SummaryWe assessed the safety and feasibility of a unified conservative treatment protocol for osteoporotic vertebral fractures in the elderly patients with a 24-week follow-up. Our results showed that initial hospitalization with rigorous bed rest followed by a rehabilitation program using a Jewett brace was safe and feasible in managing patients.PurposeThe purpose of this study was to prove the safety and feasibility of a unified conservative treatment protocol, which included initial hospitalization with rigorous bed rest followed by a rehabilitation program with Jewett brace for osteoporotic vertebral fractures (OVFs) in the elderly patients with a 24-week follow-up.MethodsBetween April 2012 and Mach 2015, one hundred fifty-four patients met the eligibility for this study. Radiological findings at the 3-week, 6~8-week, 24-week assessment were evaluated. Among these, 11 patients underwent early surgery within the first 2 weeks after admission and 19 patients lost follow-up. Therefore, 124 patients were assessed at the final follow-up visit.ResultsThe average vertebral instability in all the present series was 4.9 ± 4.8° at 3-week, 2.9 ± 3.5° at 6~8-week, and 1.8 ± 3.0° at 24-week follow-up visit. Delayed union was observed in 16 patients on the 24-week follow-up visit. Therefore, the present conservative treatment protocol resulted in bony union in 98 out of 124 patients (79.0%, per protocol set analysis) and 98 out of 154 patients including drop-out (63.6%, intention-to-treat analysis). There was no severe adverse event related to initial bed rest. The vertebral instability at 3-week assessment was significantly higher in the delayed union group when compared with that in the union group. Univariate analyses followed by multivariate logistic regression analysis revealed that T2-weighted image of confined high intensity on MRI and having more than 5° of vertebral instability on dynamic X-ray at 3-week assessment are the independent risk factors for delayed union of conservative treatment in the present series.ConclusionsOur results showed that initial hospitalization with rigorous bed rest followed by a rehabilitation program using a Jewett brace was safe and feasible. Therefore, the present conservative treatment protocol can be one of the acceptable treatment options in managing OVF patients.

No abstract

Attenuation of the secondary injury of spinal cord injury (SCI) can suppress the spread of spinal cord tissue damage, possibly resulting in spinal cord sparing that can improve functional prognoses. Granulocyte colony-stimulating factor (G-CSF) is a haematological cytokine commonly used to treat neutropenia. Previous reports have shown that G-CSF promotes functional recovery in rodent models of SCI. Based on preclinical results, we conducted early phase clinical trials, showing safety/feasibility and suggestive efficacy. These lines of evidence demonstrate that G-CSF might have therapeutic benefits for acute SCI in humans. To confirm this efficacy and to obtain strong evidence for pharmaceutical approval of G-CSF therapy for SCI, we conducted a phase 3 clinical trial designed as a prospective, randomized, double-blinded and placebo-controlled comparative trial. The current trial included cervical SCI [severity of American Spinal Injury Association (ASIA) Impairment Scale (AIS) B or C] within 48 h after injury. Patients are randomly assigned to G-CSF and placebo groups. The G-CSF group was administered 400 μg/m2/day × 5 days of G-CSF in normal saline via intravenous infusion for five consecutive days. The placebo group was similarly administered a placebo. Allocation was concealed between blinded evaluators of efficacy/safety and those for laboratory data, as G-CSF markedly increases white blood cell counts that can reveal patient treatment. Efficacy and safety were evaluated by blinded observer. Our primary end point was changes in ASIA motor scores from baseline to 3 months after drug administration. Each group includes 44 patients (88 total patients). Our protocol was approved by the Pharmaceuticals and Medical Device Agency in Japan and this trial is funded by the Center for Clinical Trials, Japan Medical Association. There was no significant difference in the primary end point between the G-CSF and the placebo control groups. In contrast, one of the secondary end points showed that the ASIA motor score 6 months (P = 0.062) and 1 year (P = 0.073) after drug administration tend to be higher in the G-CSF group compared with the placebo control group. Moreover, in patients aged over 65 years old, motor recovery 6 months after drug administration showed a strong trend towards a better recovery in the G-CSF treated group (P = 0.056) compared with the control group. The present trial failed to show a significant effect of G-CSF in primary end point although the subanalyses of the present trial suggested potential G-CSF benefits for specific population.

IntroductionGranulocyte colony-stimulating factor (G-CSF) is generally used for neutropaenia. Previous experimental studies revealed that G-CSF promoted neurological recovery after spinal cord injury (SCI). Next, we moved to early phase of clinical trials. In a phase I/IIa trial, no adverse events were observed. Next, we conducted a non-randomised, non-blinded, comparative trial, which suggested the efficacy of G-CSF for promoting neurological recovery. Based on those results, we are now performing a phase III trial.Methods and analysisThe objective of this study is to evaluate the efficacy of G-CSF for acute SCI. The study design is a prospective, multicentre, randomised, double-blinded, placebo-controlled comparative study. The current trial includes cervical SCI (severity of American Spinal Injury Association (ASIA) Impairment Scale B/C) within 48 hours after injury. Patients are randomly assigned to G-CSF and placebo groups. The G-CSF group is administered 400 µg/m2/day×5 days of G-CSF in normal saline via intravenous infusion for 5 consecutive days. The placebo group is similarly administered a placebo. Our primary endpoint is changes in ASIA motor scores from baseline to 3 months. Each group includes 44 patients (88 total patients).Ethics and disseminationThe study will be conducted according to the principles of the World Medical Association Declaration of Helsinki and in accordance with the Japanese Medical Research Involving Human Subjects Act and other guidelines, regulations and Acts. Results of the clinical study will be submitted to the head of the respective clinical study site as a report after conclusion of the clinical study by the sponsor-investigator. Even if the results are not favourable despite conducting the clinical study properly, the data will be published as a paper.Trial registration numberUMIN000018752.

To determine whether the hybrid assistive limb (HAL) for Care Support can reduce lumbar load during a patient transfer. Overview of Literature: The prevalence of work-related low back pain (LBP) among nurses is high. In particular, transferring patients poses a high risk for LBP due to the large lumbar load. Attempts to reduce the lumbar load are crucial to avoid the risk of LBP. Therefore, we investigated the effects of the HAL for Care Support. Methods: Nineteen volunteers (16 men, three women) lifted a 60-kg doll from a seated position to a standing position. The first transfer was performed without the HAL for Care Support, and the second was performed with the HAL for Care Support assistive robot. We evaluated transfer performance, the visual analog scale (VAS) score for lumbar fatigue, and electromyogram analyses of the trunk and hip. Results: Four participants (two men, two women) succeeded with the HAL for Care Support even though they were unable to perform the task without it. The mean lumbar fatigue VAS score for all participants without the HAL for Care Support was 62 mm, while that with it was 43 mm. With lumbar assistance from the HAL for Care Support, subjective lumbar fatigue during the transfer decreased significantly. A power analysis indicated adequate statistical power to detect a difference in the VAS score for lumbar fatigue (0.99). The activity of the left gluteus maximus alone increased significantly during transfers with the HAL for Care Support. No adverse events occurred during use of the HAL for Care Support for transfers. Conclusions: The HAL for Care Support was able to reduce lumbar load in a simulated patient transfer.

This study aimed to investigate whether fat infiltration in lumbar paravertebral muscles assessed by magnetic resonance imaging (MRI) could be related to dynamic sagittal spino-pelvic balance during gait in adult spinal deformity (ASD). This is a retrospective analysis of 28 patients with ASD. The fat infiltration rate of lumbar erector spinae muscles, multifidus muscles and psoas major muscles was measured by T2 weighted axial MRI at L1-2 and L4-5. Dynamic sagittal spinal and pelvic angles during gait were evaluated using 3D motion analysis. The correlation between fat infiltration rate of those muscles with variations in dynamic kinematic variables while walking and static radiological parameters was analyzed. Spinal kyphosis and pelvic anteversion significantly increased during gait. Fat infiltration rate of erector spinae muscles at L1-2 was positively correlated with thoracic kyphosis (r = 0.392, p = 0.039) and pelvic tilt (r = 0.415, p = 0.028). Increase of spinal kyphosis during walking was positively correlated with fat infiltration rate of erector spinae muscles both at L1-2 (r = 0.394, p = 0.038) and L4-5 (r = 0.428, p = 0.023). Qualitative evaluation of lumbar erector spinae muscles assessed by fat infiltration rate has the potential to reflect dynamic spino-pelvic balance during gait.

Background Several authors have reported favorable results in low back pain (LBP) for patients with lumbar disc herniation (LDH) treated with discectomy. However, detailed changes over time in the characteristics and location of LBP before and after discectomy for LDH remain unclear. To clarify these points, we conducted an observational study to determine the detailed characteristics and location of LBP before and after discectomy for LDH, using a detailed visual analog scale (VAS) bilaterally. Methods We included 65 patients with LDH treated by discectomy in this study. A detailed VAS for LBP was administered with the patient under 3 different conditions: in motion, standing, and sitting. Bilateral VAS was also administered (affected versus opposite side) for LBP, lower extremity pain (LEP), and lower extremity numbness (LEN). The Oswestry Disability Index (ODI) was used to quantify clinical status. Changes over time in these VAS and ODI were investigated. Pfirrmann grading and Modic change as seen by magnetic resonance imaging (MRI) were reviewed before and 1 year after discectomy to determine disc and endplate condition. Results Before surgery, LBP on the affected side while the patients were in motion was significantly higher than LBP while they were sitting (p = 0.025). This increased LBP on the affected side in motion was improved significantly after discectomy (p < 0.001). By contrast, the residual LBP while sitting at 1 year after surgery was significantly higher than the LBP while they were in motion or standing (p = 0.015). At 1 year following discectomy, residual LBP while sitting was significantly greater in cases showing changes in Pfirrmann grade (p = 0.002) or Modic type (p = 0.025). Conclusions Improvement of LBP on the affected side while the patient is in motion suggests that radicular LBP is improved following discectomy by nerve root decompression. Furthermore, residual LBP may reflect increased load and pressure on the disc and endplate in the sitting position.

No abstract