Dexamethasone Versus Depo Medrol in Lumbar Epidurals

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.

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