A Trial of Corticosteroids for Low Back Pain

• ClinicalTrials.gov Identifier: NCT00290589
• Recruitment Status: Completed
• First Posted: February 13, 2006
• Results First Posted: August 7, 2019
• Last Update Posted: August 7, 2019
• Sponsor: Montefiore Medical Center
• Information provided by (Responsible Party): Benjamin W. Friedman, MD, Montefiore Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Radicular Low Back Pain	Drug: Intramuscular methylprednisolone acetate; Drug: Placebo	Phase 3

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 82 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Utility of Intramuscular Corticosteroids for Radicular Low Back Pain
• Study Start Date: June 2003
• Actual Primary Completion Date: August 2007
• Actual Study Completion Date: August 2007

Arms and Interventions

Arm	Intervention/treatment
Experimental: Intramuscular methylprednisolone acetate; Methylprednisolone acetate 160mg intramuscular injection	Drug: Intramuscular methylprednisolone acetate; Intramuscular methylprednisolone acetate 160mg; Other Name: steroid
Placebo Comparator: Placebo; Placebo intramuscular injection	Drug: Placebo; Normal saline intramuscular injection; Other Name: saline solution

Outcome Measures

Primary Outcome Measures :

1. Numerical Rating Scale (0-10), an Interval Pain Scale, on Which 0 Indicates no Pain and 10 Indicates the Worst Pain Imaginable [ Time Frame: 1 month ]
   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.
2. Functional Disability Scales [ Time Frame: 1 month ]
   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.

Secondary Outcome Measures :

1. Number of Patients Using Analgesics [ Time Frame: Assessed at 1 month ]
   Use of analgesics for low back pain (within the previous 24 hours)

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 50 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

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

More Information

• Responsible Party: Benjamin W. Friedman, MD, Prof. Emergency Medicine, Montefiore Medical Center
• ClinicalTrials.gov Identifier: NCT00290589
• Other Study ID Numbers: 03-05-107
• First Posted: February 13, 2006
• Results First Posted: August 7, 2019
• Last Update Posted: August 7, 2019
• Last Verified: August 2019

• Studies a U.S. FDA-regulated Drug Product: Yes

Keywords provided by Benjamin W. Friedman, MD, Montefiore Medical Center:

low back pain; emergency department; corticosteroids

Additional relevant MeSH terms:

Back Pain; Low Back Pain; Pain; Neurologic Manifestations; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuroprotective Agents; Protective Agents; Antineoplastic Agents, Hormonal; Antineoplastic Agents