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

STUDY DESIGN: Secondary analysis of a randomized controlled trial. OBJECTIVE: 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. SUMMARY OF BACKGROUND DATA: 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. METHODS: 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 6 weeks and 1 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. RESULTS: Pearson's correlation coefficients between the changes in outcomes and the ZCQ satisfaction subscale at 6 weeks and 1 year were 0.37-0.58 (symptom severity) and 0.40-0.45 (physical function subscales) (>0.30 is considered a good anchor). The area under the ROC curve values were 0.66-0.72 and 0.63-0.71 for the symptom severity and physical function subscales, respectively (>0.7 is considered acceptable). The MCIDs at 6 weeks and 1 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. CONCLUSION: 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.

Minimal clinically important differences in walking capacity and physical activity after nonsurgical treatment in patients with lumbar spinal stenosis: a secondary analysis of a randomized controlled trial.

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

A nationwide multicenter study of the cost effectiveness of five leading drugs for pharmacological management of cervicobrachial symptoms.

BACKGROUND: Cervicobrachial pain frequently affects the quality of life (QOL) of the general public and has a significant economic impact on the health care systems of various countries. There are a number of treatment options for this disease, including widely-used drug therapy, but the effectiveness of each option is indeterminate, and there have been no published cost-effectiveness analysis studies so far. This prospective observational study aimed to examine the cost-effectiveness of drug treatment for cervicobrachial symptoms. METHODS: A 6-month medication regimen for each of five frequently-prescribed drugs for cervicobrachial symptoms was administered to 322 patients at 24 centers in Japan. Outcome measures, including of the EuroQol Group 5D, Short Form-8, and Visual Analog Scale (VAS), were investigated at baseline and every month thereafter. Incremental cost-effectiveness ratios (ICERs) of the drug cost to quality-adjusted life years (QALYs) were calculated. A stratified analysis of patient characteristics was also performed to identify baseline factors potentially affecting cost-effectiveness. RESULTS: The ICER of entire drug treatment for cervicobrachial symptoms was 7,491,640 yen. Compared with the reference willingness-to-pay, the ICER was assumed to not be cost-effective. A certain number of QALYs were gained during the first 3 months after the treatment intervention, but almost no QALYs were gained during the following 3 months. Stratified analysis showed that cost-effectiveness was extremely low for patients with high baseline VAS and high QOL. CONCLUSIONS: The available medications for cervicobrachial symptoms did not have excellent cost-effectiveness. Although a certain number of QALYs were gained during the first 3 months after medication, no QALYs were gained in the latter half of the study period, suggesting that it is not advisable to continue the medication needlessly. LEVEL OF EVIDENCE: II, prospective cohort study.

Development of a Novel Rat Knee Osteoarthritis Model Induced by Medial Meniscus Extrusion.

OBJECTIVE: The medial meniscus extrusion (MME) is associated with increased stress on the knee joint, which leads to cartilage degeneration. To evaluate the etiology of knee osteoarthritis, it is extremely important to create animal models of the disease that more closely resemble actual clinical conditions in terms of symptomatology, molecular biology, and histology. This study aimed to create a clinically relevant model of MME in rats. DESIGN: Behavioral, molecular biological, and histological changes in the newly developed rat MME model were compared with those in sham and medial meniscus transection and medial collateral ligament transection (MMT) models to examine the characteristics of this model. RESULTS: In the MME rat model, behavioral evaluation shows abnormalities in gait compared with the other 2 groups, and molecular biological evaluation of the infrapatellar synovia of rats shows that gene expression of inflammatory cytokines, matrix-degrading enzymes, and pain-related nerve growth factor was increased compared with the sham group. Furthermore, histological evaluation reveals that cartilage degeneration was the most severe in the MME group. CONCLUSIONS: The newly developed MME model reproduced the characteristic pathology of MME in clinical practice, such as severe pain, inflammation, and rapid progression of osteoarthritis. The MME model, which might more closely mimic human knee osteoarthritis (OA), could be a useful model for elucidating the pathophysiology and considering therapeutic management for knee OA.

Preoperative factors affecting the two-year postoperative patient-reported outcome in single-level lumbar grade I degenerative spondylolisthesis.

Background: The choice of operative method for lumbar spinal stenosis with Meyerding grade I degenerative spondylolisthesis remains controversial. The purpose of this study was to identify the preoperative factors affecting the 2-year postoperative patient-reported outcome in Meyerding grade I degenerative spondylolisthesis. Methods: Seventy-two consecutive patients who had minimally invasive decompression alone (D group; 28) or with fusion (DF group; 44) were enrolled. The parameters investigated were the Japanese Orthopaedic Association back pain evaluation questionnaire as patient-reported assessment, and L4 slippage (L4S), lumbar lordosis (LL), and lumbar axis sacral distance (LASD) as an index of sagittal alignment for radiological evaluation. Data collected prospectively at 2 years postoperatively were examined by statistical analysis. Results: Sixty-two cases (D group; 25, DF group; 37) were finally evaluated. In multiple logistic regression analysis, preoperative L4S and LASD were extracted as significant preoperative factors affecting the 2-year postoperative outcome. Patients with preoperative L4S of 6 mm or more have a lower rate of improvement in lumbar spine dysfunction due to low back pain (risk ratio=0.188, p=.043). Patients with a preoperative LASD of 30 mm or more have a higher rate of improvement in lumbar dysfunction due to low back pain (risk ratio=11.48, p=.021). The results of multiple logistic analysis by operative method showed that there was a higher rate of improvement in lumbar spine dysfunction due to low back pain in patients with preoperative LASD of 30 mm or more in DF group (risk ratio=172.028, p=.01). Conclusions: Preoperative L4S and LASD were extracted as significant preoperative factors affecting patient-reported outcomes at 2 years postoperatively. Multiple logistic analyses by the operative method suggested that DF may be advantageous in improving lumbar dysfunction due to low back pain in patients with preoperative LASD of 30 mm or more.

Effect of Lumbar Fusion and Pelvic Fixation Rigidity on Hip Joint Stress: A Finite Element Analysis.

STUDY DESIGN: This study compared hip stress among different types of lumbopelvic fusion based on finite element (FE) analysis. OBJECTIVE: We believe that the number and placement of S2 alar iliac (AI) screws and whether the screws loosen likely influence hip joint stress in the FE model. SUMMARY OF BACKGROUND DATA: Spinopelvic fixation has been shown to increase the risk of progression for hip joint osteoarthritis. The biomechanical mechanism is not well understood. We hypothesize that the rigid pelvic fixation may induce stress at adjacent joints. MATERIALS AND METHODS: A three-dimensional nonlinear FE model was constructed from the L4 vertebra to the femoral bone. From the intact model, we made four fusion models, each with different lower vertebrae instrumentation: (1) intact, (2) L4-S1 fusion, (3) L4-S2 AI screw fixation, (4) L4-S2 AI screw fixation with S2 AI screw loosening, and (5) L4-S1 and dual sacral AI screw fixation. A compressive load of 400 N was applied vertically to the L4 vertebra, followed by an additional 10 Nm bending moment about different axes to simulate either flexion, extension, left lateral bending, or right axial rotation. The distal femoral bone was completely restrained. The von Mises stress and angular motion were analyzed across the hip joints within each fusion construct model. RESULTS: Hip joint cartilage stress and range of motion increased for all postures as pelvic fixation became more rigid. The dual sacral AI screw fixation model increased stress and angular motion at the hip joint more than intact model. Our results suggest that more rigid fixation of the pelvis induces additional stress on the hip joint, which may precipitate or accelerate adjacent joint disease. CONCLUSIONS: Dual sacral AI fixation led to the highest stress while loosening of S2 AI decreased stress on the hip joint. This study illustrates that more rigid fixation among lumbosacral fusion constructs increases biomechanical stress on the hip joints.

Lumbar paraspinal muscle morphology is associated with spinal degeneration in patients with lumbar spinal stenosis.

BACKGROUND CONTEXT: Lumbar spinal stenosis (LSS) has been reported to induce changes in paraspinal muscle morphology, but objective physical function and degenerative spine conditions are rarely assessed. PURPOSE: To identify factors associated with paraspinal muscle morphology using objective physical and degenerative spine assessments in patients with LSS. STUDY DESIGN/SETTING: Cross-sectional design. PATIENT SAMPLE: Seventy patients with neurogenic claudication caused by LSS, receiving outpatient physical therapy. OUTCOME MEASURES: Cross-sectional area (CSA) and functional CSA (FCSA) of the multifidus, erector spinae, and psoas muscles, the severity of stenosis, disc degeneration, and endplate abnormalities were evaluated by magnetic resonance imaging, as well as sagittal spinopelvic alignment by X-ray. Objective physical assessments included pedometry and claudication distance. Patient-reported outcomes included the numerical rating scale of low back pain, leg pain, and leg numbness, and the Zurich Claudication Questionnaire. METHODS: To assess the impact of LSS on paraspinal muscles, FCSA and FCSA/CSA were compared between the dominant and nondominant sides based on the patients' neurogenic symptoms, and multivariable regression analyses adjusted for age, sex, height, and weight were performed; p<.05 was considered significant. RESULTS: Seventy patients were analyzed. At one level below the maximum stenotic level, erector spinae FCSA on the dominant side was significantly lower than that on the nondominant side. In the multivariable regression analyses, at one level below the symptomatic level, disc degeneration, endplate abnormalities, and lumbar spinopelvic alignment, such as decreased lumbar lordosis and increased pelvic tilt, were negatively associated with multifidus FCSA and FCSA/CSA ratio. A significant association was observed between dural sac CSA and erector spinae FCSA. Throughout L1/2 to L5/S, disc degeneration, endplate abnormalities, and lumbar spinopelvic alignment were negatively associated with multifidus and erector spinae FCSA or FCSA/CSA. CONCLUSIONS: Lumbar paraspinal muscle asymmetry caused by LSS was observed only in erector spinae. Disc degeneration, endplate abnormalities, and lumbar spinopelvic alignment, rather than spinal stenosis and LSS symptoms, were more associated with paraspinal muscle atrophy or fat infiltration.

Branched-chain amino acids plus vitamin D supplementation promote increased muscle strength following lumbar surgery for lumbar spinal stenosis: a randomized trial.

BACKGROUND CONTEXT: Adequate nutrition is essential to address the surgical stress response and mitigate loss of muscle mass, strength, and functionality in older adults with lumbar spinal stenosis (LSS). However, it is unknown whether amino acids and/or vitamin D are beneficial in older adults following lumbar surgery for LSS. PURPOSE: To evaluate whether branched-chain amino acids (BCAA) plus vitamin D supplementation could attenuate the loss of muscle mass and strength, accelerate the return of functional mobility, and improve clinical outcomes following lumbar surgery for LSS. STUDY DESIGN/SETTING: A single-center, single-blind randomized controlled trial. PATIENT SAMPLE: Eighty patients who received lumbar surgery for LSS. OUTCOME MEASURES: The primary outcome was the Zurich claudication questionnaire (ZCQ), and secondary outcomes included knee muscle strength, muscle mass measured by bioelectrical impedance analysis, gait speed and a timed up-and-go test (TUG) at 12 weeks postoperatively. Follow-up assessment was performed for the ZCQ at 52 weeks postoperatively. METHODS: Patients ingested the supplementation (BCAA group: BCAA plus vitamin D, Nonamino acid group: nonamino acid) twice daily for 3 weeks from the day after surgery, and received two hours of postoperative inpatient rehabilitation 5 times a week. RESULTS: No significant differences were observed in the mean changes on the ZCQ between the two groups at 12 weeks and 52 weeks. At 2 weeks postoperatively, the nonamino acid group showed significant deterioration compared with the BCAA group for strengths of knee extensor and knee flexor (p < .01). At 12 weeks, the BCAA group showed significant improvements in knee extensor strength and knee flexor strength compared with the nonamino acid group (p <.01). There were no significant differences in mean changes of muscle mass, maximum gait speed, and TUG at 12 weeks between two groups. CONCLUSIONS: BCAA plus vitamin D supplementation did not improve LSS-related clinical outcomes after lumbar surgery for LSS, even though muscle strength increased. Future studies should focus on long-term outcomes for muscle mass and physical function, including development of sarcopenia and frailty.

Japanese Orthopaedic Association (JOA) clinical practice guidelines on the management of lumbar spinal stenosis, 2021 - Secondary publication.

BACKGROUND: The Japanese Orthopaedic Association (JOA) guideline for the management of lumbar spinal stenosis (LSS) was first published in 2011. Since then, the medical care system for LSS has changed and many new articles regarding the epidemiology and diagnostics of LSS, conservative treatments such as new pharmacotherapy and physical therapy, and surgical treatments including minimally invasive surgery have been published. In addition, various issues need to be examined, such as verification of patient-reported outcome measures, and the economic effect of revised medical management of patients with lumbar spinal disorders. Accordingly, in 2019 the JOA clinical guidelines committee decided to update the guideline and consequently established a formulation committee. The purpose of this study was to describe the formulation we implemented for the revision of the guideline, incorporating the recent advances of evidence-based medicine. METHODS: The JOA LSS guideline formulation committee revised the previous guideline based on the method for preparing clinical guidelines in Japan proposed by the Medical Information Network Distribution Service in 2017. Background and clinical questions were determined followed by a literature search related to each question. Appropriate articles based on keywords were selected from all the searched literature. Using prepared structured abstracts, systematic reviews and meta-analyses were performed. The strength of evidence and recommendations for each clinical question was decided by the committee members. RESULTS: Eight background and 15 clinical questions were determined. Answers and explanations were described for the background questions. For each clinical question, the strength of evidence and the recommendation were both decided, and an explanation was provided. CONCLUSIONS: The 2021 clinical practice guideline for the management of LSS was completed according to the latest evidence-based medicine. We expect that this guideline will be useful for all medical providers as an index in daily medical care, as well as for patients with LSS.

Psychometric Evaluation and External Validity of the Japanese Version of Lumbar Stiffness Disability Index.

Introduction: Long fusion surgery for adult spinal deformity may restrict activities of daily living due to lumbar stiffness. While the Lumbar Stiffness Disability Index (LSDI) can help assess lumbar stiffness, in Asia the external validity of this questionnaire has not been sufficiently examined. We performed the psychometric evaluation and external validation of the Japanese version of the LSDI (LSDI-J). Methods: Fifty consecutive patients (14 males and 36 females; mean age 70.6 years) who underwent lumbar fusion surgery at our institution a minimum of one year after surgery and who visited the outpatient clinic between April and May 2019, were surveyed using the LSDI-J. The mean number of fusion levels was 4.4. Cronbach's alpha coefficients were calculated for internal consistency, and the intraclass correlation coefficient (ICC) was calculated to evaluate reliability. External validity was assessed by comparisons with the Oswestry Disability Index (ODI), the Japanese Orthopaedic Association Back Pain Evaluation Questionnaire (JOABPEQ), and the lumbar range of motion (LROM) with LSDI-J scores. Results: Cronbach's alpha coefficient was 0.652 overall, and 0.849 after excluding Question 10 due to a low response rate. The ICC was 0.824 overall and 0.851 after excluding Question 10. The correlation with the ODI was 0.684, and the correlation coefficients with each domain of the JOABPEQ ranged from -0.590 to -0.413, indicating moderate correlation. However, LROM and the LSDI-J were not correlated (r=-0.055, P=0.734). Conclusions: The LSDI-J may not be suitable in Japan because there was no correlation with LROM, the most important factor for external validity. It may be necessary to investigate why the LSDI-J did not apply to the Japanese population in terms of lower limb function. Alternatively, a unique method may be needed to assess lumbar stiffness disability that is more suitable for actual clinical practice in Japan.

MRI grading of spinal stenosis is not associated with the severity of low back pain in patients with lumbar spinal stenosis.

BACKGROUND: Although lumbar spinal stenosis (LSS) often coexists with other degenerative conditions, few studies have fully assessed possible contributing factors for low back pain (LBP) in patients with LSS. The purpose of this study was to identify factors associated with the severity of LBP in patients with LSS. METHODS: The patients with neurogenic claudication caused by LSS, which was confirmed by magnetic resonance imaging (MRI) were included in this cross-sectional study. Data included ratings of LBP, buttock and leg pain, and numbness on a numerical rating scale (NRS), 36-item Short-Form Survey (SF-36) scores, muscle mass measured by bioelectrical impedance analysis, and radiographic measurements including lumbopelvic alignment and slippage. The severity of LSS, endplate defects, Modic endplate changes, intervertebral disc degeneration, and facet joint osteoarthritis were evaluated on MRI. Spearman correlation and multivariate linear regression analyses were used to examine the factors associated with the severity of LBP (NRS score). RESULTS: A total of 293 patients (135 male and 158 female, average age 72.6 years) were analyzed. LBP was moderately correlated with buttock and leg pain, and buttock and leg numbness. Significant but weak correlations were observed between LBP and body mass index, appendicular and trunk muscle mass, all domains of SF-36, pelvic tilt, total number of endplate defects and Modic endplate changes, and summary score of disc degeneration grading, but not severity or number of spinal stenoses. In the multivariate regression analysis, age, female sex, trunk muscle mass, diabetes, NRS buttock and leg pain, NRS buttock and leg numbness, SF-36 vitality, pelvic tilt, and total number of endplate defects were associated with the severity of LBP. CONCLUSIONS: Trunk muscle mass, lumbopelvic alignment, and endplate defects, but not severity of stenosis are partly associated with severity of LBP, but buttock and leg pain and buttock and leg numbness have strongest relationships with LBP in patients with LSS.

Supervised physical therapy versus surgery for patients with lumbar spinal stenosis: a propensity score-matched analysis.

BACKGROUND: Previous studies comparing surgical with nonsurgical treatment for lumbar spinal stenosis (LSS) reported that surgery is superior to nonsurgical treatments, but intensive and adequate volume of physical therapy were rarely performed. The purpose of this study was to compare the 1-year follow-up outcomes of patients with LSS treated with supervised physical therapy or surgery using propensity score-matched analysis. METHODS: A total of 224 patients with LSS who received supervised physical therapy (n = 38) or surgery (n = 186) were included, of which 66 were matched on baseline demographics, radiological findings, and patient-reported outcomes. The physical therapy group received supervised physical therapy twice weekly for 6 weeks. The physical therapy sessions included manual therapy, individually tailored exercises, cycling, and body-weight supported treadmill walking. The surgery group underwent decompression surgery with or without spinal fusion. A propensity score analysis was performed using a one-to-one nearest neighbor approach. RESULTS: The surgery group showed greater improvements in Zurich claudication questionnaire symptom severity and physical function, SF-36 physical functioning, bodily pain, and mental health, but had more severe stenosis and symptoms and mental health problems than the physical therapy group at baseline (P <  0.05). After propensity score matching, there were no significant differences in baseline characteristics, and all clinical outcomes at 1 year, except for a higher percentage of responders achieving minimum clinically important difference in the role-emotional subscale of SF-36 in the surgery group (P <  0.05). CONCLUSIONS: When baseline characteristics were considered, supervised physical therapy yielded similar effects to lumbar surgery. These results suggest that supervised physical therapy is preferred over surgery as first-choice treatment, to prevent complications and to minimize health care costs, especially in mild to moderate cases of LSS.

Endplate Deficits and Posterior Wall Injury Are Predictive of Prolonged Back Pain after Osteoporotic Vertebral Body Fracture.

Introduction: Osteoporotic vertebral compression fracture (OVCF) in the elderly is a major public health concern. This retrospective case-control study aimed to determine the difference in interobserver reliability between radiography, magnetic resonance imaging (MRI), and computed tomography (CT), respectively, and whether CT radiological findings can predict prolonged back pain at 2 weeks after OVCFs. Methods: Patients were divided into the prolonged back pain group or the recovered back pain group depending on the numerical rating scale at 2 weeks after admission. Radiography, MRI, and CT images were classified on the basis of conventions described by previous classifications. Interobserver reliability was calculated on images rated by two board-certified spine surgeons. Multivariate logistic regression models were used to evaluate whether the presence or absence of anterior wall injury, endplate deficit, posterior wall injury, lateral wall injury, or intervertebral disc deficit on CT was predictive of prolonged back pain. Results: Of the 130 patients, 89 cases (68.5%) involved prolonged back pain at 2 weeks after admission. Neither average age (79.8 vs. 80.1 years, respectively) nor duration to initial consultation (9.4 vs. 6.4 days, respectively) differed significantly between the prolonged and recovered back pain groups. Interobserver reliability was 0.51, 0.77 (0.67-0.86), and 0.82 (0.72-0.92) for radiography, MRI, and CT, respectively. After adjusting for confounding factors such as age, sex, duration to initial consultation, and extent of OVCF, the multivariate analysis showed that the presence of endplate deficit and posterior wall injury was a significant predictive factor for prolonged back pain (odds ratio [OR] 8.5, area under the curve (AUC); 0.79 and OR 2.5, AUC 0.72), respectively. Conclusions: Good reliability assessments of CT-based evaluations were noted. After a detailed novel CT evaluation at initial presentation, the presence of an endplate deficit and posterior wall injury was the significant risk factor for prolonged back pain at 2 weeks after an OVCF.

Associations between psychological factors and daily step count in patients with lumbar spinal stenosis.

BACKGROUND: Body mass index, pain, female sex, and age have been reported as predictors of physical activity in patients with lumbar spinal stenosis (LSS). However, no reports have examined the psychological factors associated with physical activity in people with LSS. PURPOSE: To use psychological assessments to identify the factors associated with physical activity measured as daily step count in people with LSS. METHODS: Seventy-one patients who received outpatient physical therapy were included. All patients completed the following scales at baseline: Zurich Claudication Questionnaire; self-paced walking test (SPWT); numerical rating scale of low back pain, leg pain, and leg numbness; Hospital Anxiety and Depression Scale (HADS); Pain Catastrophizing Scale; Pain Anxiety Symptoms Scale (PASS-20); and Tampa Scale for Kinesiophobia. Physical activity was measured using a pedometer as the average number of daily steps. RESULTS: Daily step count was significantly associated with age, number of stenoses, severity of stenosis at L3-L4, walking distance on the SPWT, PASS-20 total score, cognitive anxiety, escape/avoidance, fear, and HADS depression score (p < .05). Multiple regression analysis showed that age, severity of stenosis at L3-L4, walking distance on the SPWT, and PASS-20 fear predicted daily step count (r2 = 0.414). CONCLUSION: Older age, fewer stenoses, less severe stenosis at L3-L4, lower walking capacity, higher anxiety, and fear-avoidance beliefs about pain and depression are more closely associated with lower daily step count than are back and leg pain. Assessment and treatment of psychological factors might help to increase physical activity in patients with LSS.

Psychological Predictors of Satisfaction after Lumbar Surgery for Lumbar Spinal Stenosis.

STUDY DESIGN: A retrospective study of prospectively collected clinical data. PURPOSE: To identify preoperative psychological factors associated with patient satisfaction after surgery for lumbar spinal stenosis (LSS). OVERVIEW OF LITERATURE: Associations between depressive symptoms, anxiety, and worse surgical outcome or patient dissatisfaction have been reported in LSS patients. However, the influence of preoperative pain catastrophizing and fear-avoidance beliefs on postoperative satisfaction is not well understood. METHODS: LSS patients who underwent decompression surgery with or without fusion were included. Clinical outcomes were measured before surgery and 6 months postoperatively using the Zurich Claudication Questionnaire (ZCQ); Visual Analog Scale (VAS) of low back pain, leg pain, and leg numbness; Japanese Orthopaedic Association Back Pain Evaluation Questionnaire; and the Medical Outcomes Study 36-item Short-Form General Health Survey (SF-36). The Hospital Anxiety and Depression Scale (HADS), Pain Catastrophizing Scale, and Pain Anxiety Symptoms Scale were used to evaluate psychological status before surgery. Patients were classified as satisfied or dissatisfied with surgery based on a ZCQ satisfaction subscale cutoff score of 2.5. RESULTS: The satisfied and dissatisfied groups contained 128 and 29 patients, respectively. Six months postoperatively, outcome scores for the dissatisfied group were unchanged or worse than preoperative scores (p>0.05). Multivariate logistic regression analysis showed significant associations between dissatisfaction and preoperative low back pain VAS score ≥ median (odds ratio [OR], 0.27; 95% confidence interval [CI], 0.10-0.74; p=0.01), preoperative mental health SF-36 score ≥ median (OR, 0.26; 95% CI, 0.08-0.89; p=0.03), and preoperative anxiety HADS score ≥ median (OR, 3.95; 95% CI, 1.16-13.46; p=0.03). CONCLUSIONS: Preoperative less severe low back pain, lower mental health, and higher anxiety are associated with patient dissatisfaction with lumbar surgery, not depression, pain catastrophizing, or fear-avoidance beliefs. Pre- and postoperative psychological status should be assessed carefully and managed appropriately.

Endplate defects, not the severity of spinal stenosis, contribute to low back pain in patients with lumbar spinal stenosis.

BACKGROUND CONTEXT: It is controversial whether lumbar spinal stenosis (LSS) itself contributes to low back pain (LBP). Lower truncal skeletal muscle mass, spinopelvic malalignment, intervertebral disc degeneration, and endplate abnormalities are thought to be related to LBP. However, whether these factors cause LBP in patients with LSS is unclear. PURPOSE: To identify factors associated with LBP in patients with LSS. STUDY DESIGN/SETTING: Cross-sectional design. PATIENT SAMPLE: A total of 260 patients (119 men and 141 women, average age 72.8 years) with neurogenic claudication caused by LSS, as confirmed by magnetic resonance imaging (MRI). OUTCOME MEASURES: Ratings of LBP, buttock and leg pain, and numbness on a numerical rating scale (NRS), 36-Item Short Form Survey (SF-36) scores, muscle mass measured by bioelectrical impedance analysis, and radiographic measurements including slippage and lumbopelvic alignment. The severity of LSS, endplate defects, Modic endplate changes, intervertebral disc degeneration, and facet joint osteoarthritis were assessed on MRI. METHODS: The presence of LBP was defined as an NRS score ≥3. The demographic data, patient-reported outcomes, and radiological and MRI findings were compared between patients with and without LBP. Multivariate logistic regression analysis was used to identify the factors that were independently associated with the presence of LBP. RESULTS: There were significant differences between patients with and without LBP for buttock and leg pain and numbness on the NRS, general health on the SF-36, presence of endplate defects, presence of Modic changes, disc degeneration grading, and disc height grading (all p < .05). Multivariate logistic regression analysis showed significant associations between LBP and diabetes (OR 2.43; 95% CI 1.07-5.53), buttock and leg numbness on the NRS (OR 1.34; 95% CI 1.17-1.52), general health on the SF-36 (OR 0.97; 95% CI 0.95-0.99), and the presence of erosive endplate defects (OR 3.04; 95% CI 1.51-6.11) (all p < .05). CONCLUSIONS: These results suggest that LBP in patients with LSS should be carefully assessed not only for spinal stenosis but also clinical factors and endplate defects.

Formulation of Japanese Orthopaedic Association (JOA) clinical practice guideline for the management of low back pain- the revised 2019 edition.

BACKGROUND: The latest clinical guidelines are mandatory for physicians to follow when practicing evidence-based medicine in the treatment of low back pain. Those guidelines should target not only Japanese board-certified orthopaedic surgeons, but also primary physicians, and they should be prepared based entirely on evidence-based medicine. The Japanese Orthopaedic Association Low Back Pain guideline committee decided to update the guideline and launched the formulation committee. The purpose of this study was to describe the formulation we implemented for the revision of the guideline with the latest data of evidence-based medicine. METHODS: The Japanese Orthopaedic Association Low Back Pain guideline formulation committee revised the previous guideline based on a method for preparing clinical guidelines in Japan proposed by Medical Information Network Distribution Service Handbook for Clinical Practice Guideline Development 2014. Two key phrases, "body of evidence" and "benefit and harm balance" were focused on in the revised version. Background and clinical questions were determined, followed by literature search related to each question. Appropriate articles were selected from all the searched literature. Structured abstracts were prepared, and then meta-analyses were performed. The strength of both the body of evidence and the recommendation was decided by the committee members. RESULTS: Nine background and nine clinical qvuestions were determined. For each clinical question, outcomes from the literature were collected and meta-analysis was performed. Answers and explanations were described for each clinical question, and the strength of the recommendation was decided. For background questions, the recommendations were described based on previous literature. CONCLUSIONS: The 2019 clinical practice guideline for the management of low back pain was completed according to the latest evidence-based medicine. We strongly hope that this guideline serves as a benchmark for all physicians, as well as patients, in the management of low back pain.

Comparison of the Effectiveness of Pharmacological Treatments for Patients with Chronic Low Back Pain: A Nationwide, Multicenter Study in Japan.

INTRODUCTION: Chronic low back pain (CLBP) is a leading cause of disability, yet there is limited high-quality evidence to identify the most suitable pharmacological therapy. The purpose of this Japanese nationwide, multicenter, prospective study was to compare the effectiveness of four representative drug therapies-acetaminophen, celecoxib, loxoprofen, and a tramadol and acetaminophen (T+A) combination drug-to establish evidence for a drug of choice for CLBP. METHODS: Patients with CLBP (N=471) received one of the four treatments and were evaluated, prospectively and comprehensively, once every month for six months using a visual analog scale (VAS) for LBP, the Japanese Orthopedic Association (JOA) score, the JOA Back Pain Evaluation Questionnaire (JOABPEQ), the Roland-Morris Disability Questionnaire (RDQ), the EuroQol five-dimensions three-levels (EQ-5D-3L), and the Short Form-8 item health survey (SF-8). We conducted multivariable linear regression analyses of the four drugs at 1 and 6 months after drug allocation. Differences with P<0.05 were considered statistically significant. RESULTS: Patients who received acetaminophen showed a significant improvement from baseline in the mental health subscale of the JOABPEQ at one month (P=0.02) and the JOA score at six months (P<0.01). None of the other outcome measures among the four drugs differed significantly. Across groups, all outcome measures, except the mental component summary (MCS) score of the SF-8, improved equivalently, although most measurements showed no obvious cumulative effect over six months. The MCS score of the SF-8 decreased gradually over six months in all groups. CONCLUSIONS: Most of the outcome measures among the treated groups were not significantly different, indicating similar treatment effects of the four drugs for CLBP. Our study indicated the limit of each outcome measure for evaluating the patient status, suggesting that a single outcome measure is insufficient to reflect treatment effectiveness.

Supervised physical therapy versus unsupervised exercise for patients with lumbar spinal stenosis: 1-year follow-up of a randomized controlled trial.

OBJECTIVE: To compare the 1-year outcomes of patients with lumbar spinal stenosis treated with supervised physical therapy or unsupervised exercise. DESIGN: A single-center randomized controlled trial with concealed allocation, blinded assessor and intention-to-treat analysis. SETTING: Spine care center. SUBJECTS: A total of 86 patients presenting with symptoms of neurogenic claudication caused by lumbar spinal stenosis. INTERVENTIONS: The physical therapy group received supervised physical therapy sessions twice a week for 6 weeks and home exercise program. The home exercise group received 6-week home exercise program only. MAIN MEASURES: The primary outcome was symptom severity on the Zurich claudication questionnaire at 1 year. Secondary outcomes included physical function, pain, health-related quality of life and the surgery rate after 1 year. RESULTS: At 1 year, more patients in the physical therapy group than in the home exercise group achieved minimum clinically important differences in Zurich claudication questionnaire symptom severity (60.5% vs 32.6%; adjusted odds ratio [AOR] 4.3, [95% CI [1.5-12.3], P = 0.01); Zurich claudication questionnaire physical function (55.8% vs 32.6%; AOR 3.0 [1.1-8.1], P = 0.03); SF-36 bodily pain (48.8% vs 25.6%; AOR 2.8 [1.1-7.3], P = 0.03), and SF-36 general health (20.9% vs 7.0%; AOR 6.1 [1.1-33.0], P = 0.04). The surgery rate at 1 year was lower in the physical therapy than in the home exercise group (7.0% vs 23.3%; AOR 0.2 [0.04-0.9] P = 0.04). CONCLUSIONS: Supervised physical therapy produced greater improvements in symptom severity and physical function than unsupervised exercise and was associated with lower likelihood of receiving surgery within 1 year.

Impact of background factors on outcomes of pharmacological therapy for chronic low back pain: A nationwide multicenter prospective study.

BACKGROUND: Chronic low back pain (CLBP) is a major cause of chronic pain with nociceptive, neuropathic or both pain components, and a leading cause of disability. The objectives of this study were to determine the impact of background factors including previous use of drugs on outcomes of pharmacological therapy for CLBP in a nationwide multicenter prospective study. METHODS: The subjects were 474 patients (male: 41.9%, median age: 73.0) with CLBP. Background factors that could influence outcomes after pharmacological treatment for 6 months were examined: age, gender, body mass index (BMI), duration of CLBP, osteoporosis, history of spinal surgery, history of malignant tumor, smoking habit, employment status (yes or no), exercise habit (frequency), number of live-in family members, having something to do for pleasure, Center for Epidemiologic Studies depression scale (CES-D) score, and medication at baseline. Japanese Orthopaedic Association (JOA) score, visual analogue scale (VAS) for LBP, JOA Back Pain Evaluation Questionnaire (JOABPEQ), Roland-Morris Disability Questionnaire (RDQ), Short-form 8-item health survey (SF-8), and EQ-5D were used for evaluation at baseline and after 6 months. Multivariate linear regression models were used in statistical analysis. RESULTS: Drugs for neuropathic pain at baseline (p < 0.001), Tramacet® at baseline (p < 0.05), weak opioids at baseline (p < 0.05), older age (p < 0.001), long disease duration (p < 0.005), history of spinal surgery (p < 0.001), and smoking habit (p < 0.001) had significant negative effects on outcomes. Employment (p < 0.05), exercise habit (p < 0.05), and CED-D at baseline (p < 0.001) had positive effects on outcomes. CONCLUSIONS: This is the first study to identify significant prognostic factors for outcomes of pharmacological treatment of CLBP. The neuropathic pain component of CLBP at baseline is a major significant negative factor for most outcomes involving improved pain, activities of daily life, and quality of life. Treatment strategies developed with consideration of these factors may be advantageous for recovery from CLBP.