The Efficacy of Oral Steroids in the Treatment of Acute Sciatica
Condition: Sciatica
MeSH terms: Sciatica
Study type: Interventional
Phase: Phase 3

Summary: 
      Sciatica (lumbosacral radiculopathy) is a common diagnosis in primary care, occurring in
      approximately one percent of all patients with acute low back pain. (1, 2) Traditional
      treatment generally involves pain control (acetominophen, NSAID's, or narcotics), activity as
      tolerated, and time. (1, 3-8 ) The general consensus is that fifty percent of patients with
      sciatica recover within six weeks, and that ninety percent are better in twelve weeks.(4, 8)
      Those patients with intractable pain or progressive neurologic symptoms usually receive
      epidural steroid injections and, if necessary, decompressive laminectomy or discectomy. (2,
      8, 9)

      Low back pain and sciatica result in tremendous losses to our society in terms of decreased
      productivity and cost of treatment. (1, 12) Oral steroids are inexpensive and relatively safe
      medications that, if effective in reducing the pain and disability associated with sciatica,
      could improve the quality of patients' lives, and result in significant cost savings to
      society at large. We hypothesize that the use of oral steroids to treat acute sciatica will
      speed patients' recovery as measured by: changes in physical findings, rates of return to
      work and activities of daily living, pain and disability assessment scores, and decreases in
      the use of narcotic and non-steroidal anti-inflammatory drugs (NSAID's), and in the need for
      epidural injection or surgical intervention.
    

Detailed description: 
      Inclusion Criteria

      To be included in this study patients had to have a diagnosis of acute sciatica as determined
      by the principle investigator based on the following criteria: unilateral leg pain extending
      below the knee (with or without strength, sensory, or reflex changes), and a positive
      straight leg raising sign (defined as as pain radiating from the buttock to below the knee
      with elevation of the leg between zero and sixty degrees). Patients had to be between twenty
      and sixty years of age, and had to be entered in [recruited into] the study within one week
      of the onset of their symptoms.

      Exclusion Criteria

      Patients were excluded from the study if they were pregnant or had a history of diabetes,
      renal failure, upper gastro-intestinal bleed, or major psychiatric disease. Patients also had
      to be free of symptoms suggesting more serious underlying disease as defined by the United
      States Agency for Healthcare Policy Research document: "Acute Low Back Problems In Adults".
      (11) "Red Flag" symptoms" included: a history of cancer, unexplained weight loss, fever or
      chills, night sweats, a history of intravenous drug use, saddle anesthesia, bowel or bladder
      incontinence, bone pathology, or a Neurologic emergency. Additionally, patients could be
      excluded for any condition that the principle investigator thought might jeopardize their
      safety.

      Randomization and Blinding

      Once the diagnosis of acute sciatica had been confirmed, subjects were randomized to receive
      either a nine day tapering course of prednisone or placebo capsules. The principle
      investigator and research nurse were blinded as to group assignment. All subjects received
      current standard therapy for sciatica, including: a NSAID (ibuprofen, naproxen, etodolac, or
      nambumetone), narcotics if needed (hydrocodone, propoxyphene, oxycodone, or morphine),
      activity as tolerated, and a referral for physical therapy.

      Study Design

      Upon entering the study all patients underwent physical exam with attention to: straight leg
      raising test (positive or negative), contralateral straight leg raising (positive or
      negative), knee and ankle stretch reflexes (0-3+), foot sensation (normal or decreased),
      strength (0-5) of quadriceps, foot dorsiflexors, foot plantar flexors, and ability to perform
      five heel lifts (0-5). Patients also completed three written instruments: a "12 Item Health
      Status Questionnaire" (13), a "Roland-Morris Disability Questionnaire" (14), and a
      "Roland-Morris Pain Rating Scale" (14). Also noted at the intake visit and each subsequent
      visit were the number of hours each patient was working or, if they were not employed or were
      retired, their estimated percent of daily living activities they were able to accomplish.
      Lastly, note was made of whether the patient had undergone epidural steroid injection or
      surgical intervention since the previous visit. Each patient underwent the same exam and
      completed the same questionnaires weekly for four weeks post recruitment, and then monthly
      for five months. This led to a total of 6 months of follow-up.

      All patients received non-steroidal anti-inflammatory medication and narcotic medication if
      needed for pain control. Patients randomized to the study group received tapering course of
      prednisone: 60 mg for three days, 40 mg for three days, and 20 mg for three days. Patients
      randomized to the control (placebo) group received capsules identical in appearance to the
      prednisone capsules but containing an inert filler substance. Patients were questioned at
      each visit to determine whether they were taking their study medication (first nine days of
      the study) and whether they were still taking non-steroidal or narcotic medication (entire
      study).

      Patients were encouraged to begin non-weight-bearing aerobic activities such as swimming
      and/or bike riding as soon as their pain had subsided to a reasonable degree. At this point,
      patients generally also referred to see a physical therapist.

      Patients who had rapid improvement and were under fifty generally did not have any imaging
      studies performed. Project staff ordered plain films of the lumbosacral spine for most
      patients over age 50 . Irrespective of age, patients who had intractable pain or progressive
      neurologic symptoms generally had plain films of the lumbosacral spine done and also
      underwent magnetic resonance imaging (MRI). A separate analysis of pain level ratings,
      narcotic and NSAID use, and return to work rates, was performed for this subgroup with the
      thought that they probably represented patients with the most severe nerve root inflammation
      and that the effects of oral prednisone might be more or less obvious in this group.

      Statistical power analysis

      Statistical power analysis was performed with the primary outcome of return to work within 14
      days of the intervention. The proportion of the control group returning to work was
      hypothesized to be 50%. Oral prednisone was hypothesized to have a 50% treatment effect,
      resulting in a 75% rate of return to work within 14 days. Using chi square with continuity
      correction, statistical power analysis found that a (study and control group) sample size of
      80 per subgroup would have a power of 88% to find this difference (i.e., between 50% and
      75%)statistically significant at p<.05.
    

Intervention name(s): Oral Prednisone
Intervention type(s): Drug
Intervention MeSH terms: Prednisone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Sciatica; Lower back pain; Prednisone; Randomized, controlled clinical trial