Zurich Claudication Questionnaire Research Articles

Decompression without fusion in low-grade degenerative spondylolisthesis and stenosis patients: long-term patient-reported outcome

BackgroundOne-third of patients suffering from neurogenic claudication due to lumbar spinal stenosis have low-grade degenerative spondylolisthesis. Decompression in these patients is considered a risk factor for instability, and it remains unclear whether instrumented fusion should be added. This study aims to assess the long-term clinical outcomes of decompressive surgery without instrumented fusion in symptomatic spinal stenosis patients regardless of low-grade degenerative spondylolisthesis. MethodsIn this retrospective cohort study, lumbar spinal stenosis patients with or without spondylolisthesis undergoing decompressive surgery were studied, 9 years postoperatively. Pain, functionality, and satisfaction questionnaires were sent to 250 spondylolisthesis and 200 randomly selected stenosis patients. Demographic characteristics, surgical technique, reoperation indication and incidence, and patient-reported outcome measures were assessed. ResultsAt long-term follow-up, the mean Oswestry Disability Index was 23.6 ±20.15 in the spondylolisthesis group and 23.4 ±20.9 (p=0.957) in the stenosis group. The EuroQol-5D was 0.74±0.28 and 0.75 ±0.24 (p=0.793) respectively. The Zurich Claudication Questionnaire score was 48.2% ±18.8 and 49.6% ±18.5 (p=0.646) respectively. After nine years of follow-up, comparable satisfaction rates are reported (69% of spondylolisthesis patients and 68% of stenosis patients (p=0.855). Reoperation rates were comparable in the spondylolisthesis and stenosis group (7 versus 6%). ConclusionThis cohort study demonstrated comparable satisfaction and clinical outcomes after decompressive surgery for symptomatic spinal stenosis in patients with and without grade 1 degenerative spondylolisthesis. Decompressive surgery can, therefore, be considered an effective treatment for symptomatic lumbar spinal stenosis, even if it is accompanied by degenerative spondylolisthesis. Therefore, routinely adding instrumented spondylodesis is not deemed necessary.

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

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

Multicentre investigation on the effect of decompressive surgery on Balance and physical ActiviTy Levels amongst patients with lumbar Spinal stenosis (B-ATLAS): protocol for a prospective cohort study

IntroductionPatients with lumbar spinal stenosis may have poor balance, decreased physical function and problems maintaining physical activity levels due to radiculopathy. Decompressive surgery is often indicated if conservative management fails...

Responsiveness of the Oswestry Disability Index and Zurich Claudication Questionnaire in patients with lumbar spinal stenosis: evaluation of surgically treated patients from the NORDSTEN study

PurposeTo evaluate the responsiveness of the original low back pain specific Oswestry Disability Index (ODI) and the spinal stenosis specific Zürich Claudication Questionnaire (ZCQ), and to investigate cut-off values for clinical “success” for ODI and ZCQ in surgically treated patients with lumbar spinal stenosis (LSS).MethodsWe included 601 LSS patients (218 with, 383 without degenerative spondylolisthesis) from the NORDSTEN trials. Outcome measures included ODI and ZCQ (symptom severity and physical function scales) with three alternative response parameters: scores at follow-up, absolute and relative changes from baseline to two-year follow-up. Effect size and standardised response mean evaluated internal responsiveness. External responsiveness was assessed by the Spearman rank correlation between patient-reported global perceived effect scale (GPE) and ODI and ZCQ, and receiver operating characteristics (ROC). We evaluated which cut-off values could maximise the percentage of correctly classified patients according to the GPE-anchor “completely recovered” / “much improved” for each parameter.ResultsInternal and external responsiveness were high for all three indices with effect sizes, standardized response means, ROC and corresponding area under the curve > 0.8. Correlations with GPE responses were moderate (> 0.50) for absolute change and strong (> 0.67) for relative change and follow-up scores. The 30% ODI relative change cut-off correctly classified 81% of patients to “success”, within a range of accurate cut-offs according to the GPE-anchor.ConclusionODI and ZCQ demonstrate comparable responsiveness in evaluating outcomes for surgically treated LSS patients. The 30% ODI threshold was consistent with treatment “success” in NORDSTEN trials.Trial registrationClinicalTrials.gov; NCT02007083 10/12/2013, NCT02051374 31/01/2014 and NCT03562936 20/06/2018.

Decompression alone or with fusion for degenerative lumbar spondylolisthesis (Nordsten-DS): five year follow-up of a randomised, multicentre, non-inferiority trial

ObjectiveTo assess whether decompression alone is non-inferior to decompression with instrumented fusion five years after primary surgery in patients with degenerative lumbar spondylolisthesis.DesignFive year follow-up of a randomised, multicentre, non-inferiority...

Calculation of the minimum clinically important difference (MCID) using different methodologies: case study and practical guide

IntroductionEstablishing thresholds of change that are actually meaningful for the patient in an outcome measurement instrument is paramount. This concept is called the minimum clinically important difference (MCID). We summarize available MCID calculation methods relevant to spine surgery, and outline key considerations, followed by a step-by-step working example of how MCID can be calculated, using publicly available data, to enable the readers to follow the calculations themselves.MethodsThirteen MCID calculations methods were summarized, including anchor-based methods, distribution-based methods, Reliable Change Index, 30% Reduction from Baseline, Social Comparison Approach and the Delphi method. All methods, except the latter two, were used to calculate MCID for improvement of Zurich Claudication Questionnaire (ZCQ) Symptom Severity of patients with lumbar spinal stenosis. Numeric Rating Scale for Leg Pain and Japanese Orthopaedic Association Back Pain Evaluation Questionnaire Walking Ability domain were used as anchors.ResultsThe MCID for improvement of ZCQ Symptom Severity ranged from 0.8 to 5.1. On average, distribution-based methods yielded lower MCID values, than anchor-based methods. The percentage of patients who achieved the calculated MCID threshold ranged from 9.5% to 61.9%.ConclusionsMCID calculations are encouraged in spinal research to evaluate treatment success. Anchor-based methods, relying on scales assessing patient preferences, continue to be the “gold-standard” with receiver operating characteristic curve approach being optimal. In their absence, the minimum detectable change approach is acceptable. The provided explanation and step-by-step example of MCID calculations with statistical code and publicly available data can act as guidance in planning future MCID calculation studies.

Pain trajectories over 12 months following conservative care consultation in patients with lumbar spinal stenosis

ObjectiveTo investigate symptom trajectories in chiropractic patients with lumbar spinal stenosis (LSS).MethodsPatients diagnosed with LSS were recruited from chiropractic clinics and self-reported questionnaires were collected at baseline and 1-year follow-up. Patients received weekly text messages about low back pain (LBP) and leg symptoms for 1 year. Group-based trajectory modelling was performed to identify symptom trajectory groups. The groups were compared based on patient characteristics, LBP and leg pain intensity, Oswestry Disability Index (ODI) and Zurich Claudication Questionnaire (ZCQ).ResultsA total of 90 patients were included in the analysis. A three-group trajectory model was chosen: ‘improving’ (16%), ‘fluctuating/improving’ (30%), and ‘persistent’ (54%). The ‘persistent’ group had a higher proportion of women [71% (95% CI 57–82%)] than the ‘improving’ group 29% (95% CI 11–56%), and a higher ODI score at both baseline [34.2 (95% CI 29.7–38.8) vs. 22.8 (16.4–29.1)] and 1-year follow-up [28.1 (95% CI 23.2–33.0) vs. 4.8 (0.1–9.4)]. Similar differences were observed for ZCQ symptom and function scores.ConclusionsPain symptoms in people with LSS followed distinctly different trajectories. Half of the sample had a pattern of consistently severe symptoms over a year, while the other half either improved rapidly or experienced fluctuating symptoms with some improvement.

Predictors of Patient Dissatisfaction after Lumbar Spinal Canal Stenosis Surgery: A Multicenter Retrospective Study.

Recently, patient satisfaction has gained prominence as a crucial measure for ensuring patient-centered care. Furthermore, patient satisfaction after lumbar spinal canal stenosis (LCS) surgery is an important metric for physician's decision of surgical indication and informed consent to patient. This study aimed to elucidate how patient satisfaction changed after LCS surgery to identify factors that predict patient dissatisfaction. We retrospectively reviewed time-course data of patients aged ≥40 years who underwent LCS surgery at multiple hospitals. The participants completed the Zurich Claudication Questionnaire (ZCQ) and the Japanese Orthopaedic Association Back Pain Evaluation Questionnaire (JOABPEQ) before surgery and then 6 months and 1 year postsurgery. Patient satisfaction was categorized according to the postoperative score of the satisfaction domain of the ZCQ: satisfied, score ≤2.0; moderately satisfied, 2.0< score ≤2.5; and dissatisfied, score >2.5. The study enrolled 241 patients. Our data indicated a satisfaction rate of around 70% at 6 months and then again 1 year after LCS surgery. Among those who were dissatisfied 6 months after LCS surgery, 47.6% were more satisfied 1 year postsurgery. Furthermore, 86.2% of those who were satisfied 6 months after LCS surgery remained satisfied at 1 year. Multivariable analysis revealed that age (relative risk, 0.5; 95% confidence interval, 0.2-0.8) and preoperative score of psychological disorders on the JOABPEQ (relative risk, 0.2; 95% confidence interval, 0.03-0.08) were significantly associated with LCS surgery dissatisfaction. In addition, the receiver operating characteristic curve analysis revealed that the cutoff value for the preoperative score of psychological disorder of the JOABPEQ was estimated at 40 for LCS surgery dissatisfaction. Age and psychological disorders were identified as significant predictors of dissatisfaction, with a JOABPEQ cutoff value providing potential clinical applicability.

Change in Lumbar Lordosis after Decompressive Surgery in Lumbar Spinal Stenosis Patients and Associations with Patient Related Outcomes 2 Years after Surgery. Radiological and Clinical Results from the NORDSTEN Spinal Stenosis Trial.

A prospective cohort study. The aim was to investigate changes in lumbar lordosis (LL) and its association to changes in patient reported outcome measures (PROMs) after decompressive surgery for lumbar spinal stenosis (LSS). Few studies have addressed change in LL after decompression surgery for LSS in relation to outcomes. Pre- and postoperative data from 310 patients having standing x-ray both before and 2 years after surgery were included. The patients were grouped based on the change in LL preoperatively to 2 years after surgery; group 1: <5 degrees (n=196), group 2: ≥5 <10 degrees (n=55) or group 3: ≥10 degrees (n=59) of change in LL. The changes in function, disability and pain were assessed by the Oswestry Disability Index (ODI), Numeric Rating Scale (NRS), and the Zurich claudication questionnaire (ZCQ). The three groups were compared regarding baseline variables using the ANOVA test for continuous variables and the chi-square test for categorical variables. The groups were further compared with a likelihood ratio test in relation to changes in PROMs 2 year after surgery and outcomes were adjusted for respective baseline PROMs, age, sex, smoking, BMI, Schizas and Pfirrmann scores. LL was significantly changed at group level 2 years after surgery with a mean difference of 2.2 (SD 9.4) degrees ( P =0.001). The three LL change groups did not show any significant differences in patient characteristics, function, disability, and pain at baseline. The two groups with a change of more than 5 degrees in LL 2 year after surgery (group 2 and 3) had significantly greater improvements in ODI ( P =0.022) and ZCQ function ( P =0.016) in the adjusted analyses, but was not significant for back and leg pain. Changed LL after decompressive surgery for LSS was associated with improved ODI and physical function.

Lumbar Facet Arthroplasty Versus Fusion for Grade-I Degenerative Spondylolisthesis with Stenosis: A Prospective Randomized Controlled Trial.

The comparative effectiveness of decompression plus lumbar facet arthroplasty versus decompression plus instrumented lumbar spinal fusion in patients with lumbar spinal stenosis and grade-I degenerative spondylolisthesis is unknown. In this randomized, controlled, Food and Drug Administration Investigational Device Exemption trial, we assigned patients who had single-level lumbar spinal stenosis and grade-I degenerative spondylolisthesis to undergo decompression plus lumbar facet arthroplasty (arthroplasty group) or decompression plus fusion (fusion group). The primary outcome was a predetermined composite clinical success score. Secondary outcomes included the Oswestry Disability Index (ODI), visual analog scale (VAS) back and leg pain, Zurich Claudication Questionnaire (ZCQ), Short Form (SF)-12, radiographic parameters, surgical variables, and complications. A total of 321 adult patients were randomized in a 2:1 fashion, with 219 patients assigned to undergo facet arthroplasty and 102 patients assigned to undergo fusion. Of these, 113 patients (51.6%) in the arthroplasty group and 47 (46.1%) in the fusion group who had either reached 24 months of postoperative follow-up or were deemed early clinical failures were included in the primary outcome analysis. The arthroplasty group had a higher proportion of patients who achieved composite clinical success than did the fusion group (73.5% versus 25.5%; p < 0.001), equating to a between-group difference of 47.9% (95% confidence interval, 33.0% to 62.8%). The arthroplasty group outperformed the fusion group in most patient-reported outcome measures (including the ODI, VAS back pain, and all ZCQ component scores) at 24 months postoperatively. There were no significant differences between groups in surgical variables or complications, except that the fusion group had a higher rate of developing symptomatic adjacent segment degeneration. Among patients with lumbar spinal stenosis and grade-I degenerative spondylolisthesis, lumbar facet arthroplasty was associated with a higher rate of composite clinical success than fusion was at 24 months postoperatively. Therapeutic Level I . See Instructions for Authors for a complete description of levels of evidence.

Feasibility, safety, and efficacy of a new percutaneous interspinous device: a retrospective multicenter study.

To evaluate safety and efficacy of the novel percutaneous interspinous device (PID) for the treatment of symptomatic degenerative lumbar spinal stenosis (DLSS) in 3 different centers. From November 2016 to March 2020, 255 patients (male 125, mean age 71.2years old range 49-91years old) with neurogenic claudication, confirmed by electromyography, related to mono or bi-segmental lumbar central canal and/or foraminal stenosis were enrolled in the study. Magnetic resonance (MR) and/or computer tomography (CT), physical exam, and Visual Analogue Scale (VAS) and Zurich Claudication Questionnaire (ZCQ) were performed before and 6months after the procedure. All treatments were performed under fluoroscopic guidance with local anesthesia and mild sedation. Technical success was defined as correct placement of the Lobster® (Demetrios Medical, Firenze, Italy) PID as demonstrated by computer tomography (CT) performed immediately after treatment; spinoplasty was performed in selected patients. PID placement was accomplished with a 99.6% success rate (257/258). The one device that was not implanted was due to a spinous process fracture. In 28 patients, more than 1 device was implanted in the same session (max 3 PIDs); 6 patients required a second implant in different session. A total of 172 prophylactic spinoplasties were performed (59.3%). No major complications occurred; 3 device misplacements were successfully treated with percutaneous retrieval and new device deployment. 99.6% of patients experienced clinical improvement. Lobster PID is an effective and safe minimally invasive decompression method for central canal and neural foraminal stenosis when patients are correctly selected.

The Impact of Frailty on Surgical Outcome of Patients with Lumbar Spinal Canal Stenosis.

Frailty is an important factor in surgical outcomes. The current study aimed to evaluate the effect of preoperative frailty on postoperative outcomes in older patients with lumbar spinal canal stenosis (LSCS). We retrospectively examined 209 patients aged ≥65 years who underwent surgery for LSCS. Health-related quality-of-life (HRQOL) tools, including the Roland-Morris Disability Questionnaire (RDQ), Zurich Claudication Questionnaire (ZCQ), and Japanese Orthopaedic Association Back Pain Evaluation Questionnaire (JOABPEQ), were used in the assessment conducted before surgery and at 6 months and 1 year after surgery. Frailty was categorized based on the 11-item modified frailty index (mFI-11). Patients with mFI-11 of 0, <0.21, and >0.21 were classified under the robust (R), pre-frailty (P), and frailty (F) groups, respectively. According to the mFI-11, 24, 138, and 47 patients were included in the R, P, and F groups, respectively. Regarding preoperative radiographic parameters, there was a remarkable increase in the sagittal vertical axis and a significant decrease in the development of lumbar lordosis with frailty progression. The preoperative scores of RDQ and ZCQ, and lumbar function, walking ability, social life, and psychological disorder domain scores of JOABPEQ differed significantly among these groups. The frequency of revision surgery was not higher in the F group than in the other groups. After adjustment for factors have shown different distributions among the three groups, the frequency of effective surgical cases did not show a clear trend among the three groups in all domains of the JOABPEQ. The preoperative HRQOL scores and the radiographic parameters of patients with LSCS worsened with frailty severity. However, frailty did not affect the rate of revision surgery and surgical efficacy in patients with LSCS. Although this study has limitations, our findings indicated that even LSCS patients with frailty can be considered for surgery if they have an indication for LSCS surgery.

Preoperative fatty infiltration of paraspinal muscles assessed by MRI is associated with less improvement of leg pain 2 years after surgery for lumbar spinal stenosis

PurposeFatty infiltration (FI) of the paraspinal muscles may associate with pain and surgical complications in patients with lumbar spinal stenosis (LSS). We evaluated the prognostic influence of MRI-assessed paraspinal muscles’ FI on pain or disability 2 years after surgery for LSS.MethodsA muscle fat index (MFI) was calculated (by dividing signal intensity of psoas to multifidus and erector spinae) on preoperative axial T2-weighted MRI of patients with LSS. Pain and disability 2 years after surgery were assessed using the Oswestry disability index, the Zurich claudication questionnaire and numeric rating scales for leg and back pain. Multivariate linear and logistic regression analyses (adjusted for preoperative outcome scores, age, body mass index, sex, smoking status, grade of spinal stenosis, disc degeneration and facet joint osteoarthritis) were used to assess the associations between MFI and patient-reported clinical outcomes. In the logistic regression models, odds ratios (OR) and 95% confidence intervals (CI) were calculated for associations between the MFI and ≥ 30% improvement of the outcomes (dichotomised into yes/no).ResultsA total of 243 patients were evaluated (mean age 66.6 ± 8.5 years), 49% females (119). Preoperative MFI and postoperative leg pain were significantly associated, both with leg pain as continuous (coefficient − 3.20, 95% CI − 5.61, − 0.80) and dichotomised (OR 1.51, 95% CI 1.17, 1.95) scores. Associations between the MFI and the other outcome measures were not statistically significant.ConclusionPreoperative FI of the paraspinal muscles on MRI showed statistically significant association with postoperative NRS leg pain but not with ODI or ZCQ.

Responsiveness of the Zurich Claudication Questionnaire in Patients With Lumbar Spinal Stenosis Undergoing Nonsurgical Treatment: A Secondary Analysis of a Randomized Controlled Trial.

Secondary analysis of a randomized controlled trial. We investigated the ability to distinguish patients with lumbar spinal stenosis (LSS) who improved from those who did not after receiving nonsurgical treatment. We used the disorder-specific Zurich Claudication Questionnaire (ZCQ) satisfaction subscale as an external anchor and estimated the minimal clinically important differences (MCIDs) for the ZCQ symptom severity and physical function subscales. The ZCQ satisfaction subscale effectively distinguishes surgical patients who improved from those who did not for LSS. However, its responsiveness in nonsurgical treatment has not been evaluated yet. Eighty-four patients with LSS who received supervised physical therapy or a home exercise program were included. Patients were classified as responders or nonresponders according to the cutoff of 2.5 for the ZCQ satisfaction subscales at six weeks and one year. The external responsiveness of the ZCQ satisfaction subscale was assessed using correlational and receiver-operating characteristic (ROC) curve analyses. MCIDs for the ZCQ symptom severity and physical function subscales were estimated using anchor and distribution approaches. Pearson correlation coefficients between the changes in outcomes and the ZCQ satisfaction subscale at six weeks and one year were 0.37 to 0.58 (symptom severity) and 0.40 to 0.45 (physical function subscales) (>0.30 is considered a good anchor). The area under the ROC curve values were 0.66 to 0.72 and 0.63 to 0.71 for the symptom severity and physical function subscales, respectively (>0.7 is considered acceptable). The MCIDs at six weeks and one year estimated from anchor-based approaches were -0.64 to -0.13 (symptom severity) and -0.39 to 0.10 (physical function), and those from the distribution-based approaches were -0.31 to -0.30 and -0.29 to -0.27, respectively. The findings of this study suggest that the ZCQ satisfaction subscale has less ability to distinguish patients with LSS who improved in the ZCQ symptom severity and physical function subscales from those who did not after nonsurgical treatment, compared to those after surgical treatment.

Pharmacopuncture Therapy as an Adjunctive Treatment for Patients with Lumbar Spinal Stenosis: A Pragmatic Randomized Controlled Pilot Trial.

Pharmacopuncture therapy (PPT) combines medicinal extracts with acupuncture and is widely used as an adjunct in clinical practice. This study assessed the safety and feasibility of PPT in addition to conventional Korean Medicine treatment (CKMT), including electroacupuncture, cupping and infra-red, for lumbar spinal stenosis (LSS). Forty patients diagnosed with LSS were randomly assigned to undergo PPT with CKMT (experimental group) or CKMT alone (control group) at a 1:1 ratio, receiving 10 sessions of each intervention over five weeks. The primary clinical outcome was measured using the 100-mm Visual Analog Scale (VAS) for buttock and leg pain five weeks post-treatment. Secondary outcomes included clinically important difference (CID), Zurich Claudication Questionnaire, self-reported walking capacity, Modified-Modified Schober test, EuroQol 5-dimension 5-level questionnaire, and the patient's global impression of change. The adverse events were assessed at each visit. The analysis of covariance was conducted to compare between two groups. Intervention completion rates were 95% and 100% in the experimental and control groups, respectively. No statistically significant differences were found between groups regarding the primary outcome (adjusted mean difference: 8.0; 95% confidence interval: -1.4-17.4). The mean difference in the 100-mm VAS for low back pain at week 5 (adjusted mean difference: 12.9; 95% confidence interval: 2.4-23.4) and the proportion of patients who reached the minimum CID was higher in the experimental group than in the control group. However, no significant differences were observed with other secondary outcomes. One patient in the experimental group experienced a systemic skin rash that resolved the same day, whereas the adverse events in the other group were mild and transient. This trial demonstrated the feasibility of add-on effects and the safety of pharmacopuncture in patients with LSS. Further studies are warranted to evaluate the add-on effects of PPT in treating LSS. Clinical Research Information Service (CRIS), KCT0007229; registered on April 26, 2022.

The association between lumbar lordosis preoperatively and changes in PROMs for lumbar spinal stenosis patients 2 years after spinal surgery: radiological and clinical results from the NORDSTEN-spinal stenosis trial

BackgroundPatients with lumbar spinal stenosis (LSS) sometimes have lower lumbar lordosis (LL), and the incidence of LSS correlates closely with the loss of LL. The few studies that have evaluated the association between LL and clinical outcomes after non-instrumented surgery for LSS show conflicting results. This study investigates the association between preoperative LL and changes in PROMs 2 years after decompressive surgery.MethodThis prospective cohort study obtained preoperative and postoperative data for 401 patients from the multicenter randomized controlled spinal stenosis trial as part of the NORwegian degenerative spondylolisthesis and spinal STENosis (NORDSTEN) study. Before surgery, the radiological sagittal alignment parameter LL was measured using standing X-rays. The association between LL and 2-year postoperative changes was analyzed using the oswestry disability index (ODI), a numeric rating scale (NRS) for low back and leg pain, the Zurich claudication questionnaire (ZCQ), and the global perceived effect (GPE) score. The changes in PROMs 2 years after surgery for quintiles of lumbar lordosis were adjusted for the respective baseline PROMs: age, sex, smoking, and BMI. The Schizas index and the Pfirrmann index were used to analyze multiple regressions for changes in PROMs.ResultsThere were no associations in the adjusted and unadjusted analyses between preoperative LL and changes in ODI, ZCQ, GPE, and NRS for back and leg pain 2 years after surgery.ConclusionLL before surgery was not associated with changes in PROMs 2 years after surgery. Lumbar lordosis should not be a factor when considering decompressive surgery for LSS.

Is the interspinous process device safe and effective in elderly patients with lumbar degeneration? A systematic review and meta-analysis of randomized controlled trials.

Lumbar spinal stenosis is one of the most common diseases affecting the elderly that is characterized by the narrowing of the spinal canal and peripheral neural pathways which may cause back pain and neurogenic intermittent claudication in affected patients. Recently, as an alternative treatment between conservative therapy and decompression surgery, interspinous process device (IPD) such as X-stop, Coflex, DIAM, Aperius, Wallis, etc., has gained enough popularity. The purpose of this study was to evaluate the efficacy and safety of IPD in the treatment of degenerative lumbar spinal stenosis compared with decompression surgery. This study was a systematic review and meta-analysis of randomized controlled trials. 555 patients' samples were collected for this study. The Visual Analogue Scale and the Oswestry Disability Index were analyzed, as well as the Zurich Claudication Questionnaire For efficacy evaluation. Complication and reoperation rate was utilized for the assessment of safety. A comprehensive literature search was performed through Pubmed, EMBASE, Web of Science, and Cochrane Library until October 2023. Among the studies meeting the eligible criteria, any study in which IPD was utilized in the treatment of degenerative lumbar spinal stenosis was included in the current review. For efficacy evaluation, the Visual Analogue Scale and the Oswestry Disability Index were analyzed, as well as the Zurich Claudication Questionnaire. Complication and reoperation rates were utilized for the assessment of safety. Five randomized controlled trials with 555 patients were included. There were no significant differences in VAS leg pain (SMD - 0.08, 95% CI - 0.32 to 0.15) and back pain (SMD 0.09, 95%CI-0.27 to 0.45), ODI scores (MD 1.08, 95% CI - 11.23 to 13.39) and ZCQ physical function (MD-0.09, 95% CI-0.22 to 0.05) for IPD compared with decompression surgery. In terms of ZCQ symptom severity (MD - 0.22, 95% CI - 0.27 to - 016), decompression surgery showed superior to the IPD. As for complications (RR 1.08, 95% CI 0.36 to 3.27), the IPD had no advantages compared to decompression surgery, whereas inferior to it in reoperation rate (RR 2.58, 95% CI 1.67 to 3.96). This systematic review and meta-analysis indicated no superiority in the clinical outcome for IPD compared with decompression surgery. However, more clinical studies are warranted to determine the efficacy and safety of IPD.

Do patients with lumbar spinal stenosis benefit from decompression of levels with adjacent moderate stenosis? A prospective cohort study from the NORDSTEN study

BackgroundLumbar spinal stenosis (LSS) is characterized by pain that radiates to the buttocks and/or legs, aggravated by walking and relieved by forward flexion. There is poor correlation between clinical symptoms and severity of stenosis on MRI, and multilevel stenosis has not been described to present worse symptoms or treatment outcomes, compared with patients with single-level stenosis. In patients with one level with severe stenosis combined with an adjacent level with moderate stenosis, the surgeon must decide whether to decompress only the narrowest level or both, to achieve the best possible outcome. The potential benefits of performing surgery on an adjacent moderate stenosis is debated, and the scientific evidence in scarce. PurposeThe aim of the present study was to investigate whether patients with a level of adjacent moderate stenosis, along with an index stenosis, benefitted from a dual-level decompression (DLD) compared with a single-level decompression (SLD). Furthermore, to investigate whether DLD patients had longer duration of surgery and hospital stay, higher rates of complications and/or lower rate of reoperations compared with SLD patients. Study designProspective cohort study. Patient sampleWe analyzed data from the Norwegian Degenerative Spondylisthesis and Spinal Stenosis study- Spinal Stenosis Trial (NORDSTEN-SST). In this randomized multicenter study, 437 patients were included, evaluating clinical outcomes of three different surgical treatment options for LSS. Patients with degenerative spondylolisthesis were excluded. MethodBased on preoperative MRI, the present analysis included all patients who had a moderate stenosis (defined as Schizas B or C) in addition to a predefined index stenosis (the level with the smallest cross-sectional area). We compared patients who, based on the surgeons` choice, received a dual-level decompression, with those receiving a single-level decompression. Outcome measuresThe primary outcome was mean change in the Oswestry Disability Index (ODI) score from baseline to 2-year follow up. Secondary outcomes were proportion of success (30% reduction in ODI score), the Numeric Rating Scales for back and leg pain (NRS), the EuroQol 5-dimensional questionnaire utility index (EQ-5D), the Zurich Claudication Questionnaire (ZCQ), the Global Perceived Effect (GPE)-scale, duration of surgery, duration of hospital stay, perioperative complications and reoperation rates. ResultsAmong the 222 patients, included in the analysis, 108 underwent DLD and 114 underwent SLD. There was no difference in change scores for any of the investigated patient-reported outcomes between the groups after 2 years. However, the DLD group had longer duration of surgery and longer length of hospital stay. There was no difference in reoperation rates or perioperative complications. ConclusionThis study, alongside the NORDSTEN-LSS trial on patients with adjacent moderate stenosis as well as an index stenosis, showed no superior clinical effectiveness for dual-level surgery compared with single-level surgery.

Effectiveness and safety of interspinous spacer versus decompressive surgery for lumbar spinal stenosis: A meta-analysis of randomized controlled trials.

A meta-analysis of randomized controlled trials. Our meta-analysis was conducted to investigate whether interspinous spacer (IS) results in better performance for patients with lumbar spinal stenosis (LSS) when compared with decompressive surgery (DS). DS and IS are common surgeries for the treatment of LSS. However, controversy remains as to whether the IS is superior to DS. We comprehensively searched PubMed, EMBASE, and Cochrane Central Register of Controlled Trials for prospective randomized controlled trials that compared IS versus DS for LSS. The retrieved results were last updated on July 30, 2023. Eight studies involving 852 individuals were included in the meta-analysis. The pooled data indicated that IS was superior to DS considering shorter operation time (P = .003), lower dural violation rate (P = .002), better Zurich Claudication Questionnaire Physical function score (P = .03), and smaller foraminal height decrease (P = .004), but inferior to DS considering the higher rate of reoperation (P < .0001). There was no significant difference between the 2 groups regarding hospital stay (P = .26), blood loss (P = .23), spinous process fracture (P = .09), disc height decrease (P = .87), VAS leg pain score (P = .43), VAS back pain score (P = .26), Oswestry Disability Index score (P = .08), and Zurich Claudication Questionnaire symptom severity (P = .50). In summary, we considered that IS had similar effects with DS in hospital stay, blood loss, spinous process fracture, disc height decrease, VAS score, Oswestry Disability Index score, and Zurich Claudication Questionnaire Symptom severity, and was better in some indices such as operation time, dural violation, Zurich Claudication Questionnaire Physical function, and foraminal height decrease than DS. However, due to the higher rate of reoperation in the IS group, we considered that both IS and DS were acceptable strategies for treating LSS. As a novel technique, further well-designed studies with longer-term follow-up are needed to evaluate the effectiveness and safety of IS.

Lumbar fusion through the anterolateral mini-approach: comparison of anterior interbody (OLIF-AF) and percutaneous pedicle (OLIF-PF) fixations in the surgical treatment of single-level stenosis

Objective. To perform comparative analysis of the clinical efficacy and safety of indirect decompression of the spinal roots and interbody fusion through the lateral pre-psoas approach (OLIF) with anterolateral (OLIF-AF) and posterior percutaneous (OLIF-PF) screw fixations in the surgical treatment of single-segment lumbar stenosis.Material and Methods. A retrospective comparative analysis of treatment of 88 patients aged 29 to 72 years with single-level lumbar stenosis was carried out. Posterior instrumental fixation (OLIF-PF) was performed in 60 cases, and anterolateral (OLIF-AF) – in 28.Results. The compared groups did not statistically significantly differ from each other in terms of age, gender, body mass index, clinical picture and duration of symptoms before surgery, assessment of neurological status according to the Zurich Claudication Questionnaire (ZCQ), preoperative diagnosis, localization of stenosis, pain assessment in the back and leg before surgery according to a digital rating scale, physical status (ASA), health assessment (SF-12, ODI), follow-up period, as well as smoking and the presence of comorbidities (p &gt; 0.05). In the OLIF-AF group, compared to the OLIF-PF group, a statistically significant advantage was found in terms of blood loss, duration of surgery and anesthesia, the level of radiological exposure, duration of patient’s hospitalization and hospital stay in the postoperative period, as well as the duration of antibiotic prophylaxis and intraoperative volume of infusions (p &lt; 0.05). Despite earlier discharge and less use of local anesthesia (35.7 % vs 73.3 %; p = 0.001), patients in the OLIF-AF group had statistically significantly lower level of back pain on the day of discharge (3.0 vs 3.5; p = 0.034) and were less likely to need opioids (3.6 % vs 31.7 %; p = 0.003). With regard to complications and adverse events, there were no statistically significant differences during dynamic follow-up period from 3 to 50 months in both groups (17.9 % vs 28.3 %; p = 0.290), including depending on the timing of complications (early or late). In addition, no statistically significant differences were found for neurological, infectious, gastrointestinal, urological, or implant-related complications (p &gt; 0.05).Conclusions. Indirect decompression of the spinal roots and interbody fusion through the lateral pre-psoas approach in combination with OLIF-AF is an effective and safe technique for the surgical treatment of single-segment lumbar stenosis. This method allows to reduce the invasiveness of surgery and severity of the pain syndrome and to create conditions for enhanced recovery after surgery. Further multicenter randomized trials are needed to comprehensively evaluate long-term outcomes.