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The Efficacy of Oral Steroids in the Treatment of Acute Sciatica

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00317447
Recruitment Status : Completed
First Posted : April 24, 2006
Last Update Posted : April 24, 2006
Information provided by:
Kaiser Permanente

Brief 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.

Condition or disease Intervention/treatment Phase
Sciatica Drug: Oral Prednisone Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Oral Steroids in the Treatment of Acute Sciatica A Randomized Controlled Study
Study Start Date : February 2002
Study Completion Date : April 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sciatica Steroids
Drug Information available for: Prednisone

Primary Outcome Measures :
  1. Physical examination findings:
  2. straight leg raising test (positive or negative)
  3. contralateral straight leg raising (positive or negative)
  4. knee and ankle stretch reflexes (0-3+)
  5. foot sensation (normal or decreased)
  6. strength (0-5) of quadriceps
  7. foot dorsiflexors
  8. foot plantar flexors
  9. ability to perform five heel lifts (0-5)
  10. Written instruments:
  11. HSQ 12 (Health Status Questionaire)(13)
  12. Roland-Morris Disability Questionaire (14)
  13. Roland-Morris Pain Rating Scale (14)

Secondary Outcome Measures :
  1. Number of hours/week of work
  2. Estimated percent of daily living activities subjects were able to accomplish
  3. Epidural steroid injection
  4. Surgical intervention

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00317447

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United States, California
Santa Rosa, California, United States, 95403
Sponsors and Collaborators
Kaiser Permanente
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Principal Investigator: Richard Holve, MD Kaiser Permanente
USDHHS, Agency for Health Care Policy and Research. Acute low back problems in adults. Rockville, MD: AHCPR; 1994. AHCPR pub number 95-0642
Deyo RA. Back pain revisited. Newer thinking on diagnosis and therpapy. Consultant 1993 Feb:88-97
Radosevich DM. An abbreviated health status questionnaire: the HSQ12. The Newsletter of the Health Outcomes Institute. 1995;2:1-4
Elashoff JD, NQuery Advisor Version 2.0, 2000, Statistical Solutions, Saugus MA

Layout table for additonal information Identifier: NCT00317447    
Other Study ID Numbers: Oral Steroid Tx Acute Sciatica
First Posted: April 24, 2006    Key Record Dates
Last Update Posted: April 24, 2006
Last Verified: April 2006
Keywords provided by Kaiser Permanente:
Lower back pain
Randomized, controlled clinical trial
Additional relevant MeSH terms:
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Sciatic Neuropathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Neurologic Manifestations
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents