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

Completed

• Conditions: Lumbar Spinal Stenosis
• Interventions: Procedure: MRI

• Registration Number: NCT01017692
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-11-18
• Study First Submitted QC: 2009-11-19
• Study First Posted: 2009-11-20
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2013-09
• Last Update Submitted: 2015-05-22
• Last Update Posted: 2015-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lumbar Spinal Stenosis	MRI	Subjects who have undergone or will undergo an MRI, with symptoms of LSS

Primary Outcome Measures

Name	Time	Method
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	one year

Trial Locations

Locations (1)

SUNY Upstate Medical University-Department of Orthopedics; 🇺🇸 Syracuse, New York, United States