A Trial of Corticosteroids for Low Back Pain
Condition: Radicular Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): Intramuscular methylprednisolone acetate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intramuscular methylprednisolone acetate 160mg; Normal saline intramuscular injection
Other intervention name(s): steroid; saline solution
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: low back pain; emergency department; corticosteroids