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

Completed · Not applicable

Conditions studied: Lumbosacral Radiculopathy

In brief

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.

Key facts

Study ID

NCT00826124

Run by

Johns Hopkins University

People needed

131

Starts

2009-01-01

Expected to finish

2011-02-01

Last updated by the study team

2011-06-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• Walter Reed Army Medical Center — Washington D.C., District of Columbia, United States
• Johns Hopkins School of Medicine — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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