Back to resultsSteroid Injections Given at the "Level of MRI Pathology" Versus at the "Level of Clinical Symptoms" to See if One is More Effective Than the Other.
Primary Purpose
Radiculopathy, Spinal Stenosis, Intervertebral Disc Displacement
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transforaminal Epidural Steroid Injection
Sponsored by
About this trial
This is an interventional diagnostic trial for Radiculopathy
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of Single level spinal stenosis.
- Single level radiculopathy with MRI findings at a different level than clinical pattern.
- Chronic low back pain with radicular symptoms of > 4 weeks, but < 6 months.
- Failure of conservative therapy to include physical and pharmacotherapy.
- Patient is at least 21 years of age.
- Patient is willing to be blinded to treatment until after the 3-month follow up visit.
- Patient is willing and able to review and sign the study's informed consent form.
Exclusion Criteria:
- Patient has a mental or physical condition that would invalidate evaluation results.
- Patient has had prior lumbar surgery at any level.
- Patient is pregnant.
- Patient has systemic infection or infection at the proposed injection site.
Sites / Locations
- SUNY Upstate Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
MRI Pathology
Physical Exam Pathology
Arm Description
Outcomes
Primary Outcome Measures
Visual Analog Scale
Secondary Outcome Measures
Short Form 36 Health Survey
Oswestry Disability Index
Full Information
NCT ID
NCT02196883
First Posted
July 18, 2014
Last Updated
June 10, 2016
Sponsor
State University of New York - Upstate Medical University
1. Study Identification
Unique Protocol Identification Number
NCT02196883
Brief Title
Steroid Injections Given at the "Level of MRI Pathology" Versus at the "Level of Clinical Symptoms" to See if One is More Effective Than the Other.
Official Title
A Prospective, Randomized, Single Blind Study Comparing Transforaminal Epidural Steroid Injections at the Level of MRI Pathology vs Clinical Symptoms
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Withdrawn
Why Stopped
PI no longer part of practice
Study Start Date
May 2014 (undefined)
Primary Completion Date
May 2015 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
State University of New York - Upstate Medical University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Patients are being asked to participate in a research study because the patients are being treated for low back pain and the patients have decided to have an epidural steroid injection.
Low back pain has a tremendous impact on the individual and society. It not only affects the individuals quality of life, it also contributes to lost productivity and increased health care costs.
Epidural steroid injections (ESIs) are a common treatment option for many forms of low back pain. They have been used for low back problems since 1952 and are still being used as a non-surgical form of treatment for low back pain. The goal of the injections is reduction of pain, increased quality of life and improved function.
This study is being conducted to determine the outcomes of injections given at the "level of MRI Pathology" versus at the "level of clinical symptoms" to see if one is more effective than the other and to learn more about the characteristics of the two different injections.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiculopathy, Spinal Stenosis, Intervertebral Disc Displacement
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MRI Pathology
Arm Type
Active Comparator
Arm Title
Physical Exam Pathology
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Transforaminal Epidural Steroid Injection
Primary Outcome Measure Information:
Title
Visual Analog Scale
Time Frame
2 weeks to 6months
Secondary Outcome Measure Information:
Title
Short Form 36 Health Survey
Time Frame
2 weeks to 6months
Title
Oswestry Disability Index
Time Frame
2 weeks to 6months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Eligibility Criteria
Inclusion Criteria:
Diagnosis of Single level spinal stenosis.
Single level radiculopathy with MRI findings at a different level than clinical pattern.
Chronic low back pain with radicular symptoms of > 4 weeks, but < 6 months.
Failure of conservative therapy to include physical and pharmacotherapy.
Patient is at least 21 years of age.
Patient is willing to be blinded to treatment until after the 3-month follow up visit.
Patient is willing and able to review and sign the study's informed consent form.
Exclusion Criteria:
Patient has a mental or physical condition that would invalidate evaluation results.
Patient has had prior lumbar surgery at any level.
Patient is pregnant.
Patient has systemic infection or infection at the proposed injection site.
Facility Information:
Facility Name
SUNY Upstate Medical Center
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Steroid Injections Given at the "Level of MRI Pathology" Versus at the "Level of Clinical Symptoms" to See if One is More Effective Than the Other.
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