Dataset Information

No effect of 6-month intake of glucosamine sulfate on Modic changes or high intensity zones in the lumbar spine: sub-group analysis of a randomized controlled trial.

ABSTRACT: The underlying pathology and natural course of Modic changes (MC) in the vertebral body marrow and high intensity zones (HIZs) in the annulus fibrosus is not completely clarified. These findings on magnetic resonance imaging (MRI) have initiated different treatments with little or unclear effect. In a randomized trial (n=250), glucosamine sulfate (GS) had no effect on low back pain related disability. GS could still have an effect on MC and HIZ. In this sub-study, 45 patients from the trial who had MC and/or HIZ at pre-treatment underwent follow-up MRI. The aim was to examine the course of MC and HIZ and to compare this course between groups treated with 6-month intake of oral GS versus placebo.Of 141 pre-treatment MC in 42 (of 45) patients, 29 (20.6%) MC in 18 patients had altered type and 14 MC in 9 patients had altered size (decreased for 1 MC) 6-18 months later: odds ratio (OR) for type vs. size alterations 4.0; 95% confidence interval (CI) 1.2-17.7. No MC resolved. HIZ vanished from 3 of 23 discs in 3 of 21 patients with pre-treatment HIZ. Ten new MC (all type I or I/II) occurred in 8 patients and 2 new HIZs in 2 patients. The GS group (n=19) and placebo group (n=26) did not differ in proportions of MC with decreased (OR 1.6; 95% CI 0.4-6.1) or increased type I dominance at follow-up (OR placebo:GS 2.4; 95% CI 0.6-9.7), or with increased size (OR 1.0; 95% CI 0.2-4.7). HIZ vanished from 1 of 8 discs in 1 of 8 patients in the GS group vs. 2 of 15 discs in 2 of 13 patients in the placebo group (OR 0.8; 95% CI 0.02-12.2).In this sub-group analysis of a placebo-controlled trial, the effect of GS on MC and HIZs was no different from the effect of the placebo intervention. MC and HIZs remained mostly unchanged during the 6-18 months study period. Some short term changes did occur and MC more often altered type than size.NCT00404079 at http://www.clinicaltrial.gov.

SUBMITTER: Wilkens P

PROVIDER: S-EPMC3503617 | biostudies-literature | 2012 Aug

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

No effect of 6-month intake of glucosamine sulfate on Modic changes or high intensity zones in the lumbar spine: sub-group analysis of a randomized controlled trial.

Wilkens Philip P Storheim Kjersti K Scheel Inger I Berg Linda L Espeland Ansgar A

Journal of negative results in biomedicine 20120817

<h4>Background</h4>The underlying pathology and natural course of Modic changes (MC) in the vertebral body marrow and high intensity zones (HIZs) in the annulus fibrosus is not completely clarified. These findings on magnetic resonance imaging (MRI) have initiated different treatments with little or unclear effect. In a randomized trial (n=250), glucosamine sulfate (GS) had no effect on low back pain related disability. GS could still have an effect on MC and HIZ. In this sub-study, 45 patients ...[more]

PMID: 22900984

Similar Datasets

Project description:PurposeTo characterize the inter- and intraobserver variability of qualitative, non-disk contour degenerative findings of the lumbar spine at magnetic resonance (MR) imaging.Materials and methodsThe case accrual method used to perform this institutional review board-approved, HIPAA-compliant retrospective study was the random selection of 111 interpretable MR examination cases of subjects from the Spine Patient Outcomes Research Trial. The subjects were aged 18-87 years (mean, 53 years +/- 16 [standard deviation]). Four independent readers rated the cases according to defined criteria. A subsample of 40 MR examination cases was selected for reevaluation at least 1 month later. The following findings were assessed: spondylolisthesis, disk degeneration, marrow endplate abnormality (Modic changes), posterior anular hyperintense zone (HIZ), and facet arthropathy. Inter- and intraobserver agreement in rating the data was summarized by using weighted kappa statistics.ResultsInterobserver agreement was good (kappa = 0.66) in rating disk degeneration and moderate in rating spondylolisthesis (kappa = 0.55), Modic changes (kappa = 0.59), facet arthropathy (kappa = 0.54), and posterior HIZ (kappa = 0.44). Interobserver agreement in rating the extent of Modic changes was moderate: kappa Values were 0.43 for determining superior anteroposterior extent, 0.47 for determining superior craniocaudal extent, 0.57 for determining inferior anteroposterior extent, and 0.48 for determining inferior craniocaudal extent. Intraobserver agreement was good in rating spondylolisthesis (kappa = 0.66), disk degeneration (kappa = 0.74), Modic changes (kappa = 0.64), facet arthropathy (kappa = 0.69), and posterior HIZ (kappa = 0.67). Intraobserver agreement in rating the extent of Modic changes was moderate, with kappa values of 0.54 for superior anteroposterior, 0.60 for inferior anteroposterior, 0.50 for superior craniocaudal, and 0.60 for inferior craniocaudal extent determinations.ConclusionThe interpretation of general lumbar spine MR characteristics has sufficient reliability to warrant the further evaluation of these features as potential prognostic indicators.

Project description:BackgroundLumbar interbody fusion is among the most common types of spinal surgery performed. Over time, the term has evolved to encompass a number of different approaches to the intervertebral space, as well as differing implant materials. Questions remain over which approaches and materials are best for achieving fusion and restoring disc height.Questions/purposesWe reviewed the literature on the advantages and disadvantages of various methods and devices used to achieve and augment fusion between the disc spaces in the lumbar spine.MethodsUsing search terms specific to lumbar interbody fusion, we searched PubMed and Google Scholar and identified 4993 articles. We excluded those that did not report clinical outcomes, involved cervical interbody devices, were animal studies, or were not in English. After exclusions, 68 articles were included for review.ResultsPosterior approaches have advantages, such as providing 360° support through a single incision, but can result in retraction injury and do not always restore lordosis or correct deformity. Anterior approaches allow for the largest implants and good correction of deformities but can result in vascular, urinary, psoas muscle, or lumbar plexus injury and may require a second posterior procedure to supplement fixation. Titanium cages produce improved osteointegration and fusion rates but also increase subsidence caused by the stiffness of titanium relative to bone. Polyetheretherketone (PEEK) has an elasticity closer to that of bone and shows less subsidence than titanium cages, but as an inert compound PEEK results in lower fusion rates and greater osteolysis. Combination PEEK-titanium coating has not yet achieved better results. Expandable cages were developed to increase disc height and restore lumbar lordosis, but the data on their effectiveness have been inconclusive. Three-dimensionally (3D)-printed cages have shown promise in biomechanical and animal studies at increasing fusion rates and reducing subsidence, but additive manufacturing options are still in their infancy and require more investigation.ConclusionsAll of the approaches to spinal fusion have plusses and minuses that must be considered when determining which to use, and newer-technology implants, such as PEEK with titanium coating, expandable, and 3D-printed cages, have tried to improve upon the limitations of existing grafts but require further study.

Project description:Study designThis was a survey of the surgeon members of the Lumbar Spine Research Society (LSRS).ObjectiveThe purpose of this study was to assess trends in surgical practice and patient management involving elective and emergency surgery in the early months of the coronavirus pandemic.Summary of background dataThe novel coronavirus has radically disrupted medical care in the first half of 2020. Little data exists regarding the exact nature of its effect on spine care.MethodsA 53-question survey was sent to the surgeon members of the LSRS. Respondents were contacted via email 3 times over a 2-week period in late April. Questions concentrated on surgical and clinical practice patterns before and after the pandemic. Other data included elective surgical schedules and volumes, as well as which emergency cases were being performed. Surgeons were asked about the status of coronavirus disease 2019 (COVID-19) virus testing. Circumstances for performing surgical intervention on patients with and without testing as well as patients testing positive were explored.ResultsA total of 43 completed surveys were returned of 174 sent to active surgeons in the LSRS (25%). Elective lumbar spine procedures decreased by 90% in the first 2 months of the pandemic, but emergency procedures did not change. Patients with "stable" lumbar disease had surgeries deferred indefinitely, even beyond 8 weeks if necessary. In-person outpatient visits became increasingly rare events, as telemedicine consultations accounted for 67% of all outpatient spine appointments. In total, 91% surgeons were under some type of confinement. Only 11% of surgeons tested for the coronavirus on all surgical patients.ConclusionsElective lumbar surgery was significantly decreased in the first few months of the coronavirus pandemic, and much of outpatient spine surgery was practiced via telemedicine. Despite these constraints, spine surgeons performed emergency surgery when indicated, even when the COVID-19 status of patients was unknown.Level of evidenceLevel IV.

Dataset Information

No effect of 6-month intake of glucosamine sulfate on Modic changes or high intensity zones in the lumbar spine: sub-group analysis of a randomized controlled trial.

Publications

No effect of 6-month intake of glucosamine sulfate on Modic changes or high intensity zones in the lumbar spine: sub-group analysis of a randomized controlled trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets