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Lumbosacral Radiculopathy

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

Sponsored by Johns Hopkins University

About this trial

Last updated 14 years ago

Study ID

NA_00022479

Status

Completed

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 14 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

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

No

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.

Locations

Location

Status