Dexamethasone Versus Depo Medrol in Lumbar Epidurals

This study has been terminated.
(Low enrollment, too many subjects getting second injection)
Sponsor:
Information provided by (Responsible Party):
William Lavelle, State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier:
NCT01397552
First received: July 15, 2011
Last updated: September 6, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Lumbar Spine Disc Herniation
Lumbar Radiculitis
Lumbar Back Pain
Drug: Dexamethasone
Drug: methylprednisolone acetate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: A Prospective, Randomized, Double-Blind Study to Compare the Effects of Dexamethasone Versus Depo-Medrol When Used in Lumbar Epidural Injections

Resource links provided by NLM:


Further study details as provided by State University of New York - Upstate Medical University:

Primary Outcome Measures:
  • To determine if one medication is better at relieving pain than the other. [ Time Frame: 12 wk post injection ] [ Designated as safety issue: No ]
    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 examination, the 12 weeks outcome should show improvement s/p injection


Enrollment: 8
Study Start Date: September 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
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 Name: Depo-Medrol

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01397552

Locations
United States, New York
Upstate Orthpedics
East Syracuse, New York, United States, 13057
Sponsors and Collaborators
State University of New York - Upstate Medical University
Investigators
Principal Investigator: Suehun Ho, MD State University of New York - Upstate Medical University
  More Information

No publications provided

Responsible Party: William Lavelle, Associate Professor, State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier: NCT01397552     History of Changes
Other Study ID Numbers: IRB 5824
Study First Received: July 15, 2011
Last Updated: September 6, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Low Back Pain
Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Dexamethasone acetate
Methylprednisolone acetate
Prednisolone acetate
Dexamethasone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Dexamethasone 21-phosphate
Prednisolone hemisuccinate
Prednisolone phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal

ClinicalTrials.gov processed this record on September 18, 2014