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Particulate vs. Nonparticulate Epidural Steroid Injections for Lumbar Foraminal Stenosis

NCT ID: NCT03245671

Last Updated: 2017-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-31

Study Completion Date

2019-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Lumbar Spinal Stenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Decadron

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

Group Type ACTIVE_COMPARATOR

Decadron Phosphate, Injectable

Intervention Type DRUG

15 mg of Decadron will be used.

Epidural Steroid Injection

Intervention Type PROCEDURE

Patient will receive epidural steroid injections of either Kenalog or Decadron.

Kenalog

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

Group Type ACTIVE_COMPARATOR

Kenalog Injectable Product

Intervention Type DRUG

80 mg of Kenalog will be used.

Epidural Steroid Injection

Intervention Type PROCEDURE

Patient will receive epidural steroid injections of either Kenalog or Decadron.

Interventions

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Kenalog Injectable Product

80 mg of Kenalog will be used.

Intervention Type DRUG

Decadron Phosphate, Injectable

15 mg of Decadron will be used.

Intervention Type DRUG

Epidural Steroid Injection

Patient will receive epidural steroid injections of either Kenalog or Decadron.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital for Special Surgery, New York

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital for Special Surgery

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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2016-0615

Identifier Type: -

Identifier Source: org_study_id