The Efficacy of Oral Steroids in the Treatment of Acute Sciatica
Completed · Phase 3
Conditions studied: Sciatica
In brief
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.
Key facts
- Study ID
- NCT00317447
- Run by
- Kaiser Permanente
- People needed
- 160
- Starts
- 2002-02-01
- Expected to finish
- 2004-04-01
- Last updated by the study team
- 2006-04-24
Who can join
Age: 20 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
- recruited into the study within one week of the onset of symptoms
You may not qualify if…
- Current pregnancy
- A history of:
- diabetes renal failure upper gastro-intestinal bleed major psychiatric disease
- Presence of any 'red flag' symptoms suggestive of more serious underlying disease as defined by the United States Agency for Healthcare Policy Research document: "Acute Low Back Problems In Adults" (11) including:
- 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.
- Any condition that the principle investigator thought might jeopardize the patient's safety
Where it is running
- Kaiser-Permanente — Santa Rosa, California, United States
Full record on ClinicalTrials.gov
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