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

2018 ◽  
Vol 22 (8) ◽  
pp. 970-977 ◽  
Author(s):  
Eric‐Jan J. A. A. Gorp ◽  
Onno Teernstra ◽  
Hans J. Aukes ◽  
Tanja Hamm‐Faber ◽  
Katja Bürger ◽  
...  
Keyword(s):  
Failed Back Surgery Syndrome ◽  
Controlled Study ◽  
Low Back ◽  
Randomized Controlled ◽  
Long Term Effect ◽  
Failed Back Surgery ◽  
Back Surgery ◽  
Peripheral Nerve Field Stimulation

scholarly journals Long-Term Follow-Up of Inpatients with Failed Back Surgery Syndrome Who Received Integrative Korean Medicine Treatment: A Retrospective Analysis and Questionnaire Survey Study

2021 ◽  
Vol 10 (8) ◽  
pp. 1703
Author(s):  
Ju-Hun Park ◽  
Kang-Eah Choi ◽  
Sang-Gyun Kim ◽  
Hui-Yeong Chu ◽  
Sang-Woon Lee ◽  
...  
Keyword(s):  
Retrospective Analysis ◽  
Questionnaire Survey ◽  
Failed Back Surgery Syndrome ◽  
Post Treatment ◽  
Leg Pain ◽  
Korean Medicine ◽  
Failed Back Surgery ◽  
Back Surgery

Introduction: this study aimed to investigate the long-term clinical efficacy and satisfaction degree of integrative Korean medicine (KM) treatment for patients with failed back surgery syndrome (FBSS). Methods: we performed a follow-up questionnaire survey and retrospective analysis of medical records for patients with FBSS who underwent inpatient treatment for ≥ 1 week. The primary evaluation indices were numeric rating scale (NRS) scores for low back pain (LBP) and leg pain at admission and discharge. Sub-evaluation indices included the Oswestry Disability Index (ODI) and EuroQol 5-dimension (EQ-5D) score. The follow-up questionnaire survey obtained information regarding previous surgeries; reasons for satisfaction/dissatisfaction with surgical and KM treatment; and current status. Results: compared with at admission, there was a significant post-treatment decrease in the NRS scores for LBP and leg pain, as well as the ODI score. Further, there was a significant post-treatment increase in the EQ-5D score. Regarding the patients’ global impression of change for KM treatment administered during admission and at the follow-up questionnaire survey, 101 (95.3%) patients selected “minimally improved” or better. Conclusion: integrative KM treatment could effectively reduce pain, as well as improve function and health-related quality of life, in patients with FBSS.

Spinal Cord Stimulation Electrode Design: A Prospective, Randomized, Controlled Trial Comparing Percutaneous with Laminectomy Electrodes: Part II–Clinical Outcomes

Neurosurgery ◽  
2005 ◽  
Vol 57 (5) ◽  
pp. 990-996 ◽  
Author(s):  
Richard B. North ◽  
David H. Kidd ◽  
Loredana Petrucci ◽  
Michael J. Dorsi
Keyword(s):  
Spinal Cord ◽  
Controlled Trial ◽  
Clinical Results ◽  
Failed Back Surgery Syndrome ◽  
Electrode Placement ◽  
Randomized Controlled ◽  
Prospective Randomized Controlled Trial ◽  
Failed Back Surgery ◽  
Back Surgery

Abstract OBJECTIVE: Spinal cord stimulation, in use for more than 30 years, has evolved into an easily implemented technique involving percutaneous or laminectomy electrode placement. In a randomized comparison of four-contact percutaneous and four-contact insulated laminectomy electrodes placed at the same level in the dorsal, epidural midline, quantitative measures of stimulator performance revealed significant technical advantages for the laminectomy electrodes. Our prospective, randomized, controlled trial compares clinical results in these same patients. METHODS: Impartial third parties followed our series of 24 patients with failed back surgery syndrome to gather clinical outcome data. We defined “success” as at least 50% sustained relief of pain and patient satisfaction with the result of treatment. RESULTS: At a mean follow-up of 1.9 years, 10 of 12 patients receiving the laminectomy electrode and 5 of 12 patients receiving the percutaneous electrode reported a successful outcome (P < 0.05). Follow-up at a mean of 2.9 years showed that this result was maintained in 5 of 12 patients with the laminectomy electrode and 3 of 12 with the percutaneous electrode (not statistically significant). Many patients reported improvements in most activities of daily living, and loss of function was rare. In addition, 9 patients with laminectomy electrodes and 4 with percutaneous electrodes reducted or eliminated analgesic intake (P < 0.05), and 2 returned to work. No electrode migration was observed. CONCLUSION: Laminectomy electrode placement, although more invasive than percutaneous placement, yields significantly better clinical results in patients with failed back surgery syndrome at mean 1.9 years follow-up. In our small sample, however, the statistical significance of this advantage disappeared at mean 2.9 years follow-up.

Long-Term Outcome of Spinal Cord Stimulation in Failed Back Surgery Syndrome: 20 Years of Experience With 224 Consecutive Patients

Neurosurgery ◽  
2018 ◽  
Vol 84 (5) ◽  
pp. 1011-1018 ◽  
Author(s):  
Mette Nissen ◽  
Tiina-Mari Ikäheimo ◽  
Jukka Huttunen ◽  
Ville Leinonen ◽  
Mikael von und zu Fraunberg
Keyword(s):  
Spinal Cord ◽  
Pain Relief ◽  
Spinal Cord Stimulation ◽  
Failed Back Surgery Syndrome ◽  
Term Outcome ◽  
Long Term Outcome ◽  
Failed Back Surgery ◽  
Back Surgery

Abstract BACKGROUND Failed back surgery syndrome (FBSS) is a challenging condition that lacks a curative treatment. In selected patients, spinal cord stimulation (SCS) has provided a satisfactory outcome. OBJECTIVE To evaluate the long-term outcome of SCS in FBSS, as measured by (1) the explantation rate, (2) complications, and (3) patient satisfaction with the global perceived effect (GPE). METHODS We studied 224 consecutive FBSS patients who underwent an SCS trial with surgically implanted leads at our hospital between January 1996 and December 2014. The patients’ satisfaction with the GPE of treatment was measured through a postal questionnaire at the end of follow-up. RESULTS Based on a 1-wk trial, permanent SCS was implanted in 175 (78%) patients. Out of these patients, 153 (87%) reported satisfactory outcomes after 2 mo. During the mean follow-up of 6 yr, 34 (19%) of SCS devices were permanently explanted due to inadequate pain relief, and 11 (6%) were explanted for other reasons. Electrode revision due to inadequate pain relief was done for 22 patients. In total, 26 complications were reported due to: 7 deep infections, 11 hardware malfunctions, 1 subcutaneous hematoma, 4 instances of discomfort due to the pulse generator, and 3 electrode migrations. One hundred thirty patients (74%) continued with SCS until the end of follow-up. Of them, 61 (47%) returned the questionnaire, and 42 (69%) reported substantially improved or better GPE. CONCLUSION SCS can provide a good outcome in the treatment of FBSS. Patient selection could be further improved by developing novel predictive biomarkers.

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

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Xiaoping Sheng ◽  
Hongyu Yue ◽  
Qi Zhang ◽  
Deta Chen ◽  
Weidong Qiu ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Low Back Pain ◽  
Back Pain ◽  
Rating Scale ◽  
Controlled Trial ◽  
Failed Back Surgery Syndrome ◽  
Low Back ◽  
Randomized Controlled ◽  
Failed Back Surgery ◽  
Back Surgery

Abstract 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

scholarly journals Long-term Cost Utility of Spinal Cord Stimulation in Patients with Failed Back Surgery Syndrome

2017 ◽  
Vol 6 (20;6) ◽  
pp. E797-E805
Author(s):  
Shivanand P. Lad
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Stimulation ◽  
Failed Back Surgery Syndrome ◽  
Cost Utility ◽  
Conventional Management ◽  
Failed Back Surgery ◽  
Back Surgery ◽  
One Year

Background: Failed back surgery syndrome (FBSS) is a cause of significant morbidity for up to 40% of patients following spine surgery, and is estimated to cost almost $20 billion. Treatment options for these patients currently include conventional medical management (CMM), repeat operation, or spinal cord stimulation (SCS). Much of the published data regarding cost effectiveness of SCS comprise smaller scale randomized controlled trials (RCTs) rather than large databases capturing practices throughout the US. SCS has been shown to have superior outcomes to CMM or repeat spinal operation in several landmark studies, yet there are few large studies examining its long-term economic impact. Objectives: This study compares health care utilization for SCS compared to other management in patients with FBSS. Study Design: Retrospective. Setting: Inpatient and outpatient sample. Methods: Patients with a history of FBSS from 2000 to 2012 were selected. We compared those who received SCS to those who underwent conventional management. A longitudinal analysis was used to model the value of log(cost) in each one year interval using a generalized estimating equations (GEE) model to account for the correlation of the same patient’s cost in multiple years. Similarly, a Poisson GEE model with the log link was applied to correlated count outcomes. Results: We identified 122,827 FBSS patients. Of these, 5,328 underwent SCS implantation (4.34%) and 117,499 underwent conventional management. Total annual costs decreased over time following implantation of the SCS system, with follow-up analysis at 1, 3, 6, and 9 years. The longitudinal GEE model demonstrated that placement of an SCS system was associated with an initial increase in total costs at the time of implantation (cost ratio [CR]: 1.74; 95% confidence interval [CI]: 1.41, 2.15, P < 0.001), however there was a significant and sustained 68% decrease in cost in the year following SCS placement (CR: 0.32; 95% CI: 0.24, 0.42, P < 0.001) compared to CMM. There was also an aggregate time trend that for each additional year after SCS, cost decreased on average 40% percent annually (CR: 0.60; 95% CI: 0.55, 0.65, P < 0.001), with follow-up up to 1, 3, 6, and 9 years post-procedure. Limitations: Costs are not correlated with patient outcomes, patients are not stratified in terms of complexity of prior back surgery, as well as inherent limitations of a retrospective analysis. Conclusions: We found that from 2000 to 2012, only 4.3% of patients across the United States with FBSS were treated with SCS. Long-term total annual costs for these patients were significantly reduced compared to patients with conventional management. Although implantation of an SCS system results in a short-term increase in costs at one year, the subsequent annual cumulative costs were significantly decreased long-term in the following 9 years after implantation. This study combines the largest group of FBSS patients studied to date along with the longest follow-up interval ever analyzed. Since SCS has repeatedly been shown to have superior efficacy to CMM in randomized clinical trials, the current study demonstrating improved long-term health economics at 1, 3, 6, and 9 years supports the long-term cost utility of SCS in the treatment of FBSS patients.

scholarly journals Transforaminal Epidural Steroid Injections: A Systematic Review and Meta-Analysis of Efficacy and Safety

2021 ◽  
Vol S1;24 (1;S1) ◽  
pp. S209-S232 ◽  
Keyword(s):  
Systematic Review ◽  
Disc Herniation ◽  
Meta Analysis ◽  
Failed Back Surgery Syndrome ◽  
Radicular Pain ◽  
Low Back ◽  
Randomized Controlled ◽  
Failed Back Surgery ◽  
Back Surgery ◽  
Epidural Steroid

BACKGROUND: Transforaminal epidural injections have been used since the late 1990s to treat lumbar radicular pain. They have been the subject of considerable attention, with varying conclusions from systematic reviews as to their efficacy. Transforaminal injections have been associated with rare but major complications. Further, the use of transforaminal injections has increased since the passage of the Affordable Care Act. Finally, with the SARS-CoV-2 pandemic, there has been heightened concern regarding the risk associated with steroid injections. OBJECTIVES: To evaluate and update the effectiveness of transforaminal injections for 4 indications: radicular pain; from spinal stenosis; from failed back surgery syndrome; and for axial low back pain; and to evaluate the safety of the procedure. STUDY DESIGN: A systematic review and meta-analysis of the efficacy of transforaminal injections. METHODS: The available literature on transforaminal injections was reviewed and the quality assessed. The level of evidence was classified on a 5-point scale based on the quality of evidence developed by the US Preventive Services Task Force (USPSTF) and modified by the American Society of Interventional Pain Physicians (ASIPP). Data sources included relevant literature from 1966 to April 2020, and manual searches of the bibliographies of known primary and review articles. Pain relief and functional improvement were the primary outcome measures. A minimum of 6 months pain relief follow-up was required. RESULTS: For this systematic review, 66 studies were identified. Eighteen randomized controlled trials met the inclusion criteria. No observational studies were included. Eleven randomized controlled trials dealt with various aspects of transforaminal injections for radicular pain owing to disc herniation. Based on these studies, there is Level 1 evidence supporting the use of transforaminal injections for radicular pain owing to disc herniation. A meta-analysis showed that at both 3 and 6 months, there was highly statistically significant improvement in both pain and function with both particulate and nonparticulate steroids. For radicular pain from central stenosis there is one moderate quality study, with Level IV evidence. For radicular pain caused by failed back surgery syndrome there is one moderate quality study, with Level IV evidence. For radicular pain from foraminal stenosis and for axial pain there is Level V evidence, opinion-based/consensus, supporting the use of transforaminal injections. Transforaminal injections are generally safe. However, they have been associated with major neurologic complications related to cord infarct. Causes other than intraluminal injection of particulates appear to be at play. The use of an infraneural approach and of blunt needles appear to offer the greatest patient safety. Because of concern over the role of particulate steroids, multiple other injectates have been evaluated, including nonparticulate steroids, tumor necrosis factor alpha (TNF-a) inhibitors, and local anesthetics without steroids. No injectate has been proven superior. If there is concern about immunosuppression because of risk of COVID-19 infection, either the lowest possible dose of steroid or no steroid should be used. LIMITATIONS: The study was limited by the paucity of literature for some indications. CONCLUSIONS: There is Level I evidence for the use of transforaminal injections for radicular pain from disc herniations. KEY WORDS: Disc herniation, spinal pain, radicular pain, epidural steroid injection, transforaminal injection, spinal stenosis, post lumbar surgery syndrome, axial low back pain

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