Viewing Study NCT00011739



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Last Modification Date: 2024-10-26 @ 9:06 AM
Study NCT ID: NCT00011739
Status: COMPLETED
Last Update Posted: 2009-01-21
First Post: 2001-02-27

Brief Title: A Prospective Cohort Study of MR Abnormalities and Back Pain Risk
Sponsor: US Department of Veterans Affairs
Organization: VA Office of Research and Development

Study Overview

Official Title: A Prospective Cohort Study of MR Abnormalities and Back Pain Risk
Status: COMPLETED
Status Verified Date: 2003-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Low back pain is a frequent cause of disability and a common reason for outpatient care in veterans Magnetic resonance imaging MRI of the lower back often reveals abnormalitieswhich may be used to justify expensive and invasive therapy such as surgery Yet the link between MRI abnormalities and the risk of developing clinically significant back pain is far from clear This longitudinal study will determine the prevalence and incidence of MRI abnormalities among veterans and determine the extent to which specific MRI abnormalities predict future development of back pain The result should help clinicians use MR imaging more efficiently and they may ultimately help reduce the frequency of unnecessary back surgery
Detailed Description: Primary Objective

Low back pain is a frequent cause of disability and a common reason for outpatient care in veterans Magnetic resonance imaging MRI of the lower back often reveals abnormalities which may be used to justify expensive and invasive therapy such as surgery Yet the link between MRI abnormalities and the risk of developing clinically significant back pain is far from clear This longitudinal study will determine the prevalence and incidence of MRI abnormalities among veterans and determine the extent to which specific MRI abnormalities predict future development of back pain The results should help clinicians use MR imaging more efficiently and they may ultimately help reduce the frequency of unnecessary back surgery

Study Abstract

Low back pain is the second most common symptomatic reason for physician visits in the US resulting in over 24 billion annually in direct health care costs A survey of primary care patients a the Seattle VA revealed that more than one-quarter experienced back pain severe enough to require a visit to a health care practitioner Imaging plays a vital role in the valuation of patients with back pain However a causal relationship between imaging abnormalities and back pain has yet to be clearly established Abnormalities of the lumbar spine on magnetic resonance MR imaging are common and increase with age to the point that they are nearly ubiquitous over the age of 50 Despite this imaging abnormalities are often used to justify various therapies for low back pain including expensive and invasive therapy such as surgery Prior studies have examined the prevalence of imaging abnormalities but no study has investigate either the degree of risk that imaging abnormalities impart for the development of low back pain or the incidence of imaging abnormalities The goal is to examine the natural history of magnetic resonance imaging of the lumbar spine in asymptomatic subjects We want to determine the relationship of imaging abnormalities to the development of low back pain by comparing patients with normal imaging to those with abnormal imaging

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None