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

Lumbosacral Radiculopathy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00826124
• Other study ID #: NA_00022479
• Status: Completed
• Phase: N/A
• First received: January 20, 2009
• Last updated: June 22, 2011
• Start date: January 2009
• Est. completion date: February 2011

Study information

• Verified date: January 2009
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Lumbosacral Radiculopathy
• Radiculopathy

Intervention

Procedure:
• Epidural steroid injection
Injection based solely on history and physical exam
• Epidural steroid injection
Two epidural steroid injections two weeks apart based on history, physical exam and MRI
• Magnetic Resonance Imaging (MRI)
Imaging of lumbar spine

Locations

Country	Name	City	State
United States	Johns Hopkins School of Medicine	Baltimore	Maryland
United States	Walter Reed Army Medical Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Walter Reed Army Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (4)

Cohen SP, Argoff CE, Carragee EJ. Management of low back pain. BMJ. 2008 Dec 22;337:a2718. doi: 10.1136/bmj.a2718. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in numerical rating leg pain score		1 month after 2nd epidural injection	No
Secondary	change in numerical rating back pain score		1 month after 2nd epidural injection	No
Secondary	change in numerical rating scale leg pain score	Pain score 3 months after 2nd epidural steroid injection	3 months after 2nd epidural steroid injection	No
Secondary	Change in numerical rating scale back pain score	Back pain 3 months after epidural steroid injections	3 months after 2nd epidural steroid injection	No
Secondary	Change in Oswestry disability index	Measurement of functional capacity 1 month after 2nd epidural steroid injection	1 month after 2nd epidural steroid injection	No
Secondary	Change in Oswestry disability index	Measurement of functional capacity 3 months after 2nd epidural steroid injection	3 months after 2nd epidural steroid injection	No