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Sponsored by: |
Kaiser Permanente |
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Information provided by: | Kaiser Permanente |
ClinicalTrials.gov Identifier: | NCT00317447 |
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.
Condition | Intervention | Phase |
---|---|---|
Sciatica |
Drug: Oral Prednisone |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Oral Steroids in the Treatment of Acute Sciatica A Randomized Controlled Study |
Estimated Enrollment: | 160 |
Study Start Date: | February 2002 |
Estimated Study Completion Date: | April 2004 |
Ages Eligible for Study: | 20 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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
Exclusion Criteria:
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
Study ID Numbers: | Oral Steroid Tx Acute Sciatica |
Study First Received: | April 20, 2006 |
Last Updated: | April 20, 2006 |
ClinicalTrials.gov Identifier: | NCT00317447 |
Health Authority: | United States: Food and Drug Administration |
Sciatica Lower back pain Prednisone Randomized, controlled clinical trial |
Sciatica Prednisone Signs and Symptoms Neuromuscular Diseases Neuralgia Peripheral Nervous System Diseases |
Neurologic Manifestations Low Back Pain Pain Mononeuropathies Back Pain |
Anti-Inflammatory Agents Sciatic Neuropathy Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Physiological Effects of Drugs |
Nervous System Diseases Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Glucocorticoids Pharmacologic Actions |