- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01397552
Dexamethasone Versus Depo Medrol in Lumbar Epidurals
A Prospective, Randomized, Double-Blind Study to Compare the Effects of Dexamethasone Versus Depo-Medrol When Used in Lumbar Epidural Injections
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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East Syracuse, New York, United States, 13057
- Upstate Orthpedics
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Chronic low back pain of radicular origin of > 4 weeks but < 6 months
- Failure of conservative therapy to include physical therapy and pharmacotherapy
- Patient is at least 21 years of age
- Patient is willing to be blinded to treatment until after the 12 week post injection visit.
- Patient is willing and able to review and sign the study informed consent form.
Exclusion Criteria:
- Patient has a mental or physical condition that would invalidate evaluation results.
- Patient has had prior lumbar surgery at any level.
- Patient is scheduled to have more than one level of steroid injection.
- Patient is pregnant
- Patient has systemic infection at the proposed injection site
- Patient has osteopenia osteoporosis, or osteomalacia
- Patient has a disease of bone metabolism
- Patient has history of renal insufficiency or kidney disease of any kind
- Patient is undergoing chemotherapy or radiation treatment
- Patient is currently involved in a study of another product for similar purpose
- Patient requires post op management with NSAIDS
- Patient has know allergy to corticosteroids, contrast dye or anesthetics
- Patient is unable to speak/read English
- Patient is a prisoner
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Dexamethasone
Subjects randomized to receive dexamethasone, will undergo epidural using this medication, however the physician and subject will be blinded
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10 mg/mL injected into lumbar spine, one level, one injection
Other Names:
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Active Comparator: methylprednisolone acetate
Subjects randomized to receive methylprednisolone acetate, will undergo epidural using this medication, however the physician and subject will be blinded
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80 mg of methylprednisolone acetate will be given in the lumbar spine, one level, one time
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To Determine if One Medication is Better at Relieving Pain Than the Other.
Time Frame: 12 wk post injection
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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
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12 wk post injection
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Collaborators and Investigators
Investigators
- Principal Investigator: Suehun Ho, MD, State University of New York - Upstate Medical University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Pain
- Neurologic Manifestations
- Musculoskeletal Diseases
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Pathological Conditions, Anatomical
- Spinal Diseases
- Bone Diseases
- Hernia
- Back Pain
- Low Back Pain
- Intervertebral Disc Displacement
- Radiculopathy
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Neuroprotective Agents
- Protective Agents
- Dexamethasone
- Prednisolone
- Methylprednisolone Acetate
- Methylprednisolone
- Methylprednisolone Hemisuccinate
- Prednisolone acetate
- Prednisolone hemisuccinate
- Prednisolone phosphate
Other Study ID Numbers
- IRB 5824
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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