Dexamethasone Versus Depo Medrol in Lumbar Epidurals
Lumbar Spine Disc Herniation
Lumbar Back Pain
Drug: methylprednisolone acetate
|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|
- 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
|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)|
Active Comparator: Dexamethasone
Subjects randomized to receive dexamethasone, will undergo epidural using this medication, however the physician and subject will be blinded
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01397552
|United States, New York|
|East Syracuse, New York, United States, 13057|
|Principal Investigator:||Suehun Ho, MD||State University of New York - Upstate Medical University|