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A Prospective Cohort Study of MR Abnormalities and Back Pain Risk

Primary Purpose

Low Back Pain

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Low Back Pain focused on measuring Low back pain, Magnetic resonance imaging (MRI),

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • VA Puget Sound Health Care System

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 27, 2001
Last Updated
January 20, 2009
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00011739
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
Study Type
Observational

2. Study Status

Record Verification Date
February 2003
Overall Recruitment Status
Completed
Study Start Date
November 1997 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2001 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Low back pain, Magnetic resonance imaging (MRI),

7. Study Design

Enrollment
150 (false)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
VA Puget Sound Health Care System
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States

12. IPD Sharing Statement

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A Prospective Cohort Study of MR Abnormalities and Back Pain Risk

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