014. For each patient, 3 living controls, matched by age, gender, and birthplace, were otherwise randomly selected by the Population Register Center. The data on working ability were obtained from the Social Insurance Institution. Patients were divided into 3 groups: SCS trial only, SCS implanted permanently, and SCS implanted but later explanted.RESULTSA rehabilitation subsidy was given to 68 patients and 8 controls for a mean of 5.2 (95% confidence interval [CI] 2.4-8.2) and 0.2 (95% CI 0.05-0.6) days per month (P < .05). At the end of follow-up, 16 (37%), 13 (33%), 25 (22%), and 27 (5%) subjects were on disability pension (DP) in the SCS trial, SCS explanted, SCS permanent, and control groups. Patients in the SCS trial-only group were significantly more often on DP than were patients with permanent SCS (odds ratio 2.6; 95% CI 1.2-5.9; P = .02)CONCLUSIONPermanent SCS usage was associated with reduced sick leave and DP. Prospective study will be required to assess possible predictive value.

Perioperative Factors Associated with Severe Pain in Post-Anesthesia Care Unit after Thoracolumbar Spine Surgery: A Retrospective Case-Control Study.

Study DesignA retrospective case-control study.PurposeTo evaluate the effect of nitrous oxide and anesthetic and operative factors associated with severe pain in the early postoperative period after thoracolumbar spine surgery.Overview of LiteratureThoracolumbar spine surgery is the most common procedure in spine surgery, and up to 50% of the patients suffer from moderate to severe pain. Nitrous oxide has analgesic, anxiolytic, and anesthetic effects; nevertheless, its benefits for early postoperative pain control and opioid consumption remain to be established.MethodsThe medical records of eligible participants who underwent thoracolumbar spine surgery between July 2016 and February 2017 were reviewed. Enrolment was performed consecutively until reaching 90 patients for the case (severe pain) group (patients with a pain score of >7 out of 10 at least once during the post-anesthesia care unit [PACU] admission), and 90 patients for the control (mild-to-moderate pain) group (patients with a pain score of <7 in every PACU assessment). The data collected comprised patient factors, anesthetic factors, surgical factors, PACU pain score, and PACU pain management.ResultsA total of 197 patients underwent thoracolumbar spine surgery with an incidence of early postoperative severe pain of 53.3%. The case-control study revealed no differences in the factors related to pain intensity. A subgroup analysis was performed for failed back surgery syndrome (FBSS), spinal stenosis, and spondylolisthesis. After multivariate analyses, only the age group of 19–65 years and the baseline Oswestry Disability Index (ODI) were found to be significant risk factors for early postoperative severe pain in the PACU (odds ratio [OR], 2.86; 95% confidence interval [CI], 1.32–6.25; OR, 1.03; 95% CI, 1.01–1.05, respectively).ConclusionsNitrous oxide, anesthetic agents, and surgical techniques did not affect the early postoperative pain severity. Age under 66 years and the baseline ODI were the significant risk factors for pain intensity during the early postoperative period of the FBSS, spinal stenosis, and spondylolisthesis subgroups.

Burst or High-Frequency (10 kHz) Spinal Cord Stimulation in Failed Back Surgery Syndrome Patients With Predominant Back Pain: One Year Comparative Data

Burst and 10 kHz spinal cord stimulation (SCS) demonstrated improvement for failed back surgery syndrome (FBSS) with predominant, refractory back pain. Here, we report the long-term follow-up of a previously published study comparing the safety and efficacy of burst vs. 10 kHz SCS for predominant back pain (70% of global pain) of FBSS patients. This comparative, observational study extended the follow-up period up to 20 months evaluating both SCS modalities. Pain intensity (visual analog scale [VASB , VASL ]), functional capacity (Pittsburgh Sleep Quality Index [PSQI]; depression (Beck Depression Inventory [BDI]), stimulation parameters and hardware and/or stimulation associated adverse events were recorded and analyzed over time. Overall VASB (t1,12 = 66.76, p < 0.001) and VASL (t1,12 = 4.763, p < 0.049; p < 0.001) declined over time. Burst significantly decreased VASB by 87.5% (±17.7) (mean 8 ± 0.76 to 1 ± 1.41; t1 =12.3, p < 0.001), and 10 kHz significant decreased VASB by 54.9% (±44) (mean 8 ± 0.63 to 3.5 ± 3.27; t1 =3.09, p = 0.027). No significant differences for between SCS types were revealed (t1 =1.75, p = 0.13). VASL was significantly suppressed for burst (burst: 3.6 ± 1.59 to 1.5 ± 1.06; t1 = 3.32, p = 0.013). A significant effect of time was found for functional outcome with no significant differences between SCS types (PSQI: t1,12 = 8.8, p = 0.012; and BDI: t1 = 53.3, p < 0.001). No stimulation/hardware-related complications occurred. Long-term data of this comparative study suggests that burst responsiveness was superior to 10 kHz in our small-scale cohort, thus a larger, randomized-controlled comparative study design is highly recommended.

Clinical Evidence for Spinal Cord Stimulation for Failed Back Surgery Syndrome (FBSS): Systematic Review.

A systematic review. A systematic literature review of the clinical data from prospective studies was undertaken to assess the efficacy of spinal cord stimulation (SCS) in the treatment of failed back surgery syndrome (FBSS) in adults. For patients with unrelenting back pain due to mechanical instability of the spine, degenerative disc disease, spinal injury, or deformity, spinal surgery is a well-accepted treatment option; however, even after surgical intervention, many patients continue to experience chronic back pain that can be notoriously difficult to treat. Clinical evidence suggests that for patients with FBSS, repeated surgery will not likely offer relief. Additionally, evidence suggests long-term use of opioid pain medications is not effective in this population, likely presents additional complications, and requires strict management. A systematic literature review was performed using several bibliographic databases, prospective studies in adults using SCS for FBSS were included. SCS has been shown to be a safe and efficacious treatment for this patient population. Recent technological developments in SCS offer even greater pain relief to patients' refractory to other treatment options, allowing patients to regain functionality and improve their quality of life with significant reductions in pain. N/A.

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

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. 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. 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. Analysis of the data 1year 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. 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.

In-vivo Endoscopic Visualization of Pain Generators in the Lumbar Spine

In-vivo Endoscopic Visualization of Pain Generators in the Lumbar Spine

Failed back surgery syndrome: are our patients getting a fair deal?

‘The failed back surgery syndrome is easy to recognise but difficult to define,’ wrote Onesti in 2004.1 Unfortunately this remains the case today. Despite the existence of numerous definitions for failed back surgery syndrome (FBSS), none has been widely adopted. The failure to adopt a single definition of the condition may reflect the heterogeneous nature of the population described by the term. In this issue Tharamanathan et al.2 provide an estimate of the possible incidence of FBSS in England of 7853 to 31,414 new cases annually based on data from the Hospital Episode Statistics database. The figures are based on an incidence of FBSS of 10–40%.3 More recent trial-based evidence has shown failure rates to be procedure specific with a lumbar fusion failure rate of 30–46%, 35–36.2% for lumbar decompressive surgery and 19–25% for microdiscectomy.4 Patients with FBSS start their journey in surgery departments and eventually find their way into the pain clinic via various departments including radiology, physiotherapy and clinical psychology. By the time they reach the pain clinic, these patients are often frustrated, angry, miserable, desperate and in severe pain. The few studies describing the demographics of the FBSS patient indeed paint a grim picture. FBSS patients report a quality of life comparable to that experienced by those with conditions such as cancer or chronic heart failure:5 67% report an extreme pain or problem and 30% report an extreme problem with everyday activities.6 In a BMJ article, Lina Talbot, a medical registrar and FBSS sufferer herself, provides a poignant account of the agony and confusion inflicted by this condition. She highlights the lack of support and expert help for FBSS sufferers in the UK compared with other conditions. The article also points out the poor outcomes of treatment of FBSS sufferers in pain clinics with an estimate of only one in three patients experiencing 30% pain relief.7 This, as it turns out, is an overestimate as trial evidence later showed that only 9% and 18% of patients experience 50% and 30% pain relief, if we exclude spinal cord stimulation as a treatment option.8 Evidence of the effectiveness of spinal cord stimulation (SCS) specific to the FBSS patient group is derived from two randomised controlled trials;8–10 these demonstrated marked reductions in leg pain with a modest impact on low back pain. Access to SCS in England, however, remains patchy despite a positive recommendation by the National Institute for Health and Clinical Excellence.11 The aetiology of FBSS remains complex and unclear. The burden of disability associated with FBSS is substantial, as is the cost of treatment;12 the evidence for the added value of physiotherapy in FBSS sufferers is limited.13,14 Evidence for most pharmacological-based interventions is extrapolated from other patient groups, such as diabetic neuropathy and general pain populations, and is often restricted to a short follow-up.14 There remains a clear need for evidence synthesis that is specific to this patient group. We hope this issue of the British Journal of Pain will act as a knowledge platform for such evidence generation.

Counting the Costs

The purpose of this article is to review clinical and health economic evidence supporting the use of spinal cord stimulation (SCS) for failed back surgery syndrome (FBSS) and to discuss implications for case managers' decision making. Primary settings include hospital and home environments. Patients with FBSS experience persistent or recurring pain in the lower back, legs, or both after one or more spinal surgeries. Surgical revision and nonsurgical FBSS therapies often result in minimal or no clinical improvement, and reoperations often result in more pain. The efficacy and safety of SCS have improved as a result of earlier intervention, technological advances, and increased awareness of SCS proper patient selection. A recent randomized controlled trial (RCT) demonstrated that at mean 3-year follow-up, SCS achieves significantly more pain relief and treatment satisfaction and lower opiate analgesic use than reoperation in patients with FBSS. Another RCT demonstrated that at 6-month follow-up, more patients with FBSS achieve pain relief, enhanced quality of life, improved functioning, and higher treatment satisfaction levels with SCS than with conventional medical management (CMM). Health-economic FBSS studies show that SCS is more cost-effective than CMM or reoperation. SCS is a well-established FBSS treatment option with demonstrated efficacy and cost-effectiveness in selected patients. Case Managers should consider recommending SCS as one modality prior to reoperation in patients with FBSS who meet the clinical criteria for its appropriate use.

Spinal cord stimulation: indications and outcomes

Spinal cord stimulation (SCS) is the most commonly used implantable neurostimulation modality for management of pain syndromes. In this paper the authors describe the current indications for SCS and its efficacy in the treatment of those diseases. Specifically, the literature on patient selection and outcomes after SCS for failed-back surgery syndrome (FBSS), refractory angina pectoris, peripheral vascular disease, and complex regional pain syndrome (CRPS) Type I was reviewed. Effective pain relief was obtained in 60 to 80% of patients with FBSS and CRPS Type I. Furthermore, these patients had significant improvements in quality of life (QOL) and a significantly greater chance of returning to work than patients who did not undergo SCS. The use of SCS in patients with inoperable angina (that is, refractory angina pectoris) resulted in significant decreases in chest pain and hospital admissions as well as increased exercise duration, with less morbidity than with open procedures that were performed for pain control only. Patients with inoperable PVD also demonstrated significant improvements in pain relief, QOL, and limb mobility. Reported complications were mostly related to hardware and were relatively minor. Review of randomized controlled studies supports the use of SCS as an effective treatment modality for pain associated with FBSS, refractory angina pectoris, peripheral vascular disease, and CRPS Type I.

Experience of Right Leg Pain Control by Left Epidural Space Inserted Spinal Cord Stimulator -A case report-

Spinal cord stimulation (SCS) was first attempted by Shearly et al for the relief of intractable pain. A spinal cord stimulator has traditionally been used for failed back surgery syndrome (FBSS) angina pectoris, complex regional pain syndrome (CRPS) and ischemic pain in the extremity. However, the complications associated with the use of a spinal cord stimulator, such as wound infection, hematoma, lead migration and device malfunction; make its long term application difficult. Here, our experience of an interesting case, in which intractable right leg pain was controlled using a spinal cord stimulator placed in the left epidural space, is reported, with a review of the literature.

Need for precise protocol in magnetic resonance imaging of the post operative spine

Gadolinium enhanced Magnetic Resonance Imaging (MRI) for the evaluation of the post operative lumbo-sacral spine is a sensitive and specific imaging technique. A need for establishing a specific protocol for Failed Back Surgery Syndrome (FBSS) for use in the service hospitals is highlighted for convenience of patient management and preservation of active manpower. The MR scan of 50 patients performed over a span of six months, who complained of persistent low backache even after surgery, were retrospectively analysed. The specificity of this series using MRI in indicating the exact cause of FBSS was clocked at only 30%. The conditions diagnosed were rectifiable. The balance of the patients who could not be offered any specific diagnosis towards the cause, were being managed conservatively/placed in low medical category for a considerable period. It was noted with concern that there was non prevalence of sequence like the fast spin echo with gadolinium enhancement as a routine.

Treatment of Failed Back Surgery Syndrome

Objectives. To evaluate the long-term results of different therapies for failed back surgery syndrome (FBSS). Materials and Methods. From 1992 to 1997, 49 patients were treated for FBSS. Twenty patients were treated medically. Twenty-four patients, who did not respond to medical therapy, underwent spinal cord stimulator (SCS) implant and five underwent further spine surgery. All patients were evaluated by VAS, PDI, and the Oswestry Scales before treatment and at follow-up. Leg pain, back pain, work status or daily activities, drug side effects, and use of analgesic medications after implantation were examined. Follow-up ranged from 24 to 84 months (mean 42 months). Results. At last follow-up, the patients treated medically demonstrated good results on leg and low back pain in eight cases; in other cases, good results were transitory and several therapeutic courses were necessary to control the pain. Two patients treated medically had substantial side effects. All but two patients treated with SCS demonstrated good results for their leg pain; whereas those treated for back pain with SCS had poor results. Two patients still needed continuous drug administration. Conclusions. Medical therapy is effective for leg and back pain; nevertheless, several courses of therapy may be necessary. SCS is an effective treatment for leg pain, however, its effectiveness on back pain appears to be inadequate.