NCT00826124

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
131

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2009

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

January 20, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 21, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

June 23, 2011

Status Verified

January 1, 2009

Enrollment Period

2.1 years

First QC Date

January 20, 2009

Last Update Submit

June 22, 2011

Conditions

Lumbosacral Radiculopathy

Keywords

low back painradiculopathysciatica

Outcome Measures

Primary Outcomes (1)

  • change in numerical rating leg pain score

    1 month after 2nd epidural injection

Secondary Outcomes (5)

  • 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

  • Change in numerical rating scale back pain score

    3 months after 2nd epidural steroid injection

  • Change in Oswestry disability index

    1 month after 2nd epidural steroid injection

  • Change in Oswestry disability index

    3 months after 2nd epidural steroid injection

Study Arms (2)

I

ACTIVE COMPARATOR

Two epidural steroid injections two weeks apart based on history and physical exam alone

Procedure: Epidural steroid injection

II

ACTIVE COMPARATOR

Two epidural steroid injections two weeks apart based on history, physical exam and MRI

Procedure: Epidural steroid injectionProcedure: Magnetic Resonance Imaging (MRI)

Interventions

Epidural steroid injectionPROCEDURE

Injection based solely on history and physical exam

I
Magnetic Resonance Imaging (MRI)PROCEDURE

Imaging of lumbar spine

II

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18
  • Candidates for ESI based on history and physical exam
  • NRS pain score \> 4
  • Leg pain \> back pain
  • Patients already have an MRI

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307, United States

Location

Johns Hopkins School of Medicine

Baltimore, Maryland, 21205, United States

Location

Related Publications (5)

  • 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. doi: 10.1136/bmj.322.7283.400.

    PMID: 11179160BACKGROUND

  • 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. doi: 10.1148/radiol.2312030886. Epub 2004 Mar 18.

    PMID: 15031430BACKGROUND

  • 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. doi: 10.1148/radiol.2372041509.

    PMID: 16244269BACKGROUND

  • Cohen SP, Argoff CE, Carragee EJ. Management of low back pain. BMJ. 2008 Dec 22;337:a2718. doi: 10.1136/bmj.a2718. No abstract available.

    PMID: 19103627BACKGROUND

  • Cohen SP, Gupta A, Strassels SA, Christo PJ, Erdek MA, Griffith SR, Kurihara C, Buckenmaier CC 3rd, Cornblath D, Vu TN. Effect of MRI on treatment results or decision making in patients with lumbosacral radiculopathy referred for epidural steroid injections: a multicenter, randomized controlled trial. Arch Intern Med. 2012 Jan 23;172(2):134-42. doi: 10.1001/archinternmed.2011.593. Epub 2011 Dec 12.

    PMID: 22157067DERIVED

MeSH Terms

Conditions

Low Back PainRadiculopathySciatica

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesSciatic NeuropathyMononeuropathiesNeuralgia

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Steven P Cohen, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 20, 2009

First Posted

January 21, 2009

Study Start

January 1, 2009

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

June 23, 2011

Record last verified: 2009-01

Locations

US(2)