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

This study has been completed.
Sponsor:
Collaborator:
Walter Reed Army Medical Center
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00826124
First received: January 20, 2009
Last updated: June 22, 2011
Last verified: January 2009

January 20, 2009
June 22, 2011
January 2009
February 2011   (final data collection date for primary outcome measure)
change in numerical rating leg pain score [ Time Frame: 1 month after 2nd epidural injection ] [ Designated as safety issue: No ]
numerical rating leg pain score [ Time Frame: 1 and 3 months after 2nd epidural injection ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00826124 on ClinicalTrials.gov Archive Site
  • change in numerical rating back pain score [ Time Frame: 1 month after 2nd epidural injection ] [ Designated as safety issue: No ]
  • change in numerical rating scale leg pain score [ Time Frame: 3 months after 2nd epidural steroid injection ] [ Designated as safety issue: No ]
    Pain score 3 months after 2nd epidural steroid injection
  • Change in numerical rating scale back pain score [ Time Frame: 3 months after 2nd epidural steroid injection ] [ Designated as safety issue: No ]
    Back pain 3 months after epidural steroid injections
  • Change in Oswestry disability index [ Time Frame: 1 month after 2nd epidural steroid injection ] [ Designated as safety issue: No ]
    Measurement of functional capacity 1 month after 2nd epidural steroid injection
  • Change in Oswestry disability index [ Time Frame: 3 months after 2nd epidural steroid injection ] [ Designated as safety issue: No ]
    Measurement of functional capacity 3 months after 2nd epidural steroid injection
numerical rating back pain score; Oswestry disability index [ Time Frame: 1 and 3 months after 2nd epidural injection ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Does Magnetic Resonance Imaging (MRI) Improve Interventional Outcomes for Lumbosacral Radiculopathy?
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Lumbosacral Radiculopathy
  • 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
  • Active Comparator: I
    Two epidural steroid injections two weeks apart based on history and physical exam alone
    Intervention: Procedure: Epidural steroid injection
  • Active Comparator: II
    Two epidural steroid injections two weeks apart based on history, physical exam and MRI
    Interventions:
    • Procedure: Epidural steroid injection
    • Procedure: Magnetic Resonance Imaging (MRI)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
131
February 2011
February 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00826124
NA_00022479
Yes
Steven P. Cohen, MD, Johns Hopkins Medical Institutions, Pain Management Division
Johns Hopkins University
Walter Reed Army Medical Center
Principal Investigator: Steven P Cohen, MD Johns Hopkins Medical Institutions
Johns Hopkins University
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP