Particulate vs. Nonparticulate Epidural Steroid Injections for Lumbar Foraminal Stenosis

Lumbar Spinal Stenosis Clinical Trial

Official title:

Particulate vs. Nonparticulate Epidural Steroid Injections for the Treatment of Symptomatic Unilateral Lumbar Foraminal Stenosis: a Prospective Double-blinded Randomized Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03245671
• Other study ID #: 2016-0615
• Status: Withdrawn
• Phase: Phase 4
• First received: August 7, 2017
• Last updated: December 4, 2017
• Start date: December 2017
• Est. completion date: April 2019

Study information

• Verified date: December 2017
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Lumbar Spinal Stenosis
• Spinal Stenosis

Intervention

Drug:
• Kenalog Injectable Product
80 mg of Kenalog will be used.
• 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.

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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