A Trial of Corticosteroids for Low Back Pain

NCT00290589 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 03-05-107
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

Low back pain is a common symptom that functionally disables many people. When the low back pain is accompanied by pain that shoots down the leg, it is felt to be caused by a herniated disc. We are conducting this study to determine if a powerful anti-inflammatory agent will decrease the pain and functional impairment that is associated with this illness.

Conditions

Radicular Low Back Pain

Keywords

low back pain; emergency department; corticosteroids

Outcome Measures

Primary Outcomes (2)

• Numerical Rating Scale (0-10), an Interval Pain Scale, on Which 0 Indicates no Pain and 10 Indicates the Worst Pain Imaginable

  Improvement in Numerical Rating Scale between the time of the emergency department visit and the one month telephone call is rated on an 11-point scale ranging from 0-10 with 0 indicating no pain and 10 indicating worse pain imaginable.

  1 month

• Functional Disability Scales

  The low back pain functional disability scale is the Roland Morris Disability questionnaire score (RMDQ). The RMDQ is a 24-item low back pain functional scale recommended for use in low back pain research.Higher scores signify greater low back-related functional impairment.0= no functional impairment, 24= severe functional impairment.

  1 month

Secondary Outcomes (1)

• Number of Patients Using Analgesics

  Assessed at 1 month

Study Arms (2)

Intramuscular methylprednisolone acetate

EXPERIMENTAL

Methylprednisolone acetate 160mg intramuscular injection

Drug: Intramuscular methylprednisolone acetate

Placebo

PLACEBO COMPARATOR

Placebo intramuscular injection

Drug: Placebo

Interventions

Intramuscular methylprednisolone acetate DRUG

Intramuscular methylprednisolone acetate 160mg

Also known as: steroid

Intramuscular methylprednisolone acetate

Placebo DRUG

Normal saline intramuscular injection

Also known as: saline solution

Placebo

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years old, non-traumatic low back pain for one week or less,

You may not qualify if:

• fever, pregnancy, lactation, allergy or intolerance to study medication, suspected active oncologic, urologic, or gynecologic disease

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Low Back Pain; Emergencies

Interventions

Steroids; Saline Solution

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Fused-Ring Compounds; Polycyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Benjamin W. Friedman, MD, MS
• Organization: Montefiore Medical Center

befriedm@montefiore.org

(718)920-6266

Study Officials

• Benjamin W Friedman, MD, MS

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Emergency Medicine

Study Record Dates

• First Submitted: February 9, 2006
• First Posted: February 13, 2006
• Study Start: June 1, 2003
• Primary Completion: August 1, 2007
• Study Completion: August 1, 2007
• Last Updated: August 7, 2019
• Results First Posted: August 7, 2019

Record last verified: 2019-08

Locations

US (1)