Does Magnetic Resonance Imaging (MRI) Improve Interventional Outcomes for Lumbosacral Radiculopathy? - Full Text View

Sponsors and Collaborators:	Johns Hopkins University Walter Reed Army Medical Center
Information provided by:	Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT00826124

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:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
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:

MedlinePlus related topics: Back Pain MRI Scans

U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:

numerical rating leg pain score [ Time Frame: 1 and 3 months after 2nd epidural injection ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

numerical rating back pain score; Oswestry disability index [ Time Frame: 1 and 3 months after 2nd epidural injection ] [ Designated as safety issue: No ]

Estimated Enrollment:	131
Study Start Date:	January 2009
Estimated Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
I: Active Comparator 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
II: Active Comparator 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)

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

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 Medical Institutions

More Information

Publications:

Kendrick D, Fielding K, Bentley E, Kerslake R, Miller P, Pringle M. Radiography of the lumbar spine in primary care patients with low back pain: randomised controlled trial. BMJ. 2001 Feb 17;322(7283):400-5.

Gilbert FJ, Grant AM, Gillan MG, Vale LD, Campbell MK, Scott NW, Knight DJ, Wardlaw D; Scottish Back Trial Group. Low back pain: influence of early MR imaging or CT on treatment and outcome--multicenter randomized trial. Radiology. 2004 May;231(2):343-51. Epub 2004 Mar 18.

Modic MT, Obuchowski NA, Ross JS, Brant-Zawadzki MN, Grooff PN, Mazanec DJ, Benzel EC. Acute low back pain and radiculopathy: MR imaging findings and their prognostic role and effect on outcome. Radiology. 2005 Nov;237(2):597-604.

Cohen SP, Argoff CE, Carragee EJ. Management of low back pain. BMJ. 2008 Dec 22;337:a2718. No abstract available.

Responsible Party:	Johns Hopkins Medical Institutions, Pain Management Division ( Steven P. Cohen, MD )
Study ID Numbers:	NA_00022479
Study First Received:	January 20, 2009
Last Updated:	January 20, 2009
ClinicalTrials.gov Identifier:	NCT00826124 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Johns Hopkins University:

low back pain
radiculopathy
sciatica

Study placed in the following topic categories:

Sciatica
Signs and Symptoms
Neuromuscular Diseases
Peripheral Nervous System Diseases

Radiculopathy
Low Back Pain
Pain
Back Pain

Additional relevant MeSH terms:

Neuromuscular Diseases
Peripheral Nervous System Diseases
Nervous System Diseases
Radiculopathy

ClinicalTrials.gov processed this record on September 11, 2009