Dexamethasone Versus Depo Medrol in Lumbar Epidurals

NCT01397552 | Terminated Results

• 1 other identifier: IRB 5824
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Spine Disc Herniation; Lumbar Radiculitis; Lumbar Back Pain

Outcome Measures

Primary Outcomes (1)

• To Determine if One Medication is Better at Relieving Pain Than the Other.

  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

  12 wk post injection

Study Arms (2)

Dexamethasone

ACTIVE COMPARATOR

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

Drug: Dexamethasone

methylprednisolone acetate

ACTIVE COMPARATOR

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

Drug: methylprednisolone acetate

Interventions

Dexamethasone DRUG

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

Also known as: dexpak

Dexamethasone

methylprednisolone acetate DRUG

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

Also known as: Depo-Medrol

methylprednisolone acetate

Eligibility Criteria

• Age: 21 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• State University of New York - Upstate Medical University: lead

Study Sites (1)

Upstate Orthpedics

East Syracuse, New York, 13057, United States

Location

MeSH Terms

Conditions

Radiculopathy; Low Back Pain

Interventions

Dexamethasone; Methylprednisolone Acetate

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Methylprednisolone; Prednisolone

Results Point of Contact

• Title: William Lavelle
• Organization: Upstate Medical University

lavellew@upstate.edu

315-464-4472

Study Officials

• Suehun Ho, MD

  State University of New York - Upstate Medical University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 15, 2011
• First Posted: July 19, 2011
• Study Start: September 1, 2009
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: November 22, 2023
• Results First Posted: December 4, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)