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

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.

Study Overview

• Status: Withdrawn
• Conditions: Lumbar Spinal Stenosis
• Intervention / Treatment: Drug: Decadron Phosphate, Injectable; Procedure: Epidural Steroid Injection; Drug: Kenalog Injectable Product

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Decadron; Patients in the Decadron group will receive epidural injections containing a total of 15 mg Decadron.	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.
Active Comparator: Kenalog; Patients in the Kenalog group will receive epidural injections containing a total of 80 mg Kenalog.	Procedure: Epidural Steroid Injection; Patient will receive epidural steroid injections of either Kenalog or Decadron.; Drug: Kenalog Injectable Product; 80 mg of Kenalog will be used.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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).	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).	6 months post-injection

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hospital for Special Surgery, New York

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2017
• Primary Completion (Anticipated): April 1, 2019
• Study Completion (Anticipated): April 1, 2019

Study Registration Dates

• First Submitted: August 7, 2017
• First Submitted That Met QC Criteria: August 7, 2017
• First Posted (Actual): August 10, 2017

Study Record Updates

• Last Update Posted (Actual): December 6, 2017
• Last Update Submitted That Met QC Criteria: December 4, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Constriction, Pathologic; Spinal Stenosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Dexamethasone; Dexamethasone acetate; BB 1101; Triamcinolone Acetonide; Dexamethasone 21-phosphate
• Other Study ID Numbers: 2016-0615

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No