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.

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective, Randomized, Single Blind Study Comparing Transforaminal Epidural Steroid Injections at the Level of MRI Pathology vs Clinical Symptoms

Conditions
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Radiculopathy, Spinal Stenosis, Intervertebral Disc Displacement

Intervention / Treatment
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* Procedure: Transforaminal Epidural Steroid Injection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MRI Pathology<br> | Procedure: Transforaminal Epidural Steroid Injection<br> <br> |
| Active Comparator: Physical Exam Pathology<br> | Procedure: Transforaminal Epidural Steroid Injection<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale |  | 2 weeks to 6months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short Form 36 Health Survey |  | 2 weeks to 6months | 
| Oswestry Disability Index |  | 2 weeks to 6months |