Effect of upper extremity load on pelvic movements during wheeled upright walker use.

[Purpose] This study aimed to elucidate the effects of upper extremity loading on pelvic movements during wheeled upright walker use. [Participants and Methods] Thirteen healthy male adults participated in this intervention study. Participants walked under five conditions with targeted loads on their upper extremities of 0%, 10%, 20%, 30%, and 40% of their body weights using a wheeled upright walker with armrests. Measured items included gait velocity and stride length; the angle of the maximum trunk anterior tilt; the range of motion of the trunk and pelvis in the movements of obliquity, tilt, and rotation; and the amplitude of the center of mass in the vertical and lateral directions captured and calculated using a three-dimensional motion analysis system. [Results] Increasing the load on the upper extremities did not shorten the stride or restrict pelvic movement during gait using upright walker use. The range of pelvic rotation with walker use increased versus that of the standard gait. [Conclusion] The pelvis showed quantitative movements during gait using the wheeled upright walker with armrests. These results could be helpful in the development of robotic assistive devices.

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.

Japanese orthopaedic association cervical myelopathy evaluation questionnaire (JOACMEQ): Part 5. Determination of responsiveness.

BACKGROUND: In 1999, the Japanese Orthopaedic Association decided to develop a new Cervical Myelopathy Evaluation Questionnaire (JOACMEQ). The final version of the JOACMEQ, comprising 24 questions and five domains (cervical spine function (CF); upper extremity function (UF); lower extremity function (LF); bladder function (BF); and quality of life (QOL)), was established after three nationwide investigations. The fourth investigation, reported in this paper, was performed to confirm the responsiveness of the questionnaire. METHODS: A total of 137 patients with cervical myelopathy were included in the study. Each patient was interviewed twice using the JOACMEQ before and after treatment. At the second interview, the patients self-rated their condition in five domains for "worse," "somewhat worse," "no change," "somewhat better," or "better," and these scores were defined as the external assessment rating. The difference of the points in five domains between the first and the second interview was calculated against each external assessment. Based on the results, substantial clinical benefit (SCB) thresholds for the JOACMEQ were determined. RESULTS: The statistically significant median values of the acquired points were 17.5 for CF, 16.0 and 21.0 for UF, 27.0 and 20.5 for LF, 13.0 for BF, and 29.0 for QOL. After consideration of the results, the committee decided that an acquired point ≥20 could be interpreted as representing an SCB threshold for the JOACMEQ. CONCLUSION: We have concluded that a treatment can be judged to be effective for a patient if 1) The patient give all answers for the questions necessary to calculate the functional score of a domain and an increase of ≥20 points is obtained for that score, or 2) The functional score after treatment is > 90 points even if the answer for the unanswered questions was supposed to be the worst possible choice.

Cost-effectiveness analysis of the pharmacological management of chronic low back pain with four leading drugs.

BACKGROUND: Chronic low back pain is a major health problem that has a substantial effect on people's quality of life and places a significant economic burden on healthcare systems. However, there has been little cost-effectiveness analysis of the treatments for it. Therefore, the purpose of this prospective observational study was to evaluate the cost-effectiveness of the pharmacological management of chronic low back pain. METHODS: A total of 474 patients received pharmacological management for chronic low back pain using four leading drugs for 6 months at 28 institutions in Japan. Outcome measures, including EQ-5D, the Japanese Orthopaedic Association (JOA) score, the JOA back pain evaluation questionnaire (BPEQ), the Roland-Morris Disability Questionnaire, the Medical Outcomes Study SF-8, and the visual analog scale, were investigated at baseline and every one month thereafter. The incremental cost-utility ratio (ICUR) was calculated as drug cost over the quality-adjusted life years. An economic estimation was performed from the perspective of a public healthcare payer in Japan. Stratified analysis based on patient characteristics was also performed to explore the characteristics that affect cost-effectiveness. RESULTS: The ICUR of pharmacological management for chronic low back pain was JPY 453,756. Stratified analysis based on patient characteristics suggested that the pharmacological treatments for patients with a history of spine surgery or cancer, low frequency of exercise, long disease period, low scores in lumbar spine dysfunction and gait disturbance of the JOA BPEQ, and low JOA score at baseline were not cost-effective. CONCLUSIONS: Pharmacological management for chronic low back pain is cost-effective from the reference willingness to pay. Further optimization based on patient characteristics is expected to contribute to the sustainable development of a universal insurance system in Japan.

Incidence and risk factors for cervical lesions in patients with rheumatoid arthritis under the current pharmacologic treatment paradigm.

OBJECTIVE: To elucidate the incidence and risk factors for cervical lesions in patients with rheumatic arthritis (RA) under the current pharmacologic treatment paradigm. METHODS: Of patients with RA onset after 2000, 151 who introduced biologic agents (BAs) because of high disease activity and underwent cervical radiography more than 5 years after onset were included. Incidence of those with cervical lesions and predictors of cervical lesions were analyzed. Mean disease duration was 8.5 years. The radiographic definitions of cervical lesions were as follows: atlantoaxial subluxation (AAS), atlantodental interval >3 mm; vertical subluxation (VS), Ranawat value <13 mm; and subaxial subluxation (SS), and listhesis >2 mm. RESULTS: Radiographic evaluation indicated AAS in 43 cases (28%), VS in 10 (7%), and SS in 6 (4%). The incidence of those with any cervical lesion was 32% (48/151). Univariate analysis showed that disease duration, time from onset to BA use, and onset before 2005 were significant predictors of cervical lesions, while multivariate regression analysis showed that disease duration and Steinbrocker stage were predictors. CONCLUSION: The incidence of cervical lesions in patients with RA onset after 2000 was still high (32%). In addition, disease duration and Steinbrocker stage were predictors of cervical lesions.

Late-onset deep surgical-site infection after posterior lumbar interbody fusion in a patient treated with tocilizumab; unusual changes in inflammatory markers.

PURPOSE: To describe a case of late-onset deep surgical-site infection (SSI) after posterior lumbar interbody fusion in a patient treated with tocilizumab (TCZ) for rheumatoid arthritis (RA), with emphasis on the clinical symptoms and changes in inflammatory markers such as white blood cell (WBC) count and C-reactive protein (CRP) level. CASE REPORT: A 74-year-old woman with 3-year history of RA underwent posterior lumbar interbody fusion at the L4/5/S1 level. After confirmation of no clinical symptom of SSI postoperatively, we decided to use TCZ for the patient after 2 months postoperatively. At 8 months after beginning of TCZ, she suffered from sudden onset of severe low back pain (LBP) with fever (38 °C) 1 day after administration of TCZ. Local tissues around the operative wound showed no sign of redness, warmth, or swelling. Increases in body temperature, WBC count, and CRP level were well suppressed by TCZ. Magnetic resonance imaging performed 2 weeks after onset of LBP revealed deep SSI. After surgical debridement and administration of the sensitive antibiotics, no clinical signs of recurrent spondylitis or osteolysis of vertebral body have been seen for 3 years. CONCLUSIONS: As TCZ strongly suppresses inflammatory reactions, detecting deep SSI based on local and systemic findings and laboratory data is quite difficult. Care must be taken regarding SSI when patients treated with TCZ complain of long-lasting LBP after lumbar surgery.

Prevalence of neuropathic pain in cases with chronic pain related to spinal disorders.

BACKGROUND: The incidence and characteristics of neuropathic pain associated with spinal disorders have not yet been fully clarified. The purpose of this study was to investigate the prevalence of neuropathic pain and the degree of deterioration of quality of life (QOL) in patients with chronic pain associated with spinal disorders who visited orthopedic outpatient clinics. METHODS: This cross-sectional study was conducted in 1,857 patients recruited from 137 medical institutions nationwide. Participants were men and women aged 20-79 years with a history of spine-related pain for at least 3 months and a visual analog scale (VAS) score of at least 30 in the previous week. Patients were screened using a neuropathic pain screening questionnaire. The degree of QOL deterioration and its correlation with the presence of neuropathic pain were assessed using the Short Form Health Survey with 36 questions (SF-36). RESULTS: Overall prevalence of neuropathic pain was 53.3%. It was relatively high in patients with cervical spondylotic myelopathy (77.3%) and ligament ossification (75.7%) and relatively low in those with low back pain (29.4%) and spondylolysis (40.4%). Only 56.9% of patients with radiculopathy were diagnosed with neuropathic pain. Logistic regression analysis identified several risk factors, including advanced age, severe pain, disease duration of at least 6 months, and cervical lesions. In QOL assessment, physical functioning, role-physical, role-emotional, and social functioning were severely affected, and this trend was more pronounced in patients who were more likely to have neuropathic pain. CONCLUSIONS: The frequency of neuropathic pain tended to be higher in patients with diseases associated with spinal cord damage and lower in patients with diseases that primarily manifested as somatic pain. A bias toward allodynia symptoms in the screening questionnaire may have resulted in the failure to diagnose neuropathic pain in some patients with radiculopathy. Poor QOL, primarily from the aspect of physical functioning, was demonstrated in patients with neuropathic pain associated with spinal disorders.

Does fusion status after posterior lumbar interbody fusion affect patient-based QOL outcomes? An evaluation performed using a patient-based outcome measure.

BACKGROUND: Although delayed union or pseudoarthrosis after lumbar arthrodesis has been recognized as a major radiographic complication, little has been known about the effect of fusion status on the patient's quality-of-life (QOL) outcome. The purpose of this study was to investigate the effects of fusion status after posterior lumbar interbody fusion (PLIF) on QOL outcomes by using the Japanese Orthopaedic Association Back Pain Evaluation Questionnaire (JOABPEQ). METHODS: Among 100 patients who underwent single level PLIF for spinal canal stenosis, 29 who had not achieved fusion (incomplete fusion group) and 29 age- and sex ratio-matched patients who had achieved fusion (fusion group) 6 months after surgery were enrolled. Overall clinical evaluation was performed before and 6 months after surgery: the physician determined the Japanese Orthopaedic Association Score for Low Back Pain (JOA score); the JOABPEQ and visual analogue scale (VAS) values were collected. The recovery rate of the JOA score, changes in all JOABPEQ subdomain scores and in the VAS values were calculated. All variables were compared between the groups. RESULTS: The preoperative JOA scores, JOABPEQ scores of all subdomains, and VAS values of all categories did not differ between the groups. The recovery rate was higher in the fusion group than the incomplete fusion group (p = 0.0185). The changes in the JOABPEQ scores for walking ability and social life function were significantly greater in the fusion group than the incomplete fusion group (walking ability, p = 0.0172; social life function, p = 0.0191). The postoperative VAS values and changes in the VAS values for all categories did not differ between the groups. CONCLUSIONS: Incomplete fusion after PLIF correlated with poor improvement in walking ability and social life function. Therefore, the achievement of fusion after PLIF is essential to obtain better patient QOL outcomes.

Neurological manifestations of thoracic myelopathy.

INTRODUCTION: Investigation of preoperative manifestations of thoracic myelopathy in a large population has not been reported. The aim of this study was to identify symptoms specific to anatomical pathology or compressed segments in thoracic myelopathy through investigation of preoperative manifestations. MATERIALS AND METHODS: Subjects were 205 patients [143 men, 62 women; mean age, 62.2 (range 21-87 years)] with thoracic myelopathy who underwent surgery at our affiliate institutions from 2000 to 2011. The disease distribution included ossification of the ligamentum flavum (OLF) in 106 patients, ossification of the posterior longitudinal ligament (OPLL) in 17, OLF with OPLL in 17, intervertebral disc herniation (IDH) in 23, OLF with IDH in 3, and spondylosis in 39. We assessed (1) initial and preoperative complaints, (2) neurological findings, (3) Japanese Orthopaedic Association scores (JOA, full score, 11 points), (4) the compressed segments, and (5) preoperative duration. Multivariate analyses were performed to examine potential relationships between preoperative manifestations and anatomical pathology or compressed segments. RESULTS: The multivariate analyses revealed relationships between lower limb muscle weakness and T10/11 anterior compression; lower limb pain and T11/12 anterior compression; low back pain and T11/12 compression; and hyporeflexia in the patellar tendon reflex/foot drop and T12/L1 anterior compression. CONCLUSION: This study elucidated symptoms specific to anatomical pathology or compressed segments in thoracic myelopathy. These relationships can be helpful in the initial investigation of thoracic diseases, although additional measures such as MRI or CT are necessary for definitive diagnosis.

Validity, reliability and responsiveness of the Japanese version of the Neck Disability Index.

BACKGROUND: The Neck Disability Index (NDI) is one of the most widely used questionnaires for neck pain. The purpose of this study was to validate the Japanese NDI. METHODS: We performed two surveys with an 8-week interval in 130 patients with neck pain, radiculopathy and myelopathy. We asked patients to answer two versions of the Japanese NDI: the original NDI, which had been completed by a forward-backward translation procedure, and the modified NDI, which has the phrase "because of neck pain" to the phase "because of neck pain or numbness in the arm." The other parameters examined were the strength of pain and numbness, the Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire, the Hospital Anxiety and Depression Scale, and Short Form 36. Attending surgeons judged the symptom severity. Patients were asked to report the patient global impression of change (PGIC) at the second survey. The internal consistency, criterion-related and discriminative validity, and reliability were evaluated. RESULTS: The original NDI and the modified NDI were 26.9 ± 17.1 and 29.9 ± 15.5, respectively. The Cronbach α values of the original NDI and the modified NDI were 0.92 and 0.89, respectively. Both versions of the NDI had good to excellent correlative coefficients with the related domains. The modified NDI had a higher validity for numbness and mental health-related QOL. The symptom severity was significantly correlated with the modified NDI. The intraclass correlation coefficients of the two surveys of the modified and original NDI were comparable. The effect sizes of the modified and the original NDI were 0.64 and 0.55, respectively. Spearman's ρ between the change of the NDI and the PGIC was 0.47 in the original NDI and 0.59 in the modified NDI. CONCLUSIONS: We demonstrated the validity, reliability and responsiveness of the Japanese NDI. The modified NDI was more strongly correlated with numbness and mental health-related QOL.

Analysis of lumbar pedicle morphology in degenerative spines using multiplanar reconstruction computed tomography: what can be the reliable index for optimal pedicle screw diameter?

PURPOSE: The measurement of transverse pedicle width is still recommended for selecting a screw diameter despite being weakly correlated with the minimum pedicle diameter, except in the upper lumbar spine. The purpose of this study was to reveal the difference between the minimum pedicle diameter and conventional transverse or sagittal pedicle width in degenerative lumbar spines. METHODS: A total of 50 patients with degenerative lumbar disorders without spondylolysis or lumbar scoliosis of >10° who preoperatively underwent helical CT scans were included. The DICOM data of the scans were reconstructed by imaging software, and the transverse pedicle width (TPW), sagittal pedicle width (SPW), minimum pedicle diameter (MPD), and the cephalocaudal inclination of the pedicles were measured. RESULTS: The mean TPW/SPW/MPD values were 5.46/11.89/5.09 mm at L1, 5.76/10.44/5.39 mm at L2, 7.25/10.23/6.52 mm at L3, 9.01/9.36/6.83 mm at L4, and 12.86/8.95/7.36 mm at L5. There were significant differences between the TPW and MPD at L3, L4, and L5 (p < 0.01) and between the SPW and MPD at all levels (p < 0.01). CONCLUSIONS: The MPD was significantly smaller than the TPW and SPW at L3, L4, and L5. The actual measurements of the TPW were not appropriate for use as a direct index for the optimal pedicle screw diameter at these levels. Surgeons should be careful in determining pedicle screw diameter based on plain CT scans especially in the lower lumbar spine.

Lumbar spinal stenosis associated with peripheral arterial disease: a prospective multicenter observational study.

BACKGROUND: Intermittent claudication is a common symptom of both lumbar spinal stenosis (LSS) and peripheral arterial disease (PAD) in middle-aged and elderly people. However, the prevalence and clinical characteristics of LSS with PAD (LSSPAD) have not been investigated in a multicenter study. The aim of this study was to investigate the prevalence and clinical characteristics of LSS associated with PAD. METHODS: 570 patients diagnosed with LSS using a clinical diagnostic support tool and MRI at 64 facilities were enrolled. We evaluated each patient's medical history, physical findings, ankle brachial index, Japanese Orthopaedic Association Back Pain Evaluation Questionnaire (JOABPEQ) score, and the Short Form 36 (SF-36) score. Statistical analyses were performed to compare LSSPAD patients and LSS patients without PAD using the t test, Mann-Whitney's U test, and multivariate recurrence analysis. p values of <0.05 were considered statistically significant. RESULTS: The LSSPAD group comprised 38 patients (6.7 %); 20 (3.5 %) had pre-diagnosised PAD while 18 (3.2 %) had undetected PAD. The clinical characteristics of these patients were advanced age, diabetes, and a history of ischemic heart disease and cerebrovascular disorder. 570 patients enrolled, and 448 (78.6 %) of those patients were followed up at three months after enrollment. Pain in buttocks and legs improved less in the LSSPAD group than in the LSS group (p < 0.05). Improvements in the "general health" score in SF-36 were lower in the LSSPAD group than in the LSS group (p < 0.05). CONCLUSIONS: Advanced age, diabetes, and a history of cerebrovascular disorder and ischemic heart disease were associated with LSSPAD. Because LSSPAD patients show less improvement in QOL than patients with LSS but without PAD do, clinicians should consider the coexistence of PAD in LSS patients.

Positional occlusion of the vertebral artery in a case of rheumatoid atlantoaxial subluxation presenting with multiple cerebral and cerebellar infarction.

We report an uncommon case of positional occlusion of the vertebral artery associated with rheumatoid arthritis (RA). Plain radiography showed reducible atlantoaxial subluxation, and dynamic vertebral arteriography demonstrated positional occlusion of the left vertebral artery. The patient was treated with C1-2 posterior fusion and has since experienced no recurrent symptoms. Insufficiency of the vertebrobasilar artery is a relatively uncommon complication with cervical lesions in RA patients. However, when RA patients manifest recurrent cerebral and cerebellar symptoms, this condition should be kept in mind and actions taken to avoid further irreversible cerebral damage. Recommended imaging methods include vertebral dynamic lateral plain radiography of the cervical spine and vertebral arteriography at multiple cervical positions.

Combined C1-2 transarticular screw fixation and C1 laminoplasty with interlaminar bone transplant for retro-odontoid pseudotumor: illustrative case.

BACKGROUND: The surgical treatment for retro-odontoid pseudotumor (ROP) remains controversial. Posterior C1 laminectomy without fixation occasionally leads to postoperative enlargement of ROP. Because its pathogenesis is associated with atlantoaxial instability, atlantoaxial fixation with C1 laminectomy is commonly performed. Atlantoaxial fixation usually includes transarticular fixation and screw-rod fixation. However, these methods have some issues. That is, in transarticular fixation with C1 laminectomy, the bone grafting area is challenging to obtain. In screw-rod fixation with C1 laminectomy, extensive bleeding occurs at times if the lateral atlantoaxial joint is exposed to the transplant bone grafts. OBSERVATIONS: Herein, the authors report a case of ROP treated with combined C1-2 transarticular screw fixation and C1 laminoplasty with interlaminar bone transplant, which can help achieve adequate spinal cord decompression and can simultaneously secure the bone grafting area between the laminae. In addition, the volume of intraoperative blood loss decreased. Postoperative magnetic resonance imaging showed sufficient decompression of the spinal cord at the C1 level, and computed tomography performed after 6 months revealed bone union between the C1 and C2 laminae. LESSONS: Combined C1-2 transarticular screw fixation and C1 laminoplasty with interlaminar bone transplant is a useful method for ROP.

Comparison of femoral morphology and bone mineral density between femoral neck fractures and trochanteric fractures.

BACKGROUND: Many studies that analyzed bone mineral density (BMD) and skeletal factors of hip fractures were based on uncalibrated radiographs or dual-energy xray absorptiometry (DXA). QUESTIONS/PURPOSES: Spatial accuracy in measuring BMD and morphologic features of the femur with DXA is limited. This study investigated differences in BMD and morphologic features of the femur between two types of hip fractures using quantitative computed tomography (QCT). PATIENTS AND METHODS: Forty patients with hip fractures with normal contralateral hips were selected for this study between 2003 and 2007 (trochanteric fracture, n=18; femoral neck fracture, n=22). Each patient underwent QCT of the bilateral femora using a calibration phantom. Using images of the intact contralateral femur, BMD measurements were made at the point of minimum femoral-neck cross-sectional area, middle of the intertrochanteric region, and center of the femoral head. QCT images also were used to measure morphologic features of the hip, including hip axis length, femoral neck axis length, neck-shaft angle, neck width, head offset, anteversion of the femoral neck, and cortical index at the femoral isthmus. RESULTS: No significant differences were found in trabecular BMD between groups in those three regions. Patients with trochanteric fractures showed a smaller neck shaft angle and smaller cortical index at the femoral canal isthmus compared with patients with femoral neck fractures. CONCLUSIONS: We conclude that severe osteoporosis with thinner cortical bone of the femoral diaphysis is seen more often in patients with trochanteric fracture than in patients with femoral neck fracture. LEVELS OF EVIDENCE: Level IV, prognostic study. See Guidelines for Authors for a complete description of levels of evidence.

Disc space distraction is a potent risk factor for adjacent disc disease after PLIF.

UNLABELLED: We reported that excessive disc space distraction caused by insertion of large cages during posterior lumbar interbody fusion (PLIF) combined with pedicle screws (PS) induces adjacent segment disease (ASD). Spinous process plate (SPP) is known to allow cage subsidence when used in PLIF, since they cannot share vertical loads. We therefore hypothesize that the incidence of ASD after PLIF with SPP should be lower than that after PLIF with PS due to this loss of disc space distraction. MATERIALS AND METHODS: Radiographic ASD is defined as development of spondylolisthesis > 3 mm, decrease in disc height > 3 mm, or intervertebral angle at flexion lesser than -5°. Symptomatic ASD is defined by a decrease of ≥ 4 points in Japanese Orthopedic Association score. One hundred and thirty patients with L4 spondylolisthesis were treated with either PLIF with SPP (n = 45) or PLIF with PS (n = 85) and followed up for a minimum of 2 years (mean, 39.0 months). RESULTS: L4-5 disc space distraction in the SPP group was significantly smaller (0.4 mm) as compared to the PS group (1.8 mm). The incidence of clinical ASD in the SPP group (2%, 1/45) was also significantly less than that in the PS group (15%, 13/85). Multivariate analysis showed that disc space distraction was the most significant risk factor. CONCLUSIONS: Among various risk factors for ASD after PLIF, the excessive distraction of disc space proved to be a potent risk factor for ASD.

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.

Opinions of Japanese rheumatology physicians regarding clinical practice guidelines.

OBJECTIVE: To examine the views of rheumatology physicians concerning clinical practice guidelines in Japan, and changes to them following the dissemination of new guidelines for rheumatoid arthritis (RA) in 2004. DESIGN: Two cross-sectional questionnaire surveys, the first conducted before publication of new evidence-based RA clinical practice guidelines and the second conducted after implementation. SETTING: Rheumatology-focused practices in Japan. PARTICIPANTS: A random sample of physicians registered with the Japan Rheumatism Foundation who satisfied the registration criteria with regard to experience with RA care. RESULTS: The percentage of guideline users increased from 48 to 60% following publication of the new RA guidelines in 2004 (P < 0.01). The majority agreed that clinical practice guidelines support decision-making in practice, although the proportion of supportive responses decreased slightly in the second survey, from 83 to 77% (P < 0.01) for decision-making, while concern about restricting physician autonomy increased from 18 to 22% (P = 0.01). While only 39% of physicians felt that clinical practice guidelines would contribute to malpractice litigation, the proportion of physicians who were concerned that clinical practice guidelines would be used to bring legal action against providers was larger than that who expected they would defend providers (58 vs 30%, P < 0.001). CONCLUSIONS: Clinical practice guidelines are well accepted among Japanese rheumatology physicians, albeit that the proportion decreased slightly after the introduction of new guidelines. One reason for this may be concern about the use of the guidelines in malpractice litigation. To facilitate implementation, trends in physician support for the guidelines should be closely monitored.

Impact of Consultation Length on Satisfaction in Patients with Chronic Low Back Pain: A Nationwide Multicenter Study in Japan.

INTRODUCTION: Chronic low back pain (CLBP) is a major health burden worldwide and requires patient satisfaction with treatment. Consultation length can be an important factor in patient satisfaction, but few studies have investigated the impact of consultation length on satisfaction in patients with CLBP. This study tried to elucidate the impact of consultation length on clinical outcomes in patients with CLBP. METHODS: This study is part of an analysis using the database of the nationwide, multicenter cohort for CLBP performed by the Project Committee of the Japanese Society for Spine Surgery and Related Research. A total of 427 patients aged 20-85 years (median age, 73.0 years; female, 58.6%) with CLBP were prospectively followed-up monthly for 6 months. Multivariable nonlinear regression analyses were performed to assess the effect of consultation length on outcome measures including subjective satisfaction score, EuroQol 5-dimension, Japanese Orthopaedic Association (JOA) score, Roland-Morris Disability Questionnaire, JOA Back Pain Evaluation Questionnaire, visual analog scale (VAS) and Medical Outcome Survey short-form 8-item health survey that evaluated at the next phase. Furthermore, we assessed whether the effect of consultation length on patient satisfaction was modified by the baseline Brief Scale for Psychiatric Problems in Orthopaedic Patients (BS-POP) score for patient and physician versions. RESULTS: VAS for CLBP was the only score that correlated significantly with consultation length (P = 0.018). Satisfaction score showed a significant positive correlation with consultation length in patients with the highest baseline BS-POP scores (P < 0.2). Moreover, consultation lengths more than 7.6 min and 15.1 min offered increase of satisfaction if patients show the highest BS-POP scores on patient and physician versions, respectively. CONCLUSIONS: These findings suggest that a sufficiently long consultation is an important factor for subjective satisfaction in the patients with CLBP, particularly in patients with psychological problems.