Does Magnetic Resonance Imaging (MRI) Improve Interventional Outcomes for Lumbosacral Radiculopathy?

June 22, 2011 updated by: Johns Hopkins University

Does MRI Improve Interventional Outcomes for Lumbosacral Radiculopathy? A Randomized Study Comparing Epidural Steroid Injections Based on Clinical Findings Alone, or Clinical Findings and MRI

Epidural steroid injections (ESI) are the most frequently performed procedures in pain clinics. When performing ESI, there is no consensus about how to best select candidates for this intervention, and which level(s) to inject. Some experts advocate basing the injection level on MRI findings, whereas others recommend clinical symptoms. In order to determine whether MRI is necessary before referring patients with chronic LBP radiating into the leg(s) for pain management interventions, we will perform a randomized comparative study involving 131 patients with chronic low back and leg pain who are clinically candidates for epidural steroid injections into two groups. Group I will receive two ESI based solely on historical and physical exam (PE) findings. Group II will receive treatment only after MRI is reviewed.

The investigators' hypothesis is that MRI will not have a significant effect on treatment outcome, and will have minimal impact on patient care.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

One hundred and thirty-one patients referred to the Blaustein Pain Treatment Center with back and leg pain will be randomized to receive one of two treatments. Sixty-three patients will be allocated to group I and up to 68 to group II (see below and statistical analysis). All patients will be candidates for ESI based on history and physical exam. All 63 group I patients will receive two ESI based solely on history and PE (i.e. the treating physician will be blinded to MRI results). Group II will receive treatment based on MRI, history and PE. This probably but may not include ESI (i.e. it is conceivable that a normal MRI might result in conventional therapy instead of ESI, though chemical irritation of nerve roots often occurs without disc protrusion. We estimate this to occur in no more than 10% of cases (probably less); hence, we are planning to randomize up to 68 patients to group II. If an ESI is done, the patient will receive two injections, similar to patients in group I. Randomization will be done by a research assistant via a computerized randomization system in groups of 13. In order to ensure no serious pathology is missed in group I subjects, a separate doctor with no knowledge of treatment allocation will review the films. If there is serious pathology such as evidence of spinal metastases or infection, the patient will be excluded from the study. There will be no "control" group in this study. Both evaluating physicians and patients will be blinded until they exit the study.

Study Type

Interventional

Enrollment (Anticipated)

131

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20307
        • Walter Reed Army Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age > 18
  • Candidates for ESI based on history and physical exam
  • NRS pain score > 4
  • Leg pain > back pain
  • Patients already have an MRI

Exclusion Criteria:

  • Untreated coagulopathy
  • Previous spine surgery
  • Leg pain > 4 years duration
  • Epidural steroid injection within past 2 years
  • Serious (e.g., bowel or bladder incontinence, loss of reflexes) or progressive neurological deficit
  • Referrals from surgery diagnostic injections for surgical evaluation
  • Serious medical (e.g. congestive heart failure) or psychiatric (untreated depression) condition that might preclude optimal outcome
  • Pregnancy
  • Serious underlying pathology (e.g., vertebral fracture, spinal infection or metastases), as determined by an independent reviewer (group I) or the treating physician (group II) on MRI. The investigator and injector for group I patients will remain blinded to this review except to know that serious pathology was ruled out.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: I
Two epidural steroid injections two weeks apart based on history and physical exam alone
Procedure: Epidural steroid injection
Injection based solely on history and physical exam
Procedure: Epidural steroid injection
Two epidural steroid injections two weeks apart based on history, physical exam and MRI
Active Comparator: II
Two epidural steroid injections two weeks apart based on history, physical exam and MRI
Procedure: Epidural steroid injection
Injection based solely on history and physical exam
Procedure: Epidural steroid injection
Two epidural steroid injections two weeks apart based on history, physical exam and MRI
Procedure: Magnetic Resonance Imaging (MRI)
Imaging of lumbar spine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change in numerical rating leg pain score
Time Frame: 1 month after 2nd epidural injection
1 month after 2nd epidural injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in numerical rating back pain score
Time Frame: 1 month after 2nd epidural injection
1 month after 2nd epidural injection
change in numerical rating scale leg pain score
Time Frame: 3 months after 2nd epidural steroid injection
Pain score 3 months after 2nd epidural steroid injection
3 months after 2nd epidural steroid injection
Change in numerical rating scale back pain score
Time Frame: 3 months after 2nd epidural steroid injection
Back pain 3 months after epidural steroid injections
3 months after 2nd epidural steroid injection
Change in Oswestry disability index
Time Frame: 1 month after 2nd epidural steroid injection
Measurement of functional capacity 1 month after 2nd epidural steroid injection
1 month after 2nd epidural steroid injection
Change in Oswestry disability index
Time Frame: 3 months after 2nd epidural steroid injection
Measurement of functional capacity 3 months after 2nd epidural steroid injection
3 months after 2nd epidural steroid injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

Walter Reed Army Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

January 20, 2009

First Submitted That Met QC Criteria

January 20, 2009

First Posted (Estimate)

January 21, 2009

Study Record Updates

Last Update Posted (Estimate)

June 23, 2011

Last Update Submitted That Met QC Criteria

June 22, 2011

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NA_00022479

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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