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Particulate vs. Nonparticulate Epidural Steroid Injections for Lumbar Foraminal Stenosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03245671
Recruitment Status : Withdrawn (Unable to address regulatory concerns.)
First Posted : August 10, 2017
Last Update Posted : December 6, 2017
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

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.

Condition or disease Intervention/treatment Phase
Lumbar Spinal Stenosis Drug: Kenalog Injectable Product Drug: Decadron Phosphate, Injectable Procedure: Epidural Steroid Injection Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Particulate vs. Nonparticulate Epidural Steroid Injections for the Treatment of Symptomatic Unilateral Lumbar Foraminal Stenosis: a Prospective Double-blinded Randomized Study
Estimated Study Start Date : December 2017
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Spinal Stenosis

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

Procedure: Epidural Steroid Injection
Patient will receive epidural steroid injections of either Kenalog or Decadron.




Primary Outcome Measures :
  1. Improvement in function (2 weeks post-injection) [ Time Frame: 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. Improvement in function (6 weeks post-injection) [ Time Frame: 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).

  3. Improvement in function (3 months post-injection) [ Time Frame: 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).

  4. Improvement in function (6 months post-injection) [ Time Frame: 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 :
  1. Medication use [ Time Frame: 2 weeks, 6 weeks, 3 months, and 6 months post-injection ]
    The use of any pain medications (e.g., opioids, anti-inflammatory drugs, neuropathic medications) will be collected.

  2. Patient satisfaction with the procedure [ Time Frame: 2 weeks, 6 weeks, 3 months, and 6 months post-injection ]
    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.

  3. Quality of life [ Time Frame: 2 weeks, 6 weeks, 3 months, and 6 months post-injection ]
    This will be assessed using the Veterans RAND 12-item Health Survey.

  4. Side effects [ Time Frame: 2 weeks, 6 weeks, 3 months, and 6 months post-injection ]
    Side effects, including bleeding, infection, allergic reaction, dural puncture, nerve damage, and paralysis, will be collected.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03245671


Locations
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United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
Sponsors and Collaborators
Hospital for Special Surgery, New York
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Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT03245671    
Other Study ID Numbers: 2016-0615
First Posted: August 10, 2017    Key Record Dates
Last Update Posted: December 6, 2017
Last Verified: December 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spinal Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Dexamethasone
Dexamethasone acetate
Triamcinolone Acetonide
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors