Low Back PainNCT00011739
A Prospective Cohort Study of MR Abnormalities and Back Pain Risk
An observational study of Low Back Pain, run by US Department of Veterans Affairs at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Low Back Pain
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 1997to Sep 2001
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Puget Sound Health Care System
Seattle, Washington, 98108
About this study
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.
Read the 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
- Conditions
- Low Back Pain
- Keywords
- Low back pain, Magnetic resonance imaging (MRI),
- Medical subject headings
- Low Back Pain
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2001 (estimated)
- Study startNov 1997
- Study completionSep 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 150 participants
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00011739
- Sponsor's protocol ID
- S002
- Status last verified
- Feb 2003
- First submitted
- 27 Feb 2001
- Last updated
- 21 Jan 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study of MR Abnormalities and Back Pain Risk
- ClinicalTrials.gov ID
- NCT00011739
- Acronym / sponsor ID
- S002
- Conditions
- Low Back Pain
- Keywords
- Low back pain, Magnetic resonance imaging (MRI),
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Nov 1997
- Study completion
- Sep 2001
- First posted
- 1 Mar 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2009.