Dexamethasone Versus Depo Medrol in Lumbar Epidurals

NCT ID: NCT01397552

Last Updated: 2023-11-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2015-12-31

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.

Conditions

Lumbar Spine Disc Herniation; Lumbar Radiculitis; Lumbar Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Dexamethasone

Subjects randomized to receive dexamethasone, will undergo epidural using this medication, however the physician and subject will be blinded

Group Type: ACTIVE_COMPARATOR

Dexamethasone

Intervention Type: DRUG

10 mg/mL injected into lumbar spine, one level, one injection

methylprednisolone acetate

Subjects randomized to receive methylprednisolone acetate, will undergo epidural using this medication, however the physician and subject will be blinded

Group Type: ACTIVE_COMPARATOR

methylprednisolone acetate

Intervention Type: DRUG

80 mg of methylprednisolone acetate will be given in the lumbar spine, one level, one time

Interventions

Dexamethasone

10 mg/mL injected into lumbar spine, one level, one injection

Intervention Type: DRUG

methylprednisolone acetate

80 mg of methylprednisolone acetate will be given in the lumbar spine, one level, one time

Intervention Type: DRUG

Other Intervention Names

dexpak; Depo-Medrol

Eligibility 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

State University of New York - Upstate Medical University

OTHER

Sponsor Role: lead

Responsible Party

William Lavelle

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Suehun Ho, MD

Role: PRINCIPAL_INVESTIGATOR

State University of New York - Upstate Medical University

Locations

Upstate Orthpedics

East Syracuse, New York, United States

Countries

United States

Other Identifiers

IRB 5824

Identifier Type: -

Identifier Source: org_study_id