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Particulate vs. Nonparticulate Epidural Steroid Injections for Lumbar Foraminal Stenosis

Primary Purpose

Lumbar Spinal Stenosis

Status

Withdrawn

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Kenalog Injectable Product

Decadron Phosphate, Injectable

Epidural Steroid Injection

About this trial

This is an interventional treatment trial for Lumbar Spinal Stenosis

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hospital for Special Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Decadron

Kenalog

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).

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).

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).

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).

Secondary Outcome Measures

Medication use

The use of any pain medications (e.g., opioids, anti-inflammatory drugs, neuropathic medications) will be collected.

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.

Quality of life

This will be assessed using the Veterans RAND 12-item Health Survey.

Side effects

Side effects, including bleeding, infection, allergic reaction, dural puncture, nerve damage, and paralysis, will be collected.

Full Information

NCT ID

NCT03245671

First Posted

August 7, 2017

Last Updated

December 4, 2017

Sponsor

Hospital for Special Surgery, New York

1. Study Identification

Unique Protocol Identification Number

NCT03245671

Brief Title

Particulate vs. Nonparticulate Epidural Steroid Injections for Lumbar Foraminal Stenosis

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2017

Overall Recruitment Status

Withdrawn

Why Stopped

Unable to address regulatory concerns.

Study Start Date

December 2017 (Anticipated)

Primary Completion Date

April 2019 (Anticipated)

Study Completion Date

April 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospital for Special Surgery, New York

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lumbar Spinal Stenosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Decadron

Arm Type

Active Comparator

Arm Description

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

Arm Title

Kenalog

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Kenalog Injectable Product

Intervention Description

80 mg of Kenalog will be used.

Intervention Type

Drug

Intervention Name(s)

Decadron Phosphate, Injectable

Intervention Description

15 mg of Decadron will be used.

Intervention Type

Procedure

Intervention Name(s)

Epidural Steroid Injection

Intervention Description

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

Primary Outcome Measure Information:

Title

Improvement in function (2 weeks post-injection)

Description

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

Title

Improvement in function (6 weeks post-injection)

Description

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

Title

Improvement in function (3 months post-injection)

Description

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

Title

Improvement in function (6 months post-injection)

Description

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 Outcome Measure Information:

Title

Medication use

Description

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

Title

Patient satisfaction with the procedure

Description

Time Frame

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

Title

Quality of life

Description

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

Title

Side effects

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Hospital for Special Surgery

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

12. IPD Sharing Statement

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Particulate vs. Nonparticulate Epidural Steroid Injections for Lumbar Foraminal Stenosis

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