Numeric Rating Scale Leg Pain Research Articles

Clinical Importance of Redundant Nerve Roots in Patients with Symptomatic Lumbar Spinal Stenosis: A Secondary Analysis of NORDSTEN Spinal Stenosis Trial Data.

Post-hoc analysis of data from a randomized clinical trial. To compare preoperative symptoms of patients with lumbar spinal stenosis (LSS) with and without redundant nerve roots (RNR), and to compare the change in clinical outcomes between those two groups 2 years after decompression surgery. RNR are often seen on MRI in patients with spinal stenosis. Previous studies have reported that patients with RNR are older and have worse symptoms at baseline. A meta-analysis from 2018 concluded that this radiological sign could be seen as a negative predictor of outcome. High quality prospective studies are lacking. Patient characteristics and reported pain and function scores were compared between LSS groups with (RNR+) and without RNR (RNR-) at baseline and after 2 years follow-up. Primary outcome was the mean change in the Oswestry Disability Score (ODI). Secondary outcomes included mean change in scores of the Zurich Claudication Questionnaire (ZCQ) and the numeric rating scale (NRS) for leg and back pain. Out of 416 patients included in the present analysis, 163 (39%) had RNR at baseline. Both groups were similar in regard to patient age, smoking habits, BMI and duration of symptoms. Both groups also showed similar pain and function scores at baseline. The RNR+ group contained a significantly higher proportion of men, patients with severe stenosis and multiple stenotic levels on MRI. At 2-year follow-up the mean change of ODI was -22.1 in the RNR+ group and -17.4 in RNR- group (mean difference 4.7 (95%CI 1.3-8.2) P=0.007). Statistically significant differences were also found for secondary outcomes ZCQ, and NRS leg and back pain favouring the RNR+ group. Patients with RNR had similar baseline characteristics and similar symptoms as patients without. RNR before surgery were associated with better clinical improvement 2 years after decompression.

Prediction of transforaminal epidural injection success in sciatica (POTEISS): a protocol for the development of a multivariable prediction model for outcome after transforaminal epidural steroid injection in patients with lumbar radicular pain due to disc herniation or stenosis

BackgroundTransforaminal epidural injections (TEI) can alleviate symptoms and help to maintain physical functioning and quality of life in patients with lumbar radicular pain. We aim to develop a prediction model for patient outcome after TEI in patients suffering from unilateral lumbar radicular pain due to lumbar disc herniation (LDH) or single-level spinal stenosis (LSS). The secondary aim is to estimate short-term patient outcome differences between LDH and LSS patients, the association between psychological variables and patient outcome, the rate of additional injections, surgery and complications, and to explore the short-term cost-effectiveness of TEI.MethodsThis study is designed as a multi-centre, observational, prospective cohort study in two large regional hospitals in the Netherlands. Patients diagnosed with unilateral lumbar radicular pain secondary to LDH or LSS and congruent with MRI findings, who are referred for TEI along usual care pathways, are eligible for study participation. A total of 388 patients with LDH or LSS will be included. A pre-defined set of demographic, clinical and radiological variables will be used as the predictors in the model. The primary outcome measure is the Numerical Rating Scale (NRS) for leg pain. Secondary outcome measures include back pain, physical functioning, perceived recovery, pain coping strategies, anxiety and depression and use of analgesics and physical therapy. Patients will be evaluated at baseline, 2 weeks and 6 weeks after treatment. NRS leg pain and Likert perceived recovery data will be used as the dependent variables in a generalized linear mixed model for prediction of TEI outcome, with internal validation of performance (explained variation) by bootstrap resampling. Cost-effectiveness for a period of 6 weeks prior to and after treatment will be performed with decision-analytic modelling.DiscussionPatients with severe lumbar radicular pain often request additional treatment when conservative care is insufficient. TEI can offer relief of symptoms. Currently, it is not possible to predict responsiveness to this treatment for individual patients. This study is designed to explore predictors that can differentiate between patients that will and will not have a positive outcome after TEI. This information may support treatment strategies for this patient group.Trial registrationThis study is registered at ClinicalTrials.gov database under registry number NCT04540068 on September 1, 2020.

Predictors of Delayed Clinical Benefit Following Surgical Treatment for Low Grade Spondylolisthesis.

Retrospective review of prospectively collected data. To investigate what factors predict delayed improvement after surgical treatment of low grade spondylolisthesis. Lumbar surgery leads to clinical improvement in the majority of patients with low grade spondylolisthesis. Most patients improve rapidly after surgery, but some patients demonstrate a delayed clinical course. The Quality and Outcomes Database (QOD) was queried for grade 1 spondylolisthesis patients who underwent surgery who had patient reported outcome measures (PROMs) collected at baseline, 3-, 6- and 12-months, including back and leg pain numeric rating scale (NRS), Oswestry Disability Index (ODI), and EuroQol-5D (EQ-5D). Patients were stratified as "Early responders" reaching MCID at 3 months and maintaining improvement through 12 months and "Delayed responders" not reaching MCID at 3 months but ultimately reaching MCID at 12 months. These two groups were compared with respect to factors which predicted delayed improvement. Of 608 patients enrolled, 436 (72%) met inclusion criteria for this study. Overall, 317 patients (72.7%) reached MCID for ODI at 12 months following surgery. Of these patients, 249 (78.5%) exhibited a rapid clinical improvement trajectory and had achieved ODI MCID threshold by the 3-month postop follow-up. 68 patients (21.4%) showed a delayed trajectory, and had not achieved ODI MCID threshold at 3 months, but did ultimately reach MCID at 12-month follow-up. Factors associated with delayed improvement included impaired preoperative ambulatory status, better baseline back and leg pain scores, and worse 3-month leg pain scores (P<0.01). The majority of patients undergoing surgery for low grade spondylolisthesis reach ODI MCID threshold rapidly, within the first three months after surgery. Factors associated with a delayed clinical course include impaired preoperative ambulation status, relatively better preoperative back and leg pain, and persistent leg pain at 3 months.

Outcome of intradiscal condoliase injection therapy for patients with recurrent lumbar disc herniation.

Retrospective cohort study. This study aimed to compare data from patients who received intradiscal condoliase (chondroitin sulfate ABC endolyase) injection for primary lumbar disc herniation (LDH) and recurrent LDH. Chemonucleolysis with condoliase for LDH is a treatment with relatively good results and a high safety profile; however, few studies have reported recurrence after LDH surgery. The study participants were 249 patients who underwent intradiscal condoliase injection for LDH at nine participating institutions, including 241 patients with initial LDH (group C) and eight with recurrent LDH (group R). Patient characteristics including age, sex, body mass index, disease duration, intervertebral LDH level, smoking history, and diabetes history were evaluated. Low back pain/leg pain Numerical Rating Scale (NRS) scores and the Oswestry Disability Index (ODI) were used to evaluate clinical symptoms before treatment and at 6 months and 1 year after treatment. Low back pain NRS scores (before treatment and at 6 months and 1 year after treatment, respectively) in group C (4.9 → 2.6 → 1.8) showed significant improvement until 1 year after treatment. Although a tendency for improvement was observed in group R (3.5 → 2.8 → 2.2), no significant difference was noted. Groups C (6.6 → 2.4 → 1.4) and R (7.0 → 3.1 → 3.2) showed significant improvement in the leg pain NRS scores after treatment. Group C (41.4 → 19.5 → 13.7) demonstrated significant improvement in the ODI up to 1 year after treatment; however, no significant difference was found in group R (35.7 → 31.7 → 26.4). Although intradiscal condoliase injection is less effective for LDH recurrence than for initial cases, it is useful for improving leg pain and can be considered a minimally invasive and safe treatment method.

Impact of educational background on preoperative disease severity and postoperative outcomes among patients with lumbar spondylolisthesis: a Quality Outcomes Database study.

Deficiency in patient education has been correlated with increased disease-related morbidity and decreased access to care. However, the associations between educational level, preoperative disease severity, and postoperative outcomes in patients with lumbar spondylolisthesis have yet to be explored. The spondylolisthesis dataset of the Quality Outcomes Database (QOD)-a cohort with prospectively collected data by the SpineCORe study team of the 12 highest enrolling sites with an 81% follow-up at 5 years -was utilized and stratified for educational level. Patients were classified into three categories (high school or less, graduate, or postgraduate). Patient-reported outcome measures (PROMs) documented at baseline and follow-up included Oswestry Disability Index (ODI) score, EQ-5D in quality-adjusted life years, and numeric rating scale (NRS) scores for back and leg pain. Disease severity was measured with PROMs. Postoperatively, patients also completed the North American Spine Society assessment to measure their satisfaction with surgery. Multivariable regression analysis was used to compare education level with disease severity and postoperative outcomes. A total of 608 patients underwent analysis, with 260 individuals (42.8%) at an educational level of high school or less. On univariate analysis, baseline disease severity was worse among patients with lower levels of education. On multivariable regression analysis, patients with postgraduate level of education had significantly lower ODI scores (β = -3.75, 95% CI -7.31 to -0.2, p = 0.039) compared to graduates, while the other PROMs were not associated with significant differences at baseline. Five years postoperatively, patients from various educational backgrounds exhibited similar rates of minimal clinically important differences in PROMs. Nevertheless, patients with the lowest educational level had higher ODI scores (27.1, p < 0.01), lower EQ-5D scores (0.701, p < 0.01), and higher NRS leg pain (3.0, p < 0.01) and back pain (4.0, p < 0.01) scores compared to those with graduate or postgraduate levels of education. The odds for postoperative satisfaction were also comparable between cohorts at 5 years (reference, graduate level; high school or less, OR 0.87, 95% CI 0.46-1.64, p = 0.659; postgraduate, OR 1.6, 95% CI 0.7-3.65, p = 0.262). Lower patient education level was associated with a greater baseline disease severity in patients with lumbar spondylolisthesis. Surgery demonstrated similar benefits irrespective of educational background; however, individuals with lower educational level reported lower outcomes overall. This emphasizes the need for enhanced health literacy to mitigate disparities for reported outcomes.

The Combined Influence of Sleep Disturbance and Depression on 12-month Outcomes After Lumbar Spine Surgery.

Retrospective analysis of prospectively collected data. To examine the combined influence of preoperative sleep disturbance and depression on 12-month patient-reported outcomes after lumbar spine surgery (LSS). Psychological and behavioral factors are considered major risk factors for poor outcomes after LSS. However, there is a need to explore the combined effects of preoperative factors such as sleep disturbance and depression. Understanding the influence of sleep disturbance and depression can inform evidence-based preoperative assessment and shared-decision making of preoperative and postoperative treatment. Data from 700 patients undergoing LSS were analyzed. Preoperative sleep disturbance and depression were assessed with PROMIS subscales. Established thresholds defined patients with moderate/severe symptoms. Outcomes for disability (Oswestry Disability Index) and back and leg pain (Numeric Rating Scales) were assessed preoperatively and at 12 months. Separate multivariable linear regressions examined the influence of each factor on 12-month outcomes with and without accounting for the other and in combination as a 4-level variable: (1) moderate/severe sleep disturbance alone, (2) moderate/severe depression alone, (3) both moderate/severe sleep disturbance and depression, (4) no moderate/severe sleep disturbance or depression. Preoperative sleep disturbance and depression were associated with 12-month disability and pain ( P <0.05). After accounting for depression, preoperative sleep disturbance remained associated with disability, while preoperative depression adjusting for sleep disturbance remained associated with all outcomes ( P <0.05). Patients reporting both moderate/severe sleep disturbance and moderate/severe depression had 12.6 points higher disability and 1.5 points higher back and leg pain compared with patients without moderate/severe sleep disturbance or depression. The combination of sleep disturbance and depression impacts postoperative outcomes considerably. The high-risk group of patients with moderate/severe sleep disturbance and depression could benefit from targeted treatment strategies. Level II.

468 Preoperative SD and Depression, In Isolation and Combined, Are Predictors of 12-Month Disability and Pain after Lumbar Spine Surgery

OBJECTIVES/GOALS: To examine the individual and combined association between preoperative sleep disturbance (SD) and depression and 12-month disability, back pain, and leg pain after lumbar spine surgery (LSS). METHODS/STUDY POPULATION: We analyzed prospectively collected multi-center registry data from 700 patients undergoing LSS (mean age=60.9 years, 37% female, 89% white). Preoperative SD and depression were assessed with PROMIS measures. Established thresholds defined patients with moderate/severe symptoms. Disability (Oswestry Disability Index) and back and leg pain (Numeric Rating Scales) were assessed preoperatively and at 12 months. We conducted separate regressions to examine the influence of SD and depression on each outcome. Regressions examined each factor with and without accounting for the other and in combination as a 4-level variable. Covariates included age, sex, race, education, insurance, body mass index, smoking status, preoperative opioid use, fusion status, revision status, and preoperative outcome score. RESULTS/ANTICIPATED RESULTS: One hundred thirteen (17%) patients reported moderate/severe SD alone, 70 (10%) reported moderate/severe depression alone, and 57 (8%) reported both moderate/severe SD and depression. In independent models, preoperative SD and depression were significantly associated with 12-month outcomes (all p’s&lt;0.05). After accounting for depression, preoperative SD was only associated with disability, while preoperative depression adjusting for SD remained associated with all outcomes (all p’s&lt;0.05). Patients reporting both moderate/severe SD and moderate/severe depression had 12.6 points higher disability (95%CI=7.4 to 17.8) and 1.5 points higher back (95%CI=0.8 to 2.3) and leg pain (95%CI=0.7 to 2.3) compared to patients with no/mild SD and no/mild depression. DISCUSSION/SIGNIFICANCE: Preoperative SD and depression are independent predictors of 12-month disability and pain when considered in isolation. The combination of SD and depression impacts postoperative outcomes considerably. The high-risk group of patients with moderate/severe SD and depression could benefit from targeted treatment strategies.

Impact of obesity on adult spinal deformity (ASD) long-segment spinal fusion radiographic and clinical outcomes

Study designRetrospective chart review of patients receiving long-segment fusion during a five-year period. ObjectiveTo determine whether obese patients receive comparable benefits when receiving long-segment fusion compared to non-obese patients and to identify factors that may predict hardware failure and post-surgical complications among obese patients. MethodsDemographic, spinopelvic radiographic, patient-reported outcome measures (PROMs), and complications data was retrospectively collected from 120 patients who underwent long-segment fusion during a five-year period at one tertiary care medical center. Radiographic measurements were pelvic incidence, pelvic tilt (PT), lumbar lordosis, L4-S1 lordosis, thoracic kyphosis, sagittal vertical axis, PI-LL mismatch, and proximal junction cobb angle at upper instrumented vertebrae + 2 (UIV+2). PROMs were Oswestry disability index, numeric rating scale (NRS) Back Pain, NRS Leg Pain, RAND SF-36 pain, and RAND SF-36 physical functioning. Included patients were adults and had at least 2-years of postoperative follow-up. Descriptive and multivariate statistical analysis was performed with α = 0.05. ResultsPatients with a BMI ≥ 30 (n=63) and patients with a BMI < 30 (n=57) demonstrated comparable improvements (P>0.05) for all spinopelvic radiographic measurements and PROMs. Each cohort demonstrated significant improvements from pre-assessment to post-assessment on nearly all spinopelvic radiographic measurements and PROMs (P<0.05), except PT and L4-S1 lordosis where neither group improved (p=0.95 and 0.58 for PT and P=0.23 and 0.11 for L4-S1 lordosis fornon-obese and obese cohorts respectively) and SF-36 physical functioning where the non-obese cohort not statistically improve (P=0.08). Patients with a BMI ≥ 30 demonstrated an increased incidence of cardiovascular complications (P=0.0293), acute kidney injury (P=0.0241), rod fractures (P=0.0293), and reoperations (P=0.0241) when compared to patients with a BMI < 30. ConclusionThis study adds to a growing body of evidence linking demographic factors with risks of hardware failure. Further, this data challenges the assumption that obese patients may not receive sufficient benefit to be long-segment surgical candidates. However, given their elevated risk for post-operative and delayed hardware complications, obese patients should be appropriately counseling before undergoing surgery.

Comparison of minimally invasive transforaminal lumbar interbody fusion (Mis-TLIF) with bilateral decompression via unilateral approach and open-TLIF with bilateral decompression for degenerative lumbar diseases: a retrospective cohort study

ObjectivePresently, no study has compared the clinical outcomes of minimally invasive transforaminal lumbar interbody fusion (Mis-TLIF) with bilateral decompression via the unilateral approach (BDUA) and Open-TLIF with bilateral decompression for degenerative lumbar diseases (DLD). We aimed to compare the clinical outcomes of through Mis-TLIF combined with BDUA and Open-TLIF with bilateral decompression for the treatment of DLD, and reported the learning curve of the procedure of MIS-TLIF with BDUA.MethodsWe retrospectively analyzed the prospectively collected data of consecutive DLD patients in the two groups from January 2016 to January 2020.ResultsThe operative time (OT) was significantly longer in the Mis-TLIF group (n = 113) than in the Open-TLIF group (n = 135). The postoperative drainage volume (PDV) and length of stay (LOS) were significantly higher in the Open-TLIF group than in the Mis-TLIF group. Additionally, the complication rate was significantly higher in the Open-TLIF group than in the Mis-TLIF group (14.8% vs. 6.2%, P = 0.030), while there was no significant difference in the reoperation and adjacent segment disease rates between the two groups. There were no significant differences in back pain and leg pain Numerical Rating Scale (NRS) scores and Oswestry Disability Index (ODI) between the two groups preoperatively, at discharge, and 2 years postoperatively. Patients in both groups showed significant improvements in NRS scores and ODI scores after surgery. OT was negatively correlated with the number of surgeries performed (P < 0.001, r = −0.43). The learning curve of Mis-TLIF with BDUA was steep, with OT tapered to steady state in 43 cases.ConclusionCompared with Open-TLIF with bilateral decompression, Mis-TLIF with BDUA can achieve equivalent clinical outcomes, lower PDV and LOS, and lower complication rates. Although this procedure took longer, it could be a viable alternative for the treatment of DLD after a steep learning curve.

Machine Learning Models for Predicting Disability and Pain Following Lumbar Disc Herniation Surgery

Lumber disc herniation surgery can reduce pain and disability. However, a sizable minority of individuals experience minimal benefit, necessitating the development of accurate prediction models. To develop and validate prediction models for disability and pain 12 months after lumbar disc herniation surgery. A prospective, multicenter, registry-based prognostic study was conducted on a cohort of individuals undergoing lumbar disc herniation surgery from January 1, 2007, to May 31, 2021. Patients in the Norwegian Registry for Spine Surgery from all public and private hospitals in Norway performing spine surgery were included. Data analysis was performed from January to June 2023. Microdiscectomy or open discectomy. Treatment success at 12 months, defined as improvement in Oswestry Disability Index (ODI) of 22 points or more; Numeric Rating Scale (NRS) back pain improvement of 2 or more points, and NRS leg pain improvement of 4 or more points. Machine learning models were trained for model development and internal-external cross-validation applied over geographic regions to validate the models. Model performance was assessed through discrimination (C statistic) and calibration (slope and intercept). Analysis included 22 707 surgical cases (21 161 patients) (ODI model) (mean [SD] age, 47.0 [14.0] years; 12 952 [57.0%] males). Treatment nonsuccess was experienced by 33% (ODI), 27% (NRS back pain), and 31% (NRS leg pain) of the patients. In internal-external cross-validation, the selected machine learning models showed consistent discrimination and calibration across all 5 regions. The C statistic ranged from 0.81 to 0.84 (pooled random-effects meta-analysis estimate, 0.82; 95% CI, 0.81-0.84) for the ODI model. Calibration slopes (point estimates, 0.94-1.03; pooled estimate, 0.99; 95% CI, 0.93-1.06) and calibration intercepts (point estimates, -0.05 to 0.11; pooled estimate, 0.01; 95% CI, -0.07 to 0.10) were also consistent across regions. For NRS back pain, the C statistic ranged from 0.75 to 0.80 (pooled estimate, 0.77; 95% CI, 0.75-0.79); for NRS leg pain, the C statistic ranged from 0.74 to 0.77 (pooled estimate, 0.75; 95% CI, 0.74-0.76). Only minor heterogeneity was found in calibration slopes and intercepts. The findings of this study suggest that the models developed can inform patients and clinicians about individual prognosis and aid in surgical decision-making.

Immediate Effects, Detailed Clinical Outcomes, and Prognostic Factors of Chemonucleolysis Using Condoliase for Lumbar Disc Herniation.

Chemonucleolysis utilizing condoliase is a minimally invasive treatment for lumbar disc herniation (LDH) aimed at reducing intervertebral disc pressure and enhancing symptoms. In this study, lower limb pain was measured using the numeric rating scale (NRS) the day after treatment and 1 and 3 months after treatment. Prognostic factors were assessed, categorizing participants into an improvement group (I-group) for NRS lower limb pain scores of ≥3.5 and a non-improvement group (N-group) for scores of <3.5. This study included a total of 225 patients treated between April 2020 and March 2023. The mean age was 46.5 ± 16.5 years, with 151 males. The mean duration of illness was 6.2 ± 8.52 months. As of the day after treatment, 60 cases were classified into the I-group, 118 cases at 1 month after surgery, and 152 cases at 3 months after surgery. The disease duration before treatment was significantly shorter in the I-group at 1 (8.19 ± 8.74 [I-group] vs. 5.17 ± 8.04 [N-group] months) and 3 months (8.51 [I-group] ± 7.35 vs. 5.69 ± 8.87[N-group] months) after treatment. The comparison of baseline leg pain NRS shows a difference in leg pain NRS in the I-group when compared on the day after treatment (6.02 ± 2.64 [I-group] vs. 7.50 ± 1.79 [N-group]), 1 (5.13 ± 2.69 [I-group] vs. 7.58 ± 1.66 [N-group]), and 3 months (4.42 ± 2.70 [I-group] vs. 7.34 ± 1.77 [N-group]). Chemonucleolysis using condoliase for LDH can improve symptoms the day after treatment and can be a minimally invasive treatment to avoid surgery.

Multiphase Spinal Cord Stimulation in Participants With Chronic Back or Leg Pain: Results of the BENEFIT-02 Randomized Clinical Trial

ObjectiveThis study aimed to assess the safety and effectiveness of a new charge-distributed multiphase stimulation paradigm during an extended spinal cord stimulation (SCS) trial. Materials and MethodsThis prospective, multicenter, randomized, single-blind, feasibility study included participants with chronic low back and/or leg pain and baseline numerical rating scale (NRS) for overall pain intensity ≥6. After a successful commercial SCS trial, participants were randomized to multiphase SCS therapy A (approximately 600–1500 Hz) or B (approximately 300–600 Hz), delivered via an investigational external pulse generator and existing leads during an 11-to-12–day testing period. Primary end points were mean NRS change from baseline to final in-office visit for each multiphase therapy and between therapies. Secondary end points included mean NRS change from end of commercial trial to final study visit and incidence of device-related adverse events (AEs). Additional measures included patient-reported outcomes collected at home through electronic watches and written diaries. Power usage was compared between multiphase and commercial therapies. ResultsA total of 122 participants initiated a commercial trial; 77 were randomized to a multiphase arm, and 65 completed the study. Reductions in mean NRS scores from baseline to final study visit were significant for multiphase therapy A and B (−4.3 and −4.7, respectively; both p < 0.0001). There was no statistically significant difference in mean NRS reduction or percent pain relief between multiphase therapies. In an additional analysis, 63.9% of participants reported greater pain relief with multiphase than with commercial SCS therapy in the at-home setting. On average, multiphase required less power than did commercial devices. One non–serious device-related AE was reported, and no infections occurred during the extended trial. ConclusionsMultiphase SCS effectively reduced pain in participants with chronic low back and/or leg pain during a trial, with no unanticipated device-related AEs reported. Future studies should evaluate long-term effectiveness of multiphase stimulation. Clinical Trial RegistrationThe Clinicaltrials.gov registration number for the study is NCT03594266.

Promotion of higher rates of early fusion using activated titanium versus polyetheretherketone cages in adults undergoing 1- and 2-level transforaminal lumbar interbody fusion procedures: a randomized controlled trial.

There is ongoing debate on the relative benefits and drawbacks of polyetheretherketone (PEEK) versus titanium (Ti) in generating a bone-to-implant surface microenvironment conducive to osseointegration. Micro- and nanoscale internal and topographic cage modifications have recently been posited to facilitate osseointegration and fusion, but human in vivo confirmation remains lacking. The authors of this study sought to directly compare early radiological outcomes in adults undergoing 1- and 2-level transforaminal lumbar interbody fusion (TLIF) procedures using either PEEK or nano-etched Ti interbody cages with an incorporated microlattice structure. Patients were enrolled in a single academic center using a single-blind randomized controlled superiority design. Screening was undertaken from a pool of consecutive patients eligible for TLIF to undergo placement in a 1:1 ratio of either lordotic PEEK or activated Ti cages at each level of 1- or 2-level procedures. An a priori power analysis was performed and a preplanned interim analysis was undertaken once 50 of 70 patients were enrolled. Patient study data were collected perioperatively and uploaded to a Research Electronic Data Capture (REDCap) registry. Interbody fusion was assessed based on 6-month postoperative lumbar dual-energy CT (DECT) studies using the method of Brantigan and Steffee, as modified to describe the Fraser definition of locked pseudarthrosis (Brantigan-Steffee-Fraser [BSF] scale). In the final cohort of 50 patients, 40 interbody levels implanted with PEEK cages were compared with 34 interbody levels with activated Ti cages. The trial was stopped early given the results of an interim analysis with respect to the primary outcome. Surgical parameters including number of levels treated, average cage height, and position were not different between groups. For the PEEK and activated Ti groups, 20.6% versus 84.0% demonstrated BSF grade 3 fusion on 6-month postoperative DECT imaging (p < 0.001). Subsidence at 6 months on DECT was identified in 12 (41.4%) of PEEK levels versus 5 (20.8%) of activated Ti levels (p < 0.001). BSF-3 grading was predictive of segmental stability and numeric rating scale (NRS) leg pain improvement at 1 year postoperatively. Oswestry Disability Index and NRS back and leg pain scores all improved similarly in both cohorts at 1 year postoperatively. Activated Ti interbody cages mediate early fusion at significantly higher rates with lower rates of subsidence as compared with PEEK cages. These findings support the idea that interbody cage microscale properties, including surface topography, may play a primary role in facilitating osseointegration and fusion.

Outcomes of surgical intervention for degenerative lumbar spondylolisthesis: a comparative analysis of different surgical fixation techniques.

Debate regarding effectiveness of surgical modalities contributes to a lack of consensus of decision making for surgical interventions. Furthermore, data regarding cost effectiveness, surgical operative time, resources, patient hospital stay and recovery is limited, particularly in the medium term for degenerative lumbar spondylolisthesis. The objective was to compare clinical outcomes following different fixation interventions treating degenerative lumbar spondylolisthesis. A retrospective cohort study using the British Spine Registry (BSR) of 1,838 patients aged ≥18 years. Five hundred and five patients undergoing posterior lumbar interbody fusion (PLIF) and 1,333 undergoing transforaminal lumbar interbody fusion (TLIF) with 6 months follow-up, were compared. Demographics, Oswestry Disability Index (ODI), Numerical Rating Scale (NRS) [back and leg], quality of life, complications and cost effectiveness were analysed. NRS (back and leg) demonstrated a statistically significant difference favouring TLIF at 6 months (P=0.04) and (P<0.05) respectively. There was no difference in ODI improvement at 6 months between PLIF and TLIF (P=0.620), but there was a statistically significant difference in ODI scores preoperatively between PLIF and TLIF (P<0.001). EQ-5D-5L-Health VAS (P=0.136) and EQ-5D-5L (P=0.655) did not show a statistically significant difference in improvement between PLIF and TLIF. Dural tear was the most common complication and was higher in the PLIF group (5.7%) but not statistically significant. Estimated blood loss was greater for PLIF (P=0.041). Implant cost (P<0.001) was higher for TLIF whereas theatre time was higher for PLIF (P=0.031). Both PLIF and TLIF result in clinically significant improvements in ODI, NRS back pain and NRS leg pain, with superiority of TLIF for improvements in back and leg pain. Surgeons appeared to use ODI preoperatively to decide intervention with comparable improvements for both approaches. Average theatre time and blood loss volume was higher for PLIF. Factors like implant costs and costs of consumables were higher for TLIF. Costs merit further evaluation.

A Study Protocol for a Multicenter, Pragmatic, Randomized Controlled, Parallel-Grouped Pilot Clinical Trial: Effectiveness of Non-Pharmacological Versus Pharmacological Treatments for Non-Acute Lumbar Disc Herniation

Background: This study was the development of a protocol for the comparison between the efficacy of non-pharmacological and pharmacological treatment approaches for lumbar disc herniation in a pragmatic environment to obtain real-world based study data.Methods: The protocol sets out a two-armed, parallel, multicenter pragmatic, randomized-controlled trial (RCT) which will be conducted in four spine specialist hospitals in Korea to determine cost-efficiency.Results: The study will enroll 36 participants and allocate patients into either the non-pharmacological treatment group or the pharmacological treatment group in a 1:2 ratio. Patients must have evidence of disc-related disease diagnosed using MRI, as well as having lower back pain or radiating leg pain (numeric rating scale score ≥ 5). The treatment will last for 8 weeks with a 26-week follow-up. The primary outcome will be measured using the Oswestry Disability Index score from Week 9. Secondary outcomes related to lower back pain and radiating leg pain will be measured using the scores from the numeric rating scale, the visual analogue scale, the European Quality of Life 5 Dimensions 5 Level Version), the 12-item Short Form Survey, and the patient global impression of change.Conclusion: This is the first protocol for a pragmatic RCT evaluating the efficacy, safety, and cost-efficiency of non-pharmacological and pharmacological treatment strategies in a clinical setting. Following the basis of this protocol, RCTs may play an important role in establishing guidelines for treating radiating leg pain and lower back pain and provide effective information to clinicians in practical settings.

Walking speed is associated with postoperative pain catastrophizing in patients with lumbar spinal stenosis: a prospective observational study

BackgroundThe purpose of this study was to investigate whether walking speed is associated with postoperative pain catastrophizing in patients with lumbar spinal stenosis.MethodsIn this prospective observational study, consecutive patients with clinically and radiologically defined lumbar spinal stenosis underwent surgical treatment (decompression, or posterolateral or transforaminal lumbar interbody fusion) at Tottori University Hospital, between October 2015 and April 2018. The pain catastrophizing scale, walking speed, leg and back pain (numerical rating scale), and Japanese Orthopaedic Association score were evaluated preoperatively and at 3, 6, and 12 months postoperatively. Correlations between the pain catastrophizing scale and each variable were analyzed at each evaluation time point. The effect of walking speed on the pain catastrophizing scale was analyzed using mixed-effect models for repeated measurements.ResultsNinety-four patients were included at baseline, and 83, 88, and 82 patients were analyzed at 3, 6, and 12 months postoperatively, respectively. The pain catastrophizing scale was significantly correlated with walking speed, leg pain, back pain, and the Japanese Orthopaedic Association score at all evaluation time points. The pain catastrophizing scale was associated with walking speed at all evaluation time points.ConclusionsOur results suggest that changes in postoperative pain catastrophizing after lumbar spine surgery are associated with walking speed. Thus, walking speed is a necessary assessment for the management of pain catastrophizing and associated pain and disability in patients after lumbar spine surgery.

Outcomes of operative treatment for adult spinal deformity: a prospective multicenter assessment with mean 4-year follow-up.

The current literature has primarily focused on the 2-year outcomes of operative adult spinal deformity (ASD) treatment. Longer term durability is important given the invasiveness, complications, and costs of these procedures. The aim of this study was to assess minimum 3-year outcomes and complications of ASD surgery. Operatively treated ASD patients were assessed at baseline, follow-up, and through mailings. Patient-reported outcome measures (PROMs) included scores on the Oswestry Disability Index (ODI), Scoliosis Research Society-22r (SRS-22r) questionnaire, mental component summary (MCS) and physical component summary (PCS) of the SF-36, and numeric rating scale (NRS) for back and leg pain. Complications were classified as perioperative (≤ 90 days), delayed (90 days to 2 years), and long term (≥ 2 years). Analyses focused on patients with minimum 3-year follow-up. Of 569 patients, 427 (75%) with minimum 3-year follow-up (mean ± SD [range] 4.1 ± 1.1 [3.0-9.6] years) had a mean age of 60.8 years and 75% were women. Operative treatment included a posterior approach for 426 patients (99%), with a mean ± SD 12 ± 4 fusion levels. Anterior lumbar interbody fusion was performed in 35 (8%) patients, and 89 (21%) underwent 3-column osteotomy. All PROMs improved significantly from baseline to last follow-up, including scores on ODI (45.4 to 30.5), PCS (31.0 to 38.5), MCS (45.3 to 50.6), SRS-22r total (2.7 to 3.6), SRS-22r activity (2.8 to 3.5), SRS-22r pain (2.3 to 3.4), SRS-22r appearance (2.4 to 3.5), SRS-22r mental (3.4 to 3.7), SRS-22r satisfaction (2.7 to 4.1), NRS for back pain (7.1 to 3.8), and NRS for leg pain (4.8 to 3.0) (all p < 0.001). Degradations in some outcome measures were observed between the 2-year and last follow-up evaluations, but the magnitudes of these degradations were modest and arguably not clinically significant. Overall, 277 (65%) patients had at least 1 complication, including 185 (43%) perioperative, 118 (27%) delayed, and 56 (13%) long term. Notably, the 142 patients who did not achieve 3-year follow-up were similar to the study patients in terms of demographic characteristics, deformities, and baseline PROMs and had similar rates and types of complications. This prospective multicenter analysis demonstrated that operative ASD treatment provided significant improvement of health-related quality of life at minimum 3-year follow-up (mean 4.1 years), suggesting that the benefits of surgery for ASD remain durable at longer follow-up. These findings should prove useful for counseling, cost-effectiveness assessments, and efforts to improve the safety of care.

Frailty and Sarcopenia: Impact on Outcomes Following Elective Degenerative Lumbar Spine Surgery

This is a retrospective review of prospectively collected data. The aim was to evaluate the impact of frailty and sarcopenia on outcomes after lumbar spine surgery. Elderly patients are commonly diagnosed with degenerative spine disease requiring surgical intervention. Frailty and sarcopenia result from age-related decline in physiological reserve and can be associated with complications after elective spine surgery. Little is known about the impact of these factors on patient-reported outcomes (PROs). Patients older than 70 years of age undergoing elective lumbar spine surgery were included. The modified 5-item frailty index (mFI-5) was calculated. Sarcopenia was defined using total psoas index, which is obtained by dividing the mid L3 total psoas area by VB area (L3-TPA/VB). PROs included Oswestry disability index (ODI), EuroQual-5D (EQ-5D), numeric rating scale (NRS)-back pain, NRS leg pain (LP), and North American Spine Society (NASS) at postoperative 12 months. Clinical outcomes included length of stay (LOS), 90-day readmission and complications. Univariate and multivariable regression analyses were performed. Total 448 patients were included. The mean mFI-5 index was 1.6±1.0 and mean total psoas index was 1.7±0.5. There was a significant improvement in all PROs from baseline to 12 months ( P <0.0001). After adjusting for age, body mass index, smoking status, levels fused, and baseline PROs, higher mFI-5 index was associated with higher 12-month ODI ( P <0.001), lower 12-month EQ-5D ( P =0.001), higher NRS-L P ( P =0.039), and longer LOS ( P =0.007). Sarcopenia was not associated with 12-month PROs or LOS. Neither sarcopenia or mFI-5 were associated with 90-day complication and readmission. Elderly patients demonstrate significant improvement in PROs after elective lumbar spine surgery. Frailty was associated with worse 12 months postoperative ODI, EQ-5D, NRS-LP scores, and longer hospital stay. While patients with sarcopenia can expect similar outcomes compared with those without, the mFI-5 should be considered preoperatively in counseling patients regarding expectations for disability, health-related quality of life, and leg pain outcomes after elective lumbar spine surgery. 3.

Complications, Readmissions, Revisions, and Patient-reported Outcomes in Patients With Parkinson Disease Undergoing Elective Spine Surgery: A Propensity-matched Analysis.

Retrospective analysis on prospectively collected data. To determine the effectiveness of elective spine surgery in patients with Parkinson disease (PD). PD has become increasingly prevalent in an aging population. While surgical treatment for degenerative spine pathology is often required in this population, previous literature has provided mixed results regarding its effectiveness. Data from the Quality Outcomes Database (QOD) was queried between April 2013 and January 2019. Three surgical groups were identified: (1) elective lumbar surgery, (2) elective cervical surgery for myelopathy, (3) elective cervical surgery for radiculopathy. Patients without PD were propensity matched against patients with PD in a 5:1 ratio without replacement based on American Society of Anesthesiology grade, arthrodesis, surgical approach, number of operated levels, age, and baseline Oswestry Disability Index, Numerical Rating Scale (NRS) extremity pain, NRS back pain, and EuroQol 5-Dimensions (EQ-5D). The mean difference was calculated for continuous outcomes (Oswestry Disability Index, NRS leg pain, NRS back pain, and EQ-5D at 3 and 12mo after surgery) and the risk difference was calculated for binary outcomes (patient satisfaction, complications, readmission, reoperation, and mortality). For the lumbar analysis, PD patients had a higher rate of reoperation at 12 months (risk difference=0.057, P =0.015) and lower mean EQ-5D score at 12 months (mean difference=-0.053, P =0.005) when compared with patients without PD. For the cervical myelopathy cohort, PD patients had lower NRS neck pain scores at 3 months (mean difference=-0.829, P =0.005) and lower patient satisfaction at 3 months (risk difference=-0.262, P =0.041) compared with patients without PD. For the cervical radiculopathy cohort, PD patients demonstrated a lower readmission rate at 3 months (risk difference=-0.045, P =0.014) compared with patients without PD. For the matched analysis, in general, patients with and without PD had similar patient-reported outcomes and complication, readmission, and reoperation rates. These results demonstrate that a diagnosis of PD alone should not represent a major contraindication to elective spine surgery.

Inferior Clinical Outcomes for Patients with Medicaid Insurance After Surgery for Degenerative Lumbar Spondylolisthesis: A Prospective Registry Analysis of 608 Patients

It remains unclear how type of insurance coverage affects long-term, spine-specific patient-reported outcomes (PROs). This study sought to elucidate the impact of insurance on clinical outcomes after lumbar spondylolisthesis surgery. The prospective Quality Outcomes Database registry was queried for patients with grade 1 degenerative lumbar spondylolisthesis who underwent single-segment surgery. Twenty-four-month PROs were compared and included Oswestry Disability Index, Numeric Rating Scale (NRS) back pain, NRS leg pain, EuroQol-5D, and North American Spine Society Satisfaction. A total of 608 patients undergoing surgery for grade 1 degenerative lumbar spondylolisthesis (mean age, 62.5 ± 11.5 years and 59.2% women) were selected. Insurance types included private insurance (n= 319; 52.5%), Medicare (n= 235; 38.7%), Medicaid (n= 36; 5.9%), and Veterans Affairs (VA)/government (n= 17; 2.8%). One patient (0.2%) was uninsured and was removed from the analyses. Regardless of insurance status, comparedtobaseline, all 4 cohorts improved significantly regarding ODI, NRS-BP, NRS-LP, and EQ-5D scores (P< 0.001). In adjusted multivariable analyses, compared with patients with private insurance, Medicaid was associated with worse 24-month postoperative Oswestry Disability Index (β= 10.2; 95% confidence interval [CI], 3.9-16.5; P = 0.002) and NRS leg pain (β=1.3; 95% CI, 0.3-2.4; P = 0.02). Medicaid was associated with worse EuroQol-5D scores compared with private insurance (β=-0.07; 95% CI-0.01 to-0.14; P = 0.03), but not compared with Medicare and VA/government insurance (P> 0.05). Medicaid was associated with lower odds of reaching ODI minimal clinically important difference (odds ratio, 0.2; 95% CI, 0.03-0.7; P = 0.02) compared with VA/government insurance. NRS back pain and North American Spine Society satisfaction did not differ by insurance coverage (P> 0.05). Despite adjusting for potential confounding variables, Medicaid coverage was independently associated with worse 24-month PROs after lumbar spondylolisthesis surgery compared with other payer types. Although all improved postoperatively, those with Medicaid coverage had relatively inferior improvements.