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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Lumbosacral Radiculopathy

Intervention / Treatment
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* Procedure: Epidural steroid injection
* Procedure: Epidural steroid injection
* Procedure: Magnetic Resonance Imaging (MRI)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: I<br>Two epidural steroid injections two weeks apart based on history and physical exam alone | Procedure: Epidural steroid injection<br>* Injection based solely on history and physical exam<br>|
| Active Comparator: II<br>Two epidural steroid injections two weeks apart based on history, physical exam and MRI | Procedure: Epidural steroid injection<br>* Two epidural steroid injections two weeks apart based on history, physical exam and MRI<br>Procedure: Magnetic Resonance Imaging (MRI)<br>* Imaging of lumbar spine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in numerical rating leg pain score |  | 1 month after 2nd epidural injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in numerical rating back pain score |  | 1 month after 2nd epidural injection | 
| change in numerical rating scale leg pain score | Pain score 3 months after 2nd epidural steroid injection | 3 months after 2nd epidural steroid injection | 
| Change in numerical rating scale back pain score | Back pain 3 months after epidural steroid injections | 3 months after 2nd epidural steroid injection | 
| Change in Oswestry disability index | Measurement of functional capacity 1 month after 2nd epidural steroid injection | 1 month after 2nd epidural steroid injection | 
| Change in Oswestry disability index | Measurement of functional capacity 3 months after 2nd epidural steroid injection | 3 months after 2nd epidural steroid injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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low back pain, radiculopathy, sciatica