Magnetic Resonance Imaging (MRI) Interpretations for Lumbar Spinal Stenosis (LSS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01017692
Recruitment Status : Completed
First Posted : November 20, 2009
Last Update Posted : May 25, 2015
Information provided by (Responsible Party):
William Lavelle, State University of New York - Upstate Medical University

Brief Summary:
The objective of this study is to establish a relationship between the degree of radiologically established anatomical stenosis and the severity of self-assessed outcome measures in patients that have undergone and MRI.

Condition or disease Intervention/treatment
Lumbar Spinal Stenosis Procedure: MRI

Detailed Description:

Magnetic Resonance Imaging(MRI) has become the gold standard of evaluation of lumbar spinal stenosis (LSS. LSS is defined as the narrowing of the spinal canal. Thus far, there has been no formal grading system in literature. Physicians, particularly radiologists, in their interpretations, currently describe the degree of stenosis at each level as normal, mild, moderate or severe. Unfortunately, there is no consensus on criteria of these definitions. Treatments and surgical plans are based primarily on this information. Consequently, the reliability and accuracy of this information is critical in terms of optimizing outcomes.

In this study 50-100 MRI studies of patients diagnosed with symptomatic lumbar spinal stenosis will be collected, de-identified, and assigned a study identification number for tracking purposes. Three "raters" from Upstate and three "rater" from outside the institution, that have experience reviewing MRI's will be asked to review the MRI's and classify the LSS at all lumbar levels as normal, mild, moderate or severe in the central canal, lateral recesses and the neuroforamen. The raters will not have any information about the patients. The MRI's will then be given a new identification number, and the patient's self-assessment questionnaires (which are also de-identified and given the study id number) will be given to the raters, for a second review. The raters will have the patients gender, age and outcomes scores from Short form 36, Visual Analog Scale, Oswestry Disability Index and Zurich Claudication Questionnaires. The raters will classify the MRI, as normal, mild, moderate or severe using the outcomes and information supplied.

The data from both ratings will be compiled and compared to assess the reliability of the radiologically established anatomical stenosis when compared with the subjects outcome scores.

This study is for current patients in Upstate Orthopedics office.

Study Type : Observational
Actual Enrollment : 36 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Variability of Magnetic Resonancy Imaging Interpretation for Lumbar Spinal Stenosis
Study Start Date : June 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Spinal Stenosis

Group/Cohort Intervention/treatment
Lumbar Spinal Stenosis
Subjects who have undergone or will undergo an MRI, with symptoms of LSS
Procedure: MRI
MRI of lumbar spine for subjects presenting with spinal stenosis symptoms

Primary Outcome Measures :
  1. A numeric score will be calculated for the actual percent stenosis at the symptomatic level(s) and will report the predictive power of MRI based on all the analysis of MRI with and without clinical knowledge of patient's presenting symptoms [ Time Frame: one year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who are seen at SUNY Upstate Medical Univeristy, Department of Orthopedic Surgery office

Inclusion Criteria:

  • Must be at least 21 years of age
  • Must be able to undergo or have undergone an MRI of the Lumbar spine
  • Must be able to read/understand English
  • Must be a current patient in our practice

Exclusion Criteria:

  • Prisoner

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01017692

United States, New York
SUNY Upstate Medical University-Department of Orthopedics
Syracuse, New York, United States, 13202
Sponsors and Collaborators
State University of New York - Upstate Medical University
Principal Investigator: William F Lavelle, MD State University of New York - Upstate Medical University

Responsible Party: William Lavelle, Associate Professor, State University of New York - Upstate Medical University Identifier: NCT01017692     History of Changes
Other Study ID Numbers: 5825-MRI Variability
First Posted: November 20, 2009    Key Record Dates
Last Update Posted: May 25, 2015
Last Verified: September 2013

Additional relevant MeSH terms:
Constriction, Pathologic
Spinal Stenosis
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases