Radicular Low Back Pain Clinical Trial
Official title:
Utility of Intramuscular Corticosteroids for Radicular Low Back Pain
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.
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.
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