A Trial of Corticosteroids for Low Back Pain

NCT ID: NCT00290589

Last Updated: 2019-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-06-30
• Study Completion Date: 2007-08-31

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.

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.

Conditions

Radicular Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Intramuscular methylprednisolone acetate

Methylprednisolone acetate 160mg intramuscular injection

Group Type: EXPERIMENTAL

Intramuscular methylprednisolone acetate

Intervention Type: DRUG

Intramuscular methylprednisolone acetate 160mg

Placebo

Placebo intramuscular injection

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Normal saline intramuscular injection

Interventions

Intramuscular methylprednisolone acetate

Intramuscular methylprednisolone acetate 160mg

Intervention Type: DRUG

Placebo

Normal saline intramuscular injection

Intervention Type: DRUG

Other Intervention Names

steroid; saline solution

Eligibility Criteria

Inclusion Criteria

• 21-50 years old, non-traumatic 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Montefiore Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Benjamin W. Friedman, MD

Prof. Emergency Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Benjamin W Friedman, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Albert Einstein College of Medicine

Locations

Montefiore Medical Center

The Bronx, New York, United States

Countries

United States

Other Identifiers

03-05-107

Identifier Type: -

Identifier Source: org_study_id