NCT03245671

Particulate vs. Nonparticulate Epidural Steroid Injections for Lumbar Foraminal Stenosis

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

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Hospital for Special Surgery, New York · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Lumbar Spinal Stenosis

Interventions

Type	Name	Description
DRUG	Kenalog Injectable Product	80 mg of Kenalog will be used.
DRUG	Decadron Phosphate, Injectable	15 mg of Decadron will be used.
PROCEDURE	Epidural Steroid Injection	Patient will receive epidural steroid injections of either Kenalog or Decadron.

Timeline

• Start date: 2017-12-01
• Primary completion: 2019-04-01
• Completion: 2019-04-01
• First posted: 2017-08-10
• Last updated: 2017-12-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study