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NCT00018876 · ClinicalTrials.gov registry record · Phase 1
Low-Dose Radiation to Prevent Complications of Back Surgery
A Phase 1 study of Failed Back Surgery Syndrome and Postlaminectomy Syndrome, sponsored by University of Pittsburgh.
- Completed
- Registry status
- Phase 1
- Development phase
- 46
- Enrollment target
- 1
- Study location
NCT00018876 is a Phase 1 study of Failed Back Surgery Syndrome and Postlaminectomy Syndrome that has completed, run by University of Pittsburgh. The registered enrollment target is 46 participants. The trial reports 1 study location across 1 state.
The verdict
NCT00018876, a Phase 1 study of Failed Back Surgery Syndrome and Postlaminectomy Syndrome, has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 46 participants
- Enrollment target
- 1
- Study location
Study Summary
More than 10,000 people each year in the United States have "failed back surgery syndrome" caused by scars that form around the outer surface of the spinal cord. Such scarring, known as peridural fibrosis, is common after back surgery known as either lumbar discectomy or laminectomy. Peridural fibrosis may cause recurring low back pain or leg pain after surgery. Operating again to remove the scar tissue often leads to more scarring. Researchers have not previously studied radiation as a way to prevent peridural fibrosis. We will test whether low-dose radiation given 24 hours before surgery will decrease the amount of peridural fibrosis and if this reduction will lead to improved results of surgery. Half of the participants will receive radiation before surgery and the other half will not. We will evaluate patients at followup visits 1, 3, 6, and 12 months after surgery with a physical exam and questionnaire. At 12 months, we will obtain magnetic resonance imaging (MRI) of the lower spine.
Conditions Studied
Interventions
- PROCEDURE Lumbar nerve root decompression
- PROCEDURE Preoperative low-dose external beam radiation
Study Locations (1)
Pennsylvania
- University of Pittsburgh Medical Center - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2000-10 |
| Est. Completion | 2002-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00018876
The ClinicalTrials.gov registry entry for NCT00018876 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pittsburgh, which has 1,238 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Failed Back Surgery Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Lumbar nerve root decompression is the first listed.
NCT00018876 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT00018876 about?
NCT00018876 is a clinical study titled "Low-Dose Radiation to Prevent Complications of Back Surgery". More than 10,000 people each year in the United States have "failed back surgery syndrome" caused by scars that form around the outer surface of the spinal cord. Such scarring, known as peridural fibrosis, is common after back surgery known as either lumbar discectomy or laminectomy. Peridural fibro...
What is the current status of trial NCT00018876?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 46 participants. The study started on 2000-10. Estimated completion is 2002-10.
What conditions does trial NCT00018876 study?
This clinical trial studies the following conditions: Failed Back Surgery Syndrome, Postlaminectomy Syndrome, Postdiscectomy Epidural Fibrosis.
What interventions are being tested in trial NCT00018876?
The interventions under investigation include: Lumbar nerve root decompression (PROCEDURE), Preoperative low-dose external beam radiation (PROCEDURE).
Who is sponsoring clinical trial NCT00018876?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00018876 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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