Predicting the Occurrence of New Vertebral Fractures Using the Vertebral Bone Quality Score: A Prospective Cohort Study Using 11-Year MRI Follow-up Data from the Minami-Aizu Study.

Background: Previous studies have recognized the potential of the Vertebral Bone Quality (VBQ) score for predicting fractures. However, these studies often have lacked longitudinal perspectives and have not focused on community populations. Our study aimed to enhance the predictive capacity of the VBQ score by investigating its correlation with new vertebral fractures (NVFs) that were detected 11 years later in a community-based cohort and by developing a comprehensive prediction model. Methods: This study was a population-based study conducted in the Minami-Aizu area in Fukushima Prefecture, Japan. One hundred and thirty participants voluntarily underwent T1-weighted magnetic resonance imaging (MRI) of the lumbar spine in 2004 and 2015. VBQ scores were ascertained from the 2004 scans. NVFs that occurred between 2004 and 2015 were detected based on a ≥20% reduction in vertebral height on the midsagittal sections of the MRI. Other predictors that were considered included age, sex, body mass index, smoking history, heart disease, cerebrovascular disease, respiratory disease, and existing vertebral fractures (EVFs). A logistic regression analysis was conducted. Results: The logistic regression analysis indicated that the VBQ score, age, sex, and EVFs were significant predictors of NVFs. The prediction model showed an area under the curve of 0.84, suggesting excellent discriminatory power. The calibration capacity was confirmed using the Hosmer-Lemeshow test. Conclusions: The VBQ score was significantly correlated with the long-term incidence of NVFs in a community population. The prediction model exhibited satisfactory discrimination and calibration capacities, highlighting the use of the VBQ score as a potential tool for long-term prediction of NVFs. Level of Evidence: Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.

Foot Tapping Test as a Simple Quantitative Index of Motor Function for Lumbosacral Radiculopathy.

STUDY DESIGN: We conducted a retrospective review of data from patients who underwent surgical treatment for lumbosacral radiculopathy. OBJECTIVE: To assess the effectiveness of the foot tapping test (FTT) in evaluating lower limb motor function in patients with lumbosacral radiculopathy pre- and post-surgery. SUMMARY OF BACKGROUND DATA: Lumbosacral radiculopathy is becoming increasingly common in aging populations. Despite standard treatments, paralysis often leads to incomplete postoperative recovery, necessitating early detection and interventions. METHODS: We enrolled individuals who underwent surgery for lumbosacral radiculopathy at our facility between 2009 and 2020. Patients with a history of lumbar surgeries, dialysis, rheumatoid arthritis, and transitional vertebrae were excluded. The FTT score was measured by having the sole of the foot tap as many times as possible for 10 s while keeping the heel in contact with the floor. The L4, L5, and S1 groups were assigned using the scores on the side of the radiculopathy, and the control group was assigned using the scores on the intact side. Data were analyzed using Dunnett's test for group comparisons and paired t-tests for pre-post-surgery comparisons. RESULTS: Of the 522 eligible patients, 80 (159 nerve roots, one patient with hemi-prosthetic leg) were analyzed. The preoperative FTT scores in the L4 and L5 groups were significantly lower than those in the control group, indicating functional impairment. One year post-surgery, all groups showed improvements in FTT scores, with the L5 group exhibiting significant improvements compared to the control; this was supported by the results of sensitivity analyses considering the effects of paralysis and pain. CONCLUSION: The FTT is a valuable tool for the early detection of lower limb motor dysfunction in lumbosacral radiculopathy, particularly for L5 nerve root impairment, where it aids in timely surgical intervention and may improve postoperative outcomes and quality of life.

Time Course of Asymptomatic Stenosis in Multiple Lumbar Spinal Stenosis-Five-Year Results of Selective Decompression of Symptomatic Levels.

Background: In the diagnosis of lumbar spinal stenosis (LSS), finding stenosis with magnetic resonance imaging (MRI) does not always correlate with symptoms such as sciatica or intermittent claudication. We perform decompression surgery only for cases where the levels diagnosed from neurological findings are symptomatic, even if multiple stenoses are observed on MRI. The objective of this study was to examine the time course of asymptomatic stenosis in patients with LSS after they underwent decompression surgery for symptomatic stenosis. Materials and Methods: The participants in this study comprised 137 LSS patients who underwent single-level L4-5 decompression surgery from 2003 to 2013. The dural sac cross-sectional area at the L3-4 disc level was calculated based on preoperative MRI. A cross-sectional area less than 50 mm2 was defined as stenosis. The patients were grouped, according to additional spinal stenosis at the L3-4 level, into a double group (16 cases) with L3-4 stenosis, and a single group (121 cases) without L3-4 stenosis. Incidences of new-onset symptoms originating from L3-4 and additional L3-4-level surgery were examined. Results: Five years after surgery, 98 cases (72%) completed follow-up. During follow-up, 2 of 12 patients in the double group (16.7%) and 9 of 86 patients in the single group (10.5%) presented with new-onset symptoms originating from L3-4, showing no significant difference between groups. Additional L3-4 surgery was performed for one patient (8.3%) in the double group and three patients (3.5%) in the single group; again, no significant difference was shown. Conclusion: Patients with asymptomatic L3-4 stenosis on preoperative MRI were not prone to develop new symptoms or need additional L3-4-level surgery within 5 years after surgery when compared to patients without preoperative L3-4 stenosis. These results indicate that prophylactic decompression for asymptomatic levels is unnecessary.

A reduction method for anterior opening displacement in thoracolumbarvertebral fractures with diffuse idiopathic skeletal hyperostosis using the skull clamp-assisted position.

Diffuse idiopathic skeletal hyperostosis (DISH) frequently occurs in the spine, resulting in unstable fractures. Treating thoracolumbar fractures in patients with DISH is often difficult because the anterior opening of the vertebral body is exacerbated by dislocation in the prone position, making reduction difficult. In this study, we introduced a novel skull clamp-assisted positioning (SAP) technique. The patient is placed in a supine position with a skull clamp used in cervical spine surgery before surgery to prevent the progression of dislocation and to restore the patient's position. Using this method, the mean difference in local kyphosis angle improved from -2.9 (±8.4)° preoperatively to 10.9 (±7.7)° postoperatively. Furthermore, posterior displacement decreased from a preoperative mean of 5.5 (±4.3) mm to 0.3 (±0.7) mm postoperatively. Complications such as neurological sequelae, implant fracture, and surgical site infection were not observed through one year of postoperative follow-up. SAP may decrease invasiveness and complications. Longer-term studies and larger sample sizes are needed to establish long-term efficacy and benefits.

Prognostic impact and survival outcomes of colon perforation in patients with metastatic colorectal cancer: a multicenter retrospective cohort study.

BACKGROUND: Colon perforation caused by colorectal cancer (CRC) is a fatal condition requiring emergency intervention. For patients with metastatic lesions, surgeons face difficult decisions regarding whether to resect the primary and metastatic lesions. Moreover, there is currently no established treatment strategy for these patients. This study aimed to investigate the clinical practice and long-term outcomes of patients with metastatic CRC diagnosed with the onset of colon perforation. METHODS: We performed a population-based multicenter cohort study. Consecutive patients diagnosed with stage IV CRC between 2008 and 2015 at all designated cancer hospitals in Fukushima Prefecture, Japan, were enrolled in this study. We evaluated the impact of colon perforation on the survival outcomes of patients with metastatic CRC. The main outcome was the adjusted hazard ratio (aHR) of perforation for overall survival (OS). Survival time and HRs were estimated using Kaplan‒Meier and Cox proportional regression analyses. RESULTS: A total of 1258 patients were enrolled (perforation: n = 46; non-perforation: n = 1212). All but one of the patients with perforation underwent primary resection or colostomy and 25 cases were able to receive chemotherapy. The median OS for the perforation and non-perforation groups was 19.0 and 20.0 months, respectively (p = 0.96). Moreover, perforation was not an independent prognostic factor (aHR: 0.99; 95% confidence interval: 0.61-1.28). CONCLUSIONS: In metastatic CRC, perforation is not necessarily a poor prognostic factor. Patients with perforation who undergo primary tumor resection or colostomy and prompt initiation of systemic chemotherapy might be expected to have a survival time similar to that of patients with non-perforated colon.

Assessment of Lumbar Spinal Stenosis as a Risk Factor for Development of Sleep Disorder: The Locomotive Syndrome and Health Outcome in Aizu Cohort Study (LOHAS).

Purpose: Insomnia has been reported to coexist with various musculoskeletal disorders. Although lumbar spinal stenosis (LSS) is the most frequently operated on spinal disease, the causal relationship between LSS and development of sleep disorders remains unclear due to lack of longitudinal studies. This study aimed to determine whether LSS was a risk factor for developing new sleep disorders, primarily insomnia, using a prospective cohort of community residents. Patients and Methods: This study was a prospective cohort study. Participants aged ≥65 years from the "Locomotive Syndrome and Health Outcomes in Aizu Cohort Study (LOHAS)" conducted in 2008 formed our study population. LSS was diagnosed using the self-administered, self-reported history questionnaire, a validated diagnostic support tool for LSS. Sleep disorder was investigated using a questionnaire during the 2-year follow-up. The impact of LSS on sleep disorder onset was analyzed after adjusting for potential confounders, such as age, sex, obesity, hypertension, diabetes, depression, and smoking habits, using propensity score matching. Results: Of the 489 participants who were followed up for two years, 38 (7.8%) had newly developed a sleep disorder in 2010. After adjusting for confounding factors, a comparison of 133 participants each in the control and LSS groups showed significantly higher frequency of new-onset sleep disorders (19 [14.3%] in the LSS group versus 6 [4.5%] in the control group). Conclusion: LSS was found to be an independent risk factor for sleep disorders.

Knee locking caused by osteochondroma of the proximal tibia adjacent to the pes anserinus: A case report.

BACKGROUND: Osteochondroma is one of the most common benign bone tumors, and it may cause bone and joint deformities and limited range of motion of an adjacent joint. The pes anserinus region is one of the most frequent sites of osteochondroma, but knee locking caused by osteochondromas in the pes anserinus region is extremely rare. CASE SUMMARY: We describe a 13-year-old Japanese girl's extra-articular knee locking that occurred when the semitendinosus tendon got caught in osteochondroma that had developed in the pes anserinus region. The osteochondroma was surgically resected. The postoperative outcome has been excellent, with no recurrence of knee locking or tumor one-year post-surgery. CONCLUSION: When a young person develops knee locking, the possibility of extra-articular as well as intra-articular locking should be considered. Osteochondroma, one of the causes of extra-articular locking, can be treated with surgery with good postoperative results.

Clinical Indicators to Determine the Timing of Surgery for Adhesive Small Bowel Obstruction.

BACKGROUND: Decompression of the intestine with a long tube or nasogastric tube is the first-choice treatment for adhesive small bowel obstruction (ASBO). Scheduling surgery while weighing the risks of surgery against conservative care is a crucial factor in clinical decision-making. Whenever feasible, unnecessary surgeries should be avoided, and it is essential to provide clinical markers for this. This study aimed to obtain evidence regarding the optimal timing of ASBO and when conservative treatment options are not successful. METHODS: The data of patients diagnosed with ASBO and receiving long tube insertion for more than 7 days were reviewed. We investigated transit ileal drainage volume and recurrence. The primary outcomes were the change in the drainage volume from the long tube over time and the percentage of patients who required surgery. We evaluated some cutoff values to determine the indication for surgery based on the insertion duration and volume of long tube drainage. RESULTS: Ninety-nine patients were enrolled in this study. Fifty-one patients showed improvement with conservative treatment, whereas 48 ultimately required surgery. When a daily drainage volume of ≥500 mL was considered an indication for surgery, 13-37 cases (25%-72%) would be judged unnecessary within 6 days of long tube insertion, while 5 cases (9.8%) would be judged unnecessary on day 7. DISCUSSION: Unnecessary surgical interventions for ASBO might be avoided by assessing the drainage volume on day 7 after inserting a long tube.

A muscle-preserving, spinous process-splitting approach for ossification of the ligamentum flavum in the thoracic spine in professional athletes: a report of three cases.

A muscle-preserving, spinous process-splitting approach may be a less invasive approach to conventional laminectomy in patients with thoracic ossification of the ligamentum flavum. Few reports have discussed the usefulness of this procedure for thoracic lesions in professional athletes who need highly active thoracic spinal function after surgery. The treatment of thoracic ossification of the ligamentum flavum using a spinous process-splitting approach in 3 professional athletes is presented. In all three cases the patients could return to play within 3 months after surgery without complications, and in two of the cases, there was no spinal deformity or local recurrence of ossification of the ligamentum flavum at the final follow-up at least 8 years after surgery. The spinous process-splitting approach could be a safe procedure for multi-level and all other forms of ossification of the ligamentum flavum and is less invasive to the paraspinal muscles, relieves back symptoms, and restores function for athletes.

Total Talar Replacement for Idiopathic Osteonecrosis of the Talus: Investigation of Clinical Outcomes, Pain, ADL, QOL.

Background: Treatment of osteonecrosis of the talus is challenging. Nonoperative management includes nonweightbearing treatment. Various types of hindfoot fusion procedures have been performed, but delayed union and shortening of the operated leg have reportedly occurred. In contrast, talar body prosthesis is a surgical procedure with potential that relieves pain, restores ankle joint function, and is not associated with leg-length discrepancy. The aim of this study was to investigate postoperative pain, clinical outcomes, activities of daily living (ADL), and quality of life (QOL) after total talar replacement in patients with osteonecrosis of the talus. Methods: Ten ankles in 10 patients with idiopathic osteonecrosis of the talus who were treated with a total talar replacement between 2007 and 2015 were included in the investigation. Scores according to the visual analog scale (VAS), Japanese Society for Surgery of the Foot (JSSF) ankle-hindfoot scale, Functional Independence Measure (FIM), and the Self-Administered Foot Evaluation Questionnaire (SAFE-Q) were assessed. Results: The VAS score significantly improved from a mean of 80 ± 8 points before surgery to 18 ± 22 points after surgery (P < .01). The JSSF ankle-hindfoot scale score significantly improved from a mean of 53 ± 12 points before surgery to 89 ± 7 points after surgery (P < .01). The FIM score significantly improved from a mean of 122 ± 1 points before surgery to 125 ± 1 points after surgery (P < .01). The mean postoperative SAFE-Q scores were as follows: 81 ± 10.3 points for pain, 78 ± 14.7 points for physical function, 90 ± 12.4 points for social function, and 83 ± 15.4 points for shoe-related. Conclusion: Total talar replacement is a useful treatment for patients with osteonecrosis of the talus. This replacement surgery preserves the function of the ankle and subtalar joints, and improves pain, ADL, and QOL. Level of Evidence: Level IV, case series.

Generalization of a clinical diagnosis support tool for lumbar spinal stenosis: Can the ankle brachial pressure index be replaced by palpation of the posterior tibial artery in the lumbar spinal stenosis diagnostic support tool? (DISTO project).

BACKGROUND: The Japanese Society for Spine Surgery and Related Research previously developed a diagnostic support tool for lumbar spinal stenosis (LSS-DST). Using the LSS-DST, general physicians can identify potential cases of LSS. However, in the LSS-DST, measurement of the ankle brachial pressure index (ABI) is required to exclude peripheral artery lesions in the lower limbs. We can expect further application of the LSS-DST if we can identify a simpler and easier method than ABI measurement. Therefore, in this large-scale, multicenter, cross-sectional study, we verified whether palpation of the posterior tibial (PT) artery could be used instead of ABI in the LSS-DST. METHODS: This survey was conducted at 2177 hospitals and included 28,883 participants. The sensitivity and specificity of the original LSS-DST method using the ABI and that of the LSS-DST ver2.0 with PT artery palpation were assessed to screen their ability for diagnosing LSS, using the physicians' final diagnosis based on the patients' history, physical examination and radiographic findings as the gold standard. RESULTS: The sensitivity and specificity [95%CI] of the LSS-DST were 88.2% [87.5, 88.8] and 83.9% [83.4, 84.5], respectively, whereas the sensitivity and specificity of the LSS-DST ver2.0 were 87.7% [87.0, 88.3] and 78.3% [77.7, 78.9], respectively, indicating that LSS-DST ver2.0 is a useful screening tool for LSS with good sensitivity. CONCLUSION: When the item of ABI in the LSS-DST is replaced by palpation of the PT artery (LSS-DST ver2.0), its sensitivity is maintained as a screening tool for LSS. LEVEL OF EVIDENCE: Level 3.

Lumbar spinal stenosis is a risk factor for the development of dementia: locomotive syndrome and health outcomes in the Aizu cohort study.

PURPOSE: It remains unclear whether musculoskeletal diseases are risk factors for dementia development. This prospective cohort study of community-dwelling residents aimed to clarify the impact of lumbar spinal stenosis (LSS) on dementia development. METHODS: We included participants aged ≥ 65 years from the Locomotive Syndrome and Health Outcomes in the Aizu cohort study. LSS was diagnosed using the validated LSS diagnostic support tool. Dementia development between 2008 and 2015 was investigated using official long-term care insurance certification data. We analysed the effects of LSS on dementia development after adjusting for potential confounders, like age, sex, diabetes, depressive symptoms, hip and knee joint osteoarthritis, daily activity, and smoking habit. RESULTS: We included 1220 patients in the final analysis. The incidence of dementia was significantly higher in the LSS group [48 of 444 (10.8%)] than in the control group [34 of 776 (4.4%)]. Multivariable analysis using multiple imputations revealed that the confidence interval for the adjusted odds ratio of LSS for dementia development was 1.87 (95% confidence interval; 1.14-3.07). CONCLUSION: We clarified that LSS is an independent risk factor for dementia development. Our findings suggest the importance of considering the risk of dementia in the decision-making process for the treatment of LSS.

Clinical outcomes and factors involved in the local control of proton beam therapy for oligometastatic liver tumors in patients with colorectal cancer.

BACKGROUND AND PURPOSE: There are no existing reports on proton beam therapy (PBT) for local control (LC) of liver metastasis of colorectal cancer (LMCRC). We calculated the LC rate of PBT for LMCRC and explored the influence of each factor on the LC rate. MATERIALS AND METHODS: Cases in which PBT was performed at our center between 2009 and 2018 were retrospectively selected from the database. Patients with LMCRC without extrahepatic lesions and no more than three liver metastases were included. Effectiveness was assessed based on LC, overall survival (OS), and progression-free survival (PFS) rates. Adverse events (AEs) are described. Factors that may be related to LC were also investigated. RESULTS: This study included 23 men and 18 women, with a median age of 66 (range 24-87) years. A total of 63 lesions were included in the study. The most frequent dose was 72.6 Gy (relative biological effectiveness)/22 fractions. The median follow-up period was 27.6 months. The 3­year LC, OS, and PFS rates were 54.9%, 61.6%, and 16.7%, respectively. Our multivariate analysis identified the distance between the tumor and the gastrointestinal (GI) tract as a factor associated with LC (P = 0.02). No grade ≥ 3 AEs were observed. None of the patients experienced liver failure during the acute or late phase. CONCLUSION: Care must be taken with tumors that have reduced planning target volume coverage owing to organs at risk restrictions, especially in tumors near the GI tract.

Radiological and pathological characteristics of synovial hemangioma of the knee.

Synovial hemangioma, a rare benign tumor that occurs most frequently in the knee in children and young adults, has four histological subtypes: Venous, arteriovenous, cavernous and capillary hemangiomas. Since the clinical presentation and radiological findings of synovial hemangioma are non-specific, there is frequently a long period between the onset and the diagnosis. The cases of nine patients, pathologically diagnosed with synovial hemangioma and surgically treated, were retrospectively analyzed. All nine patients had persistent knee pain. In addition, three patients also had a swollen knee with intra-articular hemorrhage. Plain radiography revealed intra-articular phleboliths in two patients. In seven patients, T1-weighted magnetic resonance imaging showed low signal intensity with small signal voids. On T2-weighted imaging, all patients showed high signal intensity containing small signal voids. All patients underwent surgical excision; there was no postoperative recurrence after the final operation, and the knee pain had disappeared at the final follow-up. From the pathological findings, the diagnoses were venous hemangioma, cavernous hemangioma and capillary hemangioma (three patients each).

Relationship between physical activity and bone mineral density loss after gastrectomy in gastric cancer patients.

PURPOSE: The prevention of osteoporosis is a particularly relevant issue for gastric cancer survivors. We investigated the relationship between postoperative physical activity and the change of bone mineral density (BMD) in patients with gastric cancer. METHODS: Patients who underwent radical gastrectomy for gastric cancer were enrolled in this single-center prospective cohort study. Physical activity was evaluated using the International Physical Activity Questionnaire Short Form at postoperative month (POM) 6 and patients were classified into high, middle, and low physical activity groups accordingly. The primary outcome was the change in BMD from baseline at POM 12, which was expressed as a percentage of the young adult mean (YAM). The YAM of the lumbar spine and femoral neck was measured by dual-energy X-ray absorptiometry. RESULTS: One hundred ten patients were enrolled in this study. The physical activity level at POM 6 was classified as high (n = 50; 45%), middle (n = 25; 23%), and low (n = 35; 32%). The mean decrease of YAM% was 5.1% in the lumbar spine and 4.2% in the femoral neck at POM 12. A multivariable-adjusted logistic regression model revealed that low physical activity at POM 6 was a significant risk factor for BMD loss at POM 12 (odds ratio, 3.76; 95% confidence interval, 1.48-9.55; p = 0.005). CONCLUSION: Low physical activity after gastrectomy is an independent risk factor for decreased BMD at POM 12. The introduction of exercise may prevent osteoporosis after the surgical treatment of gastric cancer.

Fibulo-Scapho-Lunate Arthrodesis With Free Vascularized Fibular Graft for a Japanese Kyudo Archer With Osteosarcoma of the Left Distal Radius: A Case Report.

BACKGROUND: Recent progress in the chemotherapy and surgical procedures for osteosarcoma have enabled the preservation of limb function even when cancer occurs in the distal radius, a rare primary site of osteosarcoma. CASE REPORT: We describe a case of osteosarcoma that occurred in an 18-year-old, male Kyudo (Japanese archery) archer's left distal radius. Since the patient desired to resume Kyudo and the left hand was quite important for gripping a bow, we chose partial wrist arthrodesis (fibulo-scapho-lunate arthrodesis) with free vascularized fibular grafting (FVFG) as the reconstruction procedure following wide resection. After the wide resection, the major axis of bone defect was 8 cm. We harvested a free vascularized fibular graft with fascio-cutaneous flap with wide fascia to reconstruct the gliding surface of the extensor tendon. Fibula-proximal radius and fibulo-scapho-lunate fixation was performed by locking plates individually. Vascular anastomosis was performed between the radial artery and peroneal artery in a flow-through manner. Two peroneal veins were anastomosed with the radial vein and cephalic vein. CONCLUSION: Fibulo-scapho-lunate arthrodesis with FVFG may provide satisfied stability and function even in a Kyudo archer. The patient obtained sufficient wrist stability and grip strength, and could resume Kyudo.

The Relationship between Exercise-Induced Low Back Pain, the Fat Infiltration Rate of Paraspinal Muscles, and Lumbar Sagittal Balance.

Introduction: Exercise-induced low back pain (EILBP) is induced during anterior trunk tilting when walking or prolonged standing. In some elderly with chronic LBP, the pain is induced by EILBP. The paraspinal muscles play an important role in supporting the spine; therefore, a dysfunction of back muscles and kyphotic alignment are considered to be associated with EILBP. However, few reports are showing the relationship between EILBP and degenerative muscle changes. This study aimed to clarify the relationship between EILBP, degenerative changes of paraspinal muscles, and spinal alignment in an epidemiological study. Methods: A total of 324 subjects were included in the analysis. The presence of EILBP was determined through a medical interview and physical examination. The subjects underwent lumbar spine magnetic resonance image (MRI) and X-ray. The fat infiltration rate (FIR) of the multifidus, erector spinae, and psoas major were analyzed using MRI. For lumbar sagittal balance, L1 axis S1 distance (LASD) was measured using X-ray images. Multivariate logistic regression analysis was used to analyze the association between the presence of EILBP and FIR or LASD. Results: The prevalence of EILBP was 21% and it increased with age. The subjects with EILBP had statistically higher FIR of the multifidus, erector spinae, and psoas major than those without EILBP. There was a significant association between the presence of EILBP and higher FIR of the erector spinae at L1-2 and L5-S1 (p<0.05). However, there were no significant associations between EILBP and LASD. Conclusions: According to the results in this study, EILBP is not rare and the FIR of the erector spinae is associated with the presence of EILBP.

Efficacy and Safety of Add-on Mirogabalin to NSAIDs in Lumbar Spinal Stenosis with Peripheral Neuropathic Pain: A Randomized, Open-Label Study.

INTRODUCTION: In Japan, conservative therapy for patients with lumbar spinal stenosis (LSS) includes non-steroidal anti-inflammatory drugs (NSAIDs), prostaglandin E1, tramadol, physical/exercise therapy, and nerve blocks. Mirogabalin, a selective oral α2δ ligand, is approved for treating peripheral neuropathic pain, though data regarding visual analog scores (VAS) for pain in patients with LSS are limited. We investigated the efficacy and safety of mirogabalin as an add-on treatment in patients with LSS taking NSAIDs compared with patients taking NSAIDs only. METHODS: This multicenter, randomized, open-label study (MiroTAS) was conducted at 32 centers in Japan between June 2020 and October 2021. Patients were randomly assigned to mirogabalin and NSAIDs or NSAIDs alone in a 1:1 ratio. NSAIDs were administered according to their Japanese package inserts; mirogabalin was administered based on renal function [creatinine clearance (CrCL) ≥ 60 mL/min, 5 mg twice daily (BID) in Weeks 1-2, 10 mg BID in Weeks 3-4, and 15 or 10 mg BID after Week 5; CrCL 30 to < 60 mL/min, 2.5 mg BID Weeks 1-2, 5 mg BID Weeks 3-4, and 7.5 or 5 mg BID after Week 5]. The primary endpoint was the change in VAS score for leg pain from baseline to Week 12. Secondary endpoints were quality of life, evaluated using the EuroQol five-dimensional descriptive system (EQ-5D-5L) (at baseline and Week 12) and Patient Global Impression of Change (PGIC) (at Week 12), and safety. Change in VAS score at Week 12 was calculated using a linear mixed model for repeated measures. The safety endpoints were treatment-emergent adverse events (TEAEs) and adverse drug reactions. RESULTS: In total, 220 patients who met the eligibility criteria were enrolled. In the mirogabalin and NSAIDs and NSAIDs groups, mean ages (67.8 vs. 70.9 years), proportions of female patients (54.5% vs. 49.0%), mean body weights (63.9 vs. 62.0 kg), mean CrCL values (81.5 vs. 70.7 mL/min), proportions of patients with CrCL 30 to < 60 mL/min (27.3% vs. 33.7%), mean VAS scores (63.8 vs. 62.8 mm), and proportions of patients with VAS score ≥ 60 (53.6% vs. 52.9%) at enrollment were similar. The median durations of LSS were 9.0 and 11.0 months and the spine pain DETECT questionnaire (SPDQ) scores were 6.8 and 7.8, respectively. The least square (LS) mean change in VAS score from baseline to Week 12 was - 24.1 mm in the mirogabalin and NSAIDs group and - 14.2 mm in the NSAIDs group (both P < 0.0001 vs. baseline). The difference in LS mean was - 9.9 [95% confidence interval (CI), - 18.0, - 1.8] (P = 0.0174). The improvement in EQ-5D-5L score at Week 12 was significantly greater in the mirogabalin and NSAIDs group versus the NSAIDs group [mean difference, 0.0529 (95% CI, 0.0036, 0.1022), P = 0.0357]. At Week 12, the proportions of patients with PGIC scores ≤ 3 and ≤ 2 were higher in the mirogabalin and NSAIDs group vs. the NSAIDs group (76.2% vs. 50.0%, P = 0.0006, and 47.6% vs. 32.4%, P = 0.0523). In the mirogabalin and NSAIDs group, the incidences of TEAEs and adverse drug reactions were 60.9% and 57.3%, respectively, and the most common TEAEs were somnolence (30.0%) and dizziness (25.5%). CONCLUSIONS: The addition of mirogabalin to NSAIDs improved VAS, EQ-5D-5L, and PGIC. The main TEAEs were somnolence and dizziness. The addition of mirogabalin to NSAIDs improved peripheral neuropathic pain associated with LSS and raised no new safety concerns. TRIAL REGISTRATION: Japan Registry of Clinical Trials (jRCTs021200007).

Magnitude of Dural Tube Compression Still Does Not Show a Predictive Value for Symptomatic Lumbar Spinal Stenosis for Six-Year Follow-Up: A Longitudinal Observation Study in the Community.

BACKGROUND: Lumbar spinal stenosis (LSS) is a clinical syndrome based on anatomic narrowing of the spinal canal. It is well known that anatomic narrowing of the spinal canal is essential for manifestation, but not all of them cause symptoms. There are many studies assessing the relationship between dural tube compression on MRI and clinical symptoms; however, most of them are cross-sectional. The purpose of this study was to reveal the magnitude of dural tube compression's influence on the presence or development of LSS symptoms at the six-year follow-up and the occurrence of surgery during the follow-up period or not in the community setting. METHODS: This was a longitudinal observational study of 459 participants who were assessed for typical LSS symptoms, and whose Roland-Morris Disability Questionnaire and numerical rating scale of leg pain and numbness was recorded using a questionnaire and conventional MRI of the lumbar spine. Typical LSS symptoms were judged using an LSS diagnostic support tool, which was a self-administered, self-reported history questionnaire (LSS-SSHQ). After six years, 232 subjects (follow-up rate 50.5%) were followed-up with typical LSS symptoms using LSS-SSHQ by mail. The relationship between the magnitude of dural tube compression evaluated by dural tube cross-sectional area (DCSA) in the initial assessment and the time course of typical LSS symptoms for the six-year duration were analyzed. In addition, predictors of the presence of typical LSS symptoms at the six-year follow-up were assessed. Furthermore, we investigated the relationship between typical LSS symptoms and DCSA during the initial assessment of patients who underwent surgery during the follow-up period. A multivariate logistic regression analysis was performed for statistical analysis. RESULTS: (1) Severe dural tube compression did not show that LSS symptoms continued after six years. (2) Severe dural tube compression could not detect development of LSS-symptoms and surgery during the six-year period. CONCLUSION: Severe dural tube compression could not detect typical LSS symptom development and occurrence of surgery during the six-year period.

Clinical Benefit of Polypectomy With Cutting Current for Colorectal Polyps: A Randomized Controlled Trial.

BACKGROUND/AIM: This study aimed to examine the effectiveness of polypectomy with cutting current (PCC) for colorectal polyps, compared with cold snare polypectomy (CSP). PATIENTS AND METHODS: The study design was a singlecenter randomized controlled trial. We included patients with one or more non-pedunculated colorectal polyps of 6 mm or more and less than 10 mm. The primary endpoint was the proportion of complete resection of the muscularis mucosae. RESULTS: Twenty-seven patients (37 polyps) were assigned to the CSP group, and 22 (29 polyps) were assigned to the PCC group. The number of polyps that could achieve complete muscularis mucosae resection was 7 (20.0%) in the CSP group and 24 (92.3%) in the PCC group, and the rate of complete muscularis mucosae resection was statistically significantly higher in the PCC group. CONCLUSION: PCC is a safer procedure because it can remove the muscularis mucosae more reliably.