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NCT00317447 · ClinicalTrials.gov registry record · Phase 3
The Efficacy of Oral Steroids in the Treatment of Acute Sciatica
A Phase 3 study of Sciatica, sponsored by Kaiser Permanente.
- Completed
- Registry status
- Phase 3
- Development phase
- 160
- Enrollment target
- 1
- Study location
NCT00317447: Completed Phase 3 study of Sciatica, sponsored by Kaiser Permanente.
NCT00317447 is a Phase 3 study of Sciatica that has completed, run by Kaiser Permanente. The registered enrollment target is 160 participants, above the 61-participant average among 6 other Sciatica trials with a reported enrollment target (162% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00317447, a Phase 3 study of Sciatica, has completed, sponsored by Kaiser Permanente.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 160 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG Oral Prednisone
Study Locations (1)
California
- Kaiser-Permanente - Santa Rosa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2002-02 |
| Est. Completion | 2004-04 |
| Phase | Phase 3 |
What the finished NCT00317447 record still lists
NCT00317447 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, above the 61-participant average among 6 other Sciatica trials with a reported enrollment target (162% higher).
The record links to 1 condition, with Sciatica appearing as the primary indexed condition, and to 1 intervention - of which Oral Prednisone is the first listed.
NCT00317447 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT00317447 about?
NCT00317447 is a clinical study titled "The Efficacy of Oral Steroids in the Treatment of Acute Sciatica". 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 )...
What is the current status of trial NCT00317447?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 160 participants. The study started on 2002-02. Estimated completion is 2004-04.
What conditions does trial NCT00317447 study?
This clinical trial studies the following conditions: Sciatica.
What interventions are being tested in trial NCT00317447?
The interventions under investigation include: Oral Prednisone (DRUG).
Who is sponsoring clinical trial NCT00317447?
This trial is sponsored by Kaiser Permanente, which has 294 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00317447 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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