Numeric Rating Scale Leg Pain Research Articles

Minimal clinically important difference in patients who underwent decompression alone for lumbar degenerative disease

Background ContextThe minimal clinically important difference (MCID) represents the smallest change in an outcome measure recognized as clinically meaningful to a patient after receiving a clinical intervention. Most studies that discussed the MCIDs for lumbar spinal stenosis (LSS) included mixed pathologies or procedures despite that the MCID value should be different depending on the intervention. Moreover, despite the efficacy of adopting percentage-change improvement for the MCID threshold, there are limited reports and discussions in the field of lumbar surgery. PurposeThe aim of the present study was to elucidate the MCIDs for the Oswestry Disability Index (ODI), EuroQOL 5-dimension 3-level (EQ-5D-3L), physical component summary (PCS) of the Short Form of the Medical Outcomes Study, and Numeric Rating Scale (NRS) in patients with degenerative LSS treated with decompression surgery without fusion. Study Design/SettingA multicenter retrospective cohort study was performed. Patient SampleA total of 422 patients who underwent decompression surgery for LSS and answered a complete set of questionnaires were included in the study. Patients who underwent endoscopic or revision surgery were excluded. Outcome MeasuresPreoperative and 1-year postoperative scores of each health-related quality of life questionnaires (HRQOLs) and patient satisfaction questionnaire response MethodsThe patient satisfaction question was used as an anchor, and the cutoff values were estimated based on absolute point improvement from baseline using a receiver-operating characteristic (ROC) curve analysis and the “mean change” method for MCIDs. The MCID values for percentage-change in HRQOLs were also calculated using ROC curve analysis. The three cutoff values for each HRQOL were validated using the Youden index for determining the most robust MCIDs. ResultsOf the patients, 356 (84.4%) were at least “somewhat satisfied” with the treatment results. The two cutoff values of absolute point-change in each HRQOL, which were estimated by two different anchor-based methods, were similar. The area under the curve of the ROC curve for percentage-change tended to be higher than that for absolute point-change. Moreover, the Youden index of the percentage-change in each HRQOL was higher than that of the absolute point-change calculated by either the “mean change” method or the ROC curve analysis. Based on these results, it was proposed that MCID was 42.4% for percentage-change in ODI, 22.0% for EQ-5D-3L, 13.7% for PCS, 25.0% for NRS (low back pain), 55.6% for NRS (leg pain), 22.2% for NRS (leg numbness). ConclusionsThe MCIDs of HRQOLs were calculated in patients with LSS treated with decompression surgery without concomitant fusion procedure. The MCID cutoffs based on percentage-change from baseline were more effective than those of absolute point-change.

EPIDURAL STEROID INJECTION IN HERNIATED DISC AND LUMBAR CANAL STENOSIS: IS IT JUST A PLACEBO?

ABSTRACT Objective To study the role of epidural steroid injection (ESI) in patients with lumbar disc herniation (LDH) and lumbar canal stenosis (LCS). ESIs are regularly used to support non-operative treatment for LBP, and our anecdotal impression is that a considerable proportion of patients report substantial pain relief after ESI. Methods One thousand consecutive patients (645 patients with LDH and 355 patients with LCS) who required ESI from January-August 2018 were included. All were given the same ESI, prepared with triamcinolone (80 mg), bupivacaine (0.25%, 4 ml) and normal saline (4 ml). Patients were evaluated using the numerical rating scale (NRS) immediately after the injection, after 7 days, and after 3 months. Results The mean NRS back-pain score of the LDH-group was reduced from 5 (range: 4-8) to 4 (range: 2-7) immediately after injection, 2 (range: 1-7) after 7 days and 2 (range: 1-7) after 3 months (p-value<0.001). The mean NRS back-pain score of the LCS-group was reduced from 5 (range: 4-8) to 4 (range: 2-7) immediately after injection, 2 (range: 1-7) after 7 days and 3 (range: 1-7) after 3 months (p-value <0.001). The mean NRS leg-pain score of the LDH group was reduced from 5 (range: 4-9) to 3 (range: 3-7) immediately after injection, 1 (range: 1-6) after 7 days and 2 (range: 1-7) after 3 months (p-value <0.001). The mean NRS leg-pain score of the LCS group was reduced from 5 (range: 4-9) to 4 (range: 3-7) immediately after injection, 3 (range: 1-7) after 7 days and 2 (range 1-6) after 3 months (p-value <0.001). Conclusion ESI causes statistically significant improvement in back and leg pain in patients with LDH and LCS. However, the short and medium-term efficacy of ESI in the LCS group was lower than in the LDH group. Level of evidence IV; Prospective hospital-based study.

P133. Is preoperative resolution of leg pain at rest a predictor for successful indirect decompression in anterior and lateral lumbar interbody fusion?

<h3>BACKGROUND CONTEXT</h3> The principle of indirect decompression via lateral and anterior interbody fusion has been investigated previously. Many patients respond well after such an approach, with good improvement in their pain and function. However, there is a group of patients in whom direct decompression may still be necessary. It remains unclear which patients will respond most favorably to indirect decompression. <h3>PURPOSE</h3> This study aims to investigate our hypothesis that preoperative improvement of leg pain at rest is predictive of pain relief via indirect decompression after anterior lumbar (ALIF) or lateral lumbar interbody fusion (LLIF). <h3>STUDY DESIGN/SETTING</h3> Retrospective review of prospectively collected data at a single institution between 2017 and 2018. <h3>PATIENT SAMPLE</h3> During the study period, 453 patients underwent ALIF or LLIF. Patients who lacked preoperative leg pain, those who underwent multilevel surgery, direct decompression and/or those who lacked three-month postop patient reported outcome measures were excluded. 43 patients met the inclusion criteria. <h3>OUTCOME MEASURES</h3> Patient-reported leg and back pain intensity via the numeric rating scale (NRS) and low back pain related disability scores via the Oswestry Disability Index (ODI) were analyzed. <h3>METHODS</h3> A linear regression model was used to determine whether improvement in leg pain at rest predicted improvements in pain using the NRS and low back pain-related ODI scores at 3 months and 1 year, adjusting for each individual's baseline values. <h3>RESULTS</h3> Forty-three patients (22M, 21F) with a mean age of 66±13 years underwent LLIF (n=34) or ALIF (n=9) with concomitant pedicle screw fixation. Mean NRS scores for preop leg and back pain were 6.2±2.5 and 6.8±2.2, respectively. Mean preop ODI was 44.6±17.6. Mean 3-month NRS leg and back pain scores were 2.0+2.4 and 3.8+2.3 respectively. Mean ODI at 3 months was 28.2+20.6. Preop leg pain improvement at rest was a significant predictor for postop reduction in pain at the 3-month time point when using indirect decompression (p=0.023). When adjusting for preop pain levels, individuals with preop leg pain improvement at rest demonstrated a 2.3±1.0 point greater improvement in NRS leg pain compared to those without preop leg pain improvement at rest (4.3±3.6 vs 1.8±2.3). Results did not differ when correcting for surgery type. Preop leg pain improvement at rest did not predict 1-year pain levels, or changes in disability at either timepoint (p>0.352). <h3>CONCLUSIONS</h3> In this study, improvement in leg pain at rest before surgery was a significant predictor of those patients who were successfully managed via indirect decompression with ALIF or LLIF. Preoperative improvement in leg pain at rest may be used as an important predictive tool for short-term success using indirect decompression. <h3>FDA DEVICE/DRUG STATUS</h3> This abstract does not discuss or include any applicable devices or drugs.

Association of extended duration of sciatic leg pain with worse outcome after lumbar disc herniation surgery: a register study in 6216 patients.

Sciatica is the hallmark symptom of a lumbar disc herniation (LDH). Up to 90% of LDH patients recover within 12 weeks regardless of treatment. With continued deteriorating symptoms and low patient quality of life, most surgeons recommend surgical discectomy. However, there is not yet a clear consensus regarding the proper timing of surgery. The aim of this study was to evaluate how the duration of preoperative leg pain (sciatic neuralgia) is associated with patient-reported levels of postoperative leg pain reduction and other patient-reported outcome measures (PROMs) in a prospectively collected data set from a large national cohort. All patients aged 18-65 years undergoing a lumbar discectomy during 2013-2016 and registered in Swespine (the Swedish national spine registry) with 1 year of postoperative follow-up data were included in the study (n = 6216). The patients were stratified into 4 groups according to preoperative pain duration: < 3, 3-12, 12-24, or > 24 months. Patient results assessed with the numeric rating scale (NRS) for leg pain (rated from 0 to 10), global assessment of leg pain, EQ-5D, Oswestry Disability Index (ODI), and patient satisfaction with the final surgical outcome were analyzed and compared with preoperative values and between groups. A significant improvement was seen 1 year postoperatively regardless of preoperative pain duration (change in NRS score: mean -4.83, 95% CI -4.73 to -4.93 in the entire cohort). The largest decrease in leg pain NRS score (mean -5.59, 95% CI -5.85 to -5.33) was seen in the operated group with the shortest sciatica duration (< 3 months). The patients with a leg pain duration in excess of 12 months had a significantly higher risk of having unchanged radiating leg pain 1 year postoperatively compared with those with < 12-month leg pain duration at the time of surgery (OR 2.41, 95% CI 1.81-3.21, p < 0.0001). Patients with the shortest leg pain duration (< 3 months) reported superior outcomes in all measured parameters. More significantly, using a 12-month pain duration as a cutoff, patients who had a lumbar discectomy with a preoperative symptom duration < 12 months experienced a larger reduction in leg pain and were more satisfied with their surgical outcome and perception of postoperative leg pain than those with > 12 months of sciatic leg pain.

Relief of Low Back Pain After Posterior Decompression for Lumbar Spinal Stenosis.

A retrospective study. The aim of this study was to confirm that decompression for lumbar spinal stenosis (LSS) relieves low back pain (LBP) as adequately as it relieves leg pain and to identify predictors for inadequate LBP relief. Although decompression for LSS is generally thought to yield worse results for LBP than for leg pain, some studies have reported similar improvements in pain scores between LBP and leg pain. To treat LBP or take measures to prevent inadequate LBP relief, reliable predictors for LBP relief should be identified. We retrospectively reviewed 175 patients who underwent posterior element-preserving decompression and evaluated the relief of LBP and leg pain using numeric rating scales (NRSs). Associations between demographic, clinical, or imaging parameters and LBP relief at 1 and 4 years were analyzed by stepwise linear regression analyses. The imaging parameters included Modic change type 1, disc degeneration, foraminal stenosis, vertebral slipping (within Grade 1), scoliosis (<15°) and lordosis. The mean improvements in LBP and leg pain NRS scores from baseline were 5.22 and 4.70 points (P = 0.064, paired t test) at 1 year and 5.12 and 4.62 points (P = 0.068) at 4 years, respectively. Poor LBP scores at 4 years were significantly associated with long-lasting LBP (beta = 0.31, P < 0.0001) and moderate or severe arm symptoms with cervical spinal cord compression or intramedullary hyperintense signal on T2-weighted MRI (beta = 0.22, P = 0.0014). The imaging parameters of the lumbar spine failed to show clear associations with poor LBP scores at 4 years, although Modic change type 1 showed a significant association with poor LBP scores at 1 year (beta = 0.28, P < 0.0001). Posterior decompression relieves LBP as well as leg pain. Long-lasting LBP and concurrent symptomatic cervical myelopathy are important predictors for inadequate LBP relief. There were no reliable imaging parameters predictive of inadequate LBP relief.Level of Evidence: 4.

Is Decompression and Partial Discectomy Advantageous Over Decompression Alone in Microendoscopic Decompression Of Monosegmental Unilateral Lumbar Recess Stenosis?

Endoscopic techniques are well accepted as surgical technique for decompression of lumbar lateral recess stenosis (LRS). It is uncertain if there is a difference in clinical outcome for decompression alone (DA) or decompression with partial discectomy (DPD) for the treatment of LRS. All files of patients who underwent an endoscopic procedure for lumbar LRS were identified from a prospectively collected database. Preoperative magnetic resonance imaging and endoscopic video were analyzed with special focus on the technique of nerve root decompression. Clinical outcome was assessed via a personal examination, a standardized questionnaire including the numeric rating scale (NRS) for leg and back pain, the Oswestry disability index (ODI), and the modified MacNab criteria to assess functional outcome and clinical success. Sixty-six patients were identified of which 57 attended for evaluation (86.4%). DA was performed in 15 (26.3%) patients and DPD in 42 patients (73.7%). The mean follow-up was 45.0 months (range: 16-82 months). Fifty-two patients reported to be free of leg pain (91.1%), 42 patients had no noticeable back pain (73.7%), 49 patients had full muscle strength (85.9%), and 48 patients had no sensory disturbance (84.2%). The mean NRS for leg pain was 1, the mean NRS for back pain was 2, mean ODI was 16% (range: 0%-60%). Clinical success was noted in 49 patients (85.9%) and it was significantly higher for patients following DPD (P = .024). The overall repeat procedure rate was 12% with reoperation rate at the index segment in 10.5% of cases. There were no significant differences with respect to leg and back pain, ODI, and reoperation between both groups. Microendoscopic DPD of LRS achieves a 92% clinical success rate which is significantly higher compared to 67% clinical success achieved by DA. There was no significant difference for the rate of reoperation, leg and back pain, and ODI. 4.

A novel lumbar total joint replacement may be an improvement over fusion for degenerative lumbar conditions: a comparative analysis of patient-reported outcomes at one year

Background contextEffective alternatives to lumbar fusion for degenerative conditions have remained elusive. Anterior total disc replacement does not address facet pathology or central/recess stenosis, resulting in limited indications. A posterior-based motion-preserving option that allows for neural decompression, facetectomy, and reconstruction of the disc and facets may have a role. PurposeThe purpose was to compare one-year patient-reported outcomes for a novel, all-posterior, lumbar total joint replacement (LTJR – replacing both the disc and facet joints) against transforaminal lumbar interbody fusion (TLIF) for degenerative lumbar conditions warranting fusion (degenerative spondylolisthesis, recurrent disc herniation, severe foraminal stenosis requiring facet removal, and adjacent segment degeneration). Study design/settingA retrospective analysis of prospectively collected data comparing outcomes for LTJR patients to TLIF patients at an academic teaching hospital. Patient sampleAnalysis was conducted on 156 adult TLIF patients who were propensity matched to the 52 LTJR patients for a total sample of 208. Outcome measuresSelf-reported Oswestry Disability Index (ODI) and Numeric Rating Scale (NRS) for back and leg pain were compared preoperatively, 3 months and 1 year after surgery. MethodsThe implant is a motion-preserving lumbar reconstruction that replaces the function of both the disc and facets and is implanted using a bilateral transforaminal approach with complete facetectomies. Adult patients with degenerative lumbar pathology undergoing either LTJR or open TLIF were analyzed. These degenerative conditions included: grade 1 degenerative spondylolisthesis, recurrent disc herniation, adjacent segment disease, disc degeneration with severe foraminal stenosis). Trauma, tumor, grade 2 or higher spondylolisthesis, spinal deformity, and infection cases were excluded. Propensity score matching was performed to ensure parity between the cohorts. Multivariable regression analyses were done to compare the 1-year results as measured by 3 different standards to assess procedure success. ResultsAt 3 months, both the LTJR and TLIF cohorts showed significant and similar improvements in ODI and NRS back and leg pain. At 1 year, the LTJR cohort showed continued improvement in ODI and NRS back pain, while the TLIF group showed a plateau for ODI, back and leg pain. In a series of three multivariable logistic regressions, LTJR was shown to provide 3.3 times greater odds of achieving the minimal clinical symptom state in disability and pain (ODI <20%, NRS back and leg pain <2) and 2.4 and 4.1 times greater odds of achieving substantial clinical benefit (18% reduction in ODI) and minimal clinically important difference (30% reduction in ODI) as compared to TLIF. ConclusionsHere we present a comparative analysis for the first 52 patients undergoing a novel, posterior-based LTJR for the lumbar spine versus TLIF for degenerative pathology. The approach for the LTJR allows for wide neural decompression, facetectomy, and complete discectomy, with the implant working to replace the function of the disc and facets to preserve motion. At 1 year, the LTJR cohort showed significant improvement in ODI and NRS back and leg pain as compared to TLIF. These results suggest that wide neural decompression combined with motion preservation using this novel LTJR may represent a viable alternative to TLIF for treating certain degenerative conditions. A prospective controlled trial is under development to further evaluate the efficacy, safety, and durability of this procedure.

Predictors of the Best Outcomes Following Minimally Invasive Surgery for Grade 1 Degenerative Lumbar Spondylolisthesis.

The factors driving the best outcomes following minimally invasive surgery (MIS) for grade 1 degenerative lumbar spondylolisthesis are not clearly elucidated. To investigate the factors that drive the best 24-mo patient-reported outcomes (PRO) following MIS surgery for grade 1 degenerative lumbar spondylolisthesis. A total of 259 patients from the Quality Outcomes Database lumbar spondylolisthesis module underwent single-level surgery for degenerative grade 1 lumbar spondylolisthesis with MIS techniques (188 fusions, 72.6%). Twenty-four-month follow-up PROs were collected and included the Oswestry disability index (ODI) change (ie, 24-mo minus baseline value), numeric rating scale (NRS) back pain change, NRS leg pain change, EuroQoL-5D (EQ-5D) questionnaire change, and North American Spine Society (NASS) satisfaction questionnaire. Multivariable models were constructed to identify predictors of PRO change. The mean age was 64.2±11.5 yr and consisted of 148 (57.1%) women and 111 (42.9%) men. In multivariable analyses, employment was associated with superior postoperative ODI change (β-7.8; 95% CI [-12.9 to -2.6]; P=.003), NRS back pain change (β -1.2; 95% CI [-2.1 to -0.4]; P=.004), EQ-5D change (β 0.1; 95% CI [0.01-0.1]; P=.03), and NASS satisfaction (OR=3.7; 95% CI [1.7-8.3]; P<.001). Increasing age was associated with superior NRS leg pain change (β -0.1; 95% CI [-0.1 to -0.01]; P=.03) and NASS satisfaction (OR=1.05; 95% CI [1.01-1.09]; P=.02). Fusion surgeries were associated with superior ODI change (β -6.7; 95% CI [-12.7 to -0.7]; P=.03), NRS back pain change (β -1.1; 95% CI [-2.1 to -0.2]; P=.02), and NASS satisfaction (OR=3.6; 95% CI [1.6-8.3]; P=.002). Preoperative employment and surgeries, including a fusion, were predictors of superior outcomes across the domains of disease-specific disability, back pain, leg pain, quality of life, and patient satisfaction. Increasing age was predictive of superior outcomes for leg pain improvement and satisfaction.

38. Opioid use prior to adult spine deformity (ASD) surgery worsens postoperative outcomes and risks continued postoperative use, independent of spine deformity magnitude and type of surgery performed: a propensity matched cohort analysis

BACKGROUND CONTEXT Opioid use prior to spine deformity surgery may compromise postoperative outcomes. However, patient comorbidities, deformity magnitude, and type of surgery performed are also associated with patient outcomes for ASD. An analysis to control for confounding variables including patient demographics and type of surgery performed may provide greater understanding of the impact that preoperative opioid use has on surgically treated ASD patients. PURPOSE Isolate the impact of preoperative opioid use on baseline and postoperative outcomes for ASD by performing a propensity score matched (PSM) analysis to control for confounding patient demographic, spine deformity, and surgical variables. STUDY DESIGN/SETTING Propensity score matched (PSM) analysis of operatively treated ASD patients from a prospective multicenter database. PATIENT SAMPLE ASD patients, age >18 years, no history of spine surgery prior to study enrollment, ≥4 levels fused at the time of surgery after study enrollment, and minimum 2 years of postoperative follow-up. OUTCOME MEASURES Numeric rating scale (NRS) back and leg pain, Scoliosis Research Society-22r questionnaire (SRS-22r), Short Form-36v2 questionnaire (SF-36), Oswestry Disability Index (ODI), duration of hospital stay, duration of ICU stay. METHODS ASD patients (age >18 years) enrolled into a prospective multicenter ASD database were divided into preoperative opioid (OPIOID) vs nonopioid (NON) users. Propensity score matching (PSM) was used to control for patient age, medical comorbidities, deformity magnitude, and type of surgery performed. Pre- and postoperative patient-reported outcome measures, duration of ICU and hospital stay, perioperative complications, and continued opioid use at one and two years postoperative was evaluated. RESULTS Of 358 eligible patients, 262 were evaluated (mean follow-up=3.5 years). OPIOID (n=98) and NON (n=164) had similar preoperative age, deformity type and magnitude, BMI, smoking history, ASA grade, comorbidity burden, history of smoking and depression, levels fused at surgery, fusion to the pelvis, and 3 column osteotomy (p>0.05). Preoperatively, OPIOID had greater NRS back pain (7.7 vs 6.8) and leg pain (2.5 vs 2.3), worse ODI (50.8 vs 36.9), worse SF-36 PCS (37.3 vs 47.0), and worse SRS-22r self-image (2.0 vs 2.8) than NON, respectively (p 0.05). CONCLUSIONS Propensity score matched analysis of operatively treated ASD patients demonstrated patients using opioids preoperatively have greater baseline and 2-year postoperative disability compared to opioid nonusers, independent of patient demographics, deformity magnitude, and type of surgery performed. Over 50% of preoperative opioid users reported continued postoperative opioid use at one year postoperative, and over 40% had continued use at two years postoperative, compared to 18% and 12% usage at one and two years postoperatively for preoperative nonusers. Attempts should be made to eliminate opioid consumption prior to ASD surgery to improve patient outcomes. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.

Factors affecting approach selection for minimally invasive versus open surgery in the treatment of adult spinal deformity: analysis of a prospective, nonrandomized multicenter study.

Surgical decision-making and planning is a key factor in optimizing outcomes in adult spinal deformity (ASD). Minimally invasive spinal (MIS) strategies for ASD have been increasingly used as an option to decrease postoperative morbidity. This study analyzes factors involved in the selection of either a traditional open approach or a minimally invasive approach to treat ASD in a prospective, nonrandomized multicenter trial. All centers had at least 5 years of experience in minimally invasive techniques for ASD. The study enrolled 268 patients, of whom 120 underwent open surgery and 148 underwent MIS surgery. Inclusion criteria included age ≥ 18 years, and at least one of the following criteria: coronal curve (CC) ≥ 20°, sagittal vertical axis (SVA) > 5 cm, pelvic tilt (PT) > 25°, or thoracic kyphosis (TK) > 60°. Surgical approach selection was made at the discretion of the operating surgeon. Preoperative significant differences were included in a multivariate logistic regression analysis to determine odds ratios (ORs) for approach selection. Significant preoperative differences (p < 0.05) between open and MIS groups were noted for age (61.9 vs 66.7 years), numerical rating scale (NRS) back pain score (7.8 vs 7), CC (36° vs 26.1°), PT (26.4° vs 23°), T1 pelvic angle (TPA; 25.8° vs 21.7°), and pelvic incidence-lumbar lordosis (PI-LL; 19.6° vs 14.9°). No significant differences in BMI (29 vs 28.5 kg/m2), NRS leg pain score (5.2 vs 5.7), Oswestry Disability Index (48.4 vs 47.2), Scoliosis Research Society 22-item questionnaire score (2.7 vs 2.8), PI (58.3° vs 57.1°), LL (38.9° vs 42.3°), or SVA (73.8 mm vs 60.3 mm) were found. Multivariate analysis found that age (OR 1.05, p = 0.002), VAS back pain score (OR 1.21, p = 0.016), CC (OR 1.03, p < 0.001), decompression (OR 4.35, p < 0.001), and TPA (OR 1.09, p = 0.023) were significant factors in approach selection. Increasing age was the primary driver for selecting MIS surgery. Conversely, increasingly severe deformities and the need for open decompression were the main factors influencing the selection of traditional open surgery. As experience with MIS surgery continues to accumulate, future longitudinal evaluation will reveal if more experience, use of specialized treatment algorithms, refinement of techniques, and technology will expand surgeon adoption of MIS techniques for adult spinal deformity.

Microdiscectomy for Lumbar Disc Herniation: A Single-Center Observational Study

To examine outcomes and complications following first-time lumbar microdiscectomy. Prospective data for patients operated on between May 2007 and July 2016 were obtained from the Norwegian Registry for Spine Surgery. The primary outcome was change in Oswestry Disability Index (ODI) score at 1 year. Secondary endpoints were change in quality of life measured with EuroQol 5 Dimensions, back and leg pain measured with numeric rating scales, and perioperative complications within 3 months of surgery. For all enrolled patients (N= 1219) enrolled, mean improvement in ODI at 1 year was 33.3 points (95% confidence interval [CI] 31.7 to 34.9, P < 0.001). Mean improvement in EuroQol 5 Dimensions at 1 year of 0.52 point (95% CI 0.49 to 0.55, P < 0.001) represents a large effect size (Cohen's d= 1.6). Mean improvements in back pain and leg pain numeric rating scales were 3.9 points (95% CI 3.6 to 4.1, P < 0.001) and 5.0 points (95% CI 4.8 to 5.2, P < 0.001), respectively. There were 18 surgical complications in 1219 patients and 63 medical complications in 846 patients. The most common complication was micturition problems at 3 months following surgery (n= 25, 2.1%). In multivariate analysis, ODI scores of 21-40 (hazard ratio [HR] 14.5, 95% CI 1.1 to 27.9, P= 0.035), 41-60 (HR 27.5, 95% CI 13.4 to 41.7, P < 0.001), 61-80 (HR 47.4, 95% CI 33.4 to 61.4, P < 0.001) and >81 (HR 66.7, 95% CI 51.1 to 82.2, P < 0.001) were identified as positive predictors for ODI improvement at 1 year, whereas age ≥65 (HR-0.9, 95% CI-0.3 to-1.5, P=0.004) was identified as a negative predictor for ODI improvement. Microdiscectomy for lumbar disc herniation is an effective and safe treatment.

Obese Patients Benefit, but do not Fare as Well as Nonobese Patients, Following Lumbar Spondylolisthesis Surgery: An Analysis of the Quality Outcomes Database.

Given recent differing findings following 2 randomized clinical trials on degenerative lumbar spondylolisthesis (DLS) surgery, there is a need to better define how subsets of patients fare following surgery. To investigate the impact of obesity on patient-reported outcomes (PROs) following DLS surgery. A total of 12 high-enrolling sites were queried, and we found 797 patients undergoing surgery for grade 1 DLS. For univariate comparisons, patients were stratified by BMI≥30 kg/m2 (obese) and<30 kg/m2 (nonobese). Baseline, 3-mo, and 12-mo follow-up parameters were collected. PROs included the North American Spine Society satisfaction questionnaire, numeric rating scale (NRS) back pain, NRS leg pain, Oswestry Disability Index (ODI), and EuroQoL-5D (EQ-5D) Questionnaire. We identified 382 obese (47.9%) and 415 nonobese patients (52.1%). At baseline, obese patients had worse NRS back pain, NRS leg pain, ODI, and EQ-5D scores (P<.001, P=.01, P<.001, and P=.02, respectively). Both cohorts improved significantly for back and leg pain, ODI, and EQ-5D at 12 mo (P<.001). At 12 mo, similar proportions of obese and nonobese patients responded that surgery met their expectations (62.6% vs 67.4%, P=.24). In multivariate analyses, BMI was independently associated with worse NRS leg pain and EQ-5D at 12 mo (P=.01 and P<.01, respectively) despite adjusting for baseline differences. Obesity is associated with inferior leg pain and quality of life-but similar back pain, disability, and satisfaction-12 mo postoperatively. However, obese patients achieve significant improvements in all PRO metrics at 12 mo.

The effect of increasing body mass index on the pain and function of patients with adult spinal deformity.

Both adult spinal deformity (ASD) and obesity are growing concerns internationally. This study therefore aims to determine the effect of increasing body mass index (BMI) on the pain and function of patients with ASD. A retrospective review of prospectively collected data from a multicentre European database was undertaken. Initially a univariate analysis was performed on the effect of BMI on the initial presentation of functional scores in patients with ASD. The functional scores included the Numerical Rating Scale (NRS) back and leg score, Core Outcome Measures Index (COMI) back score, SRS22 total score, Short Form 36 (SF-36) [general health, physical component score (PCS) and mental component score (MCS)] and Oswestry Disability Index (ODI) score (including all domains). Subsequently a multivariate analysis controlling for age, sex, comorbidities, employment status, smoking status and radiological parameters [coronal cobb, coronal balance, sagittal balance, global tilt, and pelvic incidence minus lumbar lordosis (PI - LL) mismatch] was performed. A total of 1,004 patients were included in this study (166 male, 838 female). On univariate analysis a statistically significant (P<0.05) moderate correlation between NRS leg pain, ODI (walking, standing, sex life, social life and total score), SF-36 (physical component), sagittal balance, global tilt and age were recognised (P<0.05). A statistically significant low correlation was identified for all other outcomes, except coronal balance (P=0.640). On multivariate analysis BMI remained significantly related to all functional outcomes except ODI-pain and ODI-travelling (P>0.05). Increasing BMI has a significant adverse effect on the pain and functioning of patients with ASD. Clinicians should recognise this association and treat patients accordingly.

Predictors of patient dissatisfaction at 1 and 2 years after lumbar surgery.

As compensation transitions from a fee-for-service to pay-for-performance healthcare model, providers must prioritize patient-centered experiences. Here, the authors' primary aim was to identify predictors of patient dissatisfaction at 1 and 2 years after lumbar surgery. The Michigan Spine Surgery Improvement Collaborative (MSSIC) was queried for all lumbar operations at the 1- and 2-year follow-ups. Predictors of patients' postoperative contentment were identified per the North American Spine Surgery (NASS) Patient Satisfaction Index, wherein satisfied patients were assigned a score of 1 ("the treatment met my expectations") or 2 ("I did not improve as much as I had hoped, but I would undergo the same treatment for the same outcome") and unsatisfied patients were assigned a score of 3 ("I did not improve as much as I had hoped, and I would not undergo the same treatment for the same outcome") or 4 ("I am the same or worse than before treatment"). Multivariable Poisson generalized estimating equation models were used to report adjusted risk ratios (RRadj). Among 5390 patients with a 1-year follow-up, 22% reported dissatisfaction postoperatively. Dissatisfaction was predicted by higher body mass index (RRadj =1.07, p < 0.001), African American race compared to white (RRadj = 1.51, p < 0.001), education level less than high school graduation compared to a high school diploma or equivalent (RRadj = 1.25, p = 0.008), smoking (RRadj = 1.34, p < 0.001), daily preoperative opioid use > 6 months (RRadj = 1.22, p < 0.001), depression (RRadj = 1.31, p < 0.001), symptom duration > 1 year (RRadj = 1.32, p < 0.001), previous spine surgery (RRadj = 1.32, p < 0.001), and higher baseline numeric rating scale (NRS)-back pain score (RRadj = 1.04, p = 0.002). Conversely, an education level higher than high school graduation, independent ambulation (RRadj = 0.90, p = 0.039), higher baseline NRS-leg pain score (RRadj = 0.97, p = 0.013), and fusion surgery (RRadj = 0.88, p = 0.014) decreased dissatisfaction.Among 2776 patients with a 2-year follow-up, 22% reported dissatisfaction postoperatively. Dissatisfaction was predicted by a non-white race, current smoking (RRadj = 1.26, p = 0.004), depression (RRadj = 1.34, p < 0.001), symptom duration > 1 year (RRadj = 1.47, p < 0.001), previous spine surgery (RRadj = 1.28, p < 0.001), and higher baseline NRS-back pain score (RRadj = 1.06, p = 0.003). Conversely, at least some college education (RRadj = 0.87, p = 0.035) decreased the risk of dissatisfaction. Both comorbid conditions and socioeconomic circumstances must be considered in counseling patients on postoperative expectations. After race, symptom duration was the strongest predictor of dissatisfaction; thus, patient-centered measures must be prioritized. These findings should serve as a tool for surgeons to identify at-risk populations that may need more attention regarding effective communication and additional preoperative counseling to address potential barriers unique to their situation.

Patients undergoing surgery for lumbar spinal stenosis experience unique courses of pain and disability: A group-based trajectory analysis.

ObjectiveIdentify patient subgroups defined by trajectories of pain and disability following surgery for degenerative lumbar spinal stenosis, and investigate the construct validity of the subgroups by evaluating for meaningful differences in clinical outcomes.MethodsWe recruited patients with degenerative lumbar spinal stenosis from 13 surgical spine centers who were deemed to be surgical candidates. Study outcomes (leg and back pain numeric rating scales, modified Oswestry disability index) were measured before surgery, and after 3, 12, and 24 months. Group-based trajectory models were developed to identify trajectory subgroups for leg pain, back pain, and pain-related disability. We examined for differences in the proportion of patients achieving minimum clinically important change in pain and disability (30%) and clinical success (50% reduction in disability or Oswestry score ≤22) 12 months from surgery.ResultsData from 548 patients (mean[SD] age = 66.7[9.1] years; 46% female) were included. The models estimated 3 unique trajectories for leg pain (excellent outcome = 14.4%, good outcome = 49.5%, poor outcome = 36.1%), back pain (excellent outcome = 13.1%, good outcome = 45.0%, poor outcome = 41.9%), and disability (excellent outcome = 30.8%, fair outcome = 40.1%, poor outcome = 29.1%). The construct validity of the trajectory subgroups was confirmed by between-trajectory group differences in the proportion of patients meeting thresholds for minimum clinically important change and clinical success after 12 postoperative months (p < .001).ConclusionSubgroups of patients with degenerative lumbar spinal stenosis can be identified by their trajectories of pain and disability following surgery. Although most patients experienced important reductions in pain and disability, 29% to 42% of patients were classified as members of an outcome trajectory subgroup that experienced little to no benefit from surgery. These findings may inform appropriate expectation setting for patients and clinicians and highlight the need for better methods of treatment selection for patients with degenerative lumbar spinal stenosis.

179. Predictors of clinical outcome following surgery for lumbar spinal stenosis: a study of postoperative pain and disability trajectories

BACKGROUND CONTEXT On average, patients experience important reductions in pain and disability following surgery for degenerative lumbar spinal stenosis (LSS). However, variability in the postoperative course of symptoms suggests many patients do not fit the average symptom trajectory. PURPOSE To identify patient subgroups defined by trajectories of pain and disability following surgery for LSS and investigate the construct validity of the subgroups by evaluating meaningful differences in clinical outcomes. Identify predictors of belonging to the poor outcomes subgroup for disability, leg pain and back pain. STUDY DESIGN/SETTING Retrospective analysis of prospectively collected data. PATIENT SAMPLE Patients with LSS were recruited from 13 surgical spine centers participating in the Canadian Spine Outcomes and Research Network registry. OUTCOME MEASURES Leg and back pain numeric rating scales and the modified Oswestry disability index were measured before surgery and at 3, 12, and 24 months following surgery. METHODS Patients were fit into pain and disability trajectory subgroups with group-based trajectory modeling. Differences in the proportion of patients achieving minimum clinically important change in pain and disability (30%) and clinical success (50% reduction in disability or Oswestry score ≤22) were examined. Generalized linear mixed models adjusted for age and sex, were used to identify associations between subgroup membership and preoperative demographic, clinical history, health status and surgical factors. The subgroup with excellent outcomes was used as the reference group; associations were reported with relative risk ratios (RR). RESULTS The group-based trajectory models identified 3 unique pain trajectories each (excellent, fair and poor) for leg pain, back pain and disability. Depending on outcome 29% to 42% of patients were classified as members of an outcome trajectory subgroup that experienced little to no benefit from surgery. The construct validity of the trajectory subgroups was supported by differences in the proportion of patients meeting thresholds for minimum clinically important change and clinical success (p CONCLUSIONS The percentage of patients with poor outcomes highlights the need for better methods of treatment selection for patients with LSS. The predictors of having poor outcomes suggests it is time to look beyond pathology/surgical factors only and include mental health variables as an integral part of the surgical decision-making process in an effort to avoid patients at increased risk for surgical failure. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.

66. Preop opioid use is associated with worse postop outcomes and chronic opioid use in nonrevision adult scoliosis patients: corroboration of two independent multicenter studies

BACKGROUND CONTEXT Sagittal malalignment and failed surgery are established etiologies for pain in adult spinal deformity (ASD). However, pain in primary adult scoliosis with good sagittal alignment is poorly understood. Opioids may be administered to control pain in adult scoliosis but are controversial and may negatively impact patient outcome. Evaluation of two independent ASD datasets may reduce bias and help understand the impact of preop opioid therapy on postop outcomes. PURPOSE Compare datasets from two independent ASD studies to evaluate the impact that the presence and frequency of opioid use has upon postop outcomes in adult scoliosis patients who have no prior history of spine surgery and no sagittal malalignment. STUDY DESIGN/SETTING Comparative analysis of datasets from two prospective multicenter ASD studies. PATIENT SAMPLE ASD patients with no history of prior spine surgery and no sagittal malalignment (as defined by the Scoliosis Research Society ASD Classification) enrolled into two independent multicenter databases and subsequently surgically treated for adult scoliosis OUTCOME MEASURES Scoliosis Research Society-22r questionnaire (SRS-22r), SF-36 and SF-12 Physical Component Score (PCS) and Mental Component Score (MCS), numeric rating scale (NRS) back and leg pain METHODS Adult scoliosis patients age >18 years, no history of spine surgery, and presence of thoracic, lumbar or double scoliosis (as per SRS deformity type) were identified from 2 independent prospective databases and assessed for preop non-opioid (NON) vs opioid use and amount of use (DAILY vs WEEKLY). Mixed and sagittal deformities were eliminated to reduce confounding pain impact of sagittal malalignment. Patients were treated surgically and pre- and postop demographic, radiographic data, patient-reported outcome measures and postop opioid usage were evaluated, minimum 2-year follow-up. RESULTS Database 1 (D1; 102/102 patients; mean follow up 2.1+0.2yr) and Database 2 (D2; 116/168 patients, mean follow-up 3.3 years) demonstrated similar preop demographic, depression history, smoking history and radiographic parameters for NON, DAILY and WEEKLY (p>0.05; Table). DAILY had greater preop NRS back and leg pain, and worse preop PCS and MCS than NON (p 0.05). At last follow-up, DAILY had worse postop NRS back pain (D1=4.1, D2=4.9), worse PCS (D1=38.8, D2=41.9), and worse MCS (D1=49.7, D2=45.4) than NON and WEEKLY (p CONCLUSIONS Comparison of datasets from two independent, multicenter prospective ASD studies demonstrated dataset agreement that preop opioid use and increased frequency of preop opioid use in adult scoliosis patients with no history of prior surgery and no sagittal malalignment is associated with worse postop pain, outcomes and continued opioid use. Attempts should be made, including program development, to aid in the discontinuation of preop and postop opioid usage for adult scoliosis to help improve postop outcomes. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.

69. Coronal correction using the kickstand rod technique: a pilot adult scoliosis study and analysis of early outcomes and complications

BACKGROUND CONTEXT A major goal of adult spinal deformity (ASD) surgery is more harmonious spinal alignment. Sagittal alignment has been emphasized since it was demonstrated to have the greatest impact on postoperative pain and functional outcomes. However, growing evidence suggests the impact of coronal alignment has likely been underestimated. Kickstand rods are a new technique recently utilized for achieving coronal balance. The kickstand spans from the thoracolumbar junction to a 3rd iliac screw. Using the iliac wing as a base, kickstand distraction produces powerful coronal realignment forces. Limited literature exists for this novel technique, and its associated outcomes and complications after ASD surgery are unknown. PURPOSE The objective of this pilot study was to investigate early outcomes and complications after coronal correction with kickstand rods. STUDY DESIGN/SETTING Retrospective review of single-center database. PATIENT SAMPLE Consecutive ASD patients. OUTCOME MEASURES Radiographic alignment correction using standing long-cassette films (both coronal and sagittal spinopelvic measurements), back and leg pain assessed with numerical rating scale (NRS) scores (0-no pain; 10-unbearable pain), and associated complications. METHODS All ASD patients who had deformity correction using kickstand rods. Demographic, surgical, coronal- and sagittal-plane radiographic measurements, and back and leg pain NRS scores were analyzed. A kickstand rod correction classification was devised to illustrate our technique: Subtype (1a) Curve Pattern: C7PL towards major concavity and fractional convexity; Kickstand Distraction: corrects major curve onlySubtype (1b) Curve Pattern: C7PL towards major concavity with neutral/concave fractional curve; Kickstand Distraction: corrects major curve +/- simultaneous fractional correction; Subtype (2) Curve Pattern: C7PL towards major convexity; Kickstand Distraction: corrects fractional curve +/- simultaneous major correction; Subtype (3) Curve Pattern: global coronal balance with scoliosis; Kickstand distraction corrects major curve, but typically after fractional correction “shifts” the spine. RESULTS The cohort comprised 19 patients (mean age: 67±7 yrs; 79% women; 63% prior lumbar fusion) with mean follow-up 21 weeks (range: 2-72 weeks). All patients had posterior-only approach surgery with tri-iliac fixation (3rd iliac screw for the kickstand) for mean fusion length 12 levels. Kickstand correction was subtype 1a, 1b, 2, and 3 in 4 (21%), 6 (32%), 7 (37%), and 2 (9%) patients, respectively. 3-column osteotomy and lumbar TLIF were performed in 5 (26%) and 15 (79%) patients, respectively. Alignment was significantly improved (coronal balance: 8 to 1cm [p CONCLUSIONS Kickstand rod distraction can achieve significant coronal correction in ASD. Kickstand subtype 1a+b was most commonly utilized (since coronal curves with C7PL shifted to the major curve concavity are most common). Back and leg pain were significantly improved, and complications rates were reasonable. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.

A Comparison of Minimally Invasive Transforaminal Lumbar Interbody Fusion and Decompression Alone for Degenerative Lumbar Spondylolisthesis

Abstract INTRODUCTION The optimal minimally invasive surgical (MIS) approach for lumbar spondylolisthesis is not clearly elucidated. This study compares patient reported outcomes (PRO) following MIS transforaminal lumbar interbody fusion (MI-TLIF) and MIS decompression for degenerative lumbar spondylolisthesis. METHODS A total of 608 patients from the Quality Outcomes Database (QOD) Lumbar Spondylolisthesis Module underwent single-level surgery for degenerative grade 1 lumbar spondylolisthesis of whom 143 underwent MIS [72 MI-TLIF (50.3%) and 71 MIS decompressions (49.7%)]. Surgeries were classified as MIS if there was utilization of percutaneous screw fixation and placement of a Wiltse-plane MIS intervertebral body graft (MI-TLIF) or if there was a tubular decompression (MIS decompression). In total, 24-mo follow-up parameters were collected. PROs included the Oswestry Disability Index (ODI), numeric rating scale (NRS) Back Pain, NRS Leg Pain, EuroQoL-5D (EQ-5D) Questionnaire, and North American Spine Society (NASS) Satisfaction Questionnaire. Multivariate models were constructed adjusting for baseline patient and surgical factors. RESULTS The mean age of the MIS cohort was 67.1 ± 11.3 yr (MI-TLIF 62.1 yr vs MIS decompression 72.3 yr) and consisted of 79 (55.2%) women (MI-TLIF 55.6% vs MIS decompression 54.9%). The proportions reaching 24-mo follow-up were similar (MI-TLIF 83.3% and MIS decompression 84.5%; P = .85). MI-TLIF was associated with higher blood loss (108.8 vs 33.0 mL, P &lt; .001), longer operative times (228.2 vs 101.8 min, P &lt; .001) and length of hospitalization (2.9 vs 0.7 d, P &lt; .001). MI-TLIF was associated with a significantly lower reoperation rate (14.1% vs 1.4%, P = .004). Both cohorts demonstrated significant improvements in ODI, NRS back pain, NRS leg pain, and EQ-5D at 24 mo (P &lt; .001). In multivariate analyses, MI-TLIF was associated with superior ODI change (ß = −7.59; 95% CI [−14.96 to −0.23]; P = .04), NRS back pain change (ß = −1.54; 95% CI [−2.78 to −0.30]; P = .02), and NASS satisfaction (OR = 0.32; 95% CI [0.12-0.82]; P = .02). CONCLUSION For symptomatic, single-level degenerative spondylolisthesis, MI-TLIF was associated with a 10-fold lower reoperation rate and superior outcomes for disability, back pain, and patient satisfaction compared to MIS decompression alone.

Predictors of the Best Outcomes Following Minimally Invasive Surgery for Grade 1 Lumbar Spondylolisthesis

Abstract INTRODUCTION The factors driving the best outcomes following minimally invasive surgery (MIS) for degenerative lumbar spondylolisthesis (DLS) are not clearly elucidated. This study investigates the factors that drive the best patient reported outcomes (PRO) following MIS for DLS. METHODS A total of 608 patients from the prospective Quality Outcomes Database (QOD) Lumbar Spondylolisthesis Registry underwent surgery for grade 1 DLS of whom 259 underwent surgery with MIS techniques [187 fusions (72.2%)]. Surgeries were classified as MIS if any of the following were involved: MIS laminectomy, MIS pedicle screws, MIS interbody grafts, or percutaneous screws. Outcomes were assessed at 24 mo postoperatively. PROs included the Oswestry Disability Index (ODI), numeric rating scale (NRS) Back Pain, NRS Leg Pain, EuroQoL-5D (EQ-5D) Questionnaire, and North American Spine Society (NASS) Satisfaction Questionnaire. Multivariate models were constructed adjusting for patient characteristics, presentation characteristics, surgical variables, socioeconomic characteristics, and baseline PRO values. RESULTS The mean age of the MIS cohort was 64.2 ± 11.5 yr [148 (57.1%) women and 111 (42.9%) men]. In multivariate analyses, aside from baseline PRO values, only 3 factors were significantly associated with multiple 24-mo PRO change scores: employment, age, and the addition of fusion to surgery. Employment was associated with superior postoperative ODI (ß-7.8; 95% CI [−12.9- −2.6]; P = .003), NRS back pain (ß-1.2; 95% CI [−2.1- −0.4]; P = 0.004), EQ-5D (ß0.1; 95% CI [0.01-0.1]; P = .03), and NASS satisfaction (OR = 0.27; 95% CI [0.12-0.58]; P &lt; .001). Increasing age was associated with superior NRS leg pain (ß-0.1; 95% CI [minus;0.1- minus;0.01]; P = .03) and NASS satisfaction (OR = 0.95; 95% CI [0.92-0.99]; P = .02). The addition of a fusion was associated with superior ODI (ß-6.7; 95% CI [minus;12.7- minus;0.7]; P = .03), NRS back pain (ß-1.1; 95% CI [minus;2.1- minus;0.2]; P = .02), and NASS satisfaction (OR = 0.28; 95% CI [0.12-0.62]; P = .002). CONCLUSION Preoperative active employment, at least 4 yr of college education, and surgeries including a fusion were significant predictors of superior outcomes across the domains of disease-specific disability, back pain, leg pain, quality of life, and patient satisfaction. Increasing age was predictive of superior outcomes for leg pain and satisfaction.