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NCT01382771 · ClinicalTrials.gov registry record · Early Phase 1
Intraarticular Lumbar Joint Corticosteroid Injection(s) as a Treatment of Chronic Low Back Pain in a Selected Population
A Early Phase 1 study of Low Back Pain, sponsored by University of Florida.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 28
- Enrollment target
- 1
- Study location
NCT01382771 is a Early Phase 1 study of Low Back Pain that has completed, run by University of Florida. The registered enrollment target is 28 participants, below the 504-participant average among 122 other Low Back Pain trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01382771, a Early Phase 1 study of Low Back Pain, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 28 participants
- Enrollment target
- 1
- Study location
Study Summary
Subjects (N=120) who have had non-radicular low back pain, believed by clinical assessment and imaging to be consistent with lumbar zygapophysial joint (Z-joint) generated pain, who have failed conservative therapy including physical therapy, have had an initial \>80% pain relief on a diagnostic medial branch block, and are scheduled to undergo a routine second medial branch block for facet mediated pain will be randomized. Both groups will receive the standard of care, a medial branch block. The treatment group will also receive one set of intra-articular lumbar Z-joint corticosteroid injection and the placebo group will receive intra-articular normal saline.
Conditions Studied
Interventions
- DRUG Intra-articular corticosteroid injection
- DRUG Intra-articular saline injection
Study Locations (1)
Florida
- UF & Shands Orthopaedics and Sports Medicine Institute - Gainesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2010-10 |
| Est. Completion | 2012-09 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01382771
The ClinicalTrials.gov registry entry for NCT01382771 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 504-participant average among 122 other Low Back Pain trials with a reported enrollment target (94% lower). The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Low Back Pain appearing as the primary indexed condition, and to 2 interventions - of which Intra-articular corticosteroid injection is the first listed.
NCT01382771 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT01382771 about?
NCT01382771 is a clinical study titled "Intraarticular Lumbar Joint Corticosteroid Injection(s) as a Treatment of Chronic Low Back Pain in a Selected Population". Subjects (N=120) who have had non-radicular low back pain, believed by clinical assessment and imaging to be consistent with lumbar zygapophysial joint (Z-joint) generated pain, who have failed conservative therapy including physical therapy, have had an initial \>80% pain relief on a diagnostic med...
What is the current status of trial NCT01382771?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 28 participants. The study started on 2010-10. Estimated completion is 2012-09.
What conditions does trial NCT01382771 study?
This clinical trial studies the following conditions: Low Back Pain.
What interventions are being tested in trial NCT01382771?
The interventions under investigation include: Intra-articular corticosteroid injection (DRUG), Intra-articular saline injection (DRUG).
Who is sponsoring clinical trial NCT01382771?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01382771 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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