Zurich Claudication Questionnaire Scores Research Articles

Is the presence of foraminal stenosis associated with outcome in lumbar spinal stenosis patients treated with posterior microsurgical decompression

BackgroundWe aim to investigate associations between preoperative radiological findings of lumbar foraminal stenosis with clinical outcomes after posterior microsurgical decompression in patients with predominantly central lumbar spinal stenosis (LSS).MethodsThe study was an additional analysis in the NORDSTEN Spinal Stenosis Trial. In total, 230 men and 207 women (mean age 66.8 (SD 8.3)) were included. All patients underwent an MRI including T1- and T2-weighted sequences. Grade of foraminal stenosis was dichotomized into none to moderate (0–1) and severe (2–3) category using Lee’s classification system. The Oswestry Disability Index (ODI), Zurich Claudication Questionnaire (ZCQ), and numeric rating scale (NRS) for back and leg pain were collected at baseline and at 2-year follow-up. Primary outcome was a reduction of 30% or more on the ODI score. Secondary outcomes included the mean improvement on the ODI, ZCQ, and NRS scores. We performed multivariable regression analyses with the radiological variates foraminal stenosis, Pfirrmann grade, Schizas score, dural sac cross-sectional area, and the possible plausible confounders: patients’ gender, age, smoking status, and BMI.ResultsThe cohort of 437 patients presented a high degree of degenerative changes at baseline. Of 414 patients with adequate imaging of potential foraminal stenosis, 402 were labeled in the none to moderate category and 12 in the severe category. Of the patients with none to moderate foraminal stenosis, 71% achieved at least 30% improvement in ODI. Among the patients with severe foraminal stenosis, 36% achieved at least 30% improvement in ODI. A significant association between severe foraminal stenosis and less chance of reaching the target of 30% improvement in the ODI score after surgery was detected: OR 0.22 (95% CI 0.06, 0.83), p=0.03. When investigating outcome as continuous variables, a similar association between severe foraminal stenosis and less improved ODI with a mean difference of 9.28 points (95%CI 0.47, 18.09; p=0.04) was found. Significant association between severe foraminal stenosis and less improved NRS pain in the lumbar region was also detected with a mean difference of 1.89 (95% CI 0.30, 3.49; p=0.02). No significant association was suggested between severe foraminal stenosis and ZCQ or NRS leg pain.ConclusionIn patients operated with posterior microsurgical decompression for LSS, a preoperative severe lumbar foraminal stenosis was associated with higher proportion of patients with less than 30% improvement in ODI.Trial registrationThe study is registered at ClinicalTrials.gov (22.11.2013) under the identifier NCT02007083.

A Protocol for a Single-Centered, Pragmatic, Randomized, Controlled, Parallel Trial Comparing Comprehensive Nonsurgical Therapy Options for Individuals with Lumbar Spinal Stenosis.

Lumbar spinal stenosis (LSS) is a long-term degenerative disease. Considering the risks and advantages of the patient's age range and the characteristics of the condition, non-surgical treatment is recommended. To determine the best first-line non-surgical therapy for LSS, few studies have examined different non-surgical therapies. Therefore, the main objective of this study is to determine whether the selection of comprehensive Chinese medicine (CM) treatment for LSS is more successful than non-surgical conservative treatment. In this two-armed, parallel, single-centered, pragmatic randomized controlled study, 94 LSS participants will be randomized to receive 24 sessions of comprehensive CM therapy or conservative treatment for 3 months, with follow-up assessments at 6, 9, 12, and 15 months. The primary outcome will be based on the success rate of the Zurich Claudication Questionnaire (ZCQ) for the most clinical important difference (MCID) at 3 and 15 months. Secondary outcomes include Numerical Rating Scale (NRS) scores for back and leg pain, ZCQ scores, Oswestry Disability Index scores for lumbar dysfunction, and Short-Form 12 scores for health-related quality of life at 3, 6, 9, 12, and 15 months. Adverse events and incidences of surgery will be reported anytime during the trial and follow-up. This protocol examines the comparative efficacy of comprehensive CM therapy compared with conventional care through a pragmatic randomized controlled trial to present data to facilitate clinical or policy decision-making. The outcomes will make it easier to decide which patient-centered treatments to prioritize for LSS.

Decompression via unilateral biportal endoscopy for severe degenerative lumbar spinal stenosis: A comparative study with decompression via open discectomy.

Previous studies have shown that the Unilateral Biportal Endoscopy is an effective and safety surgery for sufficient decompression of degenerative lumbar spinal stenosis. However, data are lacking in terms of its benefits when compared with conventional open lumbar discectomy (OLD), especially in patients with severe degenerative lumbar spinal stenosis (DLSS). To compare the clini cal outcomes of two types decompressive surgery: unilateral biportal endoscopy-unilateral laminectomy bilateral decompression (UBE-ULBD) and conventional open lumbar discectomy (OLD) in severe degenerative lumbar spinal stenosis (DLSS). We retrospectively analyzed patients who underwent UBE-ULBD (n = 50, operated at 50 levels; UBE-ULBD group) and conventional open lumbar discectomy (n = 59, operated at 47 levels; OLD group) between February 2019 and July 2021. All patients were diagnosed with severe stenosis based on the Schizas classification (Grade C or D) on MRI. We compared radiographic and clinical outcome scores [including the visual analog scale (VAS), Oswestry Disability Index (ODI), and Zurich Claudication Questionnaire (ZCQ)] between the 2 groups at 1 year of follow-up. The radiographic evaluation included the cross-sectional area (CSA) of the thecal sac and paraspinal muscles on MRI. Fasting blood was drawn before and 1 and 7 days after the operation to detect creatine kinase (CK). Surgical data perioperative complications were also investigated. The baseline demographic data of the 2 groups were comparable, including VAS, ODI and ZCQ scores, the cross-sectional area of the thecal sac and paraspinal muscles and creatine kinase levels. The dural sac CSA significantly increased post -operatively in both groups, which confirmed they benefited from comparable decompressive effects. The operative duration in the OLD group was less than the UBE-ULBD group (43.9 ± 5.6 min vs. 74.2 ± 9.3 min, p < 0.05). The OLD group was associated with more estimated blood loss than the UBE-ULBD group (111.2 ± 25.0 ml vs. 41.5 ± 22.2 ml, P < 0.05). The length of hospital stay (HS) was significantly longer in the OLD group than in the UBE-ULBD group (6.8 ± 1.6 vs. 4.0 ± 1.4 days, P < 0.05). The VAS, ODI, and ZCQ scores improved in both groups after the operation. Serum creatine kinase values in the UBE-ULBD group were significantly lower than in the OLD group at 1 day after surgery (108. 1 ± 11.9 vs. 347.0 ± 19.5 U/L, P < 0.05). The degree of paraspinal muscle atrophy in the UBE-ULBD group was significantly lower than in the OLD group at 1 year (4.50 ± 0.60 vs. 11.42 ± 0.87, P < 0.05). UBE-ULBD and conventional OLD demonstrate comparable short-term clinical outcomes in treating severe DLSS. However, UBE-ULBD surgery was associated with a shorter hospital stay, less EBL and paravertebral muscle injury than OLD surgery.

A Prospective Study of Lumbar Facet Arthroplasty in the Treatment of Degenerative Spondylolisthesis and Stenosis: Results from the Total Posterior Spine System (TOPS) IDE Study.

Prospective randomized Food and Drug Administration investigational device exemption clinical trial. The purpose of the present study is to report the 1-year clinical and radiographic outcomes and safety profile of patients who underwent lumbar facet arthroplasty through implantation of the Total Posterior Spine System (TOPS) device. Lumbar facet arthroplasty is one proposed method of dynamic stabilization to treat grade-1 spondylolisthesis with stenosis; however, there are currently no Food and Drug Administration-approved devices for facet arthroplasty. Standard demographic information was collected for each patient. Radiographic parameters and patient-reported outcome measures were assessed preoperatively and at regular postoperative intervals. Complication and reoperation data were also collected for each patient. At the time of this study, 153 patients had undergone implantation of the TOPS device. The mean surgical time was 187.8 minutes and the mean estimated blood loss was 205.7cc. The mean length of hospital stay was 3.0 days. Mean Oswestry Disability Index, Visual Analog Score leg and back, and Zurich Claudication Questionnaire scores improved significantly at all postoperative time points ( P >0.001). There were no clinically significant changes in radiographic parameters, and all operative segments remained mobile at 1-year follow-up. Postoperative complications occurred in 11 patients out of the 153 patients (7.2%) who underwent implantation of the TOPS device. Nine patients (5.9%) underwent a total of 13 reoperations, 1 (0.6%) of which was for device-related failure owing to bilateral L5 pedicle screw loosening. Lumbar facet arthroplasty with the TOPS device demonstrated a statistically significant improvement in all patient-reported outcome measures and the ability to maintain motion at the index level while limiting sagittal translation with a low complication rate.

Interspinous process device versus conventional decompression for lumbar spinal stenosis: 5-year results of a randomized controlled trial.

Interspinous process distraction devices (IPDs) can be implanted to treat patients with intermittent neurogenic claudication (INC) due to lumbar spinal stenosis. Short-term results provided evidence that the outcomes of IPD implantation were comparable to those of decompressive surgery, although the reoperation rate was higher in patients who received an IPD. This study focuses on the long-term results. Patients with INC and spinal stenosis at 1 or 2 levels randomly underwent either decompression or IPD implantation. Patients were blinded to the allocated treatment. The primary outcome was the Zurich Claudication Questionnaire (ZCQ) score at 5-year follow-up. Repeated measurement analysis was applied to compare outcomes over time. In total, 159 patients were included and randomly underwent treatment: 80 patients were randomly assigned to undergo IPD implantation, and 79 underwent spinal bony decompression. At 5 years, the success rates in terms of ZCQ score were similar (68% of patients who underwent IPD implantation had a successful recovery vs 56% of those who underwent bony decompression, p = 0.422). The reoperation rate at 2 years after surgery was substantial in the IPD group (29%), but no reoperations were performed thereafter. Long-term visual analog scale score for back pain was lower in the IPD group than the bony decompression group (p = 0.02). IPD implantation is a more expensive alternative to decompressive surgery for INC but has comparable functional outcome during follow-up. The risk of reoperation due to absence of recovery is substantial in the first 2 years after IPD implantation, but if surgery is successful this positive effect remains throughout long-term follow-up. The IPD group had less back pain during long-term follow-up, but the clinical relevance of this finding is debatable.

Relationship Among the Foraminal Area and Demographic and Clinical Characteristics of Patients with Low Back Pain

Our study aims to contribute to existing knowledge by evaluating patients with low back pain to provide a more accurate relationship between the diameter of the intervertebral foramen and the clinical, demographic, and lumbar spine anatomic factors such as age, sex, body mass index, the Zurich Claudication Questionnaire, facet joint, intervertebral disc, ligamentum flavum, and spinal canal. We studied 90 consecutive patients who had undergone evaluation for low back pain. We used magnetic resonance imaging to assess the cross-sectional areas of the intervertebral foramina at each level of the lumbar spine together with the ligamentum flavum area and the dural sac cross-sectional area (DSCSA) measurements. The presence of disc and facet joint degeneration was evaluated and data on symptoms were obtained. Age (P < 0.0001), lumbar disc degeneration grade (P= 0.016), and DSCSA (P < 0.0001) were found to statistically significantly influence the foraminal area (FA). The mean FA at all lumbar levels increased with increasing DSCSA. The mean FA decreased with age at all levels except L5/S1. Lumbar disc degeneration grade 1-3 increased the mean FA at L5/S1, but not at other levels. No statistically significant effects of the side of the measurement, sex, body mass index, Zurich Claudication Questionnaire score, ligamentum flavum area, or facet joint degeneration were found. The results of the present study allow us to quantify the effect of age, DSCSA, and lumbar disc degeneration grade on the FA.

Interlaminar stabilization for spinal stenosis in the Medicare population

The number of complex fusions performed on Medicare beneficiaries, defined as ≥age 65, with lumbar spinal stenosis with or without spondylolisthesis has been increasing. Typically, these procedures are longer, more invasive and pose a greater risk for complications. Interlaminar stabilization (ILS) serves as an intermediary between decompression alone and decompression with fusion. The purpose of this study was to prospectively examine the efficacy of ILS in patients ≥age 65 through comparison to fusion in the same age group and ILS in younger patients. A prospective, multicentered, randomized controlled trial comparing decompression with ILS to decompression with posterolateral fusion with bilateral pedicle screw instrumentation. Patients from 21 sites in the United States underwent surgery for moderate stenosis with up to a grade 1 degenerative spondylolisthesis and failure of conservative treatment with low back pain at 1 or 2 contiguous levels from L1-L5. Preoperatively, patient-reported assessment had to meet the criteria of significant pain and disability (Visual Analog Scale [VAS back pain] ≥50 mm on a 100 mm scale; Oswestry Disability Index [ODI] of ≥20/50). The primary outcome was overall Composite Clinical Success (CCS) as determined by ODI scores, incidence of postoperative epidural injections and/or reoperations, incidence of device-related complications, and persistent or progressive neurological deficit. Secondary outcomes included patient satisfaction as measured by VAS for back and worse leg pain and Zurich Claudication Questionnaire scores. Narcotic usage data and radiographic assessment of changes in postoperative posterior disc height and foraminal height were also evaluated. At 1- or 2-levels, 84 patients ≥age 65 underwent decompression with ILS, 57 patients ≥age 65 underwent decompression with fusion, and 131 patients <age 65 underwent decompression with ILS. Comparisons were made between ≥age 65 ILS patients and ≥age 65 fusion patients and between <age 65 and ≥age 65 ILS patients. The patients were assessed before and after surgery at 6 weeks and 3, 6, 12, 18, 24, 48, and 60 months. At 24 and 60 months, there were no statistically significant differences in CCS or any of the individual components of CCS between the ≥ age 65 ILS and fusion groups or between the < age 65 and ≥ age 65 ILS groups. ILS Medicare patients experienced significantly shorter surgeries (p<.001), less blood loss (p<.001), and a shorter hospital stay (p<.001) than fusion patients. There were no significant differences radiographically or with regards to postoperative narcotic usage. Clinically, ILS patients ≥age 65 performed as well as both those receiving fusion and those <age 65 who received ILS. Importantly, however, for this older population, ILS Medicare patients experienced less blood loss, a shorter operation and shorter hospital stay than fusion Medicare patients.

A new interspinous process distraction device BacFuse in the treatment of lumbar spinal stenosis with 5 years follow-up study.

To explore a suitable indication of interspinous process distraction device for lumbar spinal stenosis with BacFuse.Patients of lumbar spinal stenosis (LSS) who experienced interspinous process distraction device surgery with BacFuse from June 2014 to January 2015 in our institute were included. We classified LSS into central and lateral types, and then divided these into severe and moderate according to the degree of stenosis. Each type was divided into 2 groups. Patients in group A underwent distraction without bone decompression (stand-alone), while patients in group B underwent bone decompression combined with distraction. Follow-up was performed at 1 month, 3 months, 6 months, 2 years, and 5 years after surgery. Zurich Claudication Questionnaire (ZCQ) was recorded to assess the patient's postoperative condition at each follow-up.A total of 142 patients were available for follow up at each time interval. There was a significant difference between the preoperative and final follow-up ZCQ scores for every LSS type. In addition, there was no difference between group A and group B in the postoperative ZCQ scores with the exception of the lateral severe type. In the study, 22 of the 23 patients (95.65%) in the lateral moderate type were considered to have a satisfactory result in group B, with a similar result of 93.33% (14/15) in group A (P = .75). In the lateral severe type, the patient satisfaction rate was 65.22% (15/23) and 90.63% (29/32) in group A and group B (P = .02), respectively. In the central moderate type, the patient satisfaction rate was 81.82% (15/23) and 76.92% (10/13) in group A and group B (P = .77), respectively. Satisfaction rate for the follow-up results in the central severe type reached 57.14% (4/7) in group A, and 54.55% (6/11) in group B (P = .91). Moreover, no relationship was found between satisfaction and neurogenic intermittent claudication.The most suitable indication for BacFuse treatment was the lateral moderate type. For lateral severe patients, distraction combined with decompression is suggested for a higher satisfaction rate. Severe central spinal stenosis was shown to be a relative contraindication for BacFuse.

Evaluation of the Minimum Clinically Important Differences of the Zurich Claudication Questionnaire in Patients With Lumbar Spinal Stenosis.

A case-control study. This study aimed to evaluate the minimally clinically important differences (MCIDs) of the Zurich Claudication Questionnaire (ZCQ) after microendoscopic laminectomy in patients with lumbar spinal stenosis (LSS). The ZCQ is a self-administered tool used to evaluate symptom severity and physical function in patients with LSS. It has been used in many studies worldwide. However, the MCIDs of the ZCQ have not yet been determined. The study sample consisted of 514 patients who underwent microendoscopic laminectomy for LSS at our hospital between March 2012 and May 2014. The ZCQ, which includes 7 items for symptom severity (scored from 1 to 5) and 5 items for functional disability (scored from 1 to 4), was administered preoperatively and 1-year postoperatively. The MCID was calculated by 4 approaches, including average change, minimum detectable change, change difference, and receiver operating characteristic curve. The authors calculated the area under the curve (AUC) to evaluate the accuracy of the receiver operating characteristic curve. The responsiveness of each measurement was then analyzed. The authors were able to administer the ZCQ at 1-year postoperatively in 349 patients. The ZCQ score was statistically significantly improved 1-year postoperatively. The MCID of ZCQ for symptom severity varied from 0.75 to 0.84, whereas the MCID of the ZCQ score for functional disability varied from 0.60 to 0.76. The AUC of the ZCQ for symptom severity was 0.81 and that for functional disability was 0.80. This study showed that the MCID of the ZCQ for symptom severity varied from 0.75 to 0.84 and the MCID for functional disability varied from 0.60 to 0.76. In addition, each AUC was over 0.80, indicating that MCIDs of the ZCQ were found to have a high diagnostic performance.

Successful use of percutaneous interspinous spacers and adjunctive spinoplasty in a 9 year cohort of patients

PurposeLumbar spinal canal stenosis and lumbar spinal foraminal stenosis are common, degenerative pathologies which can result in neurogenic claudication and have a negative impact on function and quality of life....

Endoscope-Assisted Minimally Invasive Interlaminar Lumbar Decompression for Spinal Stenosis

Background: Lumbar stenosis is characterized by a narrowing of the spinal canal in association with progressive degenerative changes in the lumbar spine and surrounding structures, including hypertrophy of the ligamentum flavum (LF). Objectives: The aim of this study was to examine the usefulness of endoscope-assisted interlaminar lumbar decompression (EILD) for patients with lumbar stenosis and hypertrophy of the LF. Study Design: Retrospective study. Setting: Department of Anesthesiology and Pain Medicine, Neurosurgery at Wooridul Spine Hospital. Methods: A total of 51 patients were enrolled in this study. Outcomes were evaluated at baseline and at 2 weeks and 6 months postprocedure via the Numeric Rating Scale, Oswestry Disability Index (ODI), and Zurich Claudication Questionnaire (ZCQ). Results: Mean posttreatment pain scores at 2 weeks and 6 months were significantly lower, and ODI scores were significantly decreased compared with baseline. ZCQ scores were also significantly decreased compared with pretreatment surveys. Two patients required reoperation within one month. At postprocedure 6 months, a ≥ 50% reduction in pain score was recorded in 26 (80%) of 51 patients, and there was ≥ 40% reduction in ODI score in 82% of patients. No serious complications including epidural bleeding, dural or neural injuries, or infection were recorded. Limitations: This study lacked secondary outcome substantiation. In addition, the follow-up period was short (&lt; 6 months), and no patients had postprocedure magnetic resonance imaging. The number of patients was also small. Conclusions: EILD provided good outcomes and may be a reasonable treatment option for carefully selected patients with hypertrophy of the LF.

The influence of preoperative mental health on clinical outcomes after laminectomy in patients with lumbar spinal stenosis

ObjectiveThe influence of preoperative mental health on health-related quality of life (HRQOL) in patients with lumbar spinal stenosis (LSS) remains unclear. This study aims to investigate the influence of preoperative mental health HRQOL after laminectomy in patients with LSS. Patients and MethodsWe retrospectively reviewed 122 patients who had lumbar spinous process splitting laminectomy (LSPSL) for LSS. We assessed clinical information; Japanese Orthopedic Association (JOA) score; numerical rating scale (NRS) for low back pain, for leg pain, and for leg numbness; Zurich Claudication Questionnaire (ZCQ); JOA Back Pain Evaluation Questionnaire (JOABPEQ); Roland-Morris Disability Questionnaire (RMDQ); and Short Form 8 (SF-8) as patient reported outcomes. Patients were divided into two groups (Group L ≤ 36.2 points and Group NL > 36.2 points) based on the results of the preoperative mental health (MH) score in SF-8 to examine the influence of MH in LSS. We compared the HRQOL between the two groups postoperatively. ResultsThe JOA score, NRS, and ZCQ score significantly improved after surgery. HRQOL outcomes including JOABPEQ, RMDQ, and SF-8 showed that the LSPSL improved not only the physical but also the mental function in patients with LSS. All HRQOL outcomes in Group L exhibited significantly worse scores preoperatively; however, no significant differences between two groups were found postoperatively. ConclusionsLSPSL greatly reduced low back pain, leg pain, and leg numbness. LSPSL resulted in a significant improvement based on HRQOL questionnaires even in patients with preoperative depressive mood. Not only the physical status but also the mental health may improve after LSPSL even in patients with LSS with a depressive mood preoperatively.

Decompression of lumbar canal stenosis with a bilateral interlaminar versus classic laminectomy technique: a prospective randomized study.

OBJECTIVEThe aim of this study was to compare the radiological and clinical results of bilateral interlaminar canal decompression and classic laminectomy in lumbar canal stenosis (LCS).METHODSTwo hundred eighteen patients with LCS were randomized to surgical treatment with classic laminectomy (group 1) or bilateral interlaminar canal decompression (group 2). Low-back and leg pain were evaluated according to the visual analog scale (VAS) both preoperatively and postoperatively. Disability was evaluated according to the Oswestry Disability Index (ODI) preoperatively and at 1 month, 1 year, and 3 years postoperatively. Neurogenic claudication was evaluated using the Zurich Claudication Questionnaire (ZCQ) preoperatively and 1 year postoperatively. The two treatment groups were compared in terms of neurogenic claudication, estimated blood loss (EBL), and intra- and postoperative complications.RESULTSPostoperative low-back and leg pain declined as compared to the preoperative pain. Both groups had significant improvement in VAS, ODI, and ZCQ scores, and the improvements in ODI and back pain VAS scores were significantly better in group 2. The average EBL was 140 ml in group 2 compared to 260 ml in group 1. Nine patients in the laminectomy group developed postoperative instability requiring fusion compared to only 4 cases in the interlaminar group (p = 0.15). Complications frequency did not show any statistical significance between the two groups.CONCLUSIONSBilateral interlaminar decompression is an effective method that provides sufficient canal decompression with decreased instability in cases of LCS and increases patient comfort in the postoperative period.

Validation of Patient Reported Outcomes Measurement Information System (PROMIS) Computer Adaptive Tests (CATs) in the Surgical Treatment of Lumbar Spinal Stenosis.

Prospective, cohort study. Demonstrate validity of Patient reported outcomes measurement information system (PROMIS) physical function, pain interference, and pain behavior computer adaptive tests (CATs) in surgically treated lumbar stenosis patients. There has been increasing attention given to patient reported outcomes associated with spinal interventions. Historical patient outcome measures have inadequate validation, demonstrate floor/ceiling effects, and infrequently used due to time constraints. PROMIS is an adaptive, responsive National Institutes of Health (NIH) assessment tool that measures patient-reported health status. Ninety-eight consecutive patients were surgically treated for lumbar spinal stenosis and were assessed using PROMIS CATs, Oswestry disability index (ODI), Zurich Claudication Questionnaire (ZCQ), and Short-Form 12 (SF-12). Prior lumbar surgery, history of scoliosis, cancer, trauma, or infection were excluded. Completion time, preoperative assessment, 6 weeks and 3 months postoperative scores were collected. At baseline, 49%, 79%, and 81% of patients had PROMIS pain behavior (PB), pain interference (PI), and physical function (PF) scores greater than 1 standard deviation (SD) worse than the general population. 50.6% were categorized as severely disabled, crippled, or bed bound by ODI. PROMIS CATs demonstrated convergent validity through moderate to high correlations with legacy measures (r = 0.35-0.73). PROMIS CATs demonstrated known groups validity when stratified by ODI levels of disability. ODI improvements of at least 10 points on average had changes in PROMIS scores in the expected direction (PI = -12.98, PB = -9.74, PF = 7.53). PROMIS CATs demonstrated comparable responsiveness to change when evaluated against legacy measures. PROMIS PB and PI decreased 6.66 and 9.62 and PROMIS PF increased 6.8 points between baseline and 3-months post-op (P < 0.001). Completion time for the PROMIS CATs (2.6 min) compares favorably to ODI, ZCQ, and SF-12 scores (3.1, 3.6, and 3.0 min). PROMIS CATs demonstrate convergent validity, known groups validity, and responsiveness for surgically treated patients with lumbar stenosis to detect change over time and are more efficient than legacy instruments. 2.

Lumbar spinal canal stenosis leads to locomotive syndrome in elderly patients

BackgroundLocomotive syndrome is a condition in which the ability to lead a normal life is restricted owing to a dysfunction in one or more of the parts of the musculoskeletal system. Although lumbar spinal canal stenosis (LSS) is considered to cause locomotive syndrome, a detailed assessment of the association between two pathologies has not yet been reported. MethodsThe clinical data of patients aged > 65 years old who planned to undergo surgery for LSS at multiple institutions were prospectively collected from April 2016 to August 2017. A total of 200 participants comprising 120 men and 80 women were enrolled in this study. Association of severity of LSS evaluated by Zurich Claudication Questionnaire scores with three locomotive syndrome risk tests (Stand-up Test, the Two-step Test, and a 25-question risk assessment) and Timed Up-and-Go Test were evaluated. ResultsIn the total assessment of locomotive syndrome, 96.5% of the participants were diagnosed as grade 2, and the remaining 3.5% were diagnosed as grade 1. When the participants were divided into 3 groups according to the LSS severity, the scores of all locomotive syndrome risk tests were significantly worse with increasing LSS severity. Logistic regression analysis revealed that LSS severity was positively correlated with the risk level of locomotive syndrome evaluated by the Two-step Test (OR = 3.45, CI = 1.33–8.96). ConclusionsAll LSS patients with surgical indications were diagnosed as having locomotive syndrome. In addition, our results indicated that LSS severity is potentially associated with the progression of locomotive syndrome. The treatment of LSS may be beneficial in alleviating the risk for locomotive syndrome.

A comparative study of three conservative treatments in patients with lumbar spinal stenosis: lumbar spinal stenosis with acupuncture and physical therapy study (LAP study)

BackgroundAlthough the efficiency of conservative management for lumbar spinal stenosis (LSS) has been examined, different conservative management approaches have not been compared. We have performed the first comparative trial of three types of conservative management (medication with acetaminophen, exercise, and acupuncture) in Japanese patients with LSS.MethodsPatients with L5 root radiculopathy associated with LSS who visited our hospital for surgical treatment were enrolled between December 2011 and January 2014. In this open-label study, patients were assigned to three treatment groups (medication, exercise, acupuncture) according to the visit time. The primary outcomes were Zurich claudication questionnaire (ZCQ) scores before and after 4 weeks of treatment. Least square mean analysis was used to assess the following dependent variables in the treatment groups: changes in symptom severity and physical function scores of the ZCQ and the ZCQ score of patient’s satisfaction after treatment.ResultsThirty-eight, 40, and 41 patients were allocated to the medication, exercise, and acupuncture groups, respectively. No patient underwent surgical treatment during the study period. The symptom severity scores of the ZCQ improved significantly after treatment in the medication (p = 0.048), exercise (p = 0.003), and acupuncture (p = 0.04) groups. The physical function score improved significantly in the acupuncture group (p = 0.045) but not in the medication (p = 0.20) and exercise (p = 0.29) groups. The mean reduction in the ZCQ score for physical function was significantly greater for acupuncture than for exercise. The mean ZCQ score for treatment satisfaction was significantly greater for acupuncture than for medication.ConclusionsAcupuncture was significantly more effective than physical exercise according to the physical function score of the ZCQ and than medication according to the satisfaction score. The present study provides new important information that will aid decision making in LSS treatment.Trial registrationThis study was registered with the UMIN Clinical Trials Registry (UMIN000006957).

Anterior and Lateral Lumbar Interbody Fusion With Supplemental Interspinous Process Fixation: Outcomes from a Multicenter, Prospective, Randomized, Controlled Study.

Rigid interspinous process fixation (ISPF) has received consideration as an efficient, minimally disruptive technique in supporting lumbar interbody fusion. However, despite advantageous intraoperative utility, limited evidence exists characterizing midterm to long-term clinical outcomes with ISPF. The objective of this multicenter study was to prospectively assess patients receiving single-level anterior (ALIF) or lateral (LLIF) lumbar interbody fusion with adjunctive ISPF. This was a prospective, randomized, multicenter (11 investigators), noninferiority trial. All patients received single-level ALIF or LLIF with supplemental ISPF (n = 66) or pedicle screw fixation (PSF; n = 37) for degenerative disc disease and/or spondylolisthesis (grade ≤2). The randomization patient ratio was 2:1, ISPF/PSF. Perioperative and follow-up outcomes were collected (6 weeks, 3 months, 6 months, and 12 months). For ISPF patients, mean posterior intraoperative outcomes were: blood loss, 70.9 mL; operating time, 52.2 minutes; incision length, 5.5 cm; and fluoroscopic imaging time, 10.4 seconds. Statistically significant improvement in patient Oswestry Disability Index scores were achieved by just 6 weeks after operation (P < .01) and improved out to 12 months for the ISPF cohort. Patient-reported 36-Item Short Form Health Survey and Zurich Claudication Questionnaire scores were also significantly improved from baseline to 12 months in the ISPF cohort (P < .01). A total of 92.7% of ISPF patients exhibited interspinous fusion at 12 months. One ISPF patient (1.5%) required a secondary surgical intervention of possible relation to the posterior instrumentation/procedure. ISPF can be achieved quickly, with minimal tissue disruption and complication. In supplementing ALIF and LLIF, ISPF supported significant improvement in early postoperative (≤12 months) patient-reported outcomes, while facilitating robust posterior fusion.

Clinical and radiographic outcomes of bilateral decompression via a unilateral approach with transforaminal lumbar interbody fusion for degenerative lumbar spondylolisthesis with stenosis

Background ContextLaminectomy with posterior lumbar interbody fusion (PLIF) has been shown to achieve satisfactory clinical outcomes, but it leads to potential adverse consequences associated with extensive disruption of posterior bony and soft tissue structures. PurposeThis study aimed to compare the clinical and radiographic outcomes of bilateral decompression via a unilateral approach (BDUA) with transforaminal lumbar interbody fusion (TLIF) and laminectomy with PLIF in the treatment of degenerative lumbar spondylolisthesis (DLS) with stenosis. Study DesignThis is a prospective cohort study. Patient SampleThis study compared 43 patients undergoing BDUA+TLIF and 40 patients undergoing laminectomy+PLIF. Outcome MeasuresVisual analog scale (VAS) for low back pain and leg pain, Oswestry Disability Index (ODI), and Zurich Claudication Questionnaire (ZCQ) score. MethodsThe clinical outcomes were assessed, and intraoperative data and complications were collected. Radiographic outcomes included slippage of the vertebra, disc space height, segmental lordosis, and final fusion rate. This study was supported by a grant from The National Natural Science Foundation of China (81572168). ResultsThere were significant improvements in clinical and radiographic outcomes from before surgery to 3 months and 2 years after surgery within each group. Analysis of leg pain VAS and ZCQ scores showed no significant differences in improvement between groups at either follow-up. The mean improvements in low back pain VAS and ODI scores were significantly greater in the BDUA+TLIF group than in the laminectomy+PLIF group. No significant difference was found in the final fusion rate at 2-year follow-up. The BDUA+TLIF group had significantly less blood loss, shorter length of postoperative hospital stay, and lower complication rate compared with the laminectomy+PLIF group. ConclusionsWhen compared with the conventional laminectomy+PLIF procedure, the BDUA+TLIF procedure achieves similar and satisfactory effects of decompression and fusion for DLS with stenosis. The BDUA+TLIF procedure appears to be associated with less postoperative low back discomfort and quicker recovery.

Two-Year Evaluation of the X-STOP Interspinous Spacer in Different Primary Patient Populations With Neurogenic Intermittent Claudication Because of Lumbar Spinal Stenosis

Multicenter, prospective single-arm study in patients diagnosed with neurogenic intermittent claudication because of lumbar spinal stenosis. To collect data from 2 different primary patient populations, new participants meeting entry criteria [Continued Access Program (CAP)], or subjects who had been randomly assigned to nonsurgical management in the pivotal Investigational Device Exemption study and failed to respond upon study completion [Crossover Study (COS)]. The X-STOP interspinous spacer is a minimally invasive treatment option for neurogenic intermittent claudication shown to improve pain, physical functioning, and/or overall quality of life. Fifty-five subjects were enrolled, 42 in CAP and 13 in COS. Zurich Claudication Questionnaire (ZCQ) success rates were obtained based on the number of subjects achieving a threshold level of success. Mean SF-36 domain scores were compared with baseline using repeated measures analysis of variance. Eighty percent of subjects completed the study. At 2 years, 26/43 subjects (60.5%) achieved clinically significant improvement in the Symptom Severity domain, 25/43 (58.1%) achieved clinically significant improvement in the Physical Function domain, and 31/44 (70.5%) achieved clinically significant improvement in the Patient Satisfaction domain of the ZCQ. Statistically significant improvement in mean scores was obtained in all physical domains of the SF-36 (with the exception of General Health) at 24 months. Mean improvement in ZCQ and SF-36 scores was not as pronounced in the COS cohort compared with the CAP cohort. The most frequently reported device-related or treatment-related adverse event was stenosis pain reported by 3 subjects. Overall data are consistent with the randomized pivotal Investigational Device Exemption trial. On the basis of the COS cohort which was subject to several additional years of failed conservative treatment, overall success rates do not improve as greatly in patients with long-standing lumbar spinal stenosis symptoms.

Interspinous process devices for the treatment of neurogenic intermittent claudication: a systematic review of randomized controlled trials.

The aim of this study is to compare interspinous process device (IPD) implantation to other methods for the treatment of neurogenic intermittent claudication (NIC). PubMed and Cochrane library were searched in December 2014. Randomized controlled trials (RCTs) comparing IPD implantation and nonoperative therapy or laminectomy with/without spinal fusion for the treatment of NIC due to spinal stenosis or low-grade degenerative spondylolisthesis were included. Meta-analysis and qualitative analysis were conducted as appropriate. Eleven articles (eight RCTs) were included, with two having high risk of bias. These RCTs were divided into three groups according to control cohort interventions: IPD implantation was compared with nonoperative treatment (group 1, n = 3), laminectomy (group 2, n = 3), and laminectomy associated with instrumented spinal fusion (group 3, n = 2). Group 1 studies reported better Zurich Claudication Questionnaire (ZCQ) scores for the IPD group. In group 2, two studies reported comparable ZCQ scores and one revealed comparable visual analog scale (VAS) and Oswestry Disability Index (ODI) scores; pooled analysis showed a higher reoperation rate in patients treated with IPD. In group 3, one study found that more patients in IPD group gained more than 25% improvement in VAS and ODI, with lower complication rate; the other reported better ZCQ scores in the IPD group and comparable complication and reoperation rates. IPD implantation is more effective than the other methods, but not superior to laminectomy in treating NIC.