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A Prospective Cohort Study of MR Abnormalities and Back Pain Risk

This study has been completed.
Study NCT00011739.   Last updated on June 23, 2005.   Information provided by Department of Veterans Affairs

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Descriptive Information Fields
Brief Title  A Prospective Cohort Study of MR Abnormalities and Back Pain Risk
Official Title  A Prospective Cohort Study of MR Abnormalities and Back Pain Risk
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 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 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 U.S. 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 Phase
Study Type  Observational
Study Design  Screening, Longitudinal, Defined Population
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Low Back Pain
Intervention 
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  150
Start Date  November 1997
Completion Date September 2001
Eligibility Criteria 

VA patients who did not have low back pain within the past four months of recruitment, never had spine surgery, and had no serious systematic medical problem.

Gender Both
Ages
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00011739
Organization ID S002
Secondary IDs ††
Study Sponsor  Department of Veterans Affairs
Collaborators ††
Investigators 
Information Provided By Department of Veterans Affairs
Verification Date February 2003
First Received Date  February 27, 2001
Last Updated Date June 23, 2005

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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