Dexamethasone Versus Depo Medrol in Lumbar Epidurals

• Status: Terminated
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: State University of New York - Upstate Medical University
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

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