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

Not Applicable

Completed

• Conditions: Lumbosacral Radiculopathy
• Interventions: Procedure: Epidural steroid injection; Procedure: Magnetic Resonance Imaging (MRI)

• Registration Number: NCT00826124
• Lead Sponsor: Johns Hopkins University

Brief Summary

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.

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 Timeline

• Status Verified: 2009-01
• Study Start: 2009-01
• Study First Submitted: 2009-01-20
• Study First Submitted QC: 2009-01-20
• Study First Posted: 2009-01-21
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Last Update Submitted: 2011-06-22
• Last Update Posted: 2011-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 131

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
I	Epidural steroid injection	Two epidural steroid injections two weeks apart based on history and physical exam alone
II	Epidural steroid injection	Two epidural steroid injections two weeks apart based on history, physical exam and MRI
II	Magnetic Resonance Imaging (MRI)	Two epidural steroid injections two weeks apart based on history, physical exam and MRI

Primary Outcome Measures

Name	Time	Method
change in numerical rating leg pain score	1 month after 2nd epidural injection

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Johns Hopkins School of Medicine; 🇺🇸 Baltimore, Maryland, United States

Walter Reed Army Medical Center; 🇺🇸 Washington, District of Columbia, United States