The Efficacy of Oral Steroids in the Treatment of Acute Sciatica
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| ClinicalTrials.gov Identifier: NCT00317447 |
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Recruitment Status
:
Completed
First Posted
: April 24, 2006
Last Update Posted
: April 24, 2006
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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 |
Show Detailed Description
| 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 |
- 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)
- Number of hours/week of work
- Estimated percent of daily living activities subjects were able to accomplish
- Epidural steroid injection
- Surgical intervention
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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
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 ClinicalTrials.gov identifier (NCT number): NCT00317447
| United States, California | |
| Kaiser-Permanente | |
| Santa Rosa, California, United States, 95403 | |
| Principal Investigator: | Richard Holve, MD | Kaiser Permanente |
Publications:
| ClinicalTrials.gov Identifier: | NCT00317447 History of Changes |
| 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:
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Sciatica Lower back pain Prednisone Randomized, controlled clinical trial |
Additional relevant MeSH terms:
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Sciatica Neuralgia Pain Neurologic Manifestations Nervous System Diseases Sciatic Neuropathy Mononeuropathies Peripheral Nervous System Diseases Neuromuscular Diseases |
Signs and Symptoms Prednisone Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents |