Effect of spinal cord stimulation on quality of life and opioid consumption in patients with failed back surgery syndrome.

BACKGROUND: Failed back surgery syndrome (FBSS) is a constellation of conditions occurring after spine surgeries, characterized by the presence of persistent or recurring low back pain that has a significant impact on patients' quality of life. Neuromodulation in the form of Spinal Cord Stimulation (SCS) is considered an indispensable treatment modality in the management of certain chronic pain conditions and it is showing good results for improvement in pain scores and functional capacity of the FBSS patients. OBJECTIVES: To assess the change in pain scores, quality of life, and opioid medication intake as an outcome of neuromodulation procedures performed on patients diagnosed with failed back surgery syndrome, and to detect the post-procedure complications. METHODS: A prospective observational study was conducted at two university hospitals in Egypt and the U.S.A. during the period from September 2019 to August 2021 for patients who underwent spinal cord stimulation procedures for FBSS with follow-up period of at least 1 year. Patients who are 18 years old or older diagnosed with FBSS for more than 6 months and treated with spinal cord stimulation with successful trials during this time frame were included in the study. RESULTS: Thirty-four patients were included in this study who had successful SCS trials and underwent permanent implantation of SCS devices with post-procedure follow-up period of 12 months. Patients showed a median pain numerical rating scale (NRS) of 7/10 at baseline with a median NRS of 4/10 through the follow-up period. Basic mobility and daily activity scores assessed by activity measure of post-acute care (AM-PAC) showed significant improvement from the mean of 16.87 ± 2.74 at baseline to a mean of 19.97 ± 2.93 through follow-up. In addition, there was a reduction in opioid medication usage. Post-procedure complications was of low percentage with the most detected were battery dysfunction in 7 patients and pocket pain in 6 patients. Reoperation was needed in 13 patients with 4 needed just revision and 9 patients required a complete removal of the device. CONCLUSION: Spinal cord stimulation is an effective modality of treatment for cases of failed back surgery syndrome with a statistically significant reduction in pain scores and a significant improvement in quality of life. Also, it achieves a recognizable reduction in opioid analgesic medications, with a reliable safety profile as detected with the recorded post-procedure complications. However, randomized controlled trials with more patients and long-term follow-up are highly recommended.

Relationship between number of prior lumbar spine surgeries and outcomes following spinal cord stimulator implantation: A multisite, retrospective pooled analysis.

OBJECTIVES: Lumbar spine surgery is a common procedure for treating disabling spine-related pain. In recent decades, both the number and cost of spine surgeries have increased despite technological advances and modification in surgical technique. For those patients that have continued uncontrolled back and/or lower extremity pain following lumbar spine surgery, spinal cord stimulation (SCS) has emerged as a viable treatment option. However, the impact of lumbar spine surgical history remains largely unstudied. Specifically, the current study considers the impact of number of prior lumbar spine surgeries on pain relief outcomes following SCS implantation. MATERIALS AND METHODS: We queried the electronic medical record of five separate pain practices for all patients who have undergone a SCS implant between January 1, 2017, and March 1, 2020. Inclusion criteria consisted of any patients with an SCS implant who underwent a prior lumbar spine surgery. The primary outcome was the mean calculated percentage pain relief in patients based on number of prior lumbar spine surgeries. RESULTS: There was a total of 1974 total SCS implant cases identified across five separate pain clinics. There was no difference in mean calculated pain relief in patients with one prior spine surgery versus those with two or more prior spine surgeries (28.2% vs. 25.8%, adjusted ß-coefficient -3.1, 95% CI -8.9 to 2.7, p = 0.290). Similarly, when analyzing number of spine surgeries as a continuous variable, there was no association between number of spine surgeries and calculated pain relief (adjusted ß-coefficient -1.5, 95% CI -4.0 to 1.1, p = 0.257). Additionally, after patients were stratified based on waveform, there was no association between number of prior lumbar spine surgeries (analyzed both as a categorical and continuous variable) and calculated percentage pain relief. CONCLUSIONS: This multicentered retrospective study found that there was no significant difference in pain scores in individuals who received SCS following one or more lumbar spine surgeries. Additionally, the waveform of the SCS device had no statistically significant impact on post-operative pain scores following one or more lumbar spine surgeries.

Retrograde thoracic spinal cord stimulation paddle placement for complex persistent spinal pain syndrome type 2.

BACKGROUND: Spinal cord stimulation (SCS) is a cost-effective option for treating refractory persistent spinal pain syndrome type-2 (PSPS-2). For patients with extensive spine instrumentation including the thoraco-lumbar junction, percutaneous placement of SCS leads is usually not an option being paddle leads typically implanted anterograde. Paddle lead placement will be particularly challenging in more complex cases when the instrumentation covers the targeted level. To overcome this barrier, we studied using a retrograde approach to reach the sweet spot, facilitate the placement, and reduce associated risks. OBJECTIVES: To study the use of retrograde SCS paddle as a placement method to optimize the spinal cord target and reduce the risks of conventional placement in complex cases. STUDY DESIGN: Case series and technical note. METHODS: We present three cases of thoracic retrograde SCS paddle lead placement cases, detailing patient selection, operative technique, and outcome. All the cases had extensive instrumentation to the thoraco-lumbar spine, and one had additional spinal canal stenosis. The surgical procedure entailed a retrograde midthoracic inter-laminar approach, flavectomy, and caudal placement of the paddle lead with intraoperative neurophysiologic monitoring (IONM) guidance for functional midline determination. RESULTS: All the cases had a successful lead placement over the sweet spot without complications. The same approach was used to decompress a focal spinal stenosis in one case. One case had significantly improved pain and hence underwent a pulse generator implant. The other cases had non-satisfactory pain control and were explanted. LIMITATIONS: These case description could guide technical procedural steps, however, a larger number of such cases would be needed to describe further technical nuances. CONCLUSIONS: We demonstrated that placing SCS paddle leads via retrograde midthoracic approach with IONM guidance is safe. This procedure should be an option for SCS paddle implants in patients with posterior spinal fusion encompassing the intended targeted spinal stimulation level.

Failed back surgery syndrome successfully ameliorated with Chiropractic Biophysics® structural rehabilitation improving pain, disability as well as sagittal and coronal balance: a Chiropractic Biophysics® case report with a 6†year follow-up.

[Purpose] To present the case of the amelioration of chronic pain and disability in a patient suffering from failed back surgery syndrome. [Participant and Methods] A 27-year-old male with chronic low back pain was treated with a Coflex® intra-spinous instrument, however, it was removed shortly after due to poor outcome including worsening pain and disability. Radiographic assessment revealed significant posterior translation of the thorax complicated by significant loss of the normal lumbar lordosis and a left lateral translated thoracic cage posture. Chiropractic Biophysics® technique was applied over a 5.5-month period leading to structural spine improvements as well as improved pain, Oswestry disability index (ODI) and quality of life (QOL). [Results] There was a 21 mm reduction in posterior thoracic translation, a 6.2° improvement in lumbar lordosis and a 16 mm reduction in lateral thoracic translation corresponding with improved ODI and QOL scores. A 6 year follow-up showed successful outcome despite some degenerative changes in the spine at the prior surgical level. [Conclusion] This case adds to the growing literature showing the efficacy of non-surgical spinal rehabilitative methods in improving outcomes in patients with spinal deformity and associated disabilities. This case also demonstrates necessity of the continued criterion standard of spinal radiography for biomechanical assessment.

MR Neurography of Lumbosacral Plexus: Incremental Value Over XR, CT, and MRI of L Spine With Improved Outcomes in Patients With Radiculopathy and Failed Back Surgery Syndrome.

BACKGROUND: Lower back pain is often evaluated using magnetic resonance imaging (MRI) and conventional imaging, which provide incomplete information about the etiology of pain and lead to less than optimal management. HYPOTHESIS: MR neurography (MRN) of the lumbosacral (LS) plexus renders a more accurate diagnosis, alters the management strategy, and clinical outcomes of radiculopathy or failed back surgery Syndrome (FBSS) patients when compared to the conventional imaging modalities. STUDY TYPE: Retrospective, cross-sectional. POPULATION: A total of 356 patients (mean age 65.8 ± 12.3; 48.9% female) from single university hospital over 6 years with MRN of LS plexus were included from a cohort of 14,775 total patients with lumbar spine MR imaging. ASSESSMENT: Conventional imaging obtained before and after MRN of LS plexus was reevaluated and categorized into three levels based on extent of imaging findings' correlation to presenting clinical symptoms (contributory levels). Clinical notes were reviewed for changes in ordering provider's recommended management and subsequent patients' symptom level pre-MRN to post-MRN. FIELD STRENGTH/SEQUENCE: A 5 T and 3.0 T. T1-weighted (T1W), T2-weighted (T2W), short T1 inversion recovery (STIR), T1 turbo spin echo (T1 TSE), T2 spectral attenuated inversion recovery (T2 SPAIR). STATISTICAL TESTS: Chi-squared test. Statistical significance was set at P < 0.05. RESULTS: A total of 356 total patients (174 females) with mean age ± SD was 65.8 ± 12.3 years, 4.2% of patients imaged with lumbar spine MRI. Definitely contributory studies among X-rays, computed tomography, MRI, and MRN were 3 of the 129 (2.3%), 3 of the 48 (6.2%), 35 of the 184 (19.0%), and 283 of the 356 (79.8%), respectively. Pre-MRN vs. post-MRN led to change in recommendation in 219 of the 356 (61.5%) patients and 71 of the 99 (71.7%) patients had improved symptoms. CONCLUSION: MRN of the LS plexus can provide more corroborative image findings for symptom correlation compared to other imaging modalities for accurate diagnosis, effects patient management and leads to positive clinical outcomes in a small subset of patients with radiculopathy or FBSS. EVIDENCE LEVEL: 4 TECHNICAL EFFICACY: Stage 5.

Efficacy of Continuous Intrathecal Infusion Trialing with a Mixture of Fentanyl and Bupivacaine in Chronic Low Back Pain Patients.

Intrathecal trialing is used as a screening prognostic measure prior to intrathecal drug delivery system implant. The purpose of this study was to determine the efficacy of a continuous intrathecal infusion of an admixture of bupivacaine and fentanyl in patients with chronic low back pain. Patients with refractory chronic low back pain in the setting of previous lumbar spine surgery and/or chronic vertebral compression fracture(s) were enrolled in a randomized double blind cross-over study comparing saline infusion to infusion of a solution containing bupivacaine combined with low-dose fentanyl over a 14-18 hour period. The primary outcome measure was the change in pain intensity at the end of the screening trial. Patients who experienced significant pain reduction from either infusion relative to baseline pain were offered a permanent implant. In total, 36 patients were enrolled, with 31 patients trialed and 25 implanted. At the end of the screening trial, pain scores, at rest or with activity, decreased appreciably in both groups; however, significantly better improvements occurred in the fentanyl/bupivacaine group compared to saline both with activity and at rest (P = .016 and .006, respectively). Treatment order appeared to affect outcome with saline demonstrating a placebo response. At 12 months following implant, primary and secondary outcome measures continued to be significantly reduced from baseline. Continuous intrathecal delivery of a combination of zlow-dose fentanyl with bupivacaine is superior to saline in screening intrathecal trialing for back pain reduction. With longer term delivery, a sustained reduction of chronic low back pain was also observed.

Severity of spinal degeneration does not affect the pain reduction under continuous epidural analgesia.

PURPOSE: To outline clinical effectiveness of continuous epidural analgesia (CEA) in patients with failed back surgery syndrome (FBSS) or lumbar spinal stenosis (LSS) depending on severity of spinal degeneration. METHODS: In this retrospective cohort study, all patients with FBSS or LSS who underwent CEA within an inpatient rehabilitation program were evaluated. The pain reduction was measured by VAS on an hourly basis. Substantial pain reduction was defined as a minimal clinically important difference (MCID) > 50%. Severity of spinal degeneration, side effects and patient-specific characteristics were documented. RESULT: We included a total of 148 patients with 105 patients suffering from FBSS and 48 with LSS. The average pain reduction was - 37.6 ± 19.2 in FBSS and - 38.1 ± 17.8 in LSS group (p < .001 and p < .001, respectively). In the FBSS group, sensory deficits (p = .047) and numbness (p = .002), and in the LSS group, a severe disability measured by ODI (38.2 ± 15.4 vs. 57.3 ± 11.3, p < .001) significantly contributed to a worse outcome. The severity of the spinal degeneration and psychological disorders did not affect the pain reduction in terms of MCID. CONCLUSIONS: This study provides new evidence about CEA in the treatment of FBSS and LSS. CEA provides a significant pain reduction even under intensified physiotherapeutic exercising in patients with severe spinal degeneration and a broad variety of secondary diagnoses. Neurologic deficits in case of FBSS and severe disability in case of LSS may be risk factors for less favorable outcome.

Comparison of clinical outcomes associated with spinal cord stimulation (SCS) or conventional medical management (CMM) for chronic pain: a systematic review and meta-analysis.

OBJECTIVE: This study aims to evaluate the efficacy and safety of spinal cord stimulation (SCS) compared to conventional medical management (CMM) for patients diagnosed with chronic pain. Furthermore, the study seeks to compare the utilization of analgesics, as well as the long-term outcomes in terms of quality of life and functional capacity. DATA SOURCES: We systematically searched Cochrane Library, Web of Science, PubMed, and EMBASE for randomized controlled trials from inception up to February 2022. REVIEW METHODS: Inclusion and exclusion criteria were set according to the PICOS criteria. We searched for studies in which SCS was compared with CMM alone for chronic pain. Two reviewers independently identified eligible studies and extracted data. Risk of bias assessments were performed according to Cochrane review criteria and Interventional Pain Management Techniques-quality Appraisal of Reliability and Risk of Bias Assessment (IPM-QRB) criteria. RESULTS: The present meta-analysis comprised eight studies and included a total of 893 patients. Our findings demonstrate that spinal cord stimulation (SCS) in combination with conventional medical management (CMM) is associated with a significant reduction in visual analogue scale (VAS) pain intensity (P = 0.0005) and decreased scores on the McGill Pain Questionnaire (MPQ) (P < 0.0001). Moreover, SCS plus CMM was found to improve patients' quality of life, as evidenced by improvements in SF-36 scores (P < 0.00001), EQ-5D utility index (P = 0.008), and Oswestry Disability Index (ODI) (P < 0.00001). Based on the results of four high-quality randomized controlled trials (RCTs), the level of evidence supporting the efficacy of SCS for the treatment of painful neuropathy is graded as level I to II. In contrast, there is currently only low-level evidence to support the use of high-frequency stimulation and other chronic pain conditions, which can be attributed to a lack of sufficient randomized controlled trials. LIMITATIONS: The principal limitation of our study is the significant heterogeneity observed among the cohorts investigated. The primary source of this heterogeneity is the fact that spinal cord stimulation is indicated for the treatment of multiple chronic pain conditions. Moreover, variations in the stimulation parameters, differences among manufacturers, and the specific surgical implantation settings contribute to the increased heterogeneity observed in our analyses. To address this issue, we conducted a subgroup analysis based on specific situations and performed evidence synthesis to mitigate the potential impact of heterogeneity. These approaches allow for a more precise interpretation of the results and a more accurate evaluation of the quality of the included studies. CONCLUSIONS: SCS is an effective treatment to relieve the pain level of chronic pain, decrease analgesic usage, and increase long-term quality of life and functional capacity.

Spinal Cord Stimulation Meets Them All: An Effective Treatment for Different Pain Conditions. Our Experience and Literature Review.

IntroductionSpinal Cord Stimulation (SCS) is an emerging minimally invasive technique which uses neuromodulation to manage different forms of intractable pain. SCS is a well-established option for the treatment of various pain conditions, and nowadays, indications are ever increasing.Materials and MethodsIn this study, we present our case series of 49 patients who underwent SCS at our Institution for the treatment of pain from different etiologies, and discuss our 10-year experience in SCS. For the purpose of this study, we also performed a systematic review of current indications and new perspectives in SCS.ResultsAmong our case series, patients were differentiated into two groups upon prior spinal surgery: patients who had undergone prior spinal surgery for back pain were defined as the "FBSS (failed back surgery syndrome) group," instead patient suffering from different types of pain but who had never undergone surgery were defined as the "naive group." As regards clinical response to SCS, 20 patients out of 36 (55.56%) were classified as responders in the FBSS group; in the "naïve" group, 10 patients out of 13 (76.92%) were classified as responders. Among the "not responders" group, several patients suffered from infections.Of the recent literature about SCS, 2124 records were screened and 37 studies were finally included in the qualitative synthesis for our systematic review.DiscussionIn case of FBSS, surgical revision is often associated with a high morbidity and corresponding low rates of success. Unfortunately, patients affected by chronic pain often become refractory to conservative treatments. Spinal Cord Stimulation (SCS) is nowadays considered as an effective therapy for several chronic and neuropathic pain conditions, such as failed back surgery syndrome. As regards the economic impact of SCS, implantation of an SCS system results in short-term costs increase, but the annual cumulative costs decrease during the following years after implantation, when compared to the costs of conventional management. Beyond the application for the treatment of FBSS, SCS has also been used for the treatment of other types of chronic non-oncological pain such as neuropathic pain and chronic back pain ineligible for surgical intervention. This evidence paved the way to establishing the potential role of SCS also for the treatment of oncological pain. However, the effectiveness and relative safety of SCS for cancer-related pain has not yet been adequately established.ConclusionsSpinal Cord Stimulation is a well-established treatment option in for FBSS. Beyond that, SCS has also been used for the treatment of "naive" patients, suffering from other types of chronic, both oncological and non-oncological, medical-refractory pain such as neuropathic pain and chronic back pain ineligible for surgical intervention.

Spinal Cord High-Frequency Stimulation. The Current Experience and Future Directions.

Spinal cord stimulation (SCS) is a neuromodulation technology that has emerged as a valid treatment for chronic intractable neuropathic pain. After conventional tonic SCS, new waveforms of stimulation, like high frequency (HF), have proved that they can provide safe and effective pain relief. In addition, SCS is now being utilized more broadly as a potential treatment for a range of indications, including motor disorders and spasticity. Our study presents a retrospective analysis of 20 patients with heterogenous aetiologies of neuropathic pain treated with HF stimulation, after a standardized protocol in a temporary trial. We observed a significant improvement in pain relief according to comparisons of numerical rating scale (NRS) scores before the procedure, after the clinical trial and at latest follow-up. Two unusual clinical cases were also reported, and the pertinent literature was discussed.

Long-Term Outcome in Patients With Spinal Cord Stimulation for Failed Back Surgery Syndrome: A 20-Year Audit of a Single Center.

STUDY DESIGN: This is a retrospective, observational study. INTRODUCTION: Spinal cord stimulation (SCS) has found its application in chronic pain treatment, with failed back surgery syndrome (FBSS) as one of the most important indications. However, to date, little is known about the long-term effectiveness of the treatment. The aim of this study is to analyze retrospectively the long-term outcomes of SCS treatment in a single multidisciplinary pain center on predominant radicular pain, using devices of a single manufacturer. MATERIALS AND METHODS: Patient data on overall patient satisfaction, pain intensity, and adverse events were retrospectively collected in our clinical practice between January 1998 and January 2018, for 191 patients who received a permanent SCS implant. Secondary health measures included the influence of opioid and nicotine use on pain reduction after therapy. RESULTS: The trial-to-implant ratio was 93.6%. At a mean follow-up of 10.6 years, 78.5% of the patients were satisfied with the treatment outcome, with a significant pain reduction of an average three points on a Numeric Rating Scale. Opioid and nicotine usage did not have a significant link with the pain reduction one year after the treatment. Furthermore, devices had an average battery lifespan of 8.4 years. A total of 248 revisions were recorded. A total of 24 patients (11.7%) acquired an infection; 7 of 204 patients had an infection during the trial period, 2 of 191 patients had an infection in the first postoperative year, and 15 of 191 patients had an infection after the first year. The average time to infection, if not in the first year, was 10.1 years. CONCLUSIONS: A successful long-term outcome regarding pain relief in patients with predominant radicular pain due to FBSS is established with SCS therapy.

Short-Term Health Care Costs of High-Frequency Spinal Cord Stimulation for the Treatment of Postsurgical Persistent Spinal Pain Syndrome.

OBJECTIVE: High-frequency spinal cord stimulation (HF-SCS) is a treatment option for postsurgical persistent spinal pain syndrome (type 2 PSPS). We aimed to determine the health care costs associated with this therapy in a nationwide cohort. MATERIALS AND METHODS: IBM Marketscan® Research Databases were used to identify patients who underwent HF-SCS implantation from 2016 to 2019. Inclusion criteria included prior spine surgery or diagnoses of PSPS or postlaminectomy pain syndrome any time within the two years before implantation. Inpatient and outpatient service costs, medication costs, and out-of-pocket costs were collected six months before implantation (baseline) and one, three, and six months after implantation. The six-month explant rate was calculated. Costs were compared between baseline and six months after implant via Wilcoxon sign rank test. RESULTS: In total, 332 patients were included. At baseline, patients incurred median total costs of $15,393 (Q1: $9,266, Q3: $26,216), whereas the postimplant median total costs excluding device acquisition were $727 (Q1: $309, Q3: $1,765) at one month, $2,840 (Q1: $1,170, Q3: $6,026) at three months, and $6,380 (Q1: $2,805, Q3: $12,637) at six months. The average total cost was reduced from $21,410 (SD $21,230) from baseline to $14,312 (SD $25,687) at six months after implant for an average reduction of $7,237 (95% CI = $3212-$10,777, p < 0.001). The median device acquisition costs were $42,937 (Q1: $30,102, Q3: $65,880). The explant rate within six months was 3.4% (8/234). CONCLUSIONS: HF-SCS for PSPS was associated with significant decreases in total health care costs and offsets acquisition costs within 2.4 years. With the rising incidence of PSPS, it will be critical to use clinically effective and cost-efficient therapies for treatment.

A Feasibility Study Exploring Measures of Autonomic Function in Patients With Failed Back Surgery Syndrome Undergoing Spinal Cord Stimulation.

OBJECTIVES: Failed back surgery syndrome (FBSS) is associated with impaired autonomic tone, characterized by sympathetic prevalence and vagal withdrawal. Although spinal cord stimulation (SCS) alleviates pain in FBSS, there is limited research investigating how SCS affects measures of autonomic function. This was a prospective, open-label, feasibility study exploring measures of autonomic function in patients with FBSS receiving SCS therapy. MATERIALS AND METHODS: A total of 14 patients with FBSS were recruited for baseline measurements and underwent a trial of 10-kHz SCS. There were three failed trials, resulting in the remaining 11 participants receiving a fully implanted 10-kHz SCS system. One participant requested an explant, resulting in ten participants completing both baseline and follow-up (three to six months after SCS implant) measurements. Autonomic function was assessed using time- and frequency-domain heart rate variability (HRV), baroreceptor reflex sensitivity (BRS), and muscle sympathetic nerve activity (MSNA) using microneurography. Because this was a feasibility study, most of the analysis was descriptive. However, paired t-tests and Wilcoxon signed-rank tests tested for differences between baseline and follow-up. RESULTS: In the whole (N = 14) and final (N = 10) samples, there was between-participant variation in baseline and follow-up measures. This, combined with a small sample, likely contributed to finding no statistically significant differences in any of the measures between baseline and follow-up. However, plotting baseline and follow-up scores for individual participants revealed that those who showed increases in MSNA frequency, square root of the mean of the squared differences between adjacent RR intervals (RMSSD), percentage of the number of RR intervals >50 ms (pRR50), total power, and up BRS between baseline and follow-up had distinct clustering of baseline values compared with those who showed decreases in these measures. CONCLUSIONS: Findings from this feasibility study will aid with informing hypotheses for future research. A key aspect that should be considered in future research concerns exploring the role of baseline measures of autonomic function in influencing change in autonomic function with SCS therapy.

Spinal Cord Stimulation With Additional Peripheral Nerve/Field Stimulation Versus Spinal Cord Stimulation Alone on Back Pain and Quality of Life in Patients With Persistent Spinal Pain Syndrome.

INTRODUCTION: Persistent spinal pain syndrome (PSPS) or failed back surgery syndrome (FBSS) refers to new or persistent pain following spinal surgery for back or leg pain in a subset of patients. Spinal cord stimulation (SCS) is a neuromodulation technique that can be considered in patients with predominant leg pain refractory to conservative treatment. Patients with predominant low back pain benefit less from SCS. Another neuromodulation technique for treatment of chronic low back pain is subcutaneous stimulation or peripheral nerve field stimulation (PNFS). We investigated the effect of SCS with additional PNFS on pain and quality of life of patients with PSPS compared with that of SCS alone after 12 months. MATERIALS AND METHODS: This is a comparative study of patients with PSPS who responded to treatment with either SCS + PNFS or SCS only following a multicenter randomized clinical trial protocol. In total, 75 patients completed the 12-month follow-up: 21 in the SCS-only group and 54 in the SCS + PNFS group. Outcome measures were pain (visual analog scale), quality of life (36-Item Short Form Survey [SF-36]), anxiety and depression (Hospital Anxiety and Depression Scale [HADS]), overall health (EuroQol Five-Dimension [EQ-5D]), disability (Oswestry Disability Index [ODI]), and pain assessed by the McGill questionnaire. RESULTS: There were no significant differences in baseline characteristics between the two groups. Both groups showed a significant reduction in back and leg pain at 12 months compared with baseline measurements. No significant differences were found between the groups in effect on both primary (pain) and secondary parameters (SF-36, HADS, EQ-5D, ODI, and McGill pain). CONCLUSION: In a subgroup of patients with chronic back and leg pain, SCS alone provided similar long-term pain relief and quality-of-life improvement as PNFS in addition to SCS. In patients with refractory low back pain not responding to SCS alone, adding PNFS should be recommended. CLINICAL TRIAL REGISTRATION: The Clinicaltrials.gov registration number for the study is NCT01776749.

Gradation of Clinical Holistic Response as New Composite Outcome to Evaluate Success in Spinal Cord Stimulation Studies for Pain.

INTRODUCTION: The most prominent outcome measurement in the field of neuromodulation is pain relief. Nevertheless, the number of studies that rely on composite outcomes has increased. The aims of this study are twofold: (1) to evaluate which measures are important to include in a composite outcome and (2) to develop this new composite outcome to evaluate the degree of being a clinical holistic responder with a corresponding minimal clinical important difference (MCID). MATERIALS AND METHODS: Data from patients with persistent spinal pain syndrome type 2 treated with High-Dose Spinal Cord Stimulation (HD-SCS) were used. Pain intensity for low back and leg pain, disability, health-related quality of life, medication use, and patient satisfaction were measured at baseline and after 12 months of HD-SCS. Exploratory and Confirmatory Factor Analyses were used to evaluate which measures should be included in the composite outcome. Anchor-based and distribution-based methods were applied to determine the MCID of the newly developed outcome measurement. RESULTS: A three-factor model was the most appropriate for this data set, in which leg pain intensity, EQ5D VAS, and disability had the largest loading on these factors. A clinical holistic outcome was created with a total score ranging from 0 (=better [no pain, no disability, and perfect health status]) to 300 (=worse [maximal pain, maximal disability, and worst health status]). The MCID value based on an absolute change score from baseline up to 12 months of HD-SCS was 87.97. When calculating with percentage changes, a MCID value of 48.4% was revealed. CONCLUSIONS: This new composite outcome evaluating the degree of deviation from being a holistic responder is a step toward a meaningful, overall outcome assessment for patients who are treated with SCS. Further studies to evaluate the psychometric properties and the generalizability toward other patient populations still need to be performed.

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.

Spinal Cord Stimulation-Naïve Patients vs Patients With Failed Previous Experiences With Standard Spinal Cord Stimulation: Two Distinct Entities or One Population?

INTRODUCTION: Nowadays, the success of spinal cord stimulation (SCS) is evaluated separately in patients who have previous experiences with standard SCS and in SCS-naïve patients. Nevertheless, it is yet to be evaluated whether both patient groups are effectively distinct patient groups. Therefore, the aims of this study are twofold: 1) Are there clusters in the data to distinguish between both patient groups? 2) Can we discriminate both patient groups based on routinely collected clinical parameters? MATERIALS AND METHODS: Baseline data from the Discover study were used, in which 263 patients with persistent spinal pain syndrome type 2 were included (185 neurostimulation-naïve patients and 78 patients with previous SCS experience). Pain intensity scores for low back and leg pain, functional disability, medication use, and health-related quality of life utility scores were used in the analysis. Model-based clustering was performed on standardized data. Discriminant analysis was performed with linear and quadratic discriminant analysis, with leave-one-out cross-validation to evaluate model performance. RESULTS: Model-based clustering revealed two different clusters in the data. None of the clusters clearly separated SCS-naïve patients from patients with previous SCS experience. Linear discriminant analysis resulted in a leave-one-out cross-validation error rate of 30.0% to discriminate between both patient groups, based on routinely collected clinical parameters. CONCLUSIONS: Clustering analysis did not result in clusters that separate SCS-naïve patients from patients with previous SCS experience. This may suggest that both patient groups should not be considered as two different patient groups when comparing them on routine clinical parameters, with potentially profound implications for research and clinical settings. CLINICAL TRIAL REGISTRATION: The Clinicaltrials.gov registration number for the Discover study is NCT02787265.

Early Experience With a Novel Miniaturized Spinal Cord Stimulation System for the Management of Chronic Intractable Pain of the Back and Legs.

INTRODUCTION: A novel, spinal cord stimulation (SCS) system with a battery-free miniaturized implantable pulse generator (IPG) was used in this feasibility study. The system uses an external power source that communicates bidirectionally with the IPG (< 1.5 cm3). Human factors, subject comfort, and effects on low back and leg pain were evaluated in this first-in-human study. MATERIALS AND METHODS: A prospective, multicenter, open-label clinical trial was initiated to evaluate the safety and performance of a novel miniaturized stimulator in the treatment of chronic, intractable leg and low-back pain. Eligible subjects were recruited for the study and gave consent. Subjects who passed the screening/trial phase (defined as ≥ 50% decrease in pain) continued to the long-term implant phase and were followed up at predefined time points after device activation. Interim clinical and usability outcomes were captured and reported at 90 days. RESULTS: Results of 22 subjects who chose a novel pulsed stimulation pattern therapy using the battery-free IPG (< 1.5 cm3) are described here. At 90-days follow-up, the average pain reduction was 79% in the leg (n = 22; p < 0.0001) and 76% in the low back (n = 21; p < 0.0001) compared with baseline. Responder rates (≥ 50% pain relief) at 90 days were 86% in leg pain (19/22) and 81% in low-back pain (17/21). Subjects rated the level of comfort of the external wearable power source to be 0.41 ± 0.73 at 90 days on an 11-point rating scale (0 = very comfortable, 10 = very uncomfortable). DISCUSSION: These interim results from the ongoing study indicate the favorable efficacy and usability of a novel, externally powered, battery-free SCS IPG (< 1.5 cm3) for leg and low-back pain. Study subjects wore the external power source continuously and found it comfortable, and the system provided significant pain relief. These preliminary findings warrant further investigation. CLINICAL TRIAL REGISTRATION: The Clinicaltrials.gov registration number for the study is ACTRN12618001862235.

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.

Evaluation of Patient's Quality of Life before and after Implantation of Abbott's Proclaim™ XR Spinal Cord Stimulator with BurstDR™ Stimulation in Chronic Pain Syndrome.

Background and Objectives: In case of the ineffectiveness of pharmacological and non-pharmacological treatments in managing chronic neuropathic pain, spinal cord stimulation (SCS) with BurstDR™ stimulation may reduce pain and increase the quality of life. The term "burst" refers to a series of stimulation impulses that are compressed into small packets and separated by intervals of latency. Materials and Methods: A group of 30 consecutive patients who received the BurstDR™ stimulator using the minimally invasive percutaneous method was selected. Patients selected for our study underwent numerous spinal surgeries before SCS implantation. In the study, analgesics and co-analgesics and their doses used by patients before and 6 months after SCS implantation were examined and compared. Using the visual analogue scale (VAS), pain was compared before and after the procedure. Patients` quality of life was assessed using the Oswestry Disability Index (ODI). Results: We observed a significant reduction in opioid daily doses by an average of 32.4% (±36.1%) and a reduction in paracetamol daily doses by an average of 40% (±33.4%). There was a reduction in pregabalin doses as well. Ketoprofen daily dose reduction was 85.4 mg. The mean VAS difference before and after procedure was 3.9 (±2.3), and the mean difference in ODI was 12.9 (±9), which benefits operative treatment. The VAS and ODI results were statistically significant as well. Conclusions: According to our research, BurstDR™ stimulation improves the quality of life by reducing doses of analgesics and the level of pain.