Status:
WITHDRAWN
Particulate vs. Nonparticulate Epidural Steroid Injections for Lumbar Foraminal Stenosis
Lead Sponsor:
Hospital for Special Surgery, New York
Conditions:
Lumbar Spinal Stenosis
Eligibility:
All Genders
18-90 years
Phase:
PHASE4
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 tre...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2019
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03245671
Start Date
December 1 2017
End Date
April 1 2019
Last Update
December 6 2017
Active Locations (1)
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1
Hospital for Special Surgery
New York, New York, United States, 10021