This study investigates the link between changes in physical activity (PA) measured by wearable accelerometers and the worsening of knee osteoarthritis (KOA) symptoms over two years. Using data from 782 participants in the Osteoarthritis Initiative accelerometer sub-study, PA was tracked with hip-worn ActiGraphs. Participants were classified as "worsening" if their Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score increased by >10 points and as "stable" otherwise. PA was categorized into daily counts and minutes spent in various intensity levels, and analyzed in 3 h intervals across the day. Of the participants, 123 (15.7%) experienced worsening symptoms. At baseline, both groups had similar characteristics aside from slower sit-to-stand times in the worsening group. Over two years, the worsening group had a greater decline in total daily activity counts (-18% vs. -10%) and more significant reductions during late afternoon and evening (15:00-21:00; -21% vs. -6%). This group also showed a notable decrease in gait speed, longer sit-to-stand times, and a trend towards greater medial joint space narrowing. These findings suggest that larger declines in PA, especially in activities in the late afternoon and evening, are associated with worsening KOA symptoms, although causality cannot be established.

Background:Wearable inertial measurement units (IMUs) offer scalable, objective gait assessment, but detailed stride-level validation against motion capture and their ability to reflect physical activity (PA)-related gait differences in knee osteoarthritis (KOA) remain incompletely characterized. Objective:This study aimed to evaluate the technical validity of foot-mounted IMU-derived gait parameters compared with optical motion capture in individuals with KOA and healthy controls. As a secondary exploratory aim, we assessed whether IMU-derived gait parameters differed across self-reported PA levels. Methods:In this pilot cross-sectional validation study, 20 participants (KOA: n=10, 50%; healthy controls: n=10, 50%) completed 3 standardized walking conditions (self-paced, fast-paced, and endurance-equivalent). IMU-derived gait parameters were compared with motion capture at the stride level (≥5000 strides) using Pearson correlation, intraclass correlation coefficients (ICCs), mean absolute error, root mean square error, and Bland-Altman analysis. Participants completed the Stanford Brief Activity Survey to categorize PA level. Secondary analyses emphasized effect sizes and 95% CIs given the pilot design. Feasibility was assessed by protocol completion, data completeness, and tolerability. Results:IMU-derived gait speed demonstrated strong agreement with motion capture (r=0.99; ICC=0.98, 95% CI 0.95-0.99; mean absolute error=0.07 m/s; bias=0.01 m/s; 95% limits of agreement -0.14 to 0.16 m/s). Stride length and cadence showed similarly high agreement (ICC range 0.96-0.97). All participants completed the protocol with minimal adverse events. Exploratory analyses suggested that participants reporting higher PA demonstrated directionally faster gait speed and longer stride length, with small-to-moderate effect sizes, whereas inactive participants exhibited higher stance-related rhythm parameters. Conclusions:Foot-mounted IMUs demonstrated strong stride-level agreement with motion capture across walking conditions, supporting technical validity in both KOA and healthy populations. Exploratory findings suggest that wearable-derived gait parameters may reflect activity-related differences; however, larger longitudinal studies are required to confirm these preliminary signals.

Background:The C1-2 joint is a unique structure that when arthritic, can cause pain and restrictions in cervical rotation. Steroid injections into the lateral C1-2 joint can be performed, but the literature on outcomes is limited. Objective:To describe one tertiary spine center's outcomes in treating presumed C1-2 joint pain via intra-articular steroid injections over a recent 10-year period. Methods:Consecutive patients were identified using an institutional research repository database tool with the search terminology "C1-2", "atlantoaxial joint", or "AA joint" from January 2014 to January 2024. Patients were included in the analysis if they had received a C1-2 joint steroid injection and early follow-up outcomes were available in the electronic medical record system. Results:Outcome data was available on 52 patients over a 10-year period. Success was defined as ≥50 % improvement in the NRS pain score. Nineteen patients (37 % [95 % CI: 24-50 %]) reported a successful outcome at two weeks post-procedure. Longer-term outcomes data was not available. Discussion/conclusion:Intra-articular lateral C1-2 joint steroid injections may provide modest short-term pain relief in some patients with presumed C1-2 joint pain.

Introduction:Knee osteoarthritis (KOA) is the most common form of arthritis, leading to illness, decreased physical function, and reduced health-related quality of life (HR-QoL). Sit-to-stand (STS) testing is a commonly used measure of physical capacity in KOA. This study examined whether STS performance and moderate-to-vigorous physical activity (MVPA) helped account for the association between KOA pain and subsequent HR-QoL. Methods:Data across 2 years (at year 6 and year 8 visits) were used from the Osteoarthritis Initiative (OAI), a multisite, longitudinal study of people with or at risk for KOA. We used serial mediation analysis to examine whether year 6 STS performance and year 8 MVPA accounted for the association between year 6 KOA pain and year 8 HR-QoL, adjusting for age, sex, and race. Results:Significant correlations among all model variables supported model testing. The serial mediation model revealed that an increase in KOA pain predicted worse STS performance (β = .15; P < .001). MVPA was reduced by an increase in KOA pain (β = -.13; P < .001) but not STS (β = -.02; P = .46). MVPA subsequently predicted HR-QoL (β = .12; P < .001). The overall indirect pathway was significant (β = -0.02; 95% CI, -0.040 to -0.009), but the direct pathway also remained significant (β = -0.47; 95% CI, -0.536 to -0.410), denoting a partial mediation effect. Conclusion:STS performance and MVPA partially mediated the relationship between KOA pain and HR-QoL, highlighting mechanisms to address in future interventions for improving HR-QoL. These results support STS as a complementary tool to pain for understanding MVPA participation and HR-QoL in KOA patients. The findings also underscore the importance of integrating self-management strategies to address pain in behavior-change interventions.

BACKGROUND CONTEXT When chronic low back pain (CLBP) persists after conservative management, there are limited treatment options. Increasingly, researchers and clinicians are defining distinct phenotypes within the chronic low back pain population in order to develop and provide more targeted and effective interventions. One such phenotype involves people with mechanical low back pain and impaired motor control, identified with a positive prone instability test. Implantable restorative neurostimulation (ReActiv8, Mainstay Medical, San Diego CA) was developed to deliver an electrical stimulation to the L2 medial branch in two 30-minute intervals per day to restore multifidus function and improve chronic low back pain. Preliminary results were encouraging from a feasibility study, leading to a pivotal trial called “ReActive8-B” (https://clinicaltrials.gov/study/NCT02577354). While the pivotal trial demonstrated statistically significant benefits over the sham in all secondary outcomes, the primary outcome was inconclusive. More recently, results from a 1-year RCT comparing restorative neurostimulation to optimal medical management sheds new light on the timing of recovery from this therapy. PURPOSE This study was designed to re-evaluate the ReActive8 B outcomes in light of the newly published comparative-effectiveness trial and under parameters commonly employed in interventional pain trails. STUDY DESIGN/SETTING Prospective, randomized, double-blind, multicenter sham-controlled clinical trial. PATIENT SAMPLE From 26 centers, 204 participants between ages 22-75 were recruited with mechanical low back pain on at least half of the days in the prior year, despite physical therapy and 90 days of medical management, and a positive prone instability test on physical exam. OUTCOME MEASURES Participants completed several patient-reported-outcomes at baseline and at the primary endpoint of 120 days following implantation of the active stimulator or sham stimulator, including: VAS, ODI, EQ-5D, and subject global impression of change (SGIC). METHODS Using an intention to treat analysis, we compared differences between the active stimulator group and the sham group. Demographics were expressed using descriptive statistics. Patient reported outcomes were compared between groups with a categorical analysis, setting responder thresholds at commonly used benchmarks and established minimum clinically important change (MCIC) thresholds. Statistical significance was determined by a 2-sided p-value from the Fisher's exact test with significance set at p<0.05. RESULTS A total of 200 participants (100 active, 100 sham) were included in the ITT analysis with an average age of 46.47 ± 9.42 years and 54.5% (109/200) female. From baseline to the 120-day primary endpoint, statistically significant differences were observed in favor of active treatment at the MCIC thresholds of ODI: ≥15-point improvement (64.3% vs 47.5%; p=0.022) and ≥30% improvement (58.2% vs 40.4%; p=0.016); MCIC of EQ-5D: >0.15 improvement (56.1% vs 34.7%; p=0.004); and SGIC of ''better'' or more (54.1% vs 33.3%; p=0.004). Pain outcomes produced a mixed result with non-significant differences between active treatment and sham in the proportion of patients who reported >50% VAS improvement (43.9% vs 36.4%; p=0.311) or >2-point VAS improvement (60.2% vs 49.5%; p=0.153) while the average reduction in pain statistically favored active treatment (-3.3 vs -2.4; p=0.032). CONCLUSIONS At the primary endpoint of 120 days, employing common clinically relevant thresholds for success, this reanalysis of the ReActive8 B clinical trial demonstrated statically significant benefits in favor of active treatment in disability, quality of life and patient satisfaction, while improvements in pain bore mixed results. Consistent improvements in disability, quality of life, and patient satisfaction alongside inconsistent pain results at 120 days may reflect the mechanisms of action of restorative neurostimulation, or may be due to the timing of improvements in pain this therapy provides— as demonstrated in the more recent 1-year comparative effectiveness RCT and 5-year outcomes from the treatment arm of the ReActive8 B clinical trial. FDA Device/Drug Status ReActiv8 (Approved for this indication).

BACKGROUND CONTEXT: Randomized trials have demonstrated the superiority of intraosseous basivertebral nerve ablation (BVNA) compared with sham and standard care in terms of improvements in pain, disability, and health-related quality of life in patients with vertebrogenic chronic low back pain (cLBP). PURPOSE: To assess the cost effectiveness of BVNA in patients with vertebrogenic cLBP compared to standard care alone. STUDY DESIGN/ SETTING: A model-based economic analysis. PATIENT SAMPLE: Base case analysis used INTRACEPT, a randomized trial comparing BVNA with standard care in 140 patients with vertebrogenic cLBP, recruited from 23 sites across the United States, with a follow-up, up to 5 years. Scenario analyses compared data from the Surgical Multicenter Assessment of Radiofrequency Ablation for the Treatment of Vertebrogenic Back Pain (SMART) randomized trial against a sham control, and a single-arm study. OUTCOME MEASURES: Costs and quality-adjusted life years (QALYs) were calculated to determine the incremental cost-effectiveness ratio (ICER). METHODS: A cost-effectiveness model was built in Microsoft Excel to evaluate the costs and health outcomes of patients undergoing BVNA using the Intracept Procedure (Relievant Medsystems) to treat vertebrogenic cLBP from a US payor perspective. Alternative scenario sensitivity analyses and probabilistic sensitivity analyses were conducted to assess the robustness of the model results. QALYs were discounted at 3.0% per year. RESULTS: Base case analysis showed that BVNA relative to standard care alone was a cost-effective strategy for the management of patients with vertebrogenic cLBP, with an ICER of US$11,376 per QALY at a 5-year time horizon from introduction of the procedure. Modeling demonstrated a >99% probability that this was cost effective in the US, based on a willingness-to-pay threshold of US$100,000 to US$150,000. Various sensitivity and scenario analyses produced ICERs that all remained below this threshold. CONCLUSIONS: BVNA with the Intracept Procedure offers patients with vertebrogenic cLBP, clinicians, and healthcare systems a cost-effective treatment compared to standard care alone. (c) 2024 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY- NC license (http://creativecommons.org/licenses/by-nc/4.0/)

Wearable sensors provide objective gait assessments, but their feasibility for detecting gait differences across physical activity (PA) levels in knee osteoarthritis (KOA) is underexplored. To validate gait parameters derived from wearable inertial measurement units (IMUs) and assess the feasibility of using IMUs to characterize gait metrics across varying physical activity levels in individuals with knee osteoarthritis (KOA) and healthy controls. This pilot study enrolled 20 participants (KOA: n = 10; Healthy: n = 10). KOA severity was mostly moderate to severe (Kellgren-Lawrence grades 2–4). Participants completed gait assessments using IMUs and PA assessment using the Stanford Brief Activity Survey. Exploratory trends and effect sizes were analyzed. Descriptive trends suggested higher PA levels were associated with greater stride velocity and cadence, especially in the KOA group. Effect sizes were presented to guide future study planning. IMUs feasibly captured gait variability across PA levels in this preliminary sample. Larger powered studies are needed to establish definitive associations.

Background:Intra-articular cervical facet joint corticosteroid injections are commonly performed, yet studies demonstrating benefit are limited. Purpose:To evaluate success rates of intra-articular cervical facet joint corticosteroid injections in patients with increased peri-facet edema as demonstrated by MRI with STIR sequences. Study design:Preliminary, prospective, multi-center case series. Patient sample:Thirty-three patients from three independent spine centers. Methods:Consecutive patients were enrolled with axial neck pain and peri-facet joint edema on MRI with STIR sequences when undergoing intra-articular cervical facet joint corticosteroid injections. Outcomes were prospectively collected at 2-4-weeks and at 3-months post-injection. The primary outcome was the proportion of patients with at least 50 % improvement in the numeric rating scale (NRS) pain score. Neck disability index (NDI) and global perception of change (GPC) were evaluated as secondary outcomes. Results:At 2-4-weeks post-injection, 64 % [95 %CI: 46-79 %] of the 28 patients with follow-up data met criteria for success (≥50 % improvement in NRS). 86 % [95 %CI: 69-94 %] reported that they were better or much better on the GPC, and mean NDI improved from 19.3 to 8.9. At 3-months post-injection, 35 % [95 %CI: 19-54 %] of the 26 patients with follow-up data met criteria for success, and 50 % [95 %CI: 32-68 %] reported that they were better or much better on the GPC. Mean NDI at 3-months was 11.0. Conclusions:Intra-articular cervical facet joint corticosteroid injections may provide short-term relief of neck pain in patients with peri-facet edema as demonstrated by MRI with STIR sequences. Intermediate-term results are less encouraging.

Background Tracking spine intervention outcomes is costly and time-consuming, hindering research. Mobile health (mhealth) applications offer a promising solution to reduce the need to hire personnel to recruit patients and collect data. However, evidence supporting the use of mHealth to study pain and spine interventions is limited and heterogeneous. Objectives This study aims to understand how recruitment methods influence patient recruitment and retention in a digital study tracking pain. We hypothesize that in-person recruitment, especially with a physician rather than a research assistant, leads to higher recruitment and retention. Methods We designed a prospective observational study of patients scheduled for spine injections at an academic outpatient surgical center. Eligible patients were recruited via three methods: in-person research assistant, remote research assistant via phone, or in-person clinician. Upon enrollment, a mHealth application prompted patients to complete post-injection surveys at pre-defined intervals based on injection type. Enrollment and retention rates were then compared across recruitment groups. Results Of 194 patients approached, enrollment rates differed significantly by recruitment strategy: 94.1 % for in-person physicians (N = 32 enrolled/34 approached), 85.0 % for in-person research assistants (N = 51/60), and 30.0 % for remote research assistants (N = 30/100) (p < 0.009, Fisher's exact test). Of those recruited, survey completion rates were 74.4 % (physician-recruited patients), 55.1 % (in-person research assistant), and 58.4 % (remote research assistant). Neither demographic factors (age, sex, employment, payer type) nor injection type influenced enrollment. Retention differed significantly across groups (p = 0.0174, Kruskal-Wallis test), with physician-recruited patients completing the most surveys. Moreover, Medicare patients had significantly higher completion rates than those with Medicaid. Conclusion Tracking post-injection pain using mHealth applications is feasible, though success depends heavily on recruitment strategy. In-person physician-led enrollment resulted in the highest recruitment and retention rates though the drop-out rates were still significant. Future studies should focus on refining recruitment approaches to optimize patient participation.

Accurate measurement of physical activity (PA) using accelerometers is limited by sensitivities to sensor placement, particularly between the wrist and hip. This study evaluates these differences and proposes a harmonization approach to improve comparability among individuals with chronic low back pain. Data from the comeBACK study (NIH BACPAC, 1U19AR076737-01) included 179 participants (mean age 54.6 years, 56.4% female) who wore ActiGraph GT3X+ accelerometers on both the nondominant wrist and right hip for 7 days. PA metrics-step count, sedentary time, light physical activity, and moderate to vigorous physical activity-were analyzed. On average, wrist step counts were 3,500 steps higher per day than hip counts, with greater bias at lower activity levels. A piecewise linear regression model was developed to translate wrist-derived step counts to hip-equivalent values. Wrist cutpoints derived from percentile-matched resulted in less than 5-min bias in sedentary estimate. Moderate to vigorous physical activity estimates from wrist and hip were not directly comparable; although percentile-matching cutpoint reduced bias, it resulted in high variance. Light physical activity showed moderate agreement between wear locations but also exhibited high variance. Our findings reveal significant disparities in PA estimates from wrist-and hip-worn sensors, emphasizing the importance of cautious data interpretation across different wear locations. We quantified sensor bias and proposed calibration methods to support accurate comparisons of data from these two wear locations. These findings are valuable for researchers and clinicians aiming to assess PA in individuals with low back pain and harmonize data from diverse sensor placements.

BACKGROUND CONTEXT:When chronic low back pain (cLBP) persists after conservative management, there are limited treatment options. Increasingly, researchers and clinicians are defining distinct phenotypes within the cLBP population to develop and provide more targeted and effective interventions. One such phenotype involves people with mechanical low back pain and impaired motor control, identified by physical exam or MRI evidence of multifidus dysfunction. An implantable neurostimulation device that delivers an electrical stimulation to the L2 medial branch has been recently FDA-approved, with initially encouraging preliminary results. The pivotal trial demonstrated statistically-significant benefits over sham treatment in all secondary outcomes but not the primary outcome at the 120-day primary endpoint. However, recently published 1- and 5-year studies have shown better outcomes compared to optimal medical management. PURPOSE:It was our purpose to expand the comparison of clinical outcomes between this neurostimulation treatment and sham by reevaluating the data from the aforementioned pivotal trial using common clinically-relevant thresholds of treatment success that were not included in the pivotal trial's uncommon composite definition of treatment success or in its analysis of secondary outcomes for Oswestry Disability Index (ODI) and EQ-5D that compared mean improvements instead of categorical responder rates. STUDY DESIGN/SETTING:Posthoc reanalysis of previously published data from a prospective, randomized, double-blind, multicenter sham-controlled clinical trial. PATIENT SAMPLE:From 26 centers, 204 participants age 46.53±9.38 years (range 22-71) and 53.9% (110/204) female were recruited with mechanical cLBP despite physical therapy and medical management, and a positive prone instability test on physical exam. OUTCOME MEASURES:Participants completed several patient-reported outcomes at baseline and at the primary endpoint of 120 days following activation of the implanted stimulator or sham, including: visual analog scale, ODI, EQ-5D, and subject global impression of change. METHODS:Using a complete-case analysis, we compared differences between the neurostimulation treatment group and the sham-control group. Demographics are expressed using descriptive statistics. Patient-reported outcomes are compared between groups with a categorical analysis, setting responder thresholds at commonly used benchmarks and established minimum clinically important change (MCIC) thresholds. Statistical significance is determined by a 2-sided p-value from Fisher's exact test with significance set at p<.05. Potential conflicts of interest directly related to this manuscript include research funding to support MS (level e) and DL (level b). The sponsor funded the original sham-controlled trial and funded this reanalysis but had no role in the reanalysis design, its prespecified analysis plan, its statistical analysis, or manuscript preparation. The authors had full access to the data and final responsibility for the decision to submit. RESULTS:A total of 3 patients (2 active, 1 sham) were lost to follow-up, leaving 201 participants in the complete-case analysis. From baseline to the 120-day primary endpoint, statistically-significant differences were observed in favor of active treatment at the MCIC thresholds of ODI: ≥15-point improvement (59% vs 40.6%; p=.0111) and ≥30% improvement (65.0% vs 47.5%; p=.0156); the MCIC of EQ-5D: ≥0.15 improvement (57.0% vs 36.0%; p=.0045); and subject global impression of change of "better" or more (54.0% vs 33.7%; p=.0045). Pain outcomes were mixed; categorical responder rates did not differ significantly (MCIC ≥2-point visual analog scale improvement and ≥50% improvement), although mean changes favored active treatment (-3.3±2.7 vs -2.4±2.9; p=.0209). CONCLUSIONS:Comparing bilateral L2 medial branch restorative neurostimulation to sham at the primary endpoint of 120 days, employing common clinically-relevant thresholds for treatment success, this sponsor-funded reanalysis of the sham-controlled pivotal trial demonstrated statistically-significant and clinically meaningful benefits in favor of treatment in disability, quality of life, and patient satisfaction, while changes in pain bore mixed results.

Objectives To investigate updated, sex-stratified normative data for timed-up-and-go and one-leg-standing tests among 66-year-old Koreans. Design Retrospective cross-sectional study using a large, nationally representative data set. Setting and Participants Data were obtained with official permission from the Korean National Health Insurance Service database. This study included 66-year-old citizens who participated in the National Screening Program for Transitional Ages between January 1, 2008, and December 31, 2017. Participants with missing values for the timed-up-and-go or one-leg-standing tests were excluded from the analysis. A total of 2,704,715 participants were included (53.7% female), with 2,231,397 analyzed for one-leg-standing. Methods The timed-up-and-go and one-leg-standing results were sex-stratified, and means, SDs, and the 5th, 10th, 25th, 50th, 75th, 90th, and 95th percentiles were calculated for each group. The influence of demographic, health behavior, clinical, and comorbidity variables on test performance was analyzed. Results Men outperformed women in both timed-up-and-go (men: 8.20 ± 3.33 seconds; women: 8.59 ± 3.30 seconds; P < .001) and one-leg-standing (men: 20.39 ± 9.19 seconds; women: 18.26 ± 8.72 seconds; P < .001). Both sexes showed improvements in the 2 tests over the 9-year period. Female sex, low income, obesity, and chronic conditions negatively impacted performance. Conclusions and Implications This study provides updated normative values for timed-up-and-go and one-leg-standing, facilitating more accurate mobility assessments and risk screening. Observed improvements in both tests among 66-year-olds over the time course of the study reflect positive public health trends in Korea. These findings emphasize the need for population-specific reference values and standardized protocols. Tailored health interventions are necessary for vulnerable populations. Updating cutoff values based on demographic trends may improve early intervention strategies, ultimately enhancing functional health and quality of life in older adults.

Background:"Is this injection going to hurt?" Physicians typically answer this from experience since accurate answers are not available in the literature. Objective:To quantify pain during common lumbosacral spine injections and compare to baseline pain prior to the injections. Analyze differences based on demographic and procedure variables. Methods:This is a secondary analysis of prospectively collected data from a multicenter trial of patients undergoing bilateral symmetric transforaminal epidural (TFE), facet joint (FJ), or sacroiliac joint (SIJ) injections. Numeric pain ratings (0-10) were obtained at baseline in preop ("What is your current pain?") and for each injection procedure ("How much did this injection hurt from start to finish?") first on the right side then the left. Between group comparisons used Chi-squared and ANOVA for categorical and continuous variables, respectively. T-tests compared various pain responses, and multivariate regression determined factors associated with higher procedure pain. Results:From 244 injections (124 TFE, 60 FJ, 60 SIJ) on 122 consecutive patients (mean age 57.2, 50 % female), age and BMI did not differ between injection groups while sex did (p = 0.001) with more FJ males and SIJ females. Mean baseline pain was statistically equivalent between demographic and injection groups. Mean procedure pain was consistently higher than mean baseline pain, however this difference was small and non-significant for TFE (4.0 vs 3.8) and FJ (3.9 vs 3.3), but larger and significant for SIJ (5.3 vs. 3.6; p = 0.0001). In the multivariate regression analysis only 2 variables remained associated with higher procedure pain, older age (p < 0.0001) and SIJ injection group (p = 0.0021). Conclusion:The majority of patients (79.1 %) report mild or moderate pain during common lumbosacral spine injections. The average procedure pain of 4.3 on the NPRS scale was only 0.7 points higher than baseline pain recorded in pre-op. Procedure pain from TFE and FJ injections is statistically equivalent to baseline pain and to each other, while SIJ injections produce higher procedure pain with a significant +1.7 point mean increase in pain from baseline. Finally, older adults report significantly greater procedure pain compared to those under 65 years old.

BACKGROUND:The effectiveness and safety of intraosseous basivertebral nerve ablation (BVNA) for treating vertebrogenic pain is established, but low back pain-related healthcare utilization (LBPr-HU) following BVNA continues to be defined. METHODS:LBPr-HU data were pooled from 3 prospective studies. LBPr-HU categories of interest included non-invasive conservative care, opioid utilization, lumbosacral spinal injection (LSI), lumbosacral radiofrequency ablation (LRFA), and lumbosacral spinal surgery. Pre- and post-BVNA LBPr-HU were compared at both 1- and 5-years using McNemar's test for proportions and paired t-tests for means. RESULTS:Two hundred forty-seven patients received BVNA and had 1-year follow-up; 205 had long-term follow-up (mean of 5.3 ± 1.33 years). Twenty-seven percent fewer participants initiated conservative care in the year post-BVNA compared to the year preceding BVNA (P < .001; 95% CI 19.8-34.5). Of 77/247 participants taking opioids at baseline, 40.3% and 61.7% fewer were taking them at one-year and 5.3 ± 1.33 years post-BVNA, respectively (P < .001). Of participants receiving LSIs in the year preceding BVNA, 81.2% fewer received LSI(s) in the year post-BVNA (P < .001; 95% CI 70.7-90.7); a 76.4% reduction in LSIs was maintained through a mean of 5.3 ± 1.33 years post-BVNA. LRFA rates were 1.6% at 1-year post-BVNA and 8.3% at 5.3 ± 1.33 years post-BVNA. Lumbar fusion surgery was 0.8% at 1-year post-BVNA and 6.5% at 5.3 ± 1.33 years post-BVNA. CONCLUSIONS:In this aggregate analysis of patients with vertebrogenic pain, utilization of conservative care, opioids, LSIs, and LRFA were substantially reduced through 5 years post-BVNA compared to baseline. Lumbar fusion rates were less than half the published value at 5 years in similar populations.

BACKGROUND CONTEXT:Cervical epidural steroid injections (CESIs) are commonly used in management of cervical pathology. While severe complications have been reported, they are rare, and thus their incidence and risk factors have not been well characterized. PURPOSE:To determine the incidence of complications 7, 30, and 90 days after CESI and to identify associated risk factors. STUDY DESIGN:Retrospective cohort study of a large, national administrative claims database (MeritiveTM Marketscan®). PATIENT SAMPLE:The study included 229,412 patients (mean age 52.2 ± 11.3 years, 57.1% female) undergoing 448,209 CESIs from 2008 to 2015. OUTCOME MEASURES:Complication rates following CESI, and risk factors for complication. METHODS:Adults undergoing a CESI with active enrollment for one year prior to and 90 days after CESI were included. Patients with neoplasm, fracture, infection, inflammatory spondyloarthropathy or prior cervical surgery within one year preceding CESI were excluded. Multivariable repeated measures logistic regression models were used to identify risk factors for complications at 7, 30, and 90 days. Complications were stratified into procedural and medical complications. Each time point was modeled separately with Bonferroni adjustment for the multiple time points. RESULTS:Complications increased from 1.7% to 4.1%, to 8.0% within 7, 30, and 90 days, respectively. Procedural complications occurred in 0.6% of cases within 7 days, with neurologic complications occurring in 0.5% of cases. Medical complications occurred in 1.1%, 3.6%, and 7.2% within 7, 30 and 90 days, respectively. After multivariable risk adjustment, a transforaminal approach was associated with greater odd for procedural complications within 7 days relative to an interlaminar approach (p<.001), with an odds ratio (95% confidence interval) of 1.55 (1.35, 1.77). The transforaminal approach also was associated with greater odds of neurologic complications at 7 days [1.69 (1.45, 1.95); p<.001]. A myelopathy diagnosis was not associated with risk of overall, procedural, medical, or neurological complications. The most influential factors independently associated with greater odds of any complication within 30 days included anticoagulant prescription [5.40 (4.55, 6.41); p<.001] and history of venous thromboembolism [3.01 (2.40, 3.77); p<.001]. The factors most strongly associated with procedural complications at 7 days included history of neurologic deficit [3.04 (2.65, 3.50); p<.001] and antiplatelet medication prescription [2.21 (1.49, 3.27); p=.003]. CONCLUSIONS:Complications following CESIs are infrequent. Neurologic complications were most common among procedural complications at 0.5% at 7 days. The transforaminal approach was associated with higher procedural complication rate compared to the interlaminar approach. Procedural and neurological complications were also associated with multiple factors including obesity, existing neurologic deficit, anxiety, and antiplatelet medication prescription. Attention should be given to these factors to mitigate procedural complications.

Objective: To confirm that the simplified insole does not affect the gait speed and to identify objective sensor-based gait parameters that correlate strongly with existing clinical gait assessment scales.Methods: Ten participants with gait impairment due to hemiplegic stroke were enrolled in this study. Pairs of insoles with four pressure sensors on each side were manufactured and placed in each shoe. Data were extracted during the 10-Meter Walk Test. Several sensor-derived parameters (for example stance time, heel_on-to-toe_peak time, and toe_peak pressure) were calculated and correlated with gait speed and lower extremity Fugl-Meyer (F-M) score.Results: The insole pressure sensor did not affect gait, as indicated by a strong correlation (ρ=0.988) and high agreement (ICC=0.924) between the gait speeds with and without the insole. The parameters that correlated most strongly with highest β coefficients against the clinical measures were stance time of the non-hemiplegic leg (β=-0.87 with F-M and β=-0.95 with gait speed) and heel_on-to-toe_peak time of the non-hemiplegic leg (β=-0.86 with F-M and -0.94 with gait speed).Conclusion: Stance time of the non-hemiparetic leg correlates most strongly with clinical measures and can be assessed using a non-obtrusive insole pressure sensor that does not affect gait function. These results suggest that an insole pressure sensor, which is applicable in a home environment, may be useful as a clinical endpoint in post-stroke gait therapy trials.