Clinical trial NCT03245671: Particulate vs. Nonparticulate Epidural Steroid Injections for Lumbar Foraminal Stenosis
Official title: Particulate vs. Nonparticulate Epidural Steroid Injections for the Treatment of Symptomatic Unilateral Lumbar Foraminal Stenosis: a Prospective Double-blinded Randomized Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Lumbar Spinal Stenosis
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2017-08-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Improvement in function (2 weeks post-injection)
timeFrame: 2 weeks post-injection
measure: Improvement in function (6 weeks post-injection)
timeFrame: 6 weeks post-injection
measure: Improvement in function (3 months post-injection)
timeFrame: 3 months post-injection
measure: Improvement in function (6 months post-injection)
timeFrame: 6 months post-injection
Secondary outcomes:
measure: Medication use
timeFrame: 2 weeks, 6 weeks, 3 months, and 6 months post-injection
measure: Patient satisfaction with the procedure
timeFrame: 2 weeks, 6 weeks, 3 months, and 6 months post-injection
measure: Quality of life
timeFrame: 2 weeks, 6 weeks, 3 months, and 6 months post-injection
measure: Side effects
timeFrame: 2 weeks, 6 weeks, 3 months, and 6 months post-injection
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
References: