Particulate vs. Nonparticulate Epidural Steroid Injections for Lumbar Foraminal Stenosis

Hospital for Special Surgery (HSS)

Status and phase: Withdrawn; Phase 4

Conditions: Lumbar Spinal Stenosis

Treatments: Drug: Decadron Phosphate, Injectable; Drug: Kenalog Injectable Product; Procedure: Epidural Steroid Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT03245671

2016-0615

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

Decadron

Active Comparator group

Description:

Patients in the Decadron group will receive epidural injections containing a total of 15 mg Decadron.

Treatment:

Procedure: Epidural Steroid Injection

Drug: Decadron Phosphate, Injectable

Kenalog

Active Comparator group

Description:

Patients in the Kenalog group will receive epidural injections containing a total of 80 mg Kenalog.

Treatment:

Procedure: Epidural Steroid Injection

Drug: Kenalog Injectable Product