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History of Changes for Study: NCT01397552
Dexamethasone Versus Depo Medrol in Lumbar Epidurals
Latest version (submitted November 14, 2018) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 July 18, 2011 None (earliest Version on record)
2 July 20, 2011 Eligibility, Study Description, Sponsor/Collaborators and Study Status
3 September 6, 2013 Recruitment Status, Sponsor/Collaborators, Study Status, Study Design and Outcome Measures
4 April 19, 2016 Study Status and IPDSharing
5 April 25, 2017 Study Status and Study Design
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Results Submission Events
6 November 14, 2018 Study Status, Results and Arms and Interventions
Comparison Format:

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Study NCT01397552
Submitted Date:  July 20, 2011 (v2)

Open or close this module Study Identification
Unique Protocol ID: IRB 5824
Brief Title: Dexamethasone Versus Depo Medrol in Lumbar Epidurals
Official Title: A Prospective, Randomized, Double-Blind Study to Compare the Effects of Dexamethasone Versus Depo-Medrol When Used in Lumbar Epidural Injections
Secondary IDs:
Open or close this module Study Status
Record Verification: July 2011
Overall Status: Enrolling by invitation
Study Start: September 2009
Primary Completion: December 2015 [Anticipated]
Study Completion: December 2015 [Anticipated]
First Submitted: July 15, 2011
First Submitted that
Met QC Criteria:
July 18, 2011
First Posted: July 19, 2011 [Estimate]
Last Update Submitted that
Met QC Criteria:
July 20, 2011
Last Update Posted: July 21, 2011 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: State University of New York - Upstate Medical University
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief Summary: Comparison of Dexamethasone versus Depo Medrol when used in lumbar epidural injections will be conducted on subjects that have not had previous injections or have not had an injection in the last 12 months. Subjects must be receiving one level injection and not had prior surgery at that level.
Detailed Description:

Central Epidural Steroid Injections (ESI) and Selective Nerve Root Blocks (SNRB) are often used for the non-surgical treatment of lumbar disc herniations and lumbar radiculitis (radiating pain). Numerous authors have reported on their value in treating patients with radicular pain with the possibility of delaying or even obviating the need for surgery in well-selected patients.. There are two well-performed clinical studies in the peer-reviewed medical literature that specifically examined the crossover rates to surgery for patients who received either ESI or SNRB. In a prospective study, Buttermann et al. found a crossover rate to surgery for patients with symptomatic disc herniations treated with ESI of 54% (27/50) . In a separate prospective study, Riew et al. followed patients after selective nerve root blocks and found that similarly 53% (29/55) of their patients had avoided surgery after a selective nerve root block during their initial follow-up of 13-28 months. In a later study that followed that same population, 76% (16/21) of those patients who had avoided surgery at one year still avoided surgery at a minimum of five year follow-up.

Epidural steroid injections are a common treatment option for patients with disc herniations and radiating leg pain. They have been used for low back problems since 1922 and are still an integral part of the non-surgical management of a variety of spine related problems. The goal of the injection is reduction in pain, increased quality of life and increased function.

Most practitioners will agree that, while the effects of the injection tend to be temporary-providing relief from pain for one week up to one year-an epidural can be very beneficial for a patient during an acute episode of back and/or leg pain. Importantly, an injection can provide sufficient pain relief to allow a patient to progress with a rehabilitative stretching and exercise program.

Many previous studies on epidural injections did not include use of fluoroscopy or xray to verify proper placement of the medication despite the fact that fluoroscopic guidance is routinely used today. Additionally, many studies do not classify patients according to diagnosis and tend to "lump" different types, sources of pain together.

Commonly used steroid preparations include betamethasone, triamcinolone, dexamethasone and methylprednisolone. Unfortunately, there is no consensus regarding the most effective medication, dose, volume or frequency used for ESIs.

This investigator-initiated study is being conducted to compare the effects of epidural injections on low back pain when using either dexamethasone or methylprednisolone (Depo-Medrol). The physicians listed would like to compare these two medications to assess if one is more effective than the other. Both medications are FDA approved and are not experimental.

Dexamethasone is the only nonparticulate corticosteroid, has a rapid onset that acts as an anti-inflammatory and immunosuppressant.

Depo-Medrol is a synthetic steroid (cortisone) medication which also acts as an anti-inflammatory when physicians administer an epidural for relief of low back pain.

Open or close this module Conditions
Conditions: Lumbar Spine Disc Herniation
Lumbar Radiculitis
Lumbar Back Pain
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Other
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Double (Participant, Investigator)
Allocation: Randomized
Enrollment: 100 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Active Comparator: Dexamethasone
Subjects randomized to receive dexamethasone, will undergo epidural using this medication, however the physician and subject will be blinded
Drug: Dexamethasone
10 mg/mL injected into lumbar spine, one level, one injection
Active Comparator: methylprednisolone acetate
Subjects randomized to receive methylprednisolone acetate, will undergo epidural using this medication, however the physician and subject will be blinded
Drug: methylprednisolone acetate
80 mg of methylprednisolone acetate will be given in the lumbar spine, one level, one time
Other Names:
  • Depo-Medrol
Open or close this module Outcome Measures
Primary Outcome Measures:
1. To Determine if One Medication is Better at Relieving Pain Than the Other.
Subjects will be asked to return at 2 wks, 6 wks and 12 weeks the above time points to complete outcome measurements questionnaires and undergo a neurological examinationk, the 12 weeks outcome should show improvement s/p injection

[Time Frame: 12 wk post injection]
Open or close this module Eligibility
Minimum Age: 21 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  1. Chronic low back pain of radicular origin of > 4 weeks but < 6 months
  2. Failure of conservative therapy to include physical therapy and pharmacotherapy
  3. Patient is at least 21 years of age
  4. Patient is willing to be blinded to treatment until after the 12 week post injection visit.
  5. Patient is willing and able to review and sign the study informed consent form.

Exclusion Criteria:

  1. Patient has a mental or physical condition that would invalidate evaluation results.
  2. Patient has had prior lumbar surgery at any level.
  3. Patient is scheduled to have more than one level of steroid injection.
  4. Patient is pregnant
  5. Patient has systemic infection at the proposed injection site
  6. Patient has osteopenia osteoporosis, or osteomalacia
  7. Patient has a disease of bone metabolism
  8. Patient has history of renal insufficiency or kidney disease of any kind
  9. Patient is undergoing chemotherapy or radiation treatment
  10. Patient is currently involved in a study of another product for similar purpose
  11. Patient requires post op management with NSAIDS
  12. Patient has know allergy to corticosteroids, contrast dye or anesthetics
  13. Patient is unable to speak/read English
  14. Patient is a prisoner
Open or close this module Contacts/Locations
Study Officials: Suehun Ho, MD
Principal Investigator
State University of New York - Upstate Medical University
Locations: United States, New York
Upstate Orthpedics
East Syracuse, New York, United States, 13057
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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