Particulate vs. Nonparticulate Epidural Steroid Injections for Lumbar Foraminal Stenosis

NCT03245671 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 2016-0615
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 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

Lumbar Spinal Stenosis

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Medication use

  2 weeks, 6 weeks, 3 months, and 6 months post-injection

• Patient satisfaction with the procedure

  2 weeks, 6 weeks, 3 months, and 6 months post-injection

• Quality of life

  2 weeks, 6 weeks, 3 months, and 6 months post-injection

• Side effects

  2 weeks, 6 weeks, 3 months, and 6 months post-injection

Study Arms (2)

Decadron

ACTIVE COMPARATOR

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

Drug: Decadron Phosphate, Injectable; Procedure: Epidural Steroid Injection

Kenalog

ACTIVE COMPARATOR

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

Kenalog Injectable Product DRUG

80 mg of Kenalog will be used.

Kenalog

Decadron Phosphate, Injectable DRUG

15 mg of Decadron will be used.

Decadron

Epidural Steroid Injection PROCEDURE

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

Decadron; Kenalog

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Spinal Stenosis

Interventions

dexamethasone 21-phosphate; Injections

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2017
• First Posted: August 10, 2017
• Study Start: December 1, 2017
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: December 6, 2017

Record last verified: 2017-12

Locations

US (1)