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
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 |
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.
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins School of Medicine | Baltimore | Maryland |
United States | Walter Reed Army Medical Center | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University | Walter Reed Army Medical Center |
United States,
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
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 |
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