Status:
COMPLETED
Does Magnetic Resonance Imaging (MRI) Improve Interventional Outcomes for Lumbosacral Radiculopathy?
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Walter Reed Army Medical Center
Conditions:
Lumbosacral Radiculopathy
Eligibility:
All Genders
18+ years
Phase:
NA
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, an...
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 t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2011
Estimated Enrollment :
131 Patients enrolled
Trial Details
Trial ID
NCT00826124
Start Date
January 1 2009
End Date
February 1 2011
Last Update
June 23 2011
Active Locations (2)
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1
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States, 20307
2
Johns Hopkins School of Medicine
Baltimore, Maryland, United States, 21205