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
  Purpose

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.


Condition Intervention
Lumbosacral Radiculopathy
Procedure: Epidural steroid injection
Procedure: Magnetic Resonance Imaging (MRI)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • change in numerical rating leg pain score [ Time Frame: 1 month after 2nd epidural injection ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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


Estimated Enrollment: 131
Study Start Date: January 2009
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Active Comparator: II
Two epidural steroid injections two weeks apart based on history, physical exam and MRI
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00826124

Locations
United States, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307
United States, Maryland
Johns Hopkins School of Medicine
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
Walter Reed Army Medical Center
Investigators
Principal Investigator: Steven P Cohen, MD Johns Hopkins University
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Steven P. Cohen, MD, Johns Hopkins Medical Institutions, Pain Management Division
ClinicalTrials.gov Identifier: NCT00826124     History of Changes
Other Study ID Numbers: NA_00022479
Study First Received: January 20, 2009
Last Updated: June 22, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
low back pain
radiculopathy
sciatica

Additional relevant MeSH terms:
Signs and Symptoms
Radiculopathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 20, 2014