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A Prospective Cohort Study of MR Abnormalities and Back Pain Risk



A Prospective Cohort Study of MR Abnormalities and Back Pain Risk

For Condition: Low Back Pain
Status: Completed
Sponsor(s): Department of Veterans Affairs , Department of Veterans Affairs Cooperative Studies Program
Synopsis: 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.
Details: 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
Eligibility:
Study Type:
  Observational, Screening, Longitudinal, Defined Population
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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.
Total Enrollment: 150

Location and Contact Information:

VA Puget Sound Health Care System
Seattle,  Washington,  98108
United States
 


Additional Information:
Study ID Numbers:
  S002; 
Study Start Date: November 1997
Record last reviewed: February 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00011739

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4. Spine Patient Outcomes Research Trial (SPORT): Spinal Stenosis

5. Spine Patient Outcomes Research Trial (SPORT) - Intervertebral Disc Herniation

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