WithdrawnNCT03245671Updated Dec 6, 2017

Particulate vs. Nonparticulate Epidural Steroid Injections for Lumbar Foraminal Stenosis

A Phase 4 interventional study of Kenalog Injectable Product and Decadron Phosphate, Injectable in Lumbar Spinal Stenosis, sponsored by Hospital for Special Surgery, New York. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2017-12-06.

Sponsored by Hospital for Special Surgery, New York · Phase 4, Interventional, and Treatment

Why this study was withdrawn

Unable to address regulatory concerns.

Phase: Phase 4
Study type: Interventional
Enrollment: 0
Allocation: Randomized
Ages: 18 Years to 90 Years
Sex: All

Study 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 studied

Lumbar Spinal Stenosis

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In context

Spinal Stenosis

459 studies on the registry are indexed under Spinal Stenosis; 103 are open to participants now.

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Lead sponsor

Hospital for Special Surgery, New York is the lead sponsor of 217 studies on the registry; 39 are open to participants now.

Of its 27 completed or terminated interventional studies of FDA-regulated products, 20 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 90 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Care provider)
Enrollment: 0 participants (actual)

Study arms

Active comparator
Decadron
Patients in the Decadron group will receive epidural injections containing a total of 15 mg Decadron.
Drug: Decadron Phosphate, Injectable · Procedure: Epidural Steroid Injection
Active comparator
Kenalog
Patients in the Kenalog group will receive epidural injections containing a total of 80 mg Kenalog.
Drug: Kenalog Injectable Product · Procedure: Epidural Steroid Injection

Interventions

DrugKenalog Injectable Product
80 mg of Kenalog will be used.
DrugDecadron Phosphate, Injectable
15 mg of Decadron will be used.
ProcedureEpidural Steroid Injection
Patient will receive epidural steroid injections of either Kenalog or Decadron.

What researchers measure

Primary outcomes

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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 6 months post-injection

Secondary outcomes

Medication use
The use of any pain medications (e.g., opioids, anti-inflammatory drugs, neuropathic medications) will be collected.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 2 weeks, 6 weeks, 3 months, and 6 months post-injection

Study locations

1 site

Hospital for Special Surgery
New York, New York 10021, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 6, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03245671
Lead sponsor: Hospital for Special Surgery, New York
Responsible party: Sponsor
First posted: Aug 10, 2017
Start date: Dec 2017 (estimated)
Primary completion: Apr 2019 (estimated)
Completion: Apr 2019 (estimated)
Last update: Dec 6, 2017

Oversight

FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

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