Failed Back Surgery Syndrome: 5-Year Follow-Up after Spinal Cord Stimulator Implantation

Abstract Spinal cord stimulation, in use for more than 20 years, has evolved into an easily implemented technique, with percutaneous methods for electrode placement. We have reviewed our experience with this technique in treating “failed back surgery syndrome,” and have assessed patient and treatment characteristics as predictors of long-term outcome. A series of 50 patients with failed back surgery syndrome (averaging 3.1 previous operations), who underwent spinal cord stimulator implantation, was interviewed by impartial third parties, at mean follow-up intervals of 2.2 years and 5.0 years. Successful outcome (at least 50% sustained relief of pain and patient satisfaction with the result) was recorded in 53% of patients at 2.2 years and in 47% of patients at 5.0 years postoperatively. Ten of 40 patients who were disabled preoperatively returned to work. Improvements in activities of daily living were recorded in most patients for most activities; loss of function was rare. Most patients reduced or eliminated analgesic intake. Statistical analysis (including univariate and multivariate logistic regression) of patient characteristics as prognostic factors showed significant advantages for female patients and for those with programmable multi-contact implanted devices. These results, in patients with postsurgical lumbar arachnoid and epidural fibrosis and without surgically remediable lesions, compare favorably with the results in two separate series of patients with failed back surgery syndrome, in whom 1) surgical lesions were diagnosed and repeated operation performed; and 2) monoradicular pain syndromes were diagnosed and dorsal root ganglionectomies peroformed at our institution. This suggests the need for further assessment of selection criteria, critical analysis of treatment outcome, and prospective study of spinal cord stimulation and alternative approaches to failed back surgery syndrome.

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

Neurosurgery ◽

10.1093/neuros/nyy194 ◽

2018 ◽

Vol 84 (5) ◽

pp. 1011-1018 ◽

Cited By ~ 12

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.

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Spinal Cord Stimulator Improves Pain in Patients with Failed Back Surgery Syndrome: A Prospective Study with up to 2 Years of Follow-up

10.1055/s-0040-1717411 ◽

2020 ◽

Author(s):

S Weidert ◽

R Ibrahim ◽

D Habersatter ◽

Becker CA ◽

A Greiner ◽

...

Keyword(s):

Spinal Cord ◽

Prospective Study ◽

Failed Back Surgery Syndrome ◽

Spinal Cord Stimulator ◽

Failed Back Surgery ◽

Back Surgery ◽

A Prospective Study

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

Neurosurgery ◽

10.1227/01.neu.0000180030.00167.b9 ◽

2005 ◽

Vol 57 (5) ◽

pp. 990-996 ◽

Cited By ~ 93

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.

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Faculty Opinions recommendation of Evaluation of the Effectiveness of Percutaneous Octapolar Leads in Pain Treatment with Spinal Cord Stimulation of Patients with Failed Back Surgery Syndrome During a 1-Year Follow-Up: A Prospective Multicenter International Study.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.727487703.793531395 ◽

2017 ◽

Author(s):

Massimo Allegri ◽

Susanna Gerboni

Keyword(s):

Spinal Cord ◽

Spinal Cord Stimulation ◽

Pain Treatment ◽

International Study ◽

Failed Back Surgery Syndrome ◽

Failed Back Surgery ◽

Back Surgery ◽

Stimulation Of

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Use of Spinal Cord Stimulator for Treatment of Lumbar Radiculopathy in a Patient with Severe Kyphoscoliosis

January 2018 - Pain Physician ◽

10.36076/ppj.2008/11/555 ◽

2008 ◽

Vol 4;11 (8;4) ◽

pp. 555-559 ◽

Cited By ~ 1

Author(s):

Joseph Atallah

Keyword(s):

Spinal Cord ◽

Spinal Cord Stimulation ◽

Failed Back Surgery Syndrome ◽

Radicular Pain ◽

Activity Level ◽

Spinal Cord Stimulator ◽

Lumbar Radiculopathy ◽

Failed Back Surgery ◽

Back Surgery ◽

Technical Considerations

Spinal cord stimulation (SCS) has been a therapeutic option for chronic pain for over 40 years with a common indication being failed back surgery syndrome (FBSS). This case reports the successful implantation of a spinal cord stimulator in a patient with FBSS and kyphoscoliosis for treatment of radicular pain. Technical considerations and anatomical difficulties that may be encountered during placement with kyphoscoliosis will be discussed. This patient had failed other therapies including oral medications, epidural steroid injections, spinal surgeries, and physical and aquatic therapies. On physical examination the patient had a severely deformed lumbar spine. Careful review of the spine radiographs and CT scan revealed lead placement might be possible at the level of T12-L1 or L1-2. A Medline search did not reveal a case of kyphoscoliosis with radicular pain treated with SCS. After a successful percutaneous trial, a SCS was implanted. Fourteen weeks later, the patient reported being pain free with an increased physical activity level and opioid discontinuation. Technical considerations with kyphoscoliosis may discourage pain physicians from attempting SCS. This case illustrates that with careful selection, some of these patients may be candidates for SCS with good results. Key words: Spinal cord stimulator, spinal cord stimulation, failed back surgery syndrome, kyphoscoliosis, back pain, lumbar radiculopathy

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

January 2018 - Pain Physician ◽

10.36076/ppj.20.5.e797 ◽

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.

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Failed Back Surgery Syndrome: 5-Year Follow-Up in 102 Patients Undergoing Repeated Operation

Neurosurgery ◽

10.1227/00006123-199105000-00008 ◽

1991 ◽

Vol 28 (5) ◽

pp. 685-691 ◽

Cited By ~ 196

Author(s):

Richard B. North ◽

James N. Campbell ◽

Carol S. James ◽

Mary Kay Conover-Walker ◽

Henry Wang ◽

...

Keyword(s):

Patient Characteristics ◽

Failed Back Surgery Syndrome ◽

Long Term Results ◽

Successful Outcome ◽

Lumbosacral Spine ◽

Long Term Outcome ◽

Failed Back Surgery ◽

Back Surgery

Abstract The indications for repeated operation in patients with persistent or recurrent pain after lumbosacral spine surgery are not well established. Long-term results have been reported infrequently, and in no case has mean follow-up exceeded 3 years. We report 5-year mean follow-up for a series of repeated operations performed between 1979 and 1983. Patient characteristics and modes of treatment have been assessed as predictors of long-term outcome. One hundred two patients with “failed back surgery syndrome” (averaging 2.4 previous operations), who underwent a repeated operation for lumbosacral decompression and/or stabilization, were interviewed by a disinterested third party a mean of 5.05 years postoperatively. Successful outcome (at least 50% sustained relief of pain for 2 years or at last follow-up, and patient satisfaction with the result) was recorded in 34% of patients. Twenty-one patients who were disabled preoperatively returned to work postoperatively; 15 who were working preoperatively became disabled or retired postoperatively. Improvements in activities of daily living were recorded, overall, as often as decrements. Loss of neurological function (strength, sensation, bowel and bladder control) was reported by patients more often than improvement. Most patients reduced or eliminated analgesic intake. Statistical analysis (including univariate and multivariate logistic regression) of patient characteristics as prognostic factors showed significant advantages for young patients and for female patients. Favorable outcome also was associated with a history of good results from previous operations, with the absence of epidural scar requiring surgical lysis, with employment before surgery, and with predominance of radicular (as opposed to axial) pain. These results suggest that selection criteria for repeated operation on the lumbosacral spine require further refinement, together with critical analysis of treatment outcome, and that alternative approaches to failed back surgery syndrome should be considered.

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