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The Efficacy of Oral Steroids in the Treatment of Acute Sciatica
This study has been completed.
Sponsored by: Kaiser Permanente
Information provided by: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT00317447
  Purpose

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

MedlinePlus related topics: Back Pain Sciatica
Drug Information available for: Prednisone
U.S. FDA Resources
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

Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:
  • Physical examination findings:
  • 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
  • ability to perform five heel lifts (0-5)
  • Written instruments:
  • HSQ 12 (Health Status Questionaire)(13)
  • Roland-Morris Disability Questionaire (14)
  • Roland-Morris Pain Rating Scale (14)

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

Estimated Enrollment: 160
Study Start Date: February 2002
Estimated Study Completion Date: April 2004
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00317447

Locations
United States, California
Kaiser-Permanente
Santa Rosa, California, United States, 95403
Sponsors and Collaborators
Kaiser Permanente
Investigators
Principal Investigator: Richard Holve, MD Kaiser Permanente
  More Information

Publications:
Frymoyer JW. Back pain and sciatica. N Engl J Med. 1988 Feb 4;318(5):291-300. Review. No abstract available.
Scheer SJ, Radack KL, O'Brien DR Jr. Randomized controlled trials in industrial low back pain relating to return to work. Part 2. Discogenic low back pain. Arch Phys Med Rehabil. 1996 Nov;77(11):1189-97. Review.
USDHHS, Agency for Health Care Policy and Research. Acute low back problems in adults. Rockville, MD: AHCPR; 1994. AHCPR pub number 95-0642
Daniels JM 2nd. Treatment of occupationally acquired low back pain. Am Fam Physician. 1997 Feb 1;55(2):587-96, 601-2. Review.
Deyo RA. Conservative therapy for low back pain. Distinguishing useful from useless therapy. JAMA. 1983 Aug 26;250(8):1057-62.
Deyo RA. Back pain revisited. Newer thinking on diagnosis and therpapy. Consultant 1993 Feb:88-97
Griffin G, Tudiver F, Grant WD. Do NSAIDs help in acute or chronic low back pain? Am Fam Physician. 2002 Apr 1;65(7):1319-21. Review. No abstract available.
Weber H. The natural history of disc herniation and the influence of intervention. Spine. 1994 Oct 1;19(19):2234-8; discussion 2233. Review.
Kraemer J. Natural course and prognosis of intervertebral disc diseases. International Society for the Study of the Lumbar Spine Seattle, Washington, June 1994. Spine. 1995 Mar 15;20(6):635-9. Review.
Guo HR, Tanaka S, Halperin WE, Cameron LL. Back pain prevalence in US industry and estimates of lost workdays. Am J Public Health. 1999 Jul;89(7):1029-35.
Radosevich DM. An abbreviated health status questionnaire: the HSQ12. The Newsletter of the Health Outcomes Institute. 1995;2:1-4
Roland M, Morris R. A study of the natural history of back pain. Part I: development of a reliable and sensitive measure of disability in low-back pain. Spine. 1983 Mar;8(2):141-4. No abstract available.

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

Keywords provided by Kaiser Permanente:
Sciatica
Lower back pain
Prednisone
Randomized, controlled clinical trial

Study placed in the following topic categories:
Sciatica
Prednisone
Signs and Symptoms
Neuromuscular Diseases
Neuralgia
Peripheral Nervous System Diseases
Neurologic Manifestations
Low Back Pain
Pain
Mononeuropathies
Back Pain

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 16, 2009