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.

NCT02196883 | Withdrawn DMC

• 1 other identifier: 593154-1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiculopathy; Spinal Stenosis; Intervertebral Disc Displacement

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale

  2 weeks to 6months

Secondary Outcomes (2)

• Short Form 36 Health Survey

  2 weeks to 6months

• Oswestry Disability Index

  2 weeks to 6months

Study Arms (2)

MRI Pathology

ACTIVE COMPARATOR

Procedure: Transforaminal Epidural Steroid Injection

Physical Exam Pathology

ACTIVE COMPARATOR

Procedure: Transforaminal Epidural Steroid Injection

Interventions

Transforaminal Epidural Steroid Injection PROCEDURE

MRI Pathology; Physical Exam Pathology

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• State University of New York - Upstate Medical University: lead

Study Sites (1)

SUNY Upstate Medical Center

Syracuse, New York, 13210, United States

Location

MeSH Terms

Conditions

Radiculopathy; Spinal Stenosis; Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2014
• First Posted: July 22, 2014
• Study Start: May 1, 2014
• Primary Completion: May 1, 2015
• Last Updated: June 14, 2016

Record last verified: 2014-07

Locations

US (1)