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Study Design: Prospective observational cohort study., Objective: The aim of this study was to provide external validation of the minimum clinically important difference (MCID) of the Timed-up-and-go (TUG) test., Summary of Background Data: The TUG test is one of the best explored and most frequently applied objective task-based functional outcome measure in patients with lumbar degenerative disc disease (DDD). The increased use of the TUG test is based on its solid psychometric properties; however, an external validation of the originally determined MCID is lacking., Methods: Forty-nine patients with lumbar DDD, scheduled for elective spine surgery, were assessed pre- and 6-weeks (W6) postoperative. MCID values were calculate for raw TUG test times (seconds) and standardized TUG z scores using three different computation methods and the following established patient-reported outcome measures (PROMs) as anchors: Visual Analog Scales (VAS), Core Outcome Measures Index Back, Zurich Claudication Questionnaire (ZCQ)., Results: The three computation methods generated a range of MCID values, depending on the PROM used as anchor, from 0.9 s (z score of 0.3) based on the VAS leg pain to 3.0 seconds (z score of 2.7) based on the ZCQ physical function scale. The average MCID of the TUG test across all anchors and computation methods was 2.1 s (z score of 1.5). According to the average MCID of raw TUG test values or TUG z scores, 41% and 43% of patients classified as W6 responders to surgery, respectively., Conclusion: This study confirms the ordinally reported TUG MCID values in patients undergoing surgery for lumbar. A TUG test time change of 2.1 seconds (or TUG z score change of 1.5) indicates an objective and clinically meaningful change in functional status. This report facilitates the interpretation of TUG test results in clinical routine as well as in research.Level of Evidence: 3., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

Background: The Timed Up and Go (TUG) test is the most commonly applied objective measure of functional impairment in patients with lumbar degenerative disc disease (DDD)., Objective: To demonstrate external content validity of the TUG test., Methods: Consecutive adult patients, scheduled for elective lumbar spine surgery, were screened for enrollment into a prospective observational study. Disease severity was estimated by patient-reported outcome measures (PROMs; Visual Analog Scales [VAS], Core Outcome Measures Index [COMI] back, Zurich Claudication Questionnaire [ZCQ]) and the TUG test. Pearson correlation coefficients (PCCs) were used to describe the relationship between logarithmic TUG test raw values and PROMs., Results: A total of 70 patients (mean age 55.9 ± 15.4 yr; 38.6% female; 27.1% previous spine surgery; 28.6% lower extremity motor deficits) with lumbar disc herniation (50%), lumbar spinal stenosis (34.3%), or instability requiring spinal fusion (15.7%) were included. The mean TUG test time was 10.8 ± 4.4 s; age- and sex-adjusted objective functional impairment (OFI) T-score was 134.2 ± 36.9. A total of 12 (17.1%) patients had mild, 14 (20%) moderate, and 9 (12.9%) severe OFI, while 35 (50%) had TUG test results within the normal population range (no OFI). PCCs between TUG test time and VAS back pain were r = 0.37 (P = .002), VAS leg pain r = 0.37 (P = .002), COMI back r = 0.50 (P < .001), ZCQ symptom severity r = 0.41 (P < .001), and ZCQ physical function r = 0.36 (P = .002)., Conclusion: This external validation demonstrated similar OFI rates and PCCs between logarithmic TUG test results and PROMs compared to the original article from 2016. These findings support the TUG test being a quick, easy-to-use objective test, which provides the physician with a robust estimate of pain and functional impairment., (Copyright © 2020 by the Congress of Neurological Surgeons.)

Background: The worldwide spread of smartphone usage enables new possibilities for longitudinal monitoring of objective functional impairment (OFI) in patients undergoing surgery for lumbar degenerative disc disease (DDD)., Methods: Three patients, undergoing elective surgery for lumbar DDD, self-assessed OFI using a recently validated 6-min walking test (6WT) smartphone application. Results are presented as raw 6-min walking distance (6WD) as well as in reference to age- and sex-specific healthy population reference values using standardized z-scores (number of standard deviations). In parallel, patient-reported outcome measures (PROMs), including numeric rating scale (NRS) leg-pain and Core Outcome Measures Index (COMI) were obtained before (pre) and 6 weeks (6 W) as well as 3 months (3 M) after surgery. Descriptive analyses were used to compare PROMs with repeated 6WT measurements over time. The feasibility and benefits of the longitudinal OFI measurements using the 6WT app are discussed., Results: One patient presented a favorable outcome, reflected by a clinically meaningful improvement in PROMs. Correspondingly, the 6WT distance gradually improved above the normal population values ((pre 399 m (z-score - 1.96) vs. 6 W 494 m (- 0.85) vs. 3 M 557 m (- 0.1)). One patient experienced initial improvement at 6 W, followed by a decline in 6WD at 3 M which promoted further interventions with subsequent recovery ((358 m (z-score - 3.29) vs 440 m (- 2.2) vs 431 m (- 2.32) vs 471 m (- 1.78)). The last patient showed a lack of improvement in PROMs as well as in OFI (360 m (z-score 0.0) vs 401 m (0.30) vs 345 m (- 0.11)) resulting in secondary surgery., Conclusion: The longitudinal assessment of OFI using the 6WT app was feasible and provided the physician with a detailed history of patients' postoperative walking capacity complementing commonly used PROMs.

Objective: Digital transformation enables new possibilities to assess objective functional impairment (OFI) in patients with lumbar degenerative disc disease (DDD). This study examines the psychometric properties of an app-based 6-minute walking test (6WT) and determines OFI in patients with lumbar DDD., Methods: The maximum 6-minute walking distance (6WD) was determined in patients with lumbar DDD. The results were expressed as raw 6WDs (in meters), as well as in standardized z-scores referenced to age- and sex-specific values of spine-healthy volunteers. The 6WT results were assessed for reliability and content validity using established disease-specific patient-reported outcome measures., Results: Seventy consecutive patients and 330 volunteers were enrolled. The mean 6WD was 370 m (SD 137 m) in patients with lumbar DDD. Significant correlations between 6WD and the Core Outcome Measures Index for the back (r = -0.31), Zurich Claudication Questionnaire (ZCQ) symptom severity (r = -0.32), ZCQ physical function (r = -0.33), visual analog scale (VAS) for back pain (r = -0.42), and VAS for leg pain (r = -0.32) were observed (all p < 0.05). The 6WT revealed good test-retest reliability (intraclass correlation coefficient 0.82), and the standard error of measurement was 58.3 m. A 4-tier severity stratification classified patients with z-scores > -1 (no OFI), -1 to -1.9 (mild OFI), -2 to -2.9 (moderate OFI), and ≤ -3 (severe OFI)., Conclusions: The smartphone app-based self-measurement of the 6WT is a convenient, reliable, and valid way to determine OFI in patients with lumbar DDD. The 6WT app facilitates the digital evaluation and monitoring of patients with lumbar DDD.

Background Context: The accurate determination of a patient's functional status is necessary for therapeutic decision-making and to critically appraise treatment efficacy. Current subjective patient-reported outcome measure (PROM)-based assessments have limitations and can be complimented by objective measures of function., Purpose: To systematically review the literature and provide an overview on the available objective measures of function for patients with degenerative diseases of the lumbar spine., Study Design/setting: Systematic review of the literature., Methods: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines were followed. Two reviewers independently searched the PubMed, Web of Science, EMBASE, and SCOPUS databases for permutations of the words "objective," "assessment," "function," "lumbar," and "spine" including articles on human subjects with degenerative diseases of the lumbar spine that reported on objective measures of function, published until September 2018. Risk of bias was not assessed. No funding was received. The authors report no conflicts of interest., Results: Of 2,389 identified articles, 82 were included in the final analysis. There was a significant increase of 0.12 per year in the number of publications dealing with objective measures of function since 1989 (95% CI 0.08-0.16, p<.001). Some publications studied multiple diagnoses and objective measures. The United States was the leading nation in terms of scientific output for objective outcome measures (n=21; 25.6%), followed by Switzerland (n=17; 20.7%), Canada, Germany, and the United Kingdom (each n=6; 7.3%). Our search revealed 21 different types of objective measures, predominantly applied to patients with lumbar spinal stenosis (n=67 publications; 81.7%), chronic/unspecific low back pain (n=28; 34.2%) and lumbar disc herniation (n=22; 26.8%). The Timed-Up-and-Go test was the most frequently applied measure (n=26 publications; 31.7%; cumulative number of reported subjects: 5,181), followed by the Motorized Treadmill Test (n=25 publications; 30.5%, 1,499 subjects) and with each n=9 publications (11.0%) the Five-Repetition Sit-To-Stand test (955 subjects), as well as accelerometry analyses (336 subjects). The reliability and validity of many of the less-applied objective measures was uncertain. There was profound heterogeneity in their application and interpretation of results., Conclusions: Clinical studies on patients with lumbar degenerative diseases increasingly employ objective measures of function, which offer high potential for improving the quality of outcome measurement in patient-care and research. This review provides an overview on available options. Our findings call for an agreement and standardization in terms of test selection, conduction and analysis to facilitate comparison of results across cohorts., Prospero Registration Number: CRD42019122622., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background: Sagittal balance is widely recognized as an important outcome factor in reconstructive spinal surgery for lumbar degenerative conditions. However, its role in short segmental fixation is unknown. The aim of this study was to evaluate the preoperative and short-term postoperative spino-pelvic balance after short (1 or 2 levels) lordosizing lumbar fusion for degenerative disc disease (DDD)., Methods: Twenty-six consecutive patients (13 males and 13 females) undergoing mono- or bisegmental lordosizing lumbar fusion (XLIF/TLIF) for lumbar DDD were included in the study. Clinical parameters were retrospectively collected from charts. Preoperative and early postoperative (6 weeks and 3 months) full-spine EOS X-rays were evaluated. Spinal parameters evaluating sagittal curvatures, pelvic orientation, global sagittal and coronal alignment, spino-pelvic balance, index level segmental lordosis and disc height were measured and statistically analyzed., Results: A total of 16 TLIF and 10 XLIF procedures were performed. Eighteen were mono- and 8 were bisegmental fixations for a total of 34 fused segments. Seven patients (26.9%) showed a preoperative sagittal imbalance (defined as SVA>50 mm); 7 patients presented preoperative severe pelvic retroversion (defined as PT>20°) and 1 patient presented both. Disc height, intervertebral angle and segmental lordosis at the operated level significantly increased after surgery (P<0.01). No postoperative significant change in global sagittal alignment (SVA, TPA, T1SPi, T9SPi), pelvic orientation (SS, PT), coronal alignment, lumbar and L4-S1 lordosis and thoracic kyphosis have been observed., Conclusions: Mono- and bisegmental lordosizing fusion techniques, as XLIF and TLIF, are able to restore disc height and improve segmental lordosis. However they do not allow restoration of sagittal balance or improvement of compensatory mechanisms. A limited spinal reconstructive surgery on symptomatic levels can be reasonably proposed to patients with hidden or evident sagittal imbalance with any short-term radiographic impact.

OBJECTIVE The purpose of this study was to investigate whether the intraoperative application of an epidural steroid (ES) on the decompressed nerve root improves short- and midterm subjective and objective clinical outcomes after lumbar microdiscectomy. METHODS This study was a retrospective analysis of a 2-center database including consecutive cases in which patients underwent lumbar microdiscectomy. All patients who received ES application (40 mg triamcinolone, ES group) were matched by age and sex to patients who had not received ES application (control group). Objective functional impairment (OFI) was determined using age- and sex-adjusted T-scores of the Timed Up and Go (TUG) test. Back and leg pain (visual analog scale), functional impairment (Oswestry Disability Index [ODI], Roland-Morris Disability Index [RMDI], and health-related quality of life (hrQoL; 12-Item Short Form Health Survey [SF-12] physical component summary [PSC] score and EuroQol [EQ-5D index]) were measured at baseline, on postoperative day 3, and at postoperative week 6. RESULTS Fifty-three patients who received ES application were matched with 101 controls. There were no baseline demographic or disease-specific differences between the study groups, and preoperative pain, functional impairment, and hrQoL were similar. On postoperative day 3, the ES group had less disability on the RMDI (mean 7.4 vs 10.3, p = 0.003) and higher hrQoL as determined by the SF-12 PCS (36.5 vs 32.7, p = 0.004). At week 6, the ES group had less disability on the RMDI (3.6 vs 5.7, p = 0.050) and on the ODI by trend (17.0 vs 24.4, p = 0.056); better hrQoL, determined by the SF-12 PCS (44.3 vs 39.9, p = 0.018); and lower OFI (TUG test T-score 100.5 vs 110.2, p = 0.005). The week 6 responder status based on the minimum clinically important difference (MCID) was similar in the ES and control groups for each metric. The rates and severity of complications were similar, with a 3.8% and 4.0% reoperation rate in the ES group and control group, respectively (p = 0.272). There was a tendency for shorter hospitalization in the ES group (5.0 vs 5.8 days, p = 0.066). CONCLUSIONS Intraoperative ES application on the decompressed nerve root is an effective adjunct treatment that may lower subjective and objective functional impairment and increase hrQoL in the short and intermediate term after lumbar microdiscectomy. However, group differences were lower than the commonly accepted MCIDs for each metric, indicating that the effect size of the benefit is limited. ■ CLASSIFICATION OF EVIDENCE Type of question: therapeutic; study design: retrospective cohort trial; evidence: Class II.

Background Context: The Timed Up and Go (TUG) test has recently been proposed as a simple and standardized measure for objective functional impairment (OFI) in patients with lumbar degenerative disc disease (DDD)., Purpose: The study aimed to explore the relationship between a patient's mental health status and both patient-reported outcome measures (PROMs) and TUG test results., Study Design/setting: This is a prospective institutional review board-approved two-center study., Patient Sample: The sample was composed of 375 consecutive patients scheduled for lumbar spine surgery and a healthy cohort of 110 control subjects., Outcome Measures: Patients and control subjects were assessed with the TUG test and a comprehensive panel of subjective PROMs of pain intensity (visual analog scale [VAS]), functional impairment (Roland-Morris Disability Index [RMDI]), Oswestry Disability Index [ODI]), as well as health-related quality of life (hrQoL; Euro-Qol [EQ]-5D)., Methods: Standardized age- and sex-adjusted TUG test T-scores were calculated. The dependent variable was the short-form (SF)-12 mental component summary (MCS) quartiles, and the independent variables were the TUG T-scores and PROMs. Direct and adjusted analyses of covariance were performed to estimate the interaction between the SF-12 MCS quartiles and the independent variables., Results: In patients, there was a significant decrease in the subjective PROMs, notably the VAS back pain (p=.001) and VAS leg pain (p=.035), as well as significant increase in the RMDI (p<.001), ODI (p<.001), and the EQ-5D index (p<.001) with every increase in the quartile of the SF-12 MCS. There were no significant group differences of OFI as measured by the TUG T-scores across the SF-12 MCS quartiles (p=.462). In the healthy control group, a significant decrease in VAS leg pain (p=.028), RMDI (p=.013), and ODI (p<.001), as well as a significant increase in the EQ-5D index (p<.001), was seen across the SF-12 MCS quartiles, whereas TUG T-scores remained stable (p=.897)., Conclusions: There are significant influences of mental hrQoL on subjective measures of pain, functional impairment, and hrQoL that might lead to bias when evaluating patients with lumbar DDD who suffer from reduced mental hrQoL. The TUG test appears to be a stable instrument and especially helpful in the evaluation of patients with lumbar DDD and mental health problems., (Copyright © 2016 Elsevier Inc. All rights reserved.)

OBJECTIVE The Timed Up and Go (TUG) test is a simple, objective, and standardized method to measure objective functional impairment (OFI) in patients with lumbar degenerative disc disease (DDD). The objective of the current work was to validate the OFI baseline severity stratification (BSS; with levels of "none," "mild," "moderate," and "severe"). METHODS Data were collected in a prospective IRB-approved 2-center study. Patients were assessed with a comprehensive panel of scales for measuring pain (visual analog scale [VAS] for back and leg pain), functional impairment (Roland-Morris Disability Index [RMDI] and Oswestry Disability Index [ODI]), and health-related quality of life (HRQOL; EQ-5D and SF-12). OFI BSS was determined using age- and sex-adjusted cutoff values. RESULTS A total of 375 consecutive patients scheduled for lumbar spine surgery were included. Each 1-step increase on the OFI BSS corresponded to an increase of 0.53 in the back pain VAS score, 0.69 in the leg pain VAS score, 1.81 points in the RMDI, and 5.93 points in the ODI, as well as to a decrease in HRQOL of -0.073 in the EQ-5D, -1.99 in the SF-12 physical component summary (PCS), and -1.62 in the SF-12 mental component summary (MCS; all p < 0.001). Patients with mild, moderate, and severe OFI had increased leg pain by 0.90 (p = 0.044), 1.54 (p < 0.001), and 1.94 (p < 0.001); increased ODI by 7.99 (p = 0.004), 12.64 (p < 0.001), and 17.13 (p < 0.001); and decreased SF-12 PCS by -2.57 (p = 0.049), -3.63 (p = 0.003), and -6.23 (p < 0.001), respectively. CONCLUSIONS The OFI BSS is a valid measure of functional impairment for use in daily clinical practice. The presence of OFI indicates the presence of significant functional impairment on subjective outcome measures.

Background: Numerous studies assessed the effects of smoking on lumbar degenerative disk disease (DDD); they focused on patient-reported outcome measures (PROMs) and yielded conflicting results., Methods: In this 2-center study on consecutive patients receiving surgical treatment for lumbar DDD, subjective functional impairment (SFI) in terms of PROMs including visual analog scale back and leg pain, Roland-Morris, Oswestry Disability Index, Euro-Qol-5D, and a Short-Form 12 physical component summary was determined at baseline, 3 days, 6 weeks, 6 months, and 1 year postoperatively. Age- and sex-adjusted T-scores of objective functional impairment (OFI) were determined using the Timed Up and Go test up to 6 weeks postoperatively. The responder status was defined by the minimal clinically important difference., Results: We analyzed 375 patients (n = 96 [25.6%] smokers and n = 279 [74.4%] nonsmokers). SFI on any of the PROMs before treatment was similar in smokers and nonsmokers. Smokers were more likely to have OFI in univariate logistic regression analysis (95% confidence interval 1.31-3.37, P = 0.002). In multivariate analysis, however, this relationship became insignificant (95% confidence interval 0.85-2.38, P = 0.184). The smoking status had no predictive capacity on the 6-week SFI or OFI responder status, and there were no differences in any of the PROMs until the 1-year follow-up., Conclusions: PROMs measuring SFI for pain intensity, functional impairment, and health-related quality of life were similar in smokers and nonsmokers before surgery for lumbar DDD, as well as postoperatively. The smoking status has negligible impact on the Timed Up and Go test, which appears to be a robust assessment tool for OFI., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Background: The Timed Up and Go Test (TUG Test) has previously been described as a reliable tool to evaluate objective functional impairment in patients with degenerative disc disease., Objective: The aim of this study was to assess the minimum clinically important difference (MCID) of the TUG Test., Methods: The TUG Test (measured in seconds) was correlated with validated patient-reported outcome measures (PROs) of pain intensity (Visual Analog Scale for back and leg pain), functional impairment (Oswestry Disability Index, Roland Morris Disability Index), and health-related quality of life measures (Short Form-12 and EuroQol 5D). Three established methods were used to establish anchor-based MCID values using responders of the following PROs (Visual Analog Scale back and leg pain, Oswestry Disability Index, Roland Morris Disability Index, EuroQol 5D index, and Short Form-12 Physical Component Summary) as anchors: (1) average change, (2) minimum detectable change, and (3) change difference approach., Results: One hundred patients with a mean ± SD age of 56.2 ± 16.1 years, 57 (57%) male, 45 patients undergoing microdiscectomy, 35 undergoing lumbar decompression, and 20 undergoing fusion surgery were studied. The 3 MCID computation methods revealed a range of MCID values according to the PRO used from 0.9 s (Oswestry Disability Index based on the change difference approach) to 6.0 s (EuroQol 5D index based on the minimum detectable change approach), with a mean MCID of 3.4 s for all measured PROs., Conclusion: The MCID for the TUG Test time is highly variable depending on the computation technique used. The average TUG Test MCID was 3.4 s using all 3 methods and all anchors., (Copyright © 2017 by the Congress of Neurological Surgeons)

Background: The Timed Up and Go (TUG) test, as a measure of objective functional impairment in lumbar degenerative disk disease (DDD), complements patient-reported outcome measures (PROMs) of subjective functional impairment., Methods: Prospective 2-center study on consecutive patients scheduled for surgical treatment for lumbar DDD who underwent an objective (TUG test) and subjective (PROMs) functional assessment before and 1 and 3 days after surgery. PROMs included the visual analog scale (VAS), Roland-Morris Disability Index (RMDI), Oswestry Disability Index (ODI), Euro-Qol (EQ-5D), and Short Form 12 (SF-12) questionnaires. On completion of each assessment, patients were asked whether they would prefer performing the TUG test or completing the PROMs questionnaires., Results: A total of 109 of 125 patients (87.2%) completed the assessments. Preoperatively, patients were 2.18 times as likely to prefer the TUG test to the PROMs (odds ratio [OR], 2.18; 95% confidence interval [CI], 1.27-3.75). On postoperative days 1 and 3, patients were 5.79 (OR, 5.79; 95% CI, 3.23-10.37) and 6.33 times as likely to prefer the TUG test to the PROMs, respectively (OR, 6.33; 95% CI, 3.51-11.41). There were no statistical differences in baseline characteristics, TUG t scores, VAS, RMDI, ODI, SF-12, and EQ-5D index between patients preferring either the TUG test or the PROMs questionnaires., Conclusions: The TUG test is preferred over a battery of PROMs by 60%-70% of patients with lumbar DDD not only in the preoperative, but also in the postoperative, setting. High functional disability does not result in avoidance of the TUG test, and repeated assessments lead to higher preference., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Extreme lateral interbody fusion (XLIF) is an alternative to standard posterior approaches for achieving fusion in the lumbar spine. It allows exposure of the lateral aspect of the lumbar disc through a lateral approach with the possibility to insert a wide footprint interbody cage as a stand-alone procedure or associated with a uni- or bilateral percutaneous fixation. This is a retrospective series of 20 consecutive patients operated with a XLIF procedure from 2014 to 2015. N=10 women and N=10 men with a mean age of 67.5years (range 37.9-81.2) were included in the study. N=18 patients have been operated at one level, while N=2 patients underwent a double-level XLIF. The index levels were: L2-L3 in 2, L3-L4 in 7, L4-L5 in 9 and L3-L5 in 2 patients, respectively. The mean clinico-radiological follow-up was 9.8months (range 2.5-16.6). The clinical outcome was assessed with the Oswestry Disability Index (ODI), Euro-Qol (EQ)-5D, visual analogue scale (VAS) and EQ-5D index scores. Preoperative, postoperative and follow-up sagittal balance was assessed by EOS full spine X-ray. Furthermore, presence or absence of fusion was assessed by thin cuts CT scan at the end of the follow-up. The analysis highlighted a clear clinical improvement for the study collective. The mean ODI improved from 41.6 preoperatively to 23.5 at the last follow-up (p<0.0036). EQ-5D VAS and EQ-5D index improved from 45.5 to 71.8 (p<0.0001) and from 0.454 to 0.693 (p<0.0002), respectively. Analysis of the sagittal balance revealed an increase of the total lumbar lordosis, however not in a statistically significant manner (p=0.164). Furthermore, an increase of 55.7% in mean disc height (from 7.0mm to 10.9mm) has been observed (p<0.0001). Surprisingly, the right foramen height was increased in a statistically significant manner compared to the left one, but both of them increased in absolute values. However, foraminal area on both sides did not significantly increase. The mean canal area was 115.7mm 2 preoperatively and 136.5mm 2 at follow-up (p=0.1325). Radiological fusion was observed in every case at the end of the follow-up period. The XLIF procedure accomplishes a secure and effective interbody fusion. This approach allows for an indirect decompression of neural structures by restoring foramen dimensions and disc space height, leading to an improvement of symptoms. Furthermore, XLIF seems to improve segmental sagittal balance., (Copyright © 2016 Elsevier Ltd. All rights reserved.)

Purpose: The goal of this study is to determine the relationship of radiological grading scales of lumbar degenerative disc disease (DDD) with postoperative pain intensity, functional impairment, and health-related quality of life (HRQoL)., Methods: Response to surgical treatment at 6 weeks (W6) on the visual analogue scale (VAS) for back and leg pain, Oswestry-Disability (ODI) and Roland-Morris Disability Index (RMDI), Timed Up and Go (TUG) test, EuroQol (EQ) 5D, and Short-Form Health-Survey (SF-12) physical component summary (PCS) was compared between patients with different Modic (MOD) and Pfirrmann (PFI) grades. Longitudinal outcomes at day 3 (D3), W6, 6 months (M6), and 1 year (Y1) were compared., Results: The study included 338 patients (mean age, 58.6 years), of which n = 202 (59.8%) had MOD 1-3 and n = 217 (64.2%) PFI 4-5 changes. Patients with MOD 1-3 were as likely as patients without MOD changes to be treatment-responders at W6 in terms of VAS leg pain, ODI, RMDI, TUG, EQ5D, and SF-12 PCS. Similarly, patients with PFI 4-5 were as likely as patients with PFI 1-3 changes to be treatment-responders at W6. Longitudinal outcomes were similar at D3, W6, M6, and Y1 between patients with and without MOD changes. Patients with PFI 4-5 fared similar to those with PFI 1-3 except for inferior HRQoL on the SF-12 PCS metric at Y1., Conclusions: There was no distinct relationship between commonly used radiological grading scales of lumbar DDD with clinical outcome. Therefore, no prognosis should be made on the grounds of preoperative PFI and MOD classifications for patients undergoing spine surgery for lumbar DDD.

Objective: To analyze the influence of body mass index (BMI) on subjective and objective measures of pain, functional impairment, and health-related quality of life in patients with lumbar degenerative disc disease undergoing surgery., Methods: Prospective institutional review board-approved 2-center study, measuring visual analog scale (VAS) back and leg pain, Roland-Morris Disability Index (RMDI), Oswestry Disability Index (ODI), EuroQol 5D questionnaire, and Short Form-12 at baseline, 6 weeks, 6 months, and 1 year postoperatively. T-scores of objective functional impairment (OFI) were determined using the Timed Up and Go (TUG) test., Results: A total of 375 patients with a median BMI of 26.6 kg/m 2 (94 obese patients [BMI ≥30 kg/m 2 ]) were included. Obese patients presented more VAS back pain (mean, 4.7 vs. 3.6; P = 0.001) and greater disability on the RMDI (mean, 12.6 vs. 11.3; P = 0.045). The prevalence and severity of OFI were similar in obese and nonobese patients. There was a weak positive correlation between BMI and VAS back pain (r = 0.1552; P = 0.0026), on both RMDI (r = 0.1138; P = 0.0276) and ODI (r = 0.1075; P = 0.0374). There was no correlation between BMI and TUG T-scores (r = 0.0475; P = 0.3585). Obese patients were as likely as nonobese patients to show a positive 6-week treatment response, and the outcome up to 1 year was similar., Conclusions: BMI positively correlates with VAS back pain, RMDI, and ODI. Standardized TUG T scores reflect the patient's degree of OFI well, irrespective of BMI. The TUG test appears to be a good means to estimate functional impairment in populations with a high prevalence of obesity., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Background: Demographic changes will lead to an increase of elderly people in our population and consecutively to a higher prevalence of patients suffering from degenerative disc disease (DDD). The goal of this study was to investigate age-related differences in pain intensity, subjective and objective functional impairment and health-related quality of life (HRQoL) in patients with lumbar DDD., Methods: In a prospective two-center study, back and leg pain intensity (visual analogue scale (VAS)), functional impairment (Oswestry Disability Index (ODI), Roland-Morris Disability Index (RMDI)) and HRQoL (EuroQol-5D (EQ-5D), Short-Form (SF12)) were collected for consecutive patients undergoing lumbar spine surgery. Objective functional impairment (OFI) was measured using the Timed Up and Go (TUG) test. Adjusted partial correlation was used to correlate age to each scale preoperatively, as well as to the postoperative improvement at six weeks., Results: A total of n=377 patients (161 females, 42.7%) with a mean age of 58.5 years (SD 15.7, range 18.0-93.7) were included. Unadjusted TUG test raw times naturally increased with age, whereas the age-effect on standardized OFI T-scores was close to zero in patients with a lumbar disc herniation (LDH; r=-0.0666, p=0.367) or lumbar spinal stenosis (LSS; r=-0.0134, p=0.879). There was a weak correlation between age and higher ODI (LDH: r=0.1289, p=0.089; LSS: r=0.1975; p=0.027), lower EQ-5D (LSS: r=-0.1824, p=0.042) and higher RMDI by trend (LSS: r=0.1679, p=0.061). The correlation between age and postoperative improvement was negative on the VAS for back pain (LDH: r=-0.3189, p=0.026), VAS for leg pain (LDH: r=-0.3656, p=0.009) and RMDI by trend (LSS: r=-0.2004, p=0.069), as well as positive on the EQ-5D index (r=0.2412, p=0.011), indicating that younger patients showed better improvement. Due to in-group heterogeneity, no age-effect could be calculated for patients scheduled for surgical fusion., Conclusions: The influence of age on subjective and objective measures of pain, functional impairment and HRQoL is limited for patients with LDH and LSS, but suggests an age-dependent increase of functional disability. Younger patients generally showed greater postoperative improvement at six weeks than older patients., (Copyright © 2016 Elsevier B.V. All rights reserved.)

Background: The Timed Up and Go (TUG) test is a reliable tool for evaluating objective functional impairment (OFI) in patients with degenerative disc disease before a surgical intervention. The aim of this study is to assess the validity of the TUG test to measure change in function postoperatively., Methods: In a prospective two-center study, OFI was assessed by the TUG test in patients scheduled for lumbar spine surgery, as well as 3 days (D3) and 6 weeks (W6) postoperatively. At each time point, the TUG test results were correlated with established subjective measures of pain intensity (visual analogue scale (VAS) for back and leg pain), functional impairment (Oswestry Disability Index (ODI)) and health-related quality of life (HRQoL; Short Form-12 (SF12))., Results: The patient cohort comprised 136 patients with a mean age of 57.7 years; 76 were males, 54 had a microdiscectomy for lumbar disc herniation, 58 a decompression for a lumbar spinal stenosis, 24 had a surgical fusion procedure. The mean OFI t-score was 125.1 before surgery, and as patients improved on the subjective measures in the postoperative interval, the OFI t-score likewise decreased to 118.8 (D3) and 103.4 (W6). The Pearson correlation coefficient (PCC) between the OFI t-score and VAS leg pain was 0.187 preoperatively (p = 0.029) and 0.252 at W6 (p = 0.003). The PCC between OFI t-score and the ODI was 0.324 preoperatively (p < 0.001) and 0.413 at W6 (p < 0.001). The PCC between OFI t-score and physical HRQoL (SF12) was -0.091 preoperatively (p = 0.293) and -0.330 at W6 (p < 0.001)., Conclusions: The TUG test is sensitive to change, and reflects the postoperative functional outcome even more exact than preoperatively, as indicated by better correlation coefficients of the OFI t-score with subjective measures of pain intensity, functional impairment and HRQoL.

Background: There are few objective measures of functional impairment to support clinical decision making in lumbar degenerative disc disease (DDD)., Objective: We present the validation (and reliability measures) of the Timed Up and Go (TUG) test., Methods: In a prospective, 2-center study, 253 consecutive patients were assessed using the TUG test. A representative cohort of 110 volunteers served as control subjects. The TUG test values were assessed for validity and reliability., Results: The TUG test had excellent intra- (intraclass correlation coefficient: 0.97) and interrater reliability (intraclass correlation coefficient: 0.99), with a standard error of measurement of 0.21 and 0.23 seconds, respectively. The validity of the TUG test was demonstrated by a good correlation with the Visual Analog Scale (VAS) back (Pearson's correlation coefficient [PCC]: 0.25) and VAS (PCC: 0.29) leg pain, functional impairment (Roland-Morris Disability Index [PCC: 0.38] and Oswestry Disability Index [PCC: 0.34]), as well as with health-related quality of life (Short Form-12 Mental Component Summary score [PCC: -0.25], Short Form-12 Physical Component Summary score [PCC: -0.32], and EQ-5D [PCC: -0.28]). The upper limit of "normal" was 11.52 seconds. Mild (lower than the 33rd percentile), moderate (33rd to 66th percentiles), and severe objective functional impairment (higher than the 66th percentile) as determined by the TUG test was <13.4 seconds, 13.4 to 18.4 seconds, and >18.4 seconds, respectively., Conclusion: The TUG test is a quick, easy-to-use, valid, and reliable tool to evaluate objective functional impairment in patients with lumbar degenerative disc disease. In the clinical setting, patients scoring a TUG test time of over 12 seconds can be considered to have functional impairment., Abbreviations: BMI, body mass indexDDD, degenerative disc diseaseHRQOL, health-related quality of lifeICC, intraclass correlationLDH, lumbar disc herniationLSS, lumbar spinal stenosisODI, Oswestry Disability IndexOFI, objective functional impairmentPCC, Pearson's correlation coefficientPCS, Physical Component SummaryRMDI, Roland-Morris Disability IndexSF, Short FormVAS, visual analog scale.

Objectives: A growing number of studies focus on sex differences in the pre- and postoperative setting in patients with degenerative disc disease (DDD). The exact pathomechanism behind this phenomenon, however, remains unclear. The objective of this study was to investigate pre- and postoperative sex differences in patients with lumbar DDD., Patients and Methods: In a prospective two-center study, back and leg pain (Visual Analogue Scale (VAS)), functional disability (Oswestry Disability Index (ODI) and Roland-Morris Disability Index) and health-related quality of life (HRQoL) (EuroQol 5D and Short-Form (SF12)) were collected for patients scheduled for lumbar spine surgery. In addition to the subjective functional impairment (SFI), objective functional impairment (OFI) was estimated using age- and sex-adjusted cut-off values for the timed-up-and-go (TUG) test. The 6-week responder status was defined using minimally clinically important differences of the ODI, SF12 PCS, VAS back and leg pain in all patients. Six months and one year follow-up (FU) was available in n=127 and n=87 patients, respectively., Results: The patient cohort comprised of n=214 patients (41.6% females). Preoperatively, female patients scored significantly worse on VAS back and leg pain, ODI and SF12 PCS (p<0.033), while OFI was similar (p=0.334). At the 6 week FU, sex-related differences had resolved for SFI and OFI was similar as well (p=0.333). There were no sex differences in the mean improvement after 6 weeks for all measures of pain intensity, functional impairment and HRQoL (p>0.182). Male and female patients profited equally on measures of SFI and HRQoL up to six months and one year after surgery (p>0.091)., Conclusion: Preoperatively, female patients scored worse in terms of SFI, while OFI was similar. Consecutively, OFI appears to be less prone to sex bias and may thus serve as a valuable surrogate-marker of disability. The disadvantageous preoperative SFI-status did not translate into worse postoperative results, as no sex differences were present at the 6-week, 6-months and 1-year follow-up., (Copyright © 2016 Elsevier B.V. All rights reserved.)

Sex differences in pain perception are known to exist; however, the exact pathomechanism remains unclear. This work aims to elucidate sex differences in subjective and objective measures of pain, functional impairment, and health-related quality of life (HRQoL) in patients with lumbar degenerative disc disease. In a prospective 2-center study, back and leg pain (visual analogue scale [VAS]), functional disability (Oswestry Disability Index and Roland-Morris Disability Index), and HRQoL (EuroQol-5D and Short Form [SF12]) were collected for consecutive patients undergoing lumbar spine surgery. Objective functional impairment (OFI) was estimated using age-adjusted and sex-adjusted cutoff values for the timed-up-and-go (TUG) test. A healthy cohort of n = 110 subjects served as the control group. Univariate and multivariate analyses were performed to test the association between sex and pain, subjective and OFIs, and HRQoL. The study comprised n = 305 patients (41.6% females). Female patients had more VAS back pain (P = 0.002) and leg pain (P = 0.014). They were more likely to report higher functional impairment in terms of Oswestry Disability Index (P = 0.005). Similarly, HRQoL measured with the EuroQol-5D index (P = 0.012) and SF12 physical composite score (P = 0.005) was lower in female patients. Female patients reported higher VAS back and leg pain, functional impairment, and reduced HRQoL than male patients. However, there were no sex differences with respect to the presence and degree of OFI measured by the TUG test using age-adjusted and sex-adjusted cutoff values. As such, the TUG may be a good test to overcome sex bias for the clinical assessment of patients with degenerative disc disease.

We report on the use and performance of an objective measure of functional impairment, the timed up and go (TUG) test, in clinical practice for patients with lumbar degenerative disc disease (DDD). We illustrate nine representative patients with lumbar DDD, who were selected from an ongoing prospective study, to report our clinical experience with the TUG test. In addition, a preliminary sample of 30 non-selected consecutive patients is presented. The following parameters were assessed preoperatively, and 3 days and 6 weeks postoperatively: back and leg pain using the visual analogue scale (VAS); functional impairment using the Oswestry disability index (ODI) and Roland-Morris disability index (RMDI); health-related quality of life using the EuroQol 5D (EQ5D) and Short-Form 12 (SF-12). The TUG test results improved by 2.6 and 5.4s after 3 days and 6 weeks compared to the baseline assessment. The mean VAS for back and leg pain decreased by 2.3 and 5.3, respectively, after 3 days, and by 2.7 and 4.6 after 6 weeks. The mean RMDI and ODI decreased by 3.4 and 23.3, respectively, after 3 days, and by 7.0 and 28.0 after 6 weeks. The mean EQ5D increased by 0.38 after 3 days and 0.358 after 6 weeks. The mean SF-12 mental component scale decreased by 0.2 after 3 days and increased by 5.6 after 6 weeks, whereas the mean SF-12 physical component scale increased by 6.4 after 3 days and by 9.8 after 6 weeks. The TUG test proved to be a useful, easy to use tool that could add a new, objective dimension to the armamentarium of clinical tests for the diagnosis and management of DDD. From our preliminary experience, we conclude that the TUG test accurately reflects a patient's objective functional impairment before and after surgery., (Copyright © 2015 Elsevier Ltd. All rights reserved.)

A lumbar disc herniation is a frequent pathology. The incidence of a postoperative recurrence is between 1-18%. According to the current literature, a large anular defect and a limited perioperative microdiscectomy leads to an increased risk of recurrence. In contrast, a generous perioperative microdiscectomy comes along with an accelerated postoperative disc height loss and a progressive degenerative disc disease. The present work discusses the position of an anular-closure-device in respect of the problem risk of recurrence versus postoperative degenerative disc disease.