A Trial of Corticosteroids for Low Back Pain

This study has been completed.
Sponsor:
Information provided by:
Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT00290589
First received: February 9, 2006
Last updated: October 26, 2009
Last verified: October 2009
  Purpose

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.


Condition Intervention Phase
Radicular Low Back Pain
Drug: intramuscular methylprednisolone acetate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Utility of Intramuscular Corticosteroids for Radicular Low Back Pain

Resource links provided by NLM:


Further study details as provided by Montefiore Medical Center:

Primary Outcome Measures:
  • Pain scales
  • Functional disability scales

Secondary Outcome Measures:
  • Functional status
  • Pain scales
  • Provider visits

Estimated Enrollment: 76
Study Start Date: June 2003
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Detailed Description:

This is a randomized, double-blind placebo-controlled clinical trial evaluating intramuscular methylprednisolone acetate as adjunctive therapy for radicular low back pain. This trial randomizes subjects after they had been evaluated and treated in the ED and are ready for discharge. All subjects are followed by telephone call one week and one month after ED discharge. In addition to the steroid injection, all subjects are given a complimentary one week supply of naproxen 500 mg tablets and oxycodone 5mg/ acetaminophen 325 tablets and a detailed low back pain instruction sheet. This study was approved by the Montefiore Medical Center institutional review board.

Patients are included if their low back pain lasted less than one week, if they are 50 years old or younger, and if they had not experienced any direct trauma to the back during the previous week. Low back pain is described as pain originating below the tips of the scapulae and above the buttocks.Patients are only included if their straight leg raise test, as described below, is positive. Patients are excluded if the emergency physician felt that there is a high likelihood that the patient has a secondary cause of low back pain, e.g., metastatic bone disease or infection. Patients are also excluded for temperature greater than 100.3 degrees, pregnancy, lactation, allergy to or intolerance of a study medication. Patients can only enroll once. Patients can not have had another episode of back pain within four weeks prior to the current back pain attack. Patients are excluded for systemic steroid use within four weeks, a history of back surgery, a neoplasia known to metastasize, a chronic pain syndrome, an inflammatory arthritis, suspected vascular, urologic or gynecologic pathology, or direct blunt trauma to the back within the previous week.

Rationale for the straight leg raise test: Although the true test characteristics of the straight leg raise test are unknown, a positive ipsilateral straight leg raise is felt to be a sensitive marker for a herniated intervertebral disc. Therefore, if this test is negative, it can help rule-out the disease. To maintain a homogenous cohort, subjects were stratified based on results of the straight leg raise test. Many definitions of the straight leg raise test exist. In order to identify distinct populations, the research assistants were given a strictly-defined, conservative definition of this test: namely, the test was considered positive if a subject had ipsilateral pain shooting below the knee when either leg was raised between 30 and 70 degrees, as measured with a protractor. Contralateral pain below the knee, considered more specific for a herniated disc, was also considered a positive straight leg raising test.

All patients with low back pain are treated at the discretion of the attending physician. When the patient's pain had been controlled to a level sufficient for the patient to be discharged, the patient is asked for consent to participate as a research subject. After consent is obtained, subjects receive an intramuscular injection of methylprednisolone acetate or placebo. All subjects are discharged with a "back pack" containing 14 tablets of naproxen 500mg, 12 tablets of oxycodone 5mg/ acetaminophen 325 tablets, and a standardized discharge instruction sheet.

Subjects are followed-up by telephone at one week and one month after discharge. At each of these telephone interviews, research assistants read standardized questions about pain and activity limitations from the data collection instrument.

  Eligibility

Ages Eligible for Study:   21 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 21-50 years old, non-traumtic low back pain for one week or less,

Exclusion Criteria:

  • fever, pregnancy, lactation, allergy or intolerance to study medication, suspected active oncologic, urologic, or gynecologic disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00290589

Locations
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Sponsors and Collaborators
Montefiore Medical Center
Investigators
Principal Investigator: Benjamin W Friedman, MD, MS Albert Einstein College of Medicine of Yeshiva University
  More Information

No publications provided

Responsible Party: Benjamin friedman, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT00290589     History of Changes
Other Study ID Numbers: 03-05-107
Study First Received: February 9, 2006
Last Updated: October 26, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Montefiore Medical Center:
low back pain
emergency department
corticosteroids

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 20, 2014