Failed Back Surgery Syndrome Patients Research Articles

Long-term outcomes of caudal epidural steroid injection in failed back surgery syndrome patients with loss of resistance technique

Background: Failed back surgery syndrome (FBSS) is a complicated issue with various treatment approaches. This retrospective study assesses the success and safety of caudal epidural steroid injection (CESI) in FBSS patients utilizing the loss of resistance (LOR) strategy, focusing on long-term outcomes lasting up to two years. Methods: The 75 FBSS patients had CESI with triamcinolone and normal saline under local anesthesia. The visual analog score (VAS), Oswestry disability index (ODI), and patient satisfaction score (PSS) were measured at pre-intervention and 3, 6, 12, 18, and 24 months following the procedure. Result: Majority of patients (57.33%) reported bilateral sciatica, with recurrent disc herniation (54.67%) being the most prevalent MRI finding. Significant improvements (p<0.001) in VAS, ODI, and PSS scores were seen in all subsequent periods. Furthermore, no significant issues reported, demonstrating the safety and effectiveness of CESI with LOR. Conclusions: CESI with the LOR technique is helpful treatment in FBSS at three, six, twelve, eighteen, and twenty-four months. It is easy to perform, less technically demanding, has low complications, and lower costs than surgery. A CESI may offer an alternative approach to managing FBSS for short-term and long-term outcomes.

Neuromodulation in Management of Patients with Failed Back Surgery Syndrome. An Outcome Assessment Study

Abstract Background Failed back surgery syndrome (FBSS) is a constellation of conditions that describes persistent or recurring low back pain following spine surgeries with a reported point prevalence in the general adult population of 37% and a lifetime prevalence of between 60% and 85%. It always has a significant impact on patients’ quality of life. Neuromodulation such as spinal cord stimulation has been showing significant effect and improvement in pain scores and functional capacity of the FBSS patients with a reflected effect on their daily activities and quality of life. Aim and Objectives Our aim in this study is to assess the change in pain scores, quality of life and opioid medications intake as an outcome of neuromodulation procedures performed to patients diagnosed with failed back surgery syndrome, and to detect the post procedure complications. Subjects and Methods This is a mixed prospective-retrospective study conducted at Ain Shams University (ASU) hospital and Oregon Health and Science University (OHSU) hospital during the period from September 2019 till December 2022. 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 34 patients were included in this study who had successful SCS trials and underwent a permanent implantation of SCS devices with post procedure follow up period of 12 months. Patients showed median pain numerical rating scale (NRS) of 7/10 at baseline with median NRS of 4/10 through the follow up period, also, there was a significant improvement of functional capacity using metabolic equivalent assessment with 74% of patients became moderate capacity compared to 32% at baseline. Quality of life assessed by activity measure of post-acute care (AM-PAC) showed significant improvement from mean of 16.87 ± 2.74 at baseline to mean of 19.97 ± 2.93 through follow up. Also there was a significant reduction of opioid medication usage. Post procedure complications was of low percentage with the most commonly 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 Failed back surgery syndrome is a widely described chronic pain condition which has a negative impact on the patients’ quality of life and daily activities with an evidenced effect on chronic use and abuse of opioid analgesic medications. We presented in our study that SCS could be offered as an effective modality of treatment with a statistically significant reduction in pain scores and a significant improvement in functional capacity and quality of life. Also, it has a recognizable but not statistically significant reduction in opioid analgesic medications and a very low percentage of procedure related complications.

Metalloproteinase-2 in failed back surgery syndrome caused by epidural fibrosis: can it play a role in persistent pain?

Failed Back Surgery Syndrome (FBSS) occurs in 10-40% of patients treated surgically due to disk herniation (DH). There are several factors that can cause a predisposition to FBSS, but the exact pathomechanism has not been elucidated. The aim of this study was to investigate Metalloproteinase-2 (MMP-2) and Tissue Inhibitor of Metalloproteinase-2 (TIMP-2) activities in a homogeneous group of FBSS patients with epidural fibrosis in comparison to its activity in patients with surgically treated DH. DH, FBSS, and control (CG) groups consisted of 30 subjects. The patients were assessed clinically by the Numerical Rating Scale (NRS), McGill Pain Questionnaire (SF -MPQ), Oswestry Disability Index (ODI), and Beck Depression Inventory (BDI). Serum concentrations of MMP-2 and TIMP-2 were measured by using the immunoenzymatic method. There was a significantly higher MMP-2 expression (medians: 4797.49 vs. 2656.65; p < 0.0001) and TIMP-2 concentration (medians: 166.40 vs. 109.60; p < 0.0001) in the DH compared to the CG. Significantly higher MMP-2 expression (4219.95 vs. 2656.65; p < 0.0001) and TIMP-2 concentration (medians: 150.17 vs. 109.60; p = 0.0003) were also found in the FBSS compared to the CG. The activity of MMP-2, measured as MMP-2/TIMP-2, did not significantly change between the DH, FBSS, and CG. MMP2 expression (p < 0.0001) and TIMP-2 concentration (p < 0.0001) were significantly higher in the DH than FBSS. Results indicate the presence of a contribution of MMP-2 and TIMP-2 in DH and FBSS. Unchanged activity of MMP-2 can indicate an insufficiency in the MMP-2 repair system in both diseases. Lower MMP-2 expression and TIMP-2 concentration in the FBSS group can reflect the chronicity of the process.

Efficacy of Spinal Cord Stimulation for Failed Back Surgery Syndrome in Elderly Patients: A Retrospective Study.

Failed back surgery syndrome (FBSS) refers to a condition where symptoms such as low back pain, leg pain, and numbness persist or recur after lumbar surgery; it has been reported to occur in 10%-40% of patients who have undergone lumbar surgery. Spinal cord stimulation (SCS) has been reported useful for low back and leg pain due to FBSS. In this study, we studied the efficacy and safety of SCS for FBSS in older adults. Among FBSS patients who underwent an SCS trial between November 2017 and December 2020, those with at least 50% pain reduction during the trial phase who requested spinal cord stimulator implantation underwent implantation of a stimulator under local anesthesia. The patients were divided into two groups: patients aged <75 years (<75-year-old group) and patients aged ≥75 years (≥75-year-old group). The male/female ratio, symptom duration, operative duration, visual analog scale (VAS) scores before and after one year of surgery, responder rate (RR), complications one year after surgery, and stimulator removal rate were analyzed. There were 27 cases in the <75-year-old group and 46 in the ≥75-year-old group, with no significant differences in male/female ratio, duration of pain, or operative time between the two groups. VAS scores for low back pain, leg pain, and overall pain one year after surgery were improved significantly from respective preoperative scores in both groups (P < 0.001). There were no significant differences in low back pain VAS, leg pain VAS, overall pain VAS, RR, complications one year after surgery, or stimulator removal rate between the two groups. SCS reduced pain effectively in both <75-year-old and ≥75-year-old groups with no differences in complications. Therefore, spinal cord stimulator implantation was considered a viable option for FBSS treatment in older adults because it can be performed under local anesthesia and is associated with a low incidence of complications.

Spinal Cord Stimulation for Failed Back Surgery Syndrome: to Trial or Not to Trial?

Spinal cord stimulation (SCS) is a recommended therapy to treat failed back surgery syndrome (FBSS). A trial period is practiced to enhance patient selection. However, its fundamental evidence is limited, especially concerning long-term benefit and therapy safety. We compared the long-term (5.3 ± 4.0 years) clinical outcome and therapy safety of a trialed and nontrialed implantation strategy, including multidimensional variables and pain intensity fluctuations over time. A multicenter cohort analysis was performed in 2 comparable groups of FBSS patients. Regarding eligibility, patients had to be treated with SCS for at least 3 months. While the Trial group comprised patients who underwent an SCS implantation after a successful trial, the No-Trial group encompassed patients who underwent complete implantation within 1 session. The primary outcome measures were pain intensity scores and complications. The Trial and No-Trial groups consisted of 194 and 376 patients (N = 570), respectively. A statistically but not clinically significant difference in pain intensity (P = .003; effect = 0.506 (.172–.839)) was found in favor of the Trial group. No interaction between a time dependency effect and pain intensity was noted. Whereas trialed SCS patients were more likely to cease opioid usage (P = .003; OR = .509 (.326–.792)), patients in the No-Trial group endured fewer infections (P = .006; proportion difference = .43 (.007–.083)). Although the clinical relevance of our findings should be proven in future studies, this long-term real-world data study indicates that patient-centered assessments on whether an SCS trial should be performed have to be investigated. According to the current ambiguous evidence, SCS trials should be considered on a case-by-case basis. PerspectiveThe currently available comparative evidence, together with our results, remains ambiguous on which SCS implantation strategy might be deemed superior. An SCS trial should be considered on a case-by-case basis, for which further investigation of its clinical utility in certain patient populations or character traits is warranted.

척추 수술 실패 증후군에 대한 수기요법의 효과

Objectives This study aimed to assess the efficacy and safety of manual therapy in patients with failed back surgery syndrome (FBSS). Methods We searched eight electronic databases from October 2022 and only selected randomized controlled trials (RCTs) reporting outcomes for manual therapy in FBSS patients. Included studies were analyzed qualitatively. Results A total of twelve RCTs were included and three studies were meta-analyzed. Manual therapy combined with exercise demonstrated more favorable outcomes in terms of pain reduction compared to exercise therapy only (P&lt;0.01). Some studies reported that manual therapy resulted in low efficacy, while some studies reported that specific manual techniques have a significant effect in pain relief. We, therefore, conclude that several studies have a high risk of bias. Conclusions Findings suggest that manual therapy is a safe and non-invasive, promising option for managing FBSS. However, manual therapy is not the best option in all circumstances; thus, this should be selectively applied by a well-trained practitioner. Further studies such as well-designed, risk-controlled RCTs are required to gain stronger evidence.

Non-Invasive Treatments for Failed Back Surgery Syndrome: A Systematic Review.

Systematic Review. The aim of this systematic review is to evaluate the efficacy of non-invasive procedures in relieving chronic pain due to Failed Back Surgery Syndrome (FBSS). Since patients who suffered from FBBS are often non-responders to analgesics, we compared Visual Analogical Scale for low back and leg pain, Oswestry Disability Index, trial success rate, adverse events and complications between conservative treatment groups and control groups. The included studies were 15. Spinal Cord Stimulation (SCS) was performed in 11 trials; 4 studies assessed the efficacy of different epidural injections; one study evaluated repetitive Transcranial Magnetic Stimulation. All the studies reported back and leg pain relief after treatment with SCS, with a significant superiority in high frequences (HFS) group, compared to low frequences (LFS) group. Moreover, disability decreased with each non-invasive treatment evaluated. Epidural injections of steroids and hyaluronidase have shown controversial results. Adverse events were described in 7 studies: lead migration, hardware-related events, infection and incisional pain were the most reported. Finally, trial success rate showed better outcomes for HFS. Our systematic review highlights the efficacy of conservative treatments in FBSS patients, with an improvement in pain scores and a decrease in disability index, especially after SCS with HFS. However, due to the lack of homogeneity among trials and population characteristics, further studies are needed to confirm the effectiveness of non-invasive interventions in patients affected by FBSS.

Altered central pain processing assessed by quantitative sensory testing in patients with failed back surgery syndrome

ObjectiveTo investigate the presence of altered central pain processing in patients with failed back surgery syndrome (FBSS) using quantitative sensory testing (QST). MethodsThis study included 34 patients with FBSS, 102 patients post-lumbar surgery without low back pain (LBP), and 102 healthy subjects. All subjects underwent both pressure pain threshold (PPT) and conditioned pain modulation (CPM) in both local and remote pain-free areas, as well as temporal summation (TS) in a remote pain-free area. All patient subjects were assessed using the Pain Catastrophizing Scale (PCS), Beck Anxiety Inventory (BAI), Beck Depression Index (BDI), Numeric rating pain scale (NRS) and Oswestry Disability Index (ODI). ResultsCompared with both control groups, FBSS patients showed a reduction in both PPT and CPM in both tested areas, along with increased TS in a pain-free area (P < 0.05). Furthermore, the patients with FBSS had a significantly higher prevalence of anxiety, depression and pain catastrophizing thoughts than the patient controls (P < 0.05). In the FBSS patients, there was a significant correlation between LBP at rest and both CPM and TS in the pain-free areas, and QST measurements were also associated with the ODI, PCS and BAI (P < 0.05). ConclusionThese findings support the existence of augmented central pain processing in patients with FBSS, which may be caused by dysfunction of endogenous pain facilitation and inhibition. This central amplification of pain may contribute to both LBP intensity and disability in FBSS patients. Therefore, treatment efforts should take into account functional alterations in the central nervous system of FBSS patients.

O059 / #544 ALTERED FUNCTIONAL CONNECTIVITY PATTERNS CORRELATED WITH DIFFERENT CHRONIC BACK PAIN PHENOTYPES ARE PREDICTIVE OF SPINAL CORD STIMULATION OUTCOMES IN FAILED BACK SURGERY SYNDROME PATIENTS: TRACK 3: NEUROSTIMULATION FOR BACK AND LEG PAIN

Chronic back pain (CBP) has been associated with alterations in brain functional connectivity (FC)1,2. These studies are limited and based on heterogeneous populations and on single-network analysis. Spinal cord stimulation (SCS) can be effective for pain control in failed back surgery syndrome (FBSS) patients. We have previously shown altered cross-network FC involving emotion/reward brain circuitry correlated with individual patient pain scores in a homogeneous population of FBSS patients who had already passed a trial of SCS3 and that the nature of the correlation can depend upon patient pain phenotype4.

Surgical Paddle Electrode Implantation as a Rescue Therapy to Failed Percutaneous Leads in Failed Back Surgery Syndrome Patients

IntroductionSpinal cord stimulation (SCS) to treat failed back surgery syndrome (FBSS) can be provided with either percutaneously or surgically implanted electrodes. Percutaneous electrodes are considered the first choice in many pain practices, but surgical paddle electrodes can also be indicated if a percutaneous electrode fails to retain sufficient pain relief or if percutaneous implantation is considered unachievable. Although the current efficacy of surgical paddle electrodes has been based mainly upon pain intensity scores, the evidence on surgical paddle electrodes as a rescue to failed percutaneous electrodes remains even more scarce. ObjectiveThis study aimed to evaluate the safety and clinical effectiveness of rescue surgical paddle electrodes in FBSS patients, multidimensionally. Materials and MethodsThe occurrence of complications, pain intensity scores, psychosocial-related questionnaires, and medication intake were collected. Subsequently, a Quality-of-Life Index (QLI) was calculated. A clinically relevant effect was obtained if the minimal clinically important difference regarding pain intensity was reached. ResultsA total of 25 patients were included in the study. The pain intensity scores were significantly reduced (p < 0.001), and clinically relevant reductions occurred during short-term (0–6 months), mid-term (1–3 years), and long-term follow-up (≥4 years). The structural morphine usage and QLI were significantly decreased at short-term follow-up (p = 0.038 and p = 0.036, respectively). Six complications occurred in five patients, of which, four concerned hardware-related problems and two were of biological origin. ConclusionSCS utilizing a surgical paddle electrode as a salvage treatment to failed conventional percutaneous cylindrical lead SCS can be practiced safely and effectively to treat FBSS. Because of potentially improved clinical effectiveness and cost-effectiveness resulting from fewer reoperations, a SCS treatment algorithm may benefit from expediting surgical paddle electrodes.

Cerebral current-source distribution associated with pain improvement by non-invasive painless signaling therapy in patients with failed back surgery syndrome.

BackgroundNon-invasive painless signaling therapy (NPST) is an electro-cutaneous treatment that converts endogenous pain information into synthetic non-pain information. This study explored whether pain improvement by NPST in failed back surgery syndrome (FBSS) patients is related to cerebral modulation.MethodsElectroencephalography (EEG) analysis was performed in 11 patients with FBSS. Subjects received daily NPST for 5 days. Before the first treatment, patients completed the Brief Pain Inventory (BPI) and Beck Depression Inventory and underwent baseline EEG. After the final treatment, they responded again to the BPI, reported the percent pain improvement (PPI), and then underwent post-treatment EEG. If the PPI grade was zero, they were assigned to the ineffective group, while all others were assigned to the effective group. We used standardized low-resolution brain electromagnetic tomography (sLORETA) to explore the EEG current-source distribution (CSD) associated with pain improvement by NPST.ResultsThe 11 participants had a median age of 67.0 years, and 63.6% were female. The sLORETA images revealed a beta-2 CSD increment in 12 voxels of the right anterior cingulate gyrus (ACG) and the right medial frontal area. The point of maximal CSD changes was in the right ACG. The alpha band CSD increased in 2 voxels of the left transverse gyrus.ConclusionsPain improvement by NPST in FBSS patients was associated with increased cerebral activity, mainly in the right ACG. The change in afferent information induced by NPST seems to be associated with cerebral pain perception.

Gabapentinoids Associated With Lower Explantation Rate in 203 Patients With Spinal Cord Stimulation for Failed Back Surgery Syndrome.

BACKGROUNDSpinal cord stimulation (SCS) is an effective treatment in failed back surgery syndrome (FBSS). The effect of neuropathic pain medication use on SCS outcome is poorly understood.OBJECTIVETo study the effect of gabapentinoid use on SCS outcome measured by trial success, explantation rate and opioid dose reduction during a 2-yr follow-up.METHODSThe study cohort included 203 consecutive FBSS patients who underwent SCS in a single tertiary center during January 1997 to March 2014. Purchase data of gabapentinoids, opioids, tricyclic antidepressants, serotonin and noradrenaline reuptake inhibitors, and benzodiazepines during January 1995 to March 2016 were retrieved from national registries.RESULTSIn multivariate Cox regression analysis, patients using gabapentinoids had significantly fewer explantations during the 2-yr follow-up (hazard ratio [HR] 0.2, 95% CI 0.04-0.81, P = .03). In contrast, patients with opioid use of >40 morphine milligram equivalent before implantation had significantly more explantations (HR 6.7, 95% CI 2.5-18, P < .01). In bivariate logistic regression analysis adjusted for patient specific factors, year of SCS implantation, use of neuropathic pain medication, opioids, and benzodiazepines, patients using gabapentinoids significantly more often discontinued opioids or reduced their dose by more than 50% during the 2-yr follow-up (odds ratio 5.7, 95% CI 1.4-23, P = .015).CONCLUSIONThe use of gabapentinoids was associated with a significantly lower spinal cord stimulator explantation rate and a higher chance of opioid discontinuation or >50% dose reduction. This indicates that patients with SCS could benefit from concomitant use of gabapentinoids. Prospective randomized trials are warranted to verify this hypothesis.

24-month Real-World Study of Spinal Cord Stimulation in Failed Back Surgery Patients with Refractory Pain

Failed Back Surgery Syndrome (FBSS) causes disability and lowers health-related quality of life (HRQoL) for patients. Many patients become refractory to Conventional Medical Management (CMM) and Spinal Cord Stimulation (SCS) is advised. However, comparative effectiveness research of both clinical approaches still lacks further evidence. This study describes Comparative Effectiveness Research of CMM versus SCS to provide real world evidence regarding the appropriate means for FBSS management, in terms of Patient-Reported Outcomes Measures. Naturalistic, pragmatic, prospective observational multicenter SEFUDOCE-study. FBSS patients attending clinical programmed visits in Pain Unit at Hospital Universitario de La Princesa and at Hospital General Universitario de Alicante (Spain). Study evaluates the impact on pain, functional limitation, and HRQoL of CMM versus SCS in the management of FBSS. Patients completed Pain Detect Questionnaire, Oswestry Disability Index, EQ-5D-3L, Medical Outcomes Study Sleep Scale, and Hospital Anxiety and Depression Scale at baseline and at 3, 6, 12, 18 and 24 months. Longitudinal data were analysed with repeated-measures one-way analysis of variance adjusting by confounders. Eighty-five adults patients with FBSS receiving treatment according to current clinical practice were assessed. After 24 months, the PainDETECT Questionnnaire showed that CMM patients maintained similar scores, while SCS patients reduced their overall score (current pain: 6 CMM versus 4.21 SCS, P = 0.0091; intensity strongest pain: 7.77 CMM versus 6.07 SCS, P = 0.0103; average pain: 6.46 CMM versus 4.75 SCS, P = 0.0012). For the Oswestry Disability Index, the Medical Outcomes Study Sleep Scale, and the Hospital Anxiety and Depression Scale no significant inter-group differences were found. EQ-5D utility improved in SCS patients from baseline (baseline: 0.32 CMM versus 0.22 SCS; 24-month: 0.37 CMM versus 0.63 SCS, P = 0.026). Twenty-four month follow-up showed unlikely presence of neuropathic pain and moderate disability in SCS patients, whereas the CMM patients maintained baseline health state. Given the nature of the intervention, conducting a blinded study was not considered practically feasible. A larger sample could also overcome having younger patients in the SCS arm. SCS may improve the HRQoL and functionality of FBSS patients with refractory pain in the long-term compared to CMM alone.

Early Clinical Outcome of Comparative Study between Revision Operation and Radiofrequency Treatment for Management of Failed Back Surgery Syndrome

Objective: Intractable back pain and radicular pain after lumbosacral spine surgery are challenges for surgeons because the pathophysiology of failed back surgery syndrome (FBSS) remains unknown. Various medications, exercise, reoperation, spinal cord stimulation, and various interventional treatments, such as epidural injection, and radiofrequency treatment, have been suggested as treatment options. However, the clinical outcomes for each treatment are unclear. Methods: We retrospectively evaluated clinical outcomes of consecutive FBSS patients who underwent revision operation or radiofrequency treatment from 2014 to 2017, who previously showed response to nerve block. Pain was analyzed preoperatively and 1 month, 6 months, and 12 months postoperatively using a visual analogue scale (VAS). Short Form 36 (SF-36) health survey and Oswestry Disability Index (ODI) scores were assessed preoperatively and 12 months postoperatively. Results: A total of 70 patients was included in the present study (33 males, 37 females). When comparing preoperative and postoperative 12-month results, back pain VAS score decreased from 5.5 to 4.2 for revision operation and from 5.1 to 4.7 for radiofrequency treatment. Leg pain VAS score decreased from 6.5 to 4.02 for revision operation and 6.2 to 4.3 for radiofrequency treatment. ODI score decreased from 70.9 to 36.1 for revision operation and 70.2 to 36.1 for radiofrequency treatment. SF-36 score increased from 28.9 to 64.1 for revision operation and from 29.6 to 59.6 for radiofrequency treatment. Differences between treatments were not statistically significant after 12 months (p&gt;0.05) but were at 1 month (p=0.01). Conclusion: Compared with revision operation, radiofrequency treatment is not inferior on early clinical outcome (up to 1 year following the treatment) in terms of pain relief, functional capacity, patient satisfaction, and quality of life in patients with FBSS. Radiofrequency treatment can be considered in patients who are not good candidates for surgical treatment based on imaging results or underlying diseases and who are responsive to diagnostic/therapeutic nerve blocks.

95. Effect of spinal cord stimulation on balance and gait in failed back surgery syndrome patients

<h3>BACKGROUND CONTEXT</h3> While spine surgery can produce good outcomes in many patients, there are patients who do not benefit from the intervention and have conditions not thought not to be addressable by surgical intervention. These failed back surgery syndrome (FBSS) patients may be candidates for spinal cord stimulation (SCS) for pain management. While multiple studies have reported benefits of SCS related to pain reduction, improved quality of life, and reduced pain medication intake, there has been little investigation into measurable physical functional improvement in this population. <h3>PURPOSE</h3> The purpose of this study was to evaluate the effect of SCS on traditional self-reported pain and functional measures, the psychological parameter of kinesiphobia, as well as functional measures of balance and gait, in FBSS patients. <h3>STUDY DESIGN/SETTING</h3> Prospective repeated-measures design. <h3>PATIENT SAMPLE</h3> A total of 15 symptomatic FBSS patients eligible for SCS. <h3>OUTCOME MEASURES</h3> Outcome assessment was based on visual analog scales (VAS) for back and leg pain, Oswestry Disability index (ODI), Tampa Scale for Kinesiophobia (TSK) and functional testing components including balance, sway and gait. <h3>METHODS</h3> Patients completed patients reported outcomes and functional evaluations prior to the SCS trial procedure (Pre) and at 6 (Post6) and 12 (Post12) weeks after SCS implantation. Gait and balance were evaluated using 3D human motion capture and dynamic surface EMG. Balance effort and Cone of Economy (CoE) dimensions were as measured by total sway and range of sway (RoS), respectively. Repeated measurements and one-way analysis of variance (ANOVA) were used to analyze data. <h3>RESULTS</h3> SCS implant significantly improved gait and balance in FBSS patients. The following gait parameters showerd significant improvement: Walking speed (Pre: 0.75, Post6: 0.86, Post12: 0.92 m/s, p<0.011), cadence (Pre: 85.42, Post6: 94.1, Post12: 95.94 steps/m, p<0.032), stride length (Pre: 0.98, Post6: 1.05, Post12: 1.07 m, p<0.049), and gait deviation index (GDI; Pre: 74.0, Post6: 83.2, Post12: 90.8, p<0.012). Additionally, significant improvements were seen in balance effort (head sway, Pre: 80.2, Post6: 52.2, Post12: 50.0 cm, p<0.049) sway dimensions as seen by reduced sagittal (p<0.047) and coronal (p<0.042) sway. For patient-reported outcomes, significant improvements were noted for VAS low back (Pre: 6.5, Post6: 3.6, Post12: 3.9, p<0.036), ODI (Pre: 57.6, Post6: 39.7, Post12: 38.3, p<0.006). Scores on the and TSK also improved significantly (p<0.044). <h3>CONCLUSIONS</h3> The results of this study support prior literature reporting significant improvement in pain and self-reported function reflected in VAS and ODI scores. Additionally, significant improvements were found post-SCS in gait and balance. The results suggest that SCS is associated not only with significant improvement in patient self-reported outcome measures, but also with physical functional testing. The patients included in this study showed more efficient gait patterns and improves balanced. This may be reflective of an overall improvement in activities of daily living following SCS implantation. <h3>FDA DEVICE/DRUG STATUS</h3> This abstract does not discuss or include any applicable devices or drugs.

Resource Use and Cost of Subcutaneous Nerve Stimulation Versus Optimized Medical Management in Patients With Failed Back Surgery Syndrome: An Analysis of the SubQStim Study

To undertake a detailed healthcare resource use and cost analysis of the SubQStim study, which randomized patients with failed back surgery syndrome (FBSS) with low back pain to receive subcutaneous nerve field stimulation in combination with optimized medical management (treatment) or optimized medical management alone (control). Patient-level data from the SubQStim study were used to present descriptive analyses of healthcare resource use and estimated costs for pain medication, healthcare visits, adverse events, and device acquisition/implantation. A United Kingdom National Health Service perspective was adopted, using cost data from national tariffs, drug and device prices, and social care cost studies. Results were calculated as the mean cost per patient over the nine-month follow-up period. Mean cost per patient was £18,403 in the treatment group versus £1613 in the control group. Almost 90% of the cost in the treatment group consisted of device acquisition/implantation. Higher adverse event costs were observed for patients in the treatment group, but lower costs were observed for pain medication and healthcare visits. Over nine months, opioid use decreased in the treatment group and increased in the control group. Enrolment and follow-up were terminated early in the clinical study, leading to substantial between-patient variability in each cost category. Subcutaneous nerve field stimulation has the potential to offset the initial costs of the device by reducing analgesic medication and the number of healthcare visits in FBSS patients, alongside potential gains in health-related quality of life. There remains uncertainty in long-term costs and cost-effectiveness of stimulation and longer-term follow-up analyses are needed.

High-Dose Spinal Cord Stimulation Reduces Long-Term Pain Medication Use in Patients With Failed Back Surgery Syndrome Who Obtained at Least 50% Pain Intensity and Medication Reduction During a Trial Period: A Registry-Based Cohort Study

ObjectivesHigh-dose spinal cord stimulation (HD-SCS) revealed positive results for obtaining pain relief in patients with failed back surgery syndrome (FBSS). However, it is less clear whether HD-SCS also is able to reduce pain medication use. The aim of this registry-based cohort study is to explore the impact of HD-SCS on pain medication use in FBSS patients. Materials and MethodsData from the Discover registry was used in which the effectiveness of HD-SCS was explored in neurostimulation-naïve FBSS patients as well as in rescue patients. All neurostimulation-naïve FBSS patients positively responded to a four-week SCS trial period in which at least 50% pain relief and 50% medication reduction were obtained. Medication use was measured with the Medication Quantification Scale III (MQS) in 259 patients at baseline and at 1, 3, and 12 months of HD-SCS. Additionally, defined daily doses (DDD) and morphine milligram equivalents (MME) were calculated as well. ResultsOne hundred thirty patients reached the visit at 12 months. In neurostimulation-naïve patients, a statistically significant decrease in MQS (χ2 = 62.92, p < 0.001), DDD (χ2 = 11.47, p = 0.009), and MME (χ2 = 21.55, p < 0.001) was found. In rescue patients, no statistically significant improvements were found. In both patient groups, statistically significant reductions in the proportion of patients on high-risk MME doses ≥90 were found over time. At the intraindividual level, positive correlations were found between MSQ scores and pain intensity for back (r = 0.56, r = 0.31, p < 0.001) and leg pain (r = 0.61, r = 0.22, p < 0.001) in neurostimulation-naïve and rescue patients, respectively. ConclusionsRegistry data on HD-SCS in FBSS patients revealed a statistically significant and sustained decrease in pain medication use, not only on opioids, but also on anti-neuropathic agents in neurostimulation-naïve patients, who positively responded to an SCS trial period with at least 50% pain relief and 50% pain medication decrease, but not in rescue patients.

Long-term quality of life and work status after high-dose spinal cord stimulation in patients with failed back surgery syndrome: a secondary analysis of real-world data.

In recent years, the use of high-dose spinal cord stimulation (HD-SCS) as a treatment option for patients with failed back surgery syndrome (FBSS) has drastically increased. However, to the authors' knowledge a thorough evaluation of health-related quality of life (HRQOL) and work status in these patients has not yet been performed. Moreover, it is unclear whether patients who are treated with HD-SCS can regain the same levels of HRQOL as the general population. Therefore, the aims of this study were to compare the HRQOL of patients who receive HD-SCS to HRQOL values in an age- and sex-adjusted population without FBSS and to evaluate work status in patients who are receiving HD-SCS. HRQOL, measured with the 3-level EQ-5D (EQ-5D-3L), and work status were evaluated in 185 FBSS patients at baseline (i.e., before SCS) and at 1, 3, and 12 months of treatment with HD-SCS. Difference scores in utility values between patients and an age- and sex-adjusted normal population were calculated. One-sample Wilcoxon tests were used to assess the EQ-5D-3L difference scores. Mixed models were used to evaluate the evolution over time in EQ-5D-3L utility scores and EQ-5D visual analog scale (VAS) scores in patients and matched controls. Quality-adjusted life-years (QALYs) were calculated using the area under the curve method. An overall significant increase in EQ-5D-3L utility scores and EQ-5D VAS scores was found over time in the patient group. Wilcoxon tests indicated that the difference scores in utility values between patients and the normal population were significantly different from zero at all time points. The median incremental QALY after 12 months of HD-SCS was 0.228 (Q1-Q3: 0.005-0.487) in comparison to continued conservative treatment. At 12 months, 13.75% of patients resumed work. HD-SCS may lead to significantly increased HRQOL at 12 months in patients with FBSS. Despite the increase, reaching the HRQOL level of matched controls was not achieved. Only a limited number of patients were able to return to work. This finding indicates that specialized programs to enhance return to work may be beneficial for patients undergoing SCS.

Factors Predicting the Success of Adhesiolysis Using a Steerable Catheter in Lumbar Failed Back Surgery Syndrome: A Retrospective Study.

Failed back surgery syndrome (FBSS) is a commonly encountered disease after lumbar surgery. There are many cases where it is difficult to choose a treatment because no specific cause can be found. Nevertheless, according to recent reports, adhesiolysis has shown reasonable evidence. However, considering its poor cost-effectiveness, adhesiolysis cannot be used as the first line of treatment. FBSS patients often suffer from chronic pain; accordingly, they become frustrated when this treatment produces a poor response. Therefore, before the procedure, the target group must be selected carefully. We sought to identify the pre-procedure factors predicting the effect of adhesiolysis in FBSS. A total of 150 patients were evaluated and analyzed retrospectively. Of these 150 patients, 69 were classified as responders three months after the procedure (46%). The outer diameter of the catheter during the procedure and grade of foraminal stenosis were correlated with the procedure effect. In conclusion, of the 2.1 mm diameter of the catheter, 1.7 mm of it was used during the procedure, and the milder the foraminal stenosis, the greater the pain reduction effect was three months after the procedure.

Higher Preimplantation Opioid Doses Associated With Long-Term Spinal Cord Stimulation Failure in 211 Patients With Failed Back Surgery Syndrome

ObjectiveSpinal cord stimulation (SCS) is an effective treatment in failed back surgery syndrome (FBSS). We studied the effect of preimplantation opioid use on SCS outcome and the effect of SCS on opioid use during a two-year follow-up period. Materials and methodsThe study cohort included 211 consecutive FBSS patients who underwent an SCS trial from January 1997 to March 2014. Participants were divided into groups, which were as follows: 1) SCS trial only (n = 47), 2) successful SCS (implanted and in use throughout the two-year follow-up period, n = 131), and 3) unsuccessful SCS (implanted but later explanted or revised due to inadequate pain relief, n = 29). Patients who underwent explantation for other reasons (n = 4) were excluded. Opioid purchase data from January 1995 to March 2016 were retrieved from national registries. ResultsHigher preimplantation opioid doses associated with unsuccessful SCS (ROC: AUC = 0.66, p = 0.009), with 35 morphine milligram equivalents (MME)/day as the optimal cutoff value. All opioids were discontinued in 23% of patients with successful SCS, but in none of the patients with unsuccessful SCS (p = 0.004). Strong opioids were discontinued in 39% of patients with successful SCS, but in none of the patients with unsuccessful SCS (p = 0.04). Mean opioid dose escalated from 18 ± 4 MME/day to 36 ± 6 MME/day with successful SCS and from 22 ± 8 MME/day to 82 ± 21 MME/day with unsuccessful SCS (p < 0.001). ConclusionsHigher preimplantation opioid doses were associated with SCS failure, suggesting the need for opioid tapering before implantation. With continuous SCS therapy and no explantation or revision due to inadequate pain relief, 39% of FBSS patients discontinued strong opioids, and 23% discontinued all opioids. This indicates that SCS should be considered before detrimental dose escalation.