DOCSLIB.ORG

Title: INTRACEPT: a Prospective, Randomized, Multi-Center Study Of

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Title: INTRACEPT: a Prospective, Randomized, Multi-Center Study Of Relievant Medsystems INTRACEPT CIP 0006, Rev E Title: INTRACEPT: A Prospective, Randomized, Multi-Center Study of Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain Protocol Number: CIP 0006, REV E Device: INTRACEPT® INTRAOSSEOUS NERVE ABLATION SYSTEM The device has FDA 510(k) clearance in the US and is CE Regulatory Status: marked in the EU for its intended purpose as defined in the Instructions for Use Sponsor: Relievant Medsystems 385 Moffett Park Drive, Suite 105 Sunnyvale, CA 94089 Date: OCTOBER 17, 2018 CONFIDENTIAL This document contains confidential information. It is intended solely for the recipient and must not be disclosed to any other party. The material may be used only for evaluating or conducting clinical investigations; any other proposed use requires Sponsor written consent. Page 1 of 65 CONFIDENTIAL AND PROPRIETARY October 17, 2018 Relievant Medsystems INTRACEPT CIP 0006, Rev E TABLE OF CONTENTS TABLE OF CONTENTS ............................................................................................................. 2 1.0 SYNOPSIS ................................................................................................................... 6 2.0 LIST OF ABBREVIATIONS ........................................................................................... 11 3.0 BACKGROUND .......................................................................................................... 12 3.1 Causes of Low Back Pain................................................................................................... 12 3.2 Epidemiology of Chronic Low Back Pain ............................................................................ 13 3.3 The Differential Diagnosis of Chronic Lower Back Pain ...................................................... 13 3.4 Pathophysiology of Vertebrogenic Back Pain .................................................................... 15 3.4.1 Discogenic versus Vertebrogenic Back Pain .......................................................................... 16 3.5 Treatments for Chronic Lower Back Pain ........................................................................... 17 3.6 Non-surgical Treatments for Lower Back Pain ................................................................... 18 3.6.1 Education............................................................................................................................... 18 3.6.2 Analgesics .............................................................................................................................. 18 3.6.3 Exercise.................................................................................................................................. 18 3.6.4 Physical Treatments .............................................................................................................. 18 3.6.5 Spinal Manipulative Therapy ................................................................................................. 19 3.6.6 Needle Acupuncture ............................................................................................................. 19 3.6.7 Multidisciplinary Rehabilitation ............................................................................................ 20 3.6.8 Injections and Nerve Treatments .......................................................................................... 20 3.7 Surgical Treatments for Chronic Lower Back Pain .............................................................. 20 3.7.1 Intradiscal Procedures ........................................................................................................... 20 3.7.2 Fusion Surgery ....................................................................................................................... 21 3.7.3 Total Disc Arthroplasty .......................................................................................................... 22 3.8 RF Ablation of the BVN for Treatment of Vertebrogenic Back Pain .................................... 22 3.9 Clinical Experience to Date ............................................................................................... 23 3.9.1 Feasibility Study .................................................................................................................... 23 3.9.2 Pivotal Clinical Trial – the SMART Study................................................................................ 23 4.0 DEVICE DESCRIPTION ................................................................................................ 24 4.1 The Intracept® Intraosseous Nerve Ablation System (Intracept System) ............................. 24 5.0 STUDY PROTOCOL .................................................................................................... 26 5.1 Study Objectives .............................................................................................................. 26 5.1.1 Primary Objectives ................................................................................................................ 26 5.1.2 Secondary Objectives ............................................................................................................ 26 5.2 Study Design .................................................................................................................... 26 5.3 Number of Sites ............................................................................................................... 27 5.4 Number of Subjects.......................................................................................................... 27 5.5 Study Duration................................................................................................................. 27 5.6 Study Population ............................................................................................................. 27 5.7 Subject Selection Criteria ................................................................................................. 27 5.7.1 Inclusion Criteria ................................................................................................................... 27 5.7.2 Exclusion Criteria ................................................................................................................... 28 5.8 Treatment Plan ................................................................................................................ 30 5.8.1 Screening ............................................................................................................................... 30 Page 2 of 65 CONFIDENTIAL AND PROPRIETARY October 17, 2018 Relievant Medsystems INTRACEPT CIP 0006, Rev E 5.8.2 Enrollment Monitor .............................................................................................................. 30 5.8.3 Baseline Assessments ............................................................................................................ 30 5.8.4 Randomization ...................................................................................................................... 31 5.8.5 Choosing the Target Vertebral Bodies .................................................................................. 31 5.8.6 Procedure for RF Ablation of the BVN using the Intracept System ...................................... 31 5.9 Schedule of Assessments.................................................................................................. 33 5.10 Crossover......................................................................................................................... 36 5.11 Study Exit ........................................................................................................................ 36 5.12 Study Withdrawal/Termination ........................................................................................ 36 6.0 STUDY ASSESSMENTS AND OUTCOME MEASURES .................................................... 37 6.1 Medical History ................................................................................................................ 37 6.2 Laboratory Tests .............................................................................................................. 37 6.3 Beck Depression Inventory (BDI-II) ................................................................................... 37 6.4 Imaging ........................................................................................................................... 38 6.5 Neurologic and Physical (Orthopedic) Exam ...................................................................... 39 6.6 Oswestry Disability Index (ODI) ........................................................................................ 39 6.7 Visual Analogue Scale (VAS) ............................................................................................. 39 6.8 Short Form-36 Instrument (SF-36) .................................................................................... 39 6.9 EuroQOL Quality of Life Instrument (EQ-5D-5L) ................................................................. 39 6.10 Patient Satisfaction .......................................................................................................... 40 6.11 Concomitant Back Pain Medications ................................................................................. 40 6.12 Concomitant Therapy ....................................................................................................... 40 6.13 Adverse
Load more

Recommended publications
  • Modic Type 1 Changes: Detection Performance of Fat-Suppressed
    Musculoskeletal System Modic Type 1 Changes: Detection Performance of Fat-Suppressed Fluid-Sensitive MRI Sequences Modic-Typ-1-Endplattenveränderungen: Detektionsrate mittels fettgesättigten, flüssigkeitssensitiven MRT- Sequenzen Authors Tim Finkenstaedt1,FilippoDelGrande2, Nicolae Bolog3, Nils Ulrich4,SinaTok4,OrpheusKolokythas5, Johann Steurer6, Gustav Andreisek1, Sebastian Winklhofer1, 7, on behalf of the LSOS Study Group Affiliations keitssensitiven MRT-Sequenzen gegenüber Standard T1- und 1 Institute of Diagnostic and Interventional Radiology, T2-gewichteten Sequenzen an der Lendenwirbelsäule zu ver- University Hospital Zurich, University of Zurich, Zurich, gleichen. Switzerland Material und Methoden Sagittale T1, T2 und fettgesät- 2 Institute of Diagnostic and Interventional Radiology, tigte, flüssigkeitssensitive MRT-Sequenzen von 100 Patienten Ospedale Regionale di Lugano, Lugano, Switzerland (gesamt 500 Wirbelsegmente; 52 weiblich, Durchschnitts- 3 Phoenix Diagnostic Clinic, Bucharest, Romania alter 74 ± 7,4 Jahre; 48 männlich, Durchschnittsalter 71 ± 6,3 4 Department of Neurosurgery, Spine Center, Schulthess Jahre) wurden retrospektiv untersucht. Das Vorhandensein Clinic, Zurich, Switzerland (ja/nein) und die Ausdehnung (Likert-skalierte Höhen-, Volu- 5 Institute for Radiology and Nuclear Medicine, men- und anteroposteriore Endplattenausdehnung) von Kantonsspital Winterthur, Winterthur, Switzerland Modic-1-Veränderungen auf T1/T2 gegenüber fettgesättig- 6 Horten Center for patient oriented research and ten, flüssigkeitssensitiven
    [Show full text]
  • The Endplate and Trabecular Bone in Lumbar Degenerative Disc Disease: a Narrative Review
    SN Comprehensive Clinical Medicine (2020) 2:332–337 https://doi.org/10.1007/s42399-020-00234-y SURGERY The Endplate and Trabecular Bone in Lumbar Degenerative Disc Disease: A Narrative Review Tom Marjoram1 Accepted: 29 January 2020 /Published online: 6 February 2020 # The Author(s) 2020 Abstract To review the current knowledge surrounding degenerative disc disease focusing on the changes taking place in the end plate and trabecular bone. A narrative review of the current literature. An age-related reduction in blood supply to the disc contributes to tissue degradation. Degeneration, separate from this process, represents a disruption of the normal homeostasis. A process of vascular and sensory nerve in-growth in the annulus and localised areas of the end plate is associated with markers of inflam- mation and may represent a pain source. Treatment with local anti-inflammatories has, at best, mixed results. Bone mechanical indentation testing has been used to classify changes in ageing and degeneration demonstrating a location-dependant reduction in strength specific to each process. Modic changes include a process of inflammation, alteration of the mechanical and chemical environment and changes in bone turnover. The underlying cause for their development has multiple explanations including mechanical overload and microfracture, infection and inflammation in response to herniation of disc material through the end plate. We do know, however, that they seem to be at least partially reversible and not all are symptomatic. This reversibility potentially indicates an avenue of exploration for therapy. Restoring the complex balance of disc homeostasis may hold some promise and will rely on greater understanding of the pathological and material changes occurring at the disc-bone interface and their correlation with clinical imaging.
    [Show full text]
  • Abstract Book 2021
    MAY 31 – JUNE 1: COMMITTEE MEETINGS JUNE 2‐4: SCIENTIFIC PROGRAM ABSTRACT BOOK Oral presentations at the ISSLS Virtual Annual Meeting, May 31‐June 4, 2021 O01 Human Lumbar Discs are not sterile! - Defining the Normal Intervertebral Disc Microbiome Shanmuganathan Rajasekaran1, Soundararajan Dilip Chand Raja1, Tangavel Chitraa2, Nayagam Sharon Miracle2, Muthurajan Raveendran3, Matchado Monica Steffi2, K S Vijayanand1 1. Ganga hospital, Coimbatore, TAMIL NADU, India 2. Department of Proteomics, Ganga Research Centre, Coimbatore, Tamil Nadu, India 3. Department of Plant Biology , Tamil Nadu Agricultural University, Coimbatore, Tamil Nadu, India Introduction: Traditionally, Central Nervous System, spinal cord, eye, fetus and Intervertebral Disc were considered to be to be sterile and immune privileged. With the advent of 16SrRNA sequencing, it has been proved that each of the above have a microbiome which plays an essential role in maintaining homeostasis. With increasing reports of sub-clinical infection as an etiology of disc degeneration and Modic changes, it remains unknown, whether lumbar discs are truly sterile. The primary aim of the study was to investigate the presence of Disc microbiome and its microbial composition. Materials and Methods: In order to obtain true normal controls, intervertebral discs were collected from MRI normal brain-dead voluntary organ donors with no history of back pain. The study was performed after the approval of IRB. The discs were dissected in surgical sterile conditions and were snap frozen immediately to -160⁰C and the processed samples were subjected to total DNA extraction using QIAamp® DNA Mini Kit and enrichment using NEBNext® Microbiome DNA Enrichment Kit (Cat # E612S/L; New England BioLabs, Ipswich, MA).
    [Show full text]
  • Type II Modic Changes May Not Always Represent Fat Degeneration a Study Using MR Fat Suppression Sequence
    SPINE Volume 41, Number 16, pp E987–E994 ß 2016 Wolters Kluwer Health, Inc. All rights reserved DIAGNOSTICS Type II Modic Changes May not Always Represent Fat Degeneration A Study Using MR Fat Suppression Sequence Zhiyun Feng, MD,Ã Yuanhao Liu, MD,Ã Wei Wei,y Shengping Hu, MD,y and Yue Wang, PhDÃ (24.7%) type II MCs was suppressed on FS images, that of 113 Study Design. A radiological study of type II Modic changes (75.3%) was not suppressed. The discs adjacent to type II MCs (MCs). had lower signal intensity (0.13 Æ 0.003 vs.0.14Æ 0.004, Objectives. The aim of this study was to determine the P < 0.001), lesser disc height (9.73 Æ 1.97 vs.11.07Æ 1.99, characteristics of type II MCs on fat suppression (FS) magnetic P < 0.001) and greater bulging area (80.0 Æ 31.4 vs. 61.3 Æ 27.5 resonance (MR) images and its association with radiological disc for anterior bulging, 33.72 Æ 21.24 vs. 27.93 Æ 12.79 for degeneration. Summary of Background Data. Type II MCs are common posterior bulging, and 113.7 Æ 39.9 vs. 89.2 Æ 35.2 for total < endplate signal changes on MR images. On the basis of limited bulging, P 0.05) than normal controls. Type II MCs that were histological samples, type II MCs are thought to be stable fat not suppressed on FS image were associated with greater age < degeneration. FS technique on MR, which can quantify fat [odds ratio (OR) ¼ 1.11, P 0.001], lower height (OR ¼ 0.94, < < content, may be an alternative to explore the pathology of MCs.
    [Show full text]
  • NIH HEAL Initiative Workshop on Myofascial Pain
    Initiative NIH HEAL Workshop on MYOFASCIAL PAIN Quantitative Evaluation of Myofascial Tissues: Potential Impact for Musculoskeletal Pain Research September 16-17, 2020 Co-organizers NIH Partners NCCIH NIAMS NIBIB NICHD/NCMRR NIDCR NINDS Workshop Summary #nihHEALinitiative NIH HEAL Initiative Workshop on Myofascial Pain Quantitative Evaluation of Myofascial Tissues: Potential Impact for Musculoskeletal Pain Research September 16-17, 2020 Welcome Remarks: NIH HEAL Initiative Rebecca Baker, NIH HEAL Director The National Institutes of Health (NIH) Helping to End Addiction Long-termSM (HEAL) Initiative is working to address two related crises affecting the United States: addiction/overdose and chronic pain. In 2018, more than 67,300 Americans died from drug-related overdose, including many affected by opioid addiction. The COVID-19 pandemic appears to be reversing the progress made in this area. Among American adults, 50 million are affected by chronic pain, 25 million report daily severe pain, and 20 million experience high-impact pain that interferes with work and daily life. HEAL receives $500 million/year in sustained research investment. To date, more than 25 HEAL research programs have been funded. HEAL has a trans-NIH governance structure, and research is collaboratively supported by 20 NIH institutes/centers. The two overarching goals of HEAL are to enhance pain management and improve treatment for opioid misuse and addiction. Research is being done in the following areas to meet these goals: preclinical/translational research in pain management, clinical research in pain management, novel medication options, enhanced outcomes for affected newborns, new prevention and treatment strategies, and translation of research into practice. Information on ongoing HEAL projects, workshops, and funding opportunities can be found on the HEAL website.
    [Show full text]
  • Study of Lumbar Spine by MRI with Special Reference to Disc Degeneration and Modic Changes in Rural Area
    Original Research Article DOI: 10.18231/2394-2126.2017.0140 Study of lumbar spine by MRI with special reference to disc degeneration and Modic changes in rural area Raviraj Durganand Walwante1, Shankar Sambhajirao Dhapate2,*, Satishkumar Sukhanand Porwal3 1,3Assistant Professor, 2Professor & HOD, Dept. of Anatomy, SRTR Govt. Medical College, Beed, Maharashtra *Corresponding Author: Email: [email protected] Abstract Introduction: Degenerative disease of the lumbar spine refers to a syndrome in which an intervertebral disc with adjacent spine structures is compromised; this can be due to aging process associated with pathologic process. Individuals with degenerative disease of the lumbar spine can be symptomatic or asymptomatic, although commonly the disease is asymptomatic. The symptomatic individuals can present with back pain or radicular pain syndrome (sciatica). Lumbar spine is the common area affected by degenerative changes, as it is a part of spine which is subjected to heavy mechanical stress. This disease encompasses disc degeneration, Modic changes, disc displacement, facet joint arthropathy and associated complications. Materials and Method: This is a hospital based cross-sectional descriptive study. Study population included all patients above 20 years of age with lower back pain with/without radiculopathy who were referred for lumbar spine MRI at Radiology department. Observations and Result: The study included 165 patients; the age range was from 20 to 80 years whereby eighty-two of them were females. On lumbar MRI, overall prevalence of lumbar degenerative findings was 91%. Disc degeneration (sign of reduced disc signal intensity) being the most frequent finding seen in 91% patients and Modic changes in 38%. Minority of participants (9%) had normal lumbar MRI findings.
    [Show full text]
  • The Modic Vertebral Endplate and Marrow Changes: Pathologic Significance and Relation to Low Back Pain and Segmental Instability of the REVIEW ARTICLE Lumbar Spine
    The Modic Vertebral Endplate and Marrow Changes: Pathologic Significance and Relation to Low Back Pain and Segmental Instability of the REVIEW ARTICLE Lumbar Spine R. Rahme SUMMARY: Two decades following their description, the significance of Modic vertebral endplate and R. Moussa marrow changes remains a matter of debate. These changes are closely related to the normal degenerative process affecting the lumbar spine, and their prevalence increases with age. However, the exact pathogenesis underlying these changes and their relation to segmental instability of the lumbar spine and to low back pain remain unclear. In this paper, we review the literature relevant to this topic and discuss the currently available evidence regarding the pathologic and clinical significance of Modic changes. egenerative vertebral endplate and subchondral bone of Modic changes and the relative frequency of each Modic Dmarrow changes were first noted on MR imaging by de type are most likely the result of sampling errors and variations Roos et al in 1987.1 A formal classification was subsequently among the studied populations. Modic changes are most com- provided by Modic et al in 1988,2 based on a study of 474 mon at L4-L5 and L5-S14,10,12,13 and are associated with in- patients, most of whom had chronic low back pain (LBP). creasing age.10,12 These changes usually occur adjacent to de- These authors described 2 types of endplate and marrow generated or herniated intervertebral disks.1-3,9,10,15 changes: Modic changes are uncommon in asymptomatic individu- Type 1 changes (Fig 1) were hypointense on T1-weighted als without DDD.6,16,17 In the series of Toyone et al,6 only 9.6% imaging (T1WI) and hyperintense on T2-weighted imaging of patients without DDD had such changes.
    [Show full text]
  • Pathobiology of Modic Changes
    HHS Public Access Author manuscript Author ManuscriptAuthor Manuscript Author Eur Spine Manuscript Author J. Author manuscript; Manuscript Author available in PMC 2017 June 20. Published in final edited form as: Eur Spine J. 2016 November ; 25(11): 3723–3734. doi:10.1007/s00586-016-4459-7. Pathobiology of Modic changes Stefan Dudli1, Aaron J. Fields1, Dino Samartzis2, Jaro Karppinen3, and Jeffrey C. Lotz1 Stefan Dudli: [email protected] 1Department of Orthopaedic Surgery, University of California San Francisco, 513 Parnassus Ave, S-1164, San Francisco, CA 94143-0514, USA 2Department of Orthopaedics and Traumatology, University of Hong Kong, Hong Kong, China 3Department of Physical and Rehabilitation Medicine, Medical Research Center Oulu, Finnish Institute of Occupational Health, University of Oulu and Oulu University Hospital, Oulu, Finland Abstract Purpose—Low back pain (LBP) is the most disabling condition worldwide. Although LBP relates to different spinal pathologies, vertebral bone marrow lesions visualized as Modic changes on MRI have a high specificity for discogenic LBP. This review summarizes the pathobiology of Modic changes and suggests a disease model. Methods—Non-systematic literature review. Results—Chemical and mechanical stimulation of nociceptors adjacent to damaged endplates are likely a source of pain. Modic changes are adjacent to a degenerated intervertebral disc and have three generally interconvertible types suggesting that the different Modic change types represent different stages of the same pathological process, which is characterized by inflammation, high bone turnover, and fibrosis. A disease model is suggested where disc/ endplate damage and the persistence of an inflammatory stimulus (i.e., occult discitis or autoimmune response against disc material) create predisposing conditions.
    [Show full text]
  • Vertebral Endplate (Modic) Changes and the Treatment of Back Pain Using Antibiotics
    Special Report Manniche Vertebral endplate (modic) changes & the treatment of back pain using antibiotics 11 Special Report Vertebral endplate (modic) changes and the treatment of back pain using antibiotics Clin. Pract. Claus Manniche Practice points Spine Center of Southern Denmark & • Vertebral endplate changes/modic changes (MC) are the MRI-images of inflammatory University of Southern Denmark, Oestre vertebral endplate damage that are often related to general disc degeneration. Hougvej 55, 5500 Middelfart, Denmark • In patients with prolonged back pain, the prevalence of MC is 40%. Tel.: +45 2612 5021 [email protected] • In individuals with MC, more than 90% will have back pain within 1 year. • MC often causes localized pain 24/7. • Nocturnal pain is the rule rather than the exception. • New MC type 1 occurs frequently during the course of a disc herniation. • There are currently no better diagnostic methods in MC than MRI and a case story of the typical inflammatory back pain pattern and the likely presence of a disc herniation within the recent few years. • In biopsies from prolapsed disc mass, bacteria – most commonly Propionibacterium acnes of the oral cavity class – are found in at least 40% of patients. • In a MC subgroup with persistent back pain after a disc herniation and emerging MC type 1, it is relevant to consider: ‘disc infection’. • In one high quality RCT, including a subgroup of post-prolapse/MC patients with chronic pain, demonstrated clinically significant improvements in more than 50% of the patients after 3 months of treatment with a broad spectrum antibiotic. • MC type 1 are generally considered to be an important prognostic marker of a poor 10.2217/CPR.14.69 prognosis.
    [Show full text]
  • NASA 2018 Spine Workshop
    NASA/TM-20205004306 NASA 2018 Spine Workshop Amy J. Kreykes, MD, MPH Aerospace Medicine Chief Resident University of Texas Medical Branch Richard A. Scheuring DO, MS, RMSK, FAsMA Flight Surgeon Team Lead, Musculoskeletal Medicine and Rehabilitation NASA Johnson Space Center National Aeronautics and Space Administration Johnson Space Center Houston, Texas 77058 August 2020 NASA STI Program Office ... in Profile Since its founding, NASA has been dedicated to the • CONFERENCE PUBLICATION. advancement of aeronautics and space science. The Collected papers from scientific and NASA scientific and technical information (STI) technical conferences, symposia, seminars, program plays a key part in helping NASA or other meetings sponsored or maintain this important role. co-sponsored by NASA. The NASA STI program operates under the • SPECIAL PUBLICATION. Scientific, auspices of the Agency Chief Information Officer. technical, or historical information from It collects, organizes, provides for archiving, and NASA programs, projects, and missions, disseminates NASA’s STI. The NASA STI often concerned with subjects having program provides access to the NTRS Registered substantial public interest. and its public interface, the NASA Technical Report Server, thus providing one of the largest • TECHNICAL TRANSLATION. collections of aeronautical and space science STI in English-language translations of foreign the world. Results are published in both non-NASA scientific and technical material pertinent to channels and by NASA in the NASA STI Report NASA’s mission. Series, which includes the following report types: Specialized services also include organizing • TECHNICAL PUBLICATION. Reports of and publishing research results, distributing completed research or a major significant specialized research announcements and feeds, phase of research that present the results of providing information desk and personal search NASA Programs and include extensive data or support, and enabling data exchange services.
    [Show full text]
  • Prevalence of Modic Changes in the Lumbar Vertebrae and Their
    www.nature.com/scientificreports OPEN Prevalence of Modic changes in the lumbar vertebrae and their associations with workload, Received: 10 October 2016 Accepted: 15 March 2017 smoking and weight in northern Published: 12 April 2017 China Chao Han1,*, Ming-jie Kuang2,*, Jian-xiong Ma1 & Xin-long Ma1 The distribution of Modic changes (MCs) in the lumbar endplates and the evaluation of the relationships between MCs and risk factors are vital for research into MCs. The T1-weighted and T2-weighted sagittal MRI scans of 210 patients who exhibited lumbar intervertebral disc degeneration were retrospectively reviewed. The patients’ weights, genders, smoking statuses, physical activity levels and specific types of MC were recorded. The associations between MCs and risk factors, such as physical work, smoking and body mass index, were also analysed. MCs were observed in 47 patients (22.4%), including 16 males and 31 females. Among all patients, the L5/S1 lumbar level was most likely to suffer MCs. The MCs were predominantly type II. MCs occurred more often in obese patients than in normal and overweight patients (P < 0.05). Patients whose jobs required heavy labour were more likely to develop MCs (P < 0.05). Heavy work and obesity were related to type III MCs more strongly than the other types (P > 0.05). Smoking seemed not to be correlated with the incidence of MCs (P > 0.05). Gender, obesity and heavy work were strongly associated with MCs. Biomechanical factors may play a critical role in the development of MCs. Modic changes (MCs) are lesions of the vertebral endplate and adjacent bone marrow that are visible on magnetic resonance imaging (MRI).
    [Show full text]
  • Prevalence of Modic Change Observed on Magnetic Resonance Imaging in Patients with Low Back Ache and Its Correlation with Plain Radiography in Indian Population
    ORIGINAL RESEARCH PAPER Medical Science Volume : 6 | Issue : 7 | July 2016 | ISSN - 2249-555X | IF : 3.919 | IC Value : 74.50 ORIGINAL RESEARCH PAPER Volume : 6 | Issue : 7 | July 2016 | ISSN - 2249-555X | IF : 3.919 | IC Value : 74.50 Prevalence of Modic Change Observed on Magnetic Resonance Imaging in Patients With Low Back Ache and its Correlation With Plain Radiography in Indian Population AP- Anterioposterior,CT- Computed Tomography,FLAIR- Fluid Attenuation Inversion KEYWORDS Recovery, IVD-InterVertebral Disc,MRI-Magnetic Resonance Imaging,SE- Spin Echo,USG - Ultrasonogram * Dr Bhogavalli Venkata rao Dr.Syed Nazneen Associate Professor of Radiology ,Alluri Sitarama Post graduate, Alluri Sitarama Raju Academy of Raju Academy of Medical Sciences,Eluru – 534005, Medical Sciences, Eluru – 534005, W.G.Dist, A.P W.G.Dist, A.P * Corresponding author Dr N Kiran raju Dr Shirish paul ganta Assistant Professor of Radiology ,Alluri Sitarama Associate professor of radiology, MIMS,Vijayanagaram Raju Academy of Medical Sciences,Eluru – 534005, W.G.Dist, A.P ABSTRACT Wide spectrum of disc abnormalities, including disc degeneration, disc bulging, disc protrusion, disc ex- trusions, nerve root compression and annular tears have been well recognized causes of back ache1 . In recent times Bone marrow and vertebral endplate signal changes (MODIC) seen on Magnetic Resonance imaging have also been considered to play a major role in low back ache and are dynamic markers of degenerative process affecting the vertebral bodies. INRODUCTION: can yield many diagnostic clues. It can readily reveal frac- Various life style diseases have accelerated the physiologi- tures, mal-alignment bony lesions, disc space narrowing cal aging process of the intervertebral disks and increased and paraspinal collections.
    [Show full text]