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In recent years, the incidence of spinal epidural abscesses (SEA) has tripled in number and nonoperative management has risen in popularity. While there has been a shift towards reserving surgical intervention for patients with focal neurologic deficits, a third of patients will still fail medical management and require surgical intervention. Failure to understand long-term quality of life and functional outcomes hinders effective decision making and prognostication. To describe patterns and associated factors impacting long-term quality of life following treatment of spinal epidural abscess. Multicenter cohort study at two urban academic tertiary referral centers and two community centers. Adult patients treated for a spinal epidural abscess. EuroQoL 5-Dimension 5L (EQ5D), Neuro-Quality of Life Lower Extremity – Mobility (Short Form; NeuroQoL-LE), Patient-Reported Outcomes Measurement Information System Physical Function (short form 4a; PROMIS PF), and PROMIS Global Mental Health score (PROMIS Mental). Eligible patients were enrolled and administered questionnaires. Multivariable analysis assessed the influence of ambulatory status on HRQL, adjusting for covariates including age, biologic sex, Charlson comorbidity index, intravenous drug use, management approach, and ASIA grade on presentation. Sixty-one patients were enrolled (mean age 60.5 years, 46% male). Thirty-four patients (58%) underwent operative management. Mean standard deviation (SD) results for HRQL measures were: EQ5D 0.51 (0.37), EQ5D visual analogue scale 60.34 (25.11), NeuroQoL Lower extremity 41.47 (10.64), PROMIS physical function 39.49 (10.07), and PROMIS Global Mental Health 44.23 (10.36). Adjusted analysis demonstrated ambulatory status at presentation, and at 1 year, to be important drivers of HRQL, irrespective of other factors including IVDU and ASIA grade. Patients with independent ambulatory function at 1 year had mean EQ5D utility of 0.65 (95% CI 0.55, 0.75), whereas those requiring assistive devices saw a 49% decrease with mean EQ5D utility of 0.32 (0.14, 0.51). Ambulatory status was associated with global and physical function but did not impact overall health self-assessment or mental health scores. We found that ambulatory status was the most important factor associated with long-term HRQL regardless of other factors such as ASIA grade or IVDU. Given prior literature demonstrating the protective effect of operative intervention on ambulatory function, this highlights ambulatory dysfunction as a potential indication for surgery and a marker of poor long-term prognosis, even in the absence of focal neurologic deficits. Our work also highlights the importance of optimized long-term rehabilitation strategies aimed to preserve ambulatory function in this high-risk population. Level III, cohort study [ABSTRACT FROM AUTHOR]

Various total disc replacement (TDR) designs have been compared to anterior cervical discectomy and fusion (ACDF) with favorable short and long-term outcomes in FDA-approved investigational device exemption (IDE) trials. The unique design of M6-C, with a compressible viscoelastic nuclear core and an annular structure, has previously demonstrated favorable clinical outcomes through 24 months. To evaluate the long-term safety and effectiveness of the M6-C compressible artificial cervical disc and compare to ACDF at 5 years. Prospective, multicenter, concurrently and historically controlled, FDA-approved IDE clinical trial. Subjects with one-level symptomatic degenerative cervical radiculopathy were enrolled and received M6-C (n=160) or ACDF (n=189) treatment as part of the IDE study. Safety outcomes were evaluated at 5 years for all subjects. The primary effectiveness endpoint was available at 5 years for 113 M6-C subjects and 106 ACDF controls. The primary endpoint of this analysis was composite clinical success (CCS) at 60 months. Secondary endpoints were function and pain (neck disability index, VAS), physical quality of life (SF-36, SF-12), safety, neurologic, and radiographic assessments. Propensity score subclassification was used to control for selection bias and match baseline covariates of the control group to the M6-C subjects. Sixty-month CCS rates were estimated for each treatment group using a generalized linear model controlling for propensity score. At 5 years postoperatively, the M6-C treatment resulted in 82.3% CCS while the ACDF group showed 67.0% CCS (superiority p=.013). Secondary endpoints indicated that significantly more M6-C subjects achieved VAS neck and arm pain improvements and showed maintained or improved physical functioning on quality-of-life measures compared to baseline assessments. The M6-C group-maintained flexion-extension motion, with significantly greater increases from baseline disc height and disc angle than observed in the control group. The rates of M6-C subsequent surgical interventions (SSI; 3.1%) and definitely device- or procedure-related serious adverse events (SAE failure; 3.1%) were similar to ACDF rates (SSI=5.3%, SAE failure=4.8%; p>.05 for both). Subjects treated with the M6-C artificial disc demonstrated superior 5-year achievement of clinical success when compared to ACDF controls. In addition, significantly more subjects in the M6-C group showed improved pain and physical functioning scores than observed in ACDF subjects, with no difference in reoperation rates or safety outcomes. [ABSTRACT FROM AUTHOR]

Little information is available about the minimal clinically important differences (MCIDs) for objective physical measurements in people with lumbar spinal stenosis (LSS). To use disorder-specific anchor and, multiple anchor-, and distribution-based approaches to determine the MCIDs for walking capacity and physical activity in patients with LSS receiving nonsurgical treatment. Secondary analysis of a randomized controlled trial. Sixty-nine patients with neurogenic claudication caused by LSS receiving outpatient physical therapy. Zurich claudication questionnaire (ZCQ), self-paced walking test (SPWT), and number of daily steps measured by pedometry. All patients completed the ZCQ, SPWT, and pedometry at the baseline and after 6 weeks. For the anchor-based approach, ZCQ symptom severity, physical function, and satisfaction subscales were used as the external anchors. Using the receiver-operating characteristic (ROC) curve, the MCIDs were determined based on the optimal cutoff points for changes in the SPWT or daily steps. For the distribution-based approach, the MCIDs were estimated from the standard deviations (SDs) of the baseline scores of the SPWT and daily steps. In the anchor-based approach, only the ZCQ satisfaction subscale for the SPWT (0.73), and ZCQ symptom severity subscale for daily steps (0.71) exceeded the area under the ROC curve value of 0.7, which is considered acceptable. When using these subscales as anchors, the ROC curves and optimal cutoff points indicated MCIDs of 151 m for the SPWT and 1,149 steps for daily steps. The distribution-based approach estimated the MCIDs as 280 m for the SPWT and 1,274 steps for daily steps, and had a moderate effect size (0.5 SD). The anchor-based approach had limited external responsiveness when the ZCQ was used as the anchor. However, this information may be helpful for interpreting walking capacity and physical activity in patients with LSS receiving nonsurgical treatment and for estimating power and sample size when planning new trials. [ABSTRACT FROM AUTHOR]

The lateral approach to lumbar fusion surgery provides access to the spine without needing to use a transperitoneal pathway thus reducing the incidence of morbidity compared to the anterior approach. Therefore, the frequency in which this approach has been utilized has grown warranting increased need for evaluating patient reported outcomes for this particular surgical technique. The utilization of patient-reported outcome measures (PROMs) administered as surveys is a standard procedure now in spine surgery. These surveys are used to evaluate from the patient's perspective the success of the surgery in alleviating the preoperative symptoms. More information is needed to correlate PROMs with their legacy counterparts in the context of individual pathologies and surgeries. The goal of this study is to correlate Patient-Reported Outcomes Measurement Information System Physical Function (PROMIS-PF) scores with Short Form-12 Physical Component Score (SF-12 PCS) and Veterans RAND-12 Physical Component Score (VR-12 PCS) to assess physical function in individuals undergoing Lateral Lumbar Interbody Fusion (LLIF). This study is a retrospective review. Electronic medical records of a single spine surgeon were searched for individuals undergoing primary, elective LLIF. Excluded cases were related to cancer, infection, trauma, or individuals missing the PROMs of interest. A total of 86 patients were included in the final study. Outcome measures included perioperative characteristics, minimal clinically important difference (MCID) achievement rate, and PROMs of SF-12 PCS, Oswestry Disability Index (ODI), VR-12 PCS, and PROMIS-PF. Demographics, perioperative characteristics, and PROMs were collected both preoperatively and postoperatively at six weeks, 12 weeks, six-months, one year, and two years. As we look to compare "legacy" PROMs to the newer generation of measurements, we will use SF-12 PCS, VR-12, and ODI to represent the legacy PROMs. The newer generation will be represented by PROMIS-PF. Pearson's Correlation Coefficient was used to establish the relationship between the legacy PROM values and PROMIS-PF. All PROMs other than ODI showed improvements in the mean score at each consecutive follow-up time point. PROMIS-PF showed a statistically significant Pearson's Correlation Coefficient with SF-12 PCS, VR-12 PCS, and ODI at all time points measured (p<0.05, all). The Pearson's correlation coefficient for 12-week SF-12 PCS until 2-years is reported as strongly correlated (0.500<|r|, r=0.765, r=0.824, r=0.772, r=0.757, respectively). The correlation coefficients of SF-12 PCS for the preoperative and six-week timepoints were considered moderately strong positive correlation (0.300<|r|≤0.500; r = 0.467, and 0.373, respectively). The correlation coefficients of VR-12 for the preoperative and six weeks were considered strongly positive (0.500<|r|; r = 0.576 and 0.536, respectively). The 12 weeks through 2-year timepoints for VR-12 were considered strongly positive (0.500<|r|; r = 0.770, 0.835, 0.838, 0.817, respectively). The correlation coefficient for ODI from preoperative through 2-year follow-up were all considered strongly negative (0.500<|r| for all). PROMIS-PF demonstrated a strong positive correlation with VR-12 PCS, and SF-12 PCS, and a strong negative correlation with ODI in our patient sample. These results suggest PROMIS-PF can be used as an accurate measure of physical function in patients undergoing LLIF. Therefore, the use of PROMIS-PF as a singular survey for patients may be an accurate measure of patient-reported outcomes in spine surgery. This abstract does not discuss or include any applicable devices or drugs. [ABSTRACT FROM AUTHOR]

The outcomes of revision minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF) and lateral lumbar interbody fusion (LLIF) have not been compared in the literature thus far. The purpose of this study is to compare perioperative and patient-reported outcome (PRO) data of revision MIS-TLIF and LLIF. This study is a retrospective cohort study. Patients undergoing elective revision MIS-TLIF and LLIF were identified from a prospective single surgeon registry and grouped into cohorts based on surgical approach. Only patients undergoing fusions at spinal levels accessible through both MIS-TLIF and LLIF were included. In total, 102 patients were included, with 29 MIS-TLIF patients and 73 LLIF patients. Outcome measures were perioperative data, minimal clinically important difference (MCID) achievement rates), and PROs including Veterans Rand-12 Physical and Mental Composite Score (VR-12 PCS, MCS), Patient-Reported Outcome Measurement Information System-physical function (PROMIS-PF), Patient-Health Questionnaire-9 (PHQ-9), Visual Analog Scale-Back and Leg Pain (VAS-BP, LP), and Oswestry Disability Index (ODI). Demographics, perioperative data, and PROs were obtained from the registry and compared through independent samples t-tests or chi-square tests. Improvements in PROs by six weeks and final follow-up were tabulated. Postoperative PROs and changes in PROs were compared through multivariable linear regression to account for age differences. MCID achievement rates were calculated for each group by comparing changes in PROs to thresholds reported in prior literature. MCID achievement rates were then compared between groups using multivariable logistic regression. Patients undergoing LLIF were significantly older (58.7 years) than patients undergoing MIS-TLIF (54.0 years) (p=0.047), but there were no other demographic differences between groups (p≥0.111, all). LLIF patients consumed more narcotics on postoperative day 0 (p=0.035), while there were no other differences in perioperative data. There were no significant differences in baseline PROMs (p≥0.059, all). When controlling for differences in age, there were no differences in 6-week postoperative and final follow-up PROMs (p≥ 0.061, all). The LLIF group reported greater average improvement in VAS-LP scores by six weeks postoperatively compared to the MIS-TLIF group (p=0.049), while other outcomes were statistically similar (p≥0.098, all). The LLIF group also reported greater average final follow-up improvements in PROMIS-PF scores (p=0.003), and similar final follow-up improvements otherwise (p≥0.086, all). There were no significant differences in MCID achievement of any outcome overall (p≥0.052, all). When controlling for age, revision LLIF patients reported earlier and greater reduction in leg pain by six weeks, with similar magnitudes of improvement by final follow-up and greater improvement in physical function at final follow-up. Overall, there were no differences in patients achieving clinically significant improvements in any outcomes. This abstract does not discuss or include any applicable devices or drugs. [ABSTRACT FROM AUTHOR]

In recent years, mental health has increasingly been recognized as an influential determinant of patient outcomes after surgery across many specialties. Patients with back pain, a common manifestation of spine pathology, experience high concomitant rates of depression. Roughly a quarter of patients undergoing spine surgery are regularly taking antidepressant medication, which has been associated with longer hospitals stays and increased cost. Discharge to rehab facilities can contribute significantly to overall cost of care. Recent research has focused on associations between surgical spine patients and nonhome discharge in an effort to identify potential risk factors. In recent years, mental health has increasingly been recognized as an influential determinant of patient outcomes after surgery across many specialties. Patients with back pain, a common manifestation of spine pathology, experience high concomitant rates of depression. Roughly a quarter of patients undergoing spine surgery are regularly taking antidepressant medication, which has been associated with longer hospitals stays and increased cost. Discharge to rehab facilities can contribute significantly to overall cost of care. Recent research has focused on associations between surgical spine patients and nonhome discharge in an effort to identify potential risk factors. The goal of this study was to investigate the association between antidepressant use and discharge disposition, as well as inpatient physical therapy performance. This was a retrospective cohort study. Our patient sample consisted of 1,775 patients undergoing elective lumbar fusion between 2017 and 2021 at a single, academic, teritary care center. Our primary outcome measure was discharge disposition. Secondary outomces included short-term surgical outcomes such as complications and readmission. We also used inpatient physical therapy performance as a secondary outcome, as it is often plays a role in determining discharge disposition. After approval was obtained by the Institutional Review Board, patients undergoing primary 1-3 level lumbar fusion at a single, tertiary care institution from 2017-2021 were retrospectively identified. Patient characteristics, surgical details, and surgical outcomes were collected via chart review. Medications were collected based on active medication lists at the patient's preoperative and first postoperative appointment. A patient was deemed to be taking antidepressants if they were active medication at both the preoperative and follow-up appointment. Inpatient physical therapy metrics including session distance and AMPAC (Activity Measure for Post Acute Care) scores were collected via chart review. Statistical analysis was performed to identify differences between the "antidepressant" and "no antidepressant" groups. A total of 493 patients (27.7%) were taking antidepressants perioperatively. Patients in the antidepressant group were more likely to be female (p<0.001), current smokers (p=0.012), and have a higher Elixhauser comorbidity index (p<0.001). On regression analysis, the antidepressant group was associated with discharge to rehab after surgery (p=0.026). Age (p<0.001), length of stay (p<0.001), 1st session distance (p<0.001), and improvement in gait distance (p<0.001) were associated with nonhome discharge. Antidepressant use was independently associated with discharge to a rehabilitation facility. These patients were still discharged to these facilities without performing significantly worse in in their inpatient physical therapy sessions. These findings suggest that psychosocial factors may play an important role in disposition discharge after spine surgery and patients with depression/anxiety may require additional resources while in the hospital to be discharged safely home. This abstract does not discuss or include any applicable devices or drugs. [ABSTRACT FROM AUTHOR]

Patient-reported outcome measures (PROMs) are increasingly being used in clinical care, research, and to inform policy decisions. Prior studies have demonstrated that non-English speaking patients and those of African American race and lower socioeconomic status are less likely to complete PROMs. In spine surgery populations, these groups have been shown to present with worse physical and mental health, and these disparities persist postoperatively. However, few studies have examined trends in PROMs completion rates and baseline function for spine patients broadly, including those managed nonoperatively. As the use of PROMs expands, it is pivotal that disparities in both completion rates and scores be identified, as these may bias clinical decision making, research, and policy decisions. The purpose of this study was to evaluate disparities in PROM completion rates and baseline function scores among newly presenting spine patients. Retrospective review of new patients presenting to a single multidisciplinary spine clinic from June 2020 to September 2022. A total of 10,803 consecutive new patients. The primary outcomes of interest were whether patients completed PROMs at their clinic visit, and the PROMIS Physical Function (PF), Pain Interference, and Pain Intensity t-scores reported by respondents. Chi-square and two-sided independent samples t-tests were performed to compare demographics, social vulnerability (measured using the Centers for Disease Control Social Vulnerability Index [SVI]), and diagnoses between patients who did and did not complete PROMs at the first visit. Multivariate logistic regression was used to assess likelihood of PROMs completion by race, ethnicity, and SVI, after adjusting for age, sex, body mass index (BMI), and diagnosis type. Multivariate linear regression was performed to assess the impact of race, ethnicity, and SVI on PROMIS scores in the responder group, after controlling for the same factors. Overall, 7392/10803 (68.4%) patients completed PROMs at the first clinic visit. During the study period, 783 (7.2%) underwent surgery; the remaining 10020 (92.8%) were managed nonoperatively. Patients of nonwhite race (61.4 vs 71.8%, p<0.001), Hispanic ethnicity (56.5 vs 69.5%, p<0.001), and a diagnosis other than cervical-only or lumbar-only pathology (52.9 vs 76.8%, p<0.001) were less likely to complete PROMs. Further, nonresponders resided in areas of higher social vulnerability (SVI 0.35 ± 0.26 vs 0.31 ± 0.24, p<0.001). Age, BMI, and sex were not associated with statistically significant differences in PROMs completion rates. After adjusting for these factors and diagnosis type, patients of nonwhite race (OR=0.661, 95% CI: 0.599-0.729), Hispanic ethnicity (OR=0.569, 95% CI: 0.448-0.721), and increased social vulnerability (OR=0.608, 95% CI: 0.511-0.723) remained less likely to complete PROMs (all p<0.001). In the multivariate models assessing PROMIS scores by race, ethnicity, and SVI, patients of nonwhite race reported lower levels of physical function (PROMIS PF β=-6.5, p=0.032) and higher levels of pain intensity (β=0.6, p=0.005). Hispanic ethnicity and increased social vulnerability were each associated with increased pain intensity (Hispanic β=1.5, p=0.004; SVI β=1.1, p=0.002) but no significant differences in baseline physical function were observed. Race, ethnicity, and SVI were not associated with any statistically significant differences in pain interference scores. Our study highlights disparities in PROM completion rates and suggests that nonwhite patients, those of Hispanic ethnicity, and those at increased social vulnerability may be underrepresented in spine patient-reported outcomes. As these subpopulations may also have worse physical function or pain intensity, additional strategies are needed to better capture patient reported health status in order to avoid bias in clinical care, outcomes research and health policy. This abstract does not discuss or include any applicable devices or drugs. [ABSTRACT FROM AUTHOR]

The impact of sarcopenia on surgical outcomes has been well-documented, but its specific influence on the posterior lumbar interbody fusion (PLIF) surgery requires further exploration. In this context, the present aims to investigate the impact of sarcopenia on clinical outcomes following one or two-level PLIF. Additionally, the present study also aims to evaluate if muscle indices, including gluteal muscle index, derived from CT scans, can predict clinical outcomes. Prospective observational study. A total of 115 patients who underwent one or two-level PLIF from December 2021 to December 2022 were enrolled and analyzed prospectively. Sarcopenia diagnosis, muscle indices, and demographic data were analyzed using regression analysis to identify predictive factors for the Oswestry Disability Index (ODI) 12-month postoperatively. Sarcopenia was defined according to the 2018 Asian Working Group for Sarcopenia (AWGS) guidelines. Appendicular skeletal muscle mass (ASM) was measured using a full-body DEXA scan, with low ASM defined as < 7.0 kg/m² in men and < 5.4 kg/m² in women. Muscle strength was assessed using handgrip strength (HGS), with thresholds of 29 kg for men and 18 kg for women. Poor physical performance was identified using physical performance test, including 6-meter walk speed of less than 1.0 m/s or sit-to-stand time of 12 seconds or more. Muscle indices, including psoas muscle index (PMI), paraspinal muscle index (PaMI), and gluteal muscle index (GMI), were derived from CT scans. Out of 115 patients, 77 (65.2%) were diagnosed with sarcopenia according to the AWGS criteria. The sarcopenia group had statistically significantly lower BMI, ASM, PaMI, GMI, and poor preoperative ODI compared to the normal group. RM-ANOVA analysis showed significant differences in ODI scores between groups at 3-, 6-, and 12-months postoperatively, with the sarcopenia group exhibiting significant poorer outcomes at 12-months (sarcopenia vs normal group, 0.183 ± 0.149 vs 0.107 ± 0.055, P < 0.001). Multivariate regression analysis identified poor sit-to-stand test results, weak HGS, lower ASM, and lower GMI as poor predictive factors for ODI 12-month postoperatively. Patients diagnosed with sarcopenia exhibited poorer clinical outcomes 12-months postoperatively. In our study cohort, poor sit-to-stand test results, weak HGS, lower ASM, and lower GMI were identified as predictive factors for poor outcomes. Therefore, the presence of sarcopenia in patients considering fusion surgery necessitates careful consideration, as it may predispose them to poorer clinical outcomes. This abstract does not discuss or include any applicable devices or drugs. [ABSTRACT FROM AUTHOR]

Patients undergoing anterior/posterior lumbar fusion surgery can undergo either a single-stage or multi-stage operation depending on surgeon preference. There is limited evidence directly comparing outcomes between single- and multi-stage lumbar fusion surgery. To assess differences in outcomes between patients who underwent single- versus multi-stage lumbar fusion procedures in a multi-center setting. Not Applicable Not Applicable Not Applicable The Michigan Spine Surgery Improvement Collaborative database was queried for lumbar fusion surgeries between July 2018 and January 2022. Patients who underwent single-stage and multi-stage procedures were included. Primary outcomes included postoperative complications and improvement in patient-reported outcomes (PROs) which include: NASS patient satisfaction, PROMIS Physical Function, and EQ-5D. Propensity matching was conducted followed by Poisson generalized estimating equation models for multivariate analyses. Following propensity matching, 355 patients underwent single-stage procedures and 355 patients underwent multi-stage procedures. Patients undergoing multi-stage procedures had more complications, less patient satisfaction after 1 year, and were less likely to experience improvement in back pain after 90 days and at 2 years (1.17[1.02-1.34, p = 0.026], 0.83[0.74-0.93, p < 0.001], 0.86[0.75-0.99, p = 0.039], and 0.76[0.60-0.96, p = 0.023], respectively). On a matched cohort of patients undergoing lumbar 360 fusion, we observed that patients who undergo a multi-stage approach have higher postoperative complication rates and lower patient satisfaction compared to those who underwent single-stage procedures. Our findings suggest that single-stage lumbar 360 fusion surgery is tolerated well, if not better, than the multi-staged approach. This abstract does not discuss or include any applicable devices or drugs. [ABSTRACT FROM AUTHOR]

There is a paucity of literature comparing clinical outcomes by specific cervical level. To compare clinical outcomes through patient-reported outcome measures (PROMs) and minimum clinically important difference (MCID) achievement for patients undergoing 1-level anterior cervical discectomy and fusion (ACDF) or cervical disc replacement (CDR) at each individual cervical level. Retrospective Review. Patients undergoing 1-level ACDF or CDR. Patient-Reported Outcomes Measurement Information System Physical. Function (PROMIS-PF), Visual Analog Scale (VAS) Neck, VAS Arm, and Neck Disability Index (NDI). Patients undergoing 1-level ACDF or CDR were separated into 5 different cohorts depending on surgical level: C3-C4, C4-C5, C5-C6, C6-C7, and C7-T1. Patient demographics, perioperative characteristics, and PROMs were collected. PROMs of Patient-Reported Outcomes Measurement Information System Physical Function (PROMIS-PF), Visual Analog Scale (VAS) Neck, VAS Arm, and Neck Disability Index (NDI) were collected at preoperative and up to 2-year postoperative time points. MCID achievement was calculated by comparing deltaPROM to previously established values. Univariate analysis was utilized for demographics, perioperative characteristics, and preoperative PROMs. Multivariable linear and logistic regression accounting for demographic and perioperative characteristics were utilized for postoperative PROM comparison and MCID achievement, respectively. A total of 437 patients, with 25 patients undergoing surgery at C3-C4, 57 at C4-C5, 208 at C5-C6, 138 at C6-C7, and 9 at C7-T1. The mean postoperative follow-up was 9.81±7.87 months. Patients undergoing surgery at C3-C4 demonstrated inferior PROMIS-PF at the 6-week postoperative time point (p=0.009). Patients undergoing surgery at C7-T1 demonstrated superior VAS Neck at the final postoperative follow-up (p=0.009). No significant differences were reported in magnitude of postoperative improvement or MCID achievement. Patients undergoing ACDF or CDR demonstrated similar postoperative improvement in most PROMs. Magnitude of postoperative improvement and MCID achievement were similar regardless of operated level. This abstract does not discuss or include any applicable devices or drugs. [ABSTRACT FROM AUTHOR]

Steroid injections have gained prominence in the management of lumbosacral canal stenosis, a condition characterized by narrowing of the spinal canal in the lower back. This nonsurgical approach aims to alleviate pain and inflammation, providing relief for patients experiencing symptoms such as back pain, leg pain, and numbness. The injections deliver anti-inflammatory medication directly to the affected area, offering a targeted therapeutic option for those seeking conservative treatment for lumbosacral canal stenosis. N/A N/A N/A N/A A systematic review and meta analysis were done by searching the Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, MEDLINE (including MEDLINE InProcess) (OvidSP), Web of Science, Embase (OvidSP), and Scopus databases. ROB2 Cochrane Tools Assessment for RCTs. In the analysis, we used RevMan Cochrane software. Our comprehensive analysis included 22 studies, 18 randomized clinical trials, and 4 observational studies. The pooled analysis revealed a significant improvement in ODI score (mean difference [MD]: 5.83, 95% confidence interval [CI]: 1.58 to 10.08, p = 0.007, I2 = 99%) and VAS score (MD: 1.52, 95% CI: 0.30 to 2.74, p = 0.01, I2 = 96%) in patients who received placebo/control when compared to the patients who got steroid injection. No statistically significant differences were found in the NRS score, adverse events, weight change, Roland Morris disability score, SF-36 physical functioning change, or opioid intake between the two groups. However, a substantial enhancement in walking distance was noted among patients who received a steroid injection. Steroid injections offer a valuable adjunct in the management of lumbosacral canal stenosis. They provide effective short-term relief from pain and inflammation, allowing patients to engage in rehabilitation. However, their role as a long-term solution is limited. Combining injections with comprehensive treatment strategies can yield optimal results. Regular evaluation and personalized approaches are essential for achieving sustained relief and improving the quality of life for individuals with lumbosacral canal stenosis. This abstract does not discuss or include any applicable devices or drugs. [ABSTRACT FROM AUTHOR]

Modic changes have been linked to vertebrogenic chronic low back pain (CLBP). Vertebral endplates are innervated by the basivertebral nerve, making it a promising target for basivertebral nerve ablation (BVNA). This study aimed to evaluate the long-term efficacy and safety of BVNA for CLBP with Modic changes (ClinicalTrials.gov Ref #NCT05692440). This is a small-scale longitudinal series performed in a community practice setting. BVNA was performed by a single surgeon (WS) using the INTRACEPT® device (Relievant Medsystems, Inc.). Fifty-six patients with CLBP (pain persisting for ≥ 6 months) were recruited for BVNA, and 26 of them completed their 12 months follow-up. At baseline the average age was 71.9±9.3, 69.6% (N=39) were male, and 62.5% (N=35) experienced CLBP for over five years. Clinical improvements were recorded using the Oswestry Disability Index (ODI), the Visual Analog Scale (VAS) scale, the SF-36 Physical Component Summary (SF-36 PCS) and Mental Component Summary (MCS), at baseline, 1-month, 3-months, 6-months, and 12-months. The BVNA procedure was performed by a single surgeon (WS) using the INTRACEPT® device (Relievant Medsystems, Inc.). ODI pain intensity declined by 21.1 percent [95% CI: 14.7,27.5] at 1 month, 21.2 percent [95% CI: 14.7,27.6] at 3 months, 22.9 percent [95% CI: 16.4,29.3] at 6 months, and 22.9 percent [95% CI: 16.5,29.4] at 12 months from baseline. VAS pain intensity was reduced by 2.6 [95% CI: 1.5,3.7] at 1 month, 2.5 [95% CI: 1.4,3.6] at 3 months, 2.7 [95% CI: 1.6,3.8] at 6 months, and 3.0 [95% CI: 1.9,4.1] at 12 months from baseline. SF-36 PCS improved by 10.9 [95% CI: 7.3,14.5] at 1 month, 11.5 [95% CI: 7.9,15.1] at 3 months, and 12.3 [95% CI: 8.7,15.9] at 6 months, and 11.3 [95% CI: 7.7,15.0] at 12 months from baseline. SF-36 MCS improved by 6.0 [95% CI: 2.3,9.7] at 1 month, 6.7 [95% CI: 3.0,10.4] at 3 months, 7.4 [95% CI: 3.7,11.1] at 6 months, and 7.6 [95% CI: 3.9,11.3] at 12 months from baseline. All the measurements at every timepoint were significantly improved compared to baseline at a significance level of 5%. This study provides independent evidence that BVNA performed with the INTRACEPT® device in a community practice setting effectively improves pain, physical function, and mental function in CLBP patients. Further research with larger cohorts and longer follow-up periods is warranted to solidify the long-term benefits and potential limitations of BVNA for CLBP patients. To our knowledge, this is the first independently funded US study on basivertebral nerve ablation and the first independently funded study on an FDA-cleared device, the INTRACEPT® device. This abstract does not discuss or include any applicable devices or drugs. [ABSTRACT FROM AUTHOR]