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.

Nocturnal Leg Cramps and Lumbar Spinal Stenosis: A Cross-Sectional Study in the Community.

Purpose: Nocturnal leg cramps are considered to be a symptom of lumbar spinal stenosis (LSS). However, the relationship between LSS and nocturnal leg cramps in the general population remains unclear. The purpose of this study was to investigate the prevalence and characteristics of nocturnal leg cramps in LSS in the community. Patients and Methods: 328 voluntary participants were enrolled in this study. The presence of LSS was assessed by a validated and self-administered diagnostic support tool. The presence of nocturnal leg cramps and neurological findings were evaluated by one experienced spine surgeon. To investigate the relationship between leg cramps and anatomical factors, the participants underwent an MRI scan, and the dural sac cross-sectional area (DCSA) at each lumbar intervertebral disc level was measured. Results: A total of 214 participants (65.2%) had nocturnal leg cramps, and 94 of 328 participants (28.7%) showed typical LSS symptoms. In the typical LSS symptom group, 31 participants (33.0%) had nocturnal leg cramps. In the atypical LSS symptom group, 83 participants (35.5%) had nocturnal leg cramps. There was no statistically significant difference in the prevalence of nocturnal leg cramps between the two groups. The narrowest DCSA (<25 mm2 and 25-49.4mm2) was statistically related to the presence of nocturnal leg cramp. Statistically significant differences in sensory disturbance and motor weakness were not observed between the subjects with and those without nocturnal leg cramps. Moreover, impaired PTR was statistically related to the presence of nocturnal leg cramp. Conclusion: The prevalence of nocturnal leg cramps did not differ with or without typical LSS symptoms in the community. The degree of dural tube compression that is determined by DCSA had a direct effect on the presence of nocturnal leg cramps. Neurological impairment, such as PTR abnormalities, was associated with the presence of nocturnal leg cramps.

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.

Impact of lumbar spinal stenosis on metabolic syndrome incidence in community-dwelling adults in Aizu cohort study (LOHAS).

Metabolic syndrome and lumbar spinal stenosis (LSS) are common age-related diseases. However, the causal relationship between them remains unclear. This study aimed to identify the effects of LSS on metabolic syndrome incidence in community-dwelling adults. This prospective cohort study included participants of the Aizu cohort study (LOHAS) aged < 75 years as of 2008. Participants with metabolic syndrome at baseline were excluded. The primary outcome measure was metabolic syndrome incidence, and the main explanatory variable was the presence of LSS, as assessed by a self-reported questionnaire. A multivariate Cox proportional hazard regression model was used to estimate hazard ratios (HRs) for metabolic syndrome incidence during the 6-year follow-up period. Complete-case analyses were compared with the multiple imputation results. Among 1599 participants, 1390 complete cases were analyzed (mean [SD] age 62.3 [9.0] years; females, 734 [52.8%]). Among those participants, 525 (37.8%) developed metabolic syndrome during the follow-up of 3.89 [1.96] years. The presence of LSS was associated with developing metabolic syndrome (HR, 1.41; 95% confidence interval [CI] 1.02-1.95). Multiple imputation results showed similar trends of those having complete-case data (HR, 1.47; 95% CI 1.08-2.00). This finding suggests the importance of prevention and management of LSS in community settings.

Usefulness of the Brief Scale for Psychiatric Problems in Orthopaedic Patients (BS-POP) for Predicting Poor Outcomes in Patients Undergoing Lumbar Decompression Surgery.

BACKGROUND: The Brief Scale for Psychiatric Problems in Orthopaedic Patients (BS-POP) is an original questionnaire that evaluates psychosocial problems in orthopaedic patients. The purpose of this study was to clarify the relationship between BS-POP scores and surgical outcomes in patients with lumbar spinal stenosis (LSS). METHODS: From our database, a total of 157 patients with LSS who had undergone decompression surgery and completed a 1-year follow-up were retrospectively observed. The primary outcome was the numerical rating scale (NRS) score for satisfaction with surgery (from 0: not satisfied to 10: completely satisfied). Patients with an NRS score ≥8 were classified into the satisfied group. The secondary outcomes were NRS scores for low back pain, leg pain, and leg numbness and scores on the Roland-Morris Disability Questionnaire (RDQ). BS-POP was used to detect psychiatric problems before surgery. A BS-POP score ≥11 on the physician version or a combination of 10 on the physician version and ≥15 on the patient version was considered to indicate the presence of psychiatric problems. The patients were classified into two groups and compared based on preoperative BS-POP scores at the 1-year follow-up. RESULTS: Preoperatively, 22 and 135 patients showed high and low BS-POP scores, respectively. No significant differences in preoperative symptoms were found between the two groups. At 1 year after surgery, patients with high BS-POP scores showed significantly lower satisfaction with surgery, higher NRS scores for low back pain, leg pain, and leg numbness, and lower RDQ deviation scores than did the low BS-POP group (p < 0.05). The results of the multivariable analysis indicated that preoperative high BS-POP scores were independently associated with low satisfaction with surgery (odds ratio: 5.2, 95% confidence interval: 1.9-15.1). CONCLUSION: High preoperative BS-POP scores were associated with poor outcomes for decompression surgery in patients with LSS at 1 year after surgery. These results suggest that BS-POP is a useful tool for predicting surgical outcomes in patients with LSS.

The Change of Lumbar Spinal Stenosis Symptoms over a Six-Year Period in Community-Dwelling People.

Background and Objectives: The high prevalence of lumbar spinal stenosis (LSS) and its negative impact on quality of life in the elderly is well known. However, the longitudinal time course of LSS symptoms remains unclear. The purpose of this study was to clarify the longitudinal time course and associated factors of LSS symptoms over a period of six years in a community. Materials and Methods: This study was conducted with data prospectively collected in 2004 and 2010 under a retrospective design. In 2004, 1578 subjects (age range: 40 to 79 years) were interviewed on LSS symptoms using a specially designed and validated questionnaire. In 2010, a follow-up study was performed by mail, to which 789 subjects of the 2004 study population responded. Considering that the presence of osteoarthritis (OA) of the knee or hip may influence the participants' answers in the questionnaire, analysis was performed in all 789 subjects with and 513 subjects without either knee or hip OA. Changes in LSS symptoms between the initial and the 6-year survey were investigated. Multiple logistic regression analysis was used for detecting the risk factors for LSS symptom presence at the six-year follow-up. Results: 1. At the six-year follow-up, more than half of the subjects who showed LSS symptoms at the initial analysis became LSS-negative, and 12-15% of those who were LSS-negative became LSS-positive. 2. From the multiple logistic regression analysis, a lower Roland-Morris Disability Questionnaire (RDQ) score and a positive LSS symptom at the initial analysis were detected as predictive factors of the presence of LSS symptoms at the six-year follow-up in the total number of subjects, as well as just in those who did not have either knee or hip OA. Conclusions: More than half of the subjects who were LSS-positive at their initial assessment still experienced improvement in their symptoms even after 6 years. This means that both LSS symptoms and their time course vary from person to person. Predictive factors for the presence of LSS symptoms during the six-year follow-up period were RDQ score and positive LSS symptoms.

Epidemiological study of cervical cord compression and its clinical symptoms in community-dwelling residents.

BACKGROUND: Degenerative compressive myelopathy (DCM) is caused by cervical cord compression. The relationship between the magnitude and clinical findings of cervical cord compression has been described in the literature, but the details remain unclear. This study aimed to clarify the relationship between the magnitude and clinical symptoms of cervical cord compression in community-dwelling residents. METHODS: The present study included 532 subjects. The subjective symptoms and the objective findings of one board-certified spine surgeon were assessed. The subjective symptoms were upper extremity pain and numbness, clumsy hand, fall in the past 1 year, and subjective gait disturbance. The objective findings were: Hoffmann, Trömner, and Wartenberg signs; Babinski's and Chaddock's signs; hyperreflexia of the patellar tendon and Achilles tendon reflexes; ankle clonus; Romberg and modified Romberg tests; grip and release test; finger escape sign; and grip strength. Using midsagittal T2-weighted magnetic resonance imaging, the anterior-posterior (AP) diameters (mm) of the spinal cord at the C2 midvertebral body level (DC2) and at each intervertebral disc level from C2/3 to C7/T1 (DC2/3-C7/T1) were measured. The spinal cord compression ratio (R) for each intervertebral disc level was defined and calculated as DC2/3-C7/T1 divided by DC2. The lowest R (LR) along C2/3 to C7/T1 of each individual was divided into 3 grades by the tertile method. The relationship between LR and clinical symptoms was investigated by trend analysis. RESULTS: The prevalence of subjective gait disturbance increased significantly with the severity of spinal cord compression (p = 0.002812), whereas the other clinical symptoms were not significantly related with the severity of spinal cord compression. CONCLUSIONS: The magnitude of cervical cord compression had no relationship with any of the neurologic findings. However, subjective gait disturbance might be a better indicator of the possibility of early stage cervical cord compression.

High Attention-Deficit/Hyperactivity Disorder Scale Scores Among Patients with Persistent Chronic Nonspecific Low Back Pain.

BACKGROUND: Associations between attention-deficit/hyperactivity disorder (ADHD) and chronic pain disorders, such as fibromyalgia, have been reported. However, associations between persistent chronic nonspecific low back pain (CNLBP) and ADHD have not yet been investigated. OBJECTIVES: This study aimed to investigate the positive rates of possible ADHD, as assessed by self-reported ADHD scales, in patients with persistent CNLBP, using data from self-reported questionnaires completed by patients and their families. This study also aimed to compare the self-reported scores obtained from existing standardized data for healthy individuals, and to examine whether the ADHD scale scores of patients with persistent CNLBP are associated with pain variables. STUDY DESIGN: Cross-sectional study. SETTING: The specialized pain clinic at our university hospital. METHODS: This cross-sectional study included 60 consecutive patients with persistent CNLBP who were diagnosed with a possible somatic symptom disorder and were referred to a psychiatrist in our pain clinic. The Conners' Adult ADHD Rating Scales (CAARS) self-report (CAARS-S) and observer-rated (CAARS-O) questionnaires were utilized. We investigated the CAARS scores, and the association between the CAARS subscale scores and pain variables (pain duration and pain Numeric Rating Scale) in patients with persistent CNLBP. RESULTS: Of the 60 patients, 19 (31.7%) were positive on both CAARS-S and CAARS-O questionnaires (T-score > 65). The ADHD indices, which comprised subscales of the CAARS estimating the necessity of treatment for ADHD, were significantly higher in both male and female patients with persistent CNLBP than in the Japanese standardized sample (P < 0.005). CAARS-S hyperactivity/restlessness, CAARS-O hyperactivity/restlessness, and the Diagnostic and Statistical Manual of Mental Disorders, fourth edition hyperactive-impulsive symptom subscale scores also correlated with the pain intensity (P < 0.05). LIMITATIONS: In this study, ADHD tendency was evaluated using only a self-reported questionnaire. Hence in the future, accurate and precise assessments of ADHD symptoms using structured clinical interviews conducted by ADHD experts are warranted. Additionally, the study only included patients with persistent CNLBP. Therefore in the future, it will be valuable to investigate ADHD scale scores (e.g., CAARS) among patients with CNLBP and nonspecific low back pain with larger sample sizes. CONCLUSIONS: Our findings revealed that the subscale scores on an ADHD scale were considerably high in patients with persistent CNLBP. As a previous study of our clinical experience indicates that persistent CNLBP can be substantially relieved by administering ADHD medications, ADHD screening is warranted in the treatment of persistent CNLBP.

Ossification of the ligamentum flavum in the thoracic spine mimicking sciatica in a young baseball pitcher:a case report.

Thoracic ossification of the ligamentum flavum (OLF) is a pathological condition that causes myelopathy, with unilateral lower extremity pain rarely a feature in the presenting complaint. Moreover, most symptomatic cases of thoracic OLF occur in middle-aged men, with younger individuals rarely affected.　We present a rare case of severe and chronic unilateral buttock and leg pain mimicking sciatica due to thoracic OLF in a professional baseball pitcher. A 28-year-old, right-handed, Japanese professional baseball pitcher experienced intractable left leg pain with numbness and spasticity. After the initial presentation, extensive testing focusing on lumbar, hip, and pelvis lesions failed to identify a cause for the pain. One year after onset, careful neurological examination showed signs of upper motor neuron disturbance, and thoracic computed tomography and magnetic resonance imaging revealed thoracic OLF at the level of the thoracolumbar junction. After resection of the thoracic OLF, the pain, numbness, and spasticity completely resolved. He resumed full training and was pitching in top condition within four months after surgery. Though rare, thoracic OLF should be considered in the differential diagnosis of lower extremity pain in young athletes, especially amongst high-level baseball pitchers.

Sagittal imbalance and symptoms of depression in adults: Locomotive Syndrome and Health Outcomes in the Aizu Cohort Study (LOHAS).

PURPOSE: With spinal deformities, mental health can deteriorate due to sagittal imbalance of the spine. The purpose of this study was to clarify the relationship between sagittal imbalance and symptoms of depression among local residents in the community. METHODS: This study used data from the Locomotive Syndrome and Health Outcomes in Aizu Cohort Study (LOHAS) in 2010. The sagittal vertical axis (SVA) was identified as an indicator of sagittal imbalance. Symptoms of depression were assessed using the 5-item version of the Mental Health Inventory. Participants were classified into three categories based on the SVA balance as normal (< 40 mm), moderate imbalance (40-95 mm), and severe imbalance (> 95 mm). To evaluate the relationship between sagittal imbalance of the spine and symptoms of depression, the adjusted risk ratio (RR) and the 95% confidence interval (CI) were calculated using a generalized linear model with Poisson link. RESULTS: There were 786 participants included in the statistical analysis. Overall, the mean age was 68.1 y (standard deviation, 8.8 y), and 39.4% were men. The prevalence of symptoms of depression by SVA category was 18.6% for normal, 23.8% for moderate, and 40.6% for severe. On multivariate analysis, the RR of SVA for symptoms of depression compared to the normal category was 1.12 (95% CI 0.7-1.70) for the moderate category and 2.29 (95% CI 1.01-5.17) for the severe category. CONCLUSION: In local community residents, sagittal imbalance had a significant association with symptoms of depression.

Level of Low Back Pain-Related Disability Is Associated with Risk of Subsequent Falls in an Older Population: Locomotive Syndrome and Health Outcomes in Aizu Cohort Study (LOHAS).

OBJECTIVES: To examine the longitudinal association between baseline disability due to low back pain (LBP) and future risk of falls, particularly significant falls requiring treatment, in a community-dwelling older population. METHODS: This was a prospective population-based cohort study using data from the Locomotive Syndrome and Health Outcomes in Aizu Cohort Study (LOHAS; 2008-2010). A total of 2,738 residents aged ≥60 years were enrolled. LBP was assessed using the Roland-Morris Disability Questionnaire (RMDQ), and the level of LBP-related disability was divided into three categories (none, low, and medium to high). Incidence of falls over the following year was determined using a self-reported questionnaire after the one-year follow-up period. The risk ratio (RR) for LBP-related disability associated with any fall and any fall requiring treatment was estimated using log binomial regression models. RESULTS: Data were analyzed for 1,358 subjects. The prevalence of LBP at baseline was 16.4%, whereas 122 (8.9%) participants reported a low level of LBP-related disability and 101 (7.4%) reported medium to high levels of LBP-related disability. Incidence of any fall and falls requiring treatment was reported by 22.1% and 4.6% of participants, respectively. Subjects with medium to high levels of disability were more likely to experience subsequent falls (adjusted RR = 1.53, 95% confidence interval [CI] = 1.21-1.95) and falls requiring treatment (adjusted RR = 2.55, 95% CI = 1.41-4.60) than those with no LBP-related disability. CONCLUSIONS: Level of LBP-related disability was associated with an increased risk of serious falls in a general population of community-living older adults. These findings can alert health care providers involved in fall prevention efforts to the important issue of activity-related disability due to LBP.

Efficacy and safety of controlled-release oxycodone for the management of moderate-to-severe chronic low back pain in Japan: results of an enriched enrollment randomized withdrawal study followed by an open-label extension study.

BACKGROUND: Oxycodone is one of the options for the management of CLBP in patients with an inadequate response to other analgesics. However, oxycodone is not yet approved for noncancer pain in Japan. Here, we assessed the efficacy and long-term safety of S-8117, a controlled-release oxycodone formulation, for the management of Japanese CLBP patients. PATIENTS AND METHODS: An initial enriched enrollment randomized withdrawal, double-blind, placebo-controlled, 5-week phase III trial was conducted across 54 centers in Japan to assess the efficacy of S-8117 vs placebo in moderate-to-severe CLBP patients. Subsequently, a 52-week, open-label, single-arm study was conducted across 53 centers in Japan to evaluate the long-term safety of S-8117. The primary endpoint was the time to inadequate analgesic response during 35 days of the double-blind period. Secondary endpoints were the percentages of patients with inadequate analgesic response, discontinuation rate due to inadequate analgesic effects or AEs, and changes in scores of BPI severity, BPI pain interference, SF-36, and Roland-Morris Disability Questionnaire. Safety was assessed as the incidence of AEs and ADRs. RESULTS: Of the 189 patients enrolled in the double-blind study, 130 patients who completed the initial titration period were randomized 1:1 to receive either S-8117 (n=62) or placebo (n=68). Baseline characteristics were comparable across the study groups. The time to inadequate analgesic response was significantly longer in patients treated with S-8117 than placebo (P=0.0095). Secondary endpoints corroborated the efficacy of S-8117 vs placebo. Overall, 478 AEs were reported in 73/75 patients in the long-term study. The most frequent ADRs were somnolence, constipation, and nausea. No case of drug dependence was reported in the long-term study. CONCLUSION: Short-term efficacy vs placebo and long-term safety of S-8117 were demonstrated for the management of Japanese patients with moderate-to-severe CLBP.

Reference values of the Japanese Orthopaedic Association Back Pain Evaluation Questionnaire in patients with lumbar spinal stenosis and characteristics of deterioration of QOL: Lumbar Spinal Stenosis Diagnosis Support Tool: DISTO project.

BACKGROUND: The reference values of the Japanese Orthopaedic Association Back Pain Evaluation Questionnaire (JOABPEQ) in patients with lumbar spinal stenosis (LSS) are still unknown. This multicenter cross-sectional survey was performed to determine the reference values and disease-specific characteristics of deterioration of QOL caused by LSS itself, not by aging, through comparison of patients with and without LSS who had an outpatient visit for low back pain by age and sex groups. METHODS: The present study was performed at 564 medical centers and clinics. The JOABPEQ was measured for 8338 patients aged 20 years or over who came to an outpatient clinic for low back pain (LBP) and were examined for whether they had LSS using the LSS diagnosis support tool (LSS-DST). Scores in the five JOABPEQ domains were compared between the LSS group and the LBP without LSS group (LBP group) for each age and sex group. RESULTS: Scores for Pain-related disorder, Gait disturbance, Social life disturbance, and Psychological disorders were significantly lower in the LSS group than in the LBP group. CONCLUSION: The percentiles of JOABPEQ scores in patients with LSS were clarified and could be used as reference values. Deterioration of QOL caused by LSS itself, not by aging, are characterized by Pain-related disorder, Gait disturbance, Social life disturbance, and Psychological disorders.

Efficacy And Safety Of Controlled-Release Oxycodone For The Management Of Moderate-To-Severe Chronic Non-Cancer Pain In Japanese Patients: Results From An Open-Label Study.

PURPOSE: To assess the efficacy and safety of S-8117, an oral, controlled-release formulation of oxycodone hydrochloride, in Japanese patients with chronic non-cancer pain (CNCP). PATIENTS AND METHODS: In this multicenter, non-randomized, open-label, 2-part (part 1, dose-titration followed by maintenance period; part 2, long-term administration period) study at 38 centers in Japan (2013-2015), adult patients with CNCP for ≥12 weeks were administered S-8117. The primary endpoint was proportion of patients with successful maintenance of pain control in part 1 and long-term safety in part 2. Secondary endpoints included time to inadequate analgesia, rate of transition to the maintenance period, and discontinuation due to inadequate analgesia/adverse events (AEs), Brief Pain Inventory (BPI) pain severity, BPI pain interference, 36-item Short Form Health Survey (SF-36) score, and Western Ontario and McMaster Universities (WOMAC) index, Subjective Opioid Withdrawal Scale (SOWS), Clinical Opioid Withdrawal Scale (COWS), Dependency-2-A (D-2-A), and Dependency-2-B (D-2-B) questionnaires. RESULTS: Of 130 patients (mean age, 63.6 years; women, 62.3%) in the dose-titration period, 95 entered the maintenance period; 60 of 83 who entered the long-term administration period completed it. The proportion of patients (95% confidence interval) with successful maintenance of pain control, transition to maintenance period, and discontinuation due to inadequate analgesia/AEs was 78.9% (69.4-86.6), 73.1% (64.6-80.5), and 21.1% (13.4-30.6), respectively. Time to inadequate analgesia could not be estimated. Changes from baseline in BPI, SF-36, and WOMAC index scores suggested improvements in pain relief and quality of life. Based on the SOWS, COWS, D-2-A and D-2-B questionnaires, no patient developed clinically relevant withdrawal syndrome or was ascertained to have developed drug dependence. Overall, the incidence of treatment-emergent AEs (TEAEs) was 93.8%; most common TEAEs were constipation (49.2%), nausea (42.3%), nasopharyngitis (34.6%), and somnolence (32.3%). CONCLUSION: These results demonstrate the efficacy and safety of S-8117 in Japanese patients with CNCP.

Magnitude of dural tube compression does not show a predictive value for symptomatic lumbar spinal stenosis for 1-year follow-up: a prospective cohort study in the community.

BACKGROUND: The North American Spine Society states that lumbar spinal stenosis (LSS) is a clinical syndrome, and there is insufficient evidence to make a recommendation for or against a correlation between clinical symptoms or function and the presence of anatomic narrowing of the spinal canal on MRI. The main purpose of this study was to assess the influence of the magnitude of dural tube compression on MRI on LSS symptoms at the cross-sectional and 1-year follow-up. METHODS: This was a prospective cohort study of 459 participants who were assessed for LSS using a questionnaire and conventional MRI of the lumbar spine. After 1 year, 335 subjects (follow-up rate 73.0%) were assessed for LSS using the same questionnaire. The time course of the clinical subjective symptoms of LSS and the relationship between the said symptoms of LSS and magnitude of dural tube compression on MRI were analyzed in a cross-sectional and longitudinal fashion. RESULTS: 1) The dural sac cross-sectional area (DCSA) decreased with age. 2) Severe dural tube compression had a strong influence on the presence of symptomatic LSS; however, 40%-70% of participants with severe dural tube compression did not show clinical symptoms of LSS. 3) At the 1-year follow-up, >50% of the LSS-positive participants in the initial year were reclassified as LSS negative, and 10% of the LSS-negative participants were reclassified as LSS positive. 4) The magnitude of the DCSA on MRI did not directly affect the presence of LSS at the 1-year follow-up. CONCLUSION: LSS symptoms were changeable. Anatomical dural tube compression on MRI did not predict the presence of clinical LSS symptoms at the 1-year follow-up.

Prospective one-year follow-up of lumbar spinal stenosis in a regional community.

PURPOSE: Lumbar spinal stenosis (LSS) is a common condition in the aging population. However, limited information exists on discrepancies between LSS symptoms and imaging findings and/or prognostic factors of LSS, as well as the relationship between changes in LSS symptoms and quality of life (QoL) during the natural course of LSS. The purpose of the current study was to clarify any changes in clinically diagnosed LSS at a one-year follow-up, and identify its prognostic factors, using a community-dwelling cohort. PARTICIPANTS AND METHODS: In this study, the presence of LSS, its associated comorbidities, and the status of QoL pertaining to general health and low-back pain were assessed in 1,080 community-dwelling volunteers. The same assessment was carried out a year after the initial survey. Clinically diagnosis as LSS (LSS-positive) was determined by a validated diagnostic support tool in the form of a self-administered, self-reported history questionnaire. QoL was assessed using the 36-Item Short Form Health Survey and the Roland-Morris Disability Questionnaire. RESULTS: Among subjects who were LSS-positive in the initial assessment, 54% were clinically diagnosed as negative for LSS (LSS-negative) after the one-year period, whereas 10% of those who were initially diagnosed as LSS-negative changed to LSS-positive during the same period. With the improvement or deterioration of LSS-positive/negative status, low-back pain-related QoL and some components of the 36-Item Short Form Health Survey similarly improved or deteriorated. Decisive prognostic factors of LSS-positive status were not determined at the one-year follow-up. CONCLUSION: Approximately half of the subjects who had initially been diagnosed as LSS-positive converted to LSS-negative after one year. Prognostic factors of LSS-positive diagnosis after one-year follow-up were not detected.

Soft tissue reinforcement with a Leeds-Keio artificial ligament in revision surgery for dislocated total hip arthroplasty.

INTRODUCTION: Since dislocation after total hip arthroplasty (THA) greatly diminishes patient's quality of life, the THA frequently needs revision. However, it is common for the dislocation not to heal even after reconstruction, but rather to become intractable. METHODS: The 17 patients with dislocated THA, mean age of 71 years (range 51-87 years), who underwent a revision THA together with soft tissue reinforcement with a Leeds-Keio (LK) ligament were enrolled. The purposes of reinforcement with LK ligament were to restrict the internal rotation of the hip joint, and to encourage the formation of fibrous tissue in the posterior acetabular wall to stabilise the femoral head. We determined the success rate of surgical treatment for dislocation, the Harris Hip Score (HHS), a factor of recurrent dislocation. RESULTS: There was no recurrent dislocation in 82% of the cases (14 joints) during the mean postoperative follow-up period of 63.5 months (15-96 months). The HHS was 82 ± 18 points preoperatively and 82 ± 14 points postoperatively. Recurrent dislocation after this surgical procedure occurred in 2 hips with breakage of the LK ligaments, and intracapsular dislocation in 1 hip with loosening of the LK ligament. CONCLUSIONS: Although the risk of recurrent dislocation still exists with this procedure, when performed to provide reinforcement with an LK ligament for dislocated THA it may be useful in intractable cases with soft tissue defects around the hip joint.

Association Between Subjective Sleep Quality and Future Risk of Falls in Older People: Results From LOHAS.

Background: Inadequate sleep is correlated with morbidity and mortality among older adults. However, the longitudinal relationship between subjective sleep quality and risk of falls in the elderly population remains to be clarified. Methods: Study participants were from Locomotive Syndrome and Health Outcome in Aizu Cohort Study (LOHAS) sites (1,071 community-dwelling people ≧65 years of age, mean: 71 years). Subjective sleep quality was measured by the Pittsburgh Sleep Quality Index (PSQI). Occurrence of falls (defined as experiencing at least one fall) during the subsequent year was ascertained by a self-reported questionnaire. Results: Mean global PSQI score was 4.3 (SD 3.2), with 28.9% of participants rating their sleep quality as poor (PSQI > 5). A total of 210 participants (19.6%) fell at least once in the year following sleep examination. Multivariable analysis revealed that participants reporting worse subjective sleep quality had significantly higher odds of experiencing falls during the 1-year follow-up period (adjusted odds ratio [AOR] = 1.50 for each three-point increase in global PSQI score; 95% confidence interval [CI] = 1.20, 1.89). Participants in the highest global PSQI score (PSQI > 5) quartile had significantly increased odds of experiencing falls compared to those in the lowest global score quartile (PSQI < 2; AOR = 2.14; 95% CI = 1.09, 4.22). This association was similarly significant in subgroup analyses for older men and women, nonusers of sleep medication, and those without a history of falls at baseline. Conclusion: Subjective poor sleep quality, as measured by the PSQI, is longitudinally associated with greater risk of experiencing falls in community-dwelling older adults.

Surgical Outcomes of Cervical Myelopathy in Patients with Athetoid Cerebral Palsy: A 5-Year Follow-Up.

STUDY DESIGN: Observational cohort study. PURPOSE: To assess the surgical outcomes of posterior decompression and fusion for cervical myelopathy in patients with athetoid cerebral palsy. OVERVIEW OF LITERATURE: Patients with athetoid cerebral palsy demonstrate involuntary movements and develop severe cervical spondylosis with kyphosis. In these patients, surgery is often performed at an early age because of myelopathy. A few studies have reported about the long-term outcomes of surgical treatment; however, they contain insufficient information. METHODS: From 2003 to 2008, 13 patients with cervical myelopathy due to athetoid cerebral palsy underwent posterior fusion surgery and were included in this study. The Japanese Orthopaedic Association (JOA) score, neck disability index (NDI), C2-7 angle on radiography, and need for additional surgical treatment were examined at 1 and 5 years postoperatively. RESULTS: The mean C2-7 angle was -10.5°±21.1° preoperatively and was corrected to -2.9°±13.5° immediately postoperatively. This improvement was maintained for 5 years. The JOA score was 9.5±2.5 preoperatively and 12.2±1.7 at the 5-year follow-up. NDI was 17±6.9 preoperatively and 16±7.5 at the 5-year follow-up. Patient satisfaction with surgery on a 100-point scale was 62.2±22.5 at the 5-year follow-up. Three patients needed additional surgery for loosening of screws. These results demonstrate good surgical outcomes for posterior fusion at 5 years. CONCLUSIONS: Posterior decompression and fusion should be considered a viable option for cervical myelopathy in patients with athetoid cerebral palsy.

Vertebral fracture at the caudal end of a surgical fusion for thoracic vertebral fracture in a patient with diffuse idiopathic skeletal hyperostosis (DISH).

The patient was an 86-year-old woman with back pain after a fall. She had no neurological findings at the initial visit. Plain radiographs and magnetic resonance imaging (MRI) showed diffuse idiopathic skeletal hyperostosis (DISH) and a Th10 fracture. Two weeks later, she started gait exercise with immobilization by a rigid orthosis. Twenty-five days later, she presented with paralysis and numbness of her legs. Computed tomography (CT) showed anterior expansion in the vertebral body of Th10. MRI showed an intramedullary high-intensity area on T2-weighted images at the same level. She was diagnosed as having delayed paraplegia after a Th10 fracture and transferred to our hospital for surgery. Laminectomy of Th10, posterior fusion from Th7 to L1 with pedicle screws and hooks to Th6 and L1 laminae, anterior fusion from Th9 to Th11 with a plate, and autologous bone grafting were performed simultaneously. The patient's paralysis improved, and she started gait exercise with no limitation of bed rest and without an orthosis after surgery. At 8 days after surgery, she again presented with low back pain and paralysis in her legs. CT revealed an L1 fracture, which was the caudal end of the surgical fusion. The decreased kyphosis after surgery compared to that at pre-injury might have caused a subsequent horizontal shear force to L1 when the patient sat on the bed and when she walked. In conclusion, to avoid postoperative adjacent vertebral fracture after fusion, appropriate correction of spinal alignment to that at pre-injury is needed for vertebral fractures in patients with DISH.