Particulate vs. Nonparticulate Epidural Steroid Injections for Lumbar Foraminal Stenosis

Study Overview
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Brief Summary
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Chronic lumbosacral radiculopathy secondary to lumbar spinal stenosis affects a large number of individuals, and there is a general lack of consensus in the medical community in terms of effective treatments for this problem. By assessing the relative efficacy of transforaminal epidural injections of particulate and nonparticulate steroids, this study attempts to further define the appropriate conservative management of painful unilateral radiculopathies due to unilateral lumbar foraminal stenosis. Patients will be randomized to receive a transforaminal epidural injection of either a particulate (Kenalog) or nonparticulate (Decadron) steroid. Outcomes will be assessed at 2 weeks, 6 weeks, 3 months, and 6 months following the injection.

Official Title
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Particulate vs. Nonparticulate Epidural Steroid Injections for the Treatment of Symptomatic Unilateral Lumbar Foraminal Stenosis: a Prospective Double-blinded Randomized Study

Conditions
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Lumbar Spinal Stenosis

Intervention / Treatment
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* Drug: Kenalog Injectable Product
* Drug: Decadron Phosphate, Injectable
* Procedure: Epidural Steroid Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: English speaking/reading adults age 18-90 years Patients with complaints of unilateral radicular lower extremity symptoms NRS pain score >= 5 Pain symptoms for at least 1 month's duration Patients deemed appropriate for lumbar transforaminal epidural steroid injections by treating spine specialist Targeted injection level for L4 or L5 MRI of lumbosacral spine that demonstrates and confirms single-level neural compression secondary to unilateral lumbosacral foraminal or subarticular stenosis consistent with clinical history and findings Lumbar foraminal stenosis severity of grades 1, 2, and 3 Exclusion Criteria: Patients with multiple symptomatic levels Patients who are deemed not appropriate to undergo lumbar transforaminal epidural steroid injections (e.g., allergy to local anesthetics, radiographic dye contrast, patients with high bleeding tendency, pregnancy) Patients involved with litigation or worker's compensation cases Patients who are unable to answer the questionnaires and perform follow-up visits Patients who have active, concurrent painful diagnoses (e.g., hip osteoarthritis, greater trochanteric pain syndrome, knee pain, peripheral vascular disease, or peripheral neuropathy) that may confuse clinical picture and impact patients' rating and perception of their low back and radicular symptoms Patients with other spinal pathologies confirmed on imaging that may explain patient's pain Patients who have additional severe foraminal stenosis inferior to the symptomatic level (e.g., symptomatic L4 foraminal stenosis with severe L5 foraminal stenosis) will not have those levels injected Non-English speakers

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Decadron<br>Patients in the Decadron group will receive epidural injections containing a total of 15 mg Decadron. | Drug: Decadron Phosphate, Injectable<br>* 15 mg of Decadron will be used.<br>Procedure: Epidural Steroid Injection<br>* Patient will receive epidural steroid injections of either Kenalog or Decadron.<br>|
| Active Comparator: Kenalog<br>Patients in the Kenalog group will receive epidural injections containing a total of 80 mg Kenalog. | Drug: Kenalog Injectable Product<br>* 80 mg of Kenalog will be used.<br>Procedure: Epidural Steroid Injection<br>* Patient will receive epidural steroid injections of either Kenalog or Decadron.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in function (2 weeks post-injection) | This will be measured using the Oswestry Disability Index (ODI; 0-100 scale). A higher score represents greater disability (greater pain and functional limitations). | 2 weeks post-injection | 
| Improvement in function (6 weeks post-injection) | This will be measured using the ODI (0-100 scale). A higher score represents greater disability (greater pain and functional limitations). | 6 weeks post-injection | 
| Improvement in function (3 months post-injection) | This will be measured using the ODI (0-100 scale). A higher score represents greater disability (greater pain and functional limitations). | 3 months post-injection | 
| Improvement in function (6 months post-injection) | This will be measured using the ODI (0-100 scale). A higher score represents greater disability (greater pain and functional limitations). | 6 months post-injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication use | The use of any pain medications (e.g., opioids, anti-inflammatory drugs, neuropathic medications) will be collected. | 2 weeks, 6 weeks, 3 months, and 6 months post-injection | 
| Patient satisfaction with the procedure | Satisfaction will be assessed using the North American Spine Society Outcome Questionnaire. Patients will be asked to pick from 4 multiple choice statements regarding their satisfaction with their procedure. | 2 weeks, 6 weeks, 3 months, and 6 months post-injection | 
| Quality of life | This will be assessed using the Veterans RAND 12-item Health Survey. | 2 weeks, 6 weeks, 3 months, and 6 months post-injection | 
| Side effects | Side effects, including bleeding, infection, allergic reaction, dural puncture, nerve damage, and paralysis, will be collected. | 2 weeks, 6 weeks, 3 months, and 6 months post-injection |