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NCT01129921 · ClinicalTrials.gov registry record · NA
Comparative Study of Sham Versus Mild® Procedure in Patients Diagnosed With Symptomatic Lumbar Central Canal Stenosis
A NA study of Lumbar Spine Stenosis Central Canal, sponsored by Napa Pain Institute.
- Completed
- Registry status
- NA
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT01129921: Completed NA study of Lumbar Spine Stenosis Central Canal, sponsored by Napa Pain Institute.
NCT01129921 is a NA study of Lumbar Spine Stenosis Central Canal that has completed, run by Napa Pain Institute. The registered enrollment target is 40 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01129921, a NA study of Lumbar Spine Stenosis Central Canal, has completed, sponsored by Napa Pain Institute.
- COMPLETED
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a single-center, randomized, prospective, double-blind, clinical study to assess the clinical application and outcomes with mild® devices versus sham in patients with symptomatic moderate to severe central canal spinal stenosis. Sham patients were eligible to choose to cross-over and have the actual decompression procedure after week 6 exam.
Primary Outcome
Using VAS, pain is measured on a 0 to 10 point scale where 0 represents no pain and 10 indicates severe pain. A post-treatment score of 4 points is the accepted threshold between a "mild" pain score of 1-3 points and a "moderate to severe" pain score of 5 to 10 points which represents debilitating pain that would qualify the patient for a different or additional treatment option. All patients in each arm who reported a pain score of 4 or less at six to twelve weeks post-treatment are reported be
Conditions Studied
Interventions
- DEVICE Percutaneous Lumbar Decompression
- DEVICE Sham lumbar decompression
Study Locations (1)
California
- Napa Pain Institute - Napa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2010-04 |
| Est. Completion | 2011-10 |
| Phase | NA |
What the finished NCT01129921 record still lists
NCT01129921 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Lumbar Spine Stenosis Central Canal appearing as the primary indexed condition, and to 2 interventions - of which Percutaneous Lumbar Decompression is the first listed.
NCT01129921 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT01129921 about?
NCT01129921 is a clinical study titled "Comparative Study of Sham Versus Mild® Procedure in Patients Diagnosed With Symptomatic Lumbar Central Canal Stenosis". This is a single-center, randomized, prospective, double-blind, clinical study to assess the clinical application and outcomes with mild® devices versus sham in patients with symptomatic moderate to severe central canal spinal stenosis. Sham patients were eligible to choose to cross-over and have th...
What is the current status of trial NCT01129921?
This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2010-04. Estimated completion is 2011-10.
What conditions does trial NCT01129921 study?
This clinical trial studies the following conditions: Lumbar Spine Stenosis Central Canal.
What interventions are being tested in trial NCT01129921?
The interventions under investigation include: Percutaneous Lumbar Decompression (DEVICE), Sham lumbar decompression (DEVICE).
Who is sponsoring clinical trial NCT01129921?
This trial is sponsored by Napa Pain Institute, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01129921 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01129921's enrollment target sits among peer trials
40 1447th of 2000 higher than 465 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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