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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.

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02196883
Enrollment
0
Registered
2014-07-22
Start date
2014-05-31
Completion date
Unknown
Last updated
2016-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radiculopathy, Spinal Stenosis, Intervertebral Disc Displacement

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.

Interventions

Sponsors

State University of New York - Upstate Medical University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum

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.

Design outcomes

Primary

MeasureTime frame
Visual Analog Scale2 weeks to 6months

Secondary

MeasureTime frame
Short Form 36 Health Survey2 weeks to 6months
Oswestry Disability Index2 weeks to 6months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026