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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00826124
Enrollment
131
Registered
2009-01-21
Start date
2009-01-31
Completion date
2011-02-28
Last updated
2011-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lumbosacral Radiculopathy

Keywords

low back pain, radiculopathy, sciatica

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.

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.

Interventions

Injection based solely on history and physical exam

PROCEDUREMagnetic Resonance Imaging (MRI)

Imaging of lumbar spine

Sponsors

Walter Reed Army Medical Center
CollaboratorFED
Johns Hopkins University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
change in numerical rating leg pain score1 month after 2nd epidural injection

Secondary

MeasureTime frameDescription
change in numerical rating back pain score1 month after 2nd epidural injection
change in numerical rating scale leg pain score3 months after 2nd epidural steroid injectionPain score 3 months after 2nd epidural steroid injection
Change in numerical rating scale back pain score3 months after 2nd epidural steroid injectionBack pain 3 months after epidural steroid injections
Change in Oswestry disability index1 month after 2nd epidural steroid injectionMeasurement of functional capacity 1 month after 2nd epidural steroid injection

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 27, 2026