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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.

S

State University of New York - Upstate Medical University

Status

Withdrawn

Conditions

Radiculopathy
Spinal Stenosis
Intervertebral Disc Displacement

Treatments

Procedure: Transforaminal Epidural Steroid Injection

Study type

Interventional

Funder types

Other

Identifiers

NCT02196883
593154-1

Details and patient eligibility

About

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.

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

Single Blind

0 participants in 2 patient groups

MRI Pathology
Active Comparator group
Treatment:
Procedure: Transforaminal Epidural Steroid Injection
Physical Exam Pathology
Active Comparator group
Treatment:
Procedure: Transforaminal Epidural Steroid Injection

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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