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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: Completed Early Phase 1 study of Low Back Pain, sponsored by University of Florida.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
A positive response is defined as are ≥ 80% reduction in pain (by change in NPR scores or estimated patient improvement) AND the restoration of the ability to perform at least one previously painful posture, movement, or activity without increase in pain, during the anesthetic phase of the blocks.
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 |
What the finished NCT01382771 record still lists
NCT01382771 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 504-participant average among 122 other Low Back Pain trials with a reported enrollment target (94% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Low Back Pain
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01382771's enrollment target sits among peer trials
28 111th of 122 higher than 11 of 122 other Low Back Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Low Back Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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