Comparative Study of Sham Versus Mild® Procedure in Patients Diagnosed With Symptomatic Lumbar Central Canal Stenosis
|ClinicalTrials.gov Identifier: NCT01129921|
Recruitment Status : Completed
First Posted : May 25, 2010
Results First Posted : July 16, 2013
Last Update Posted : July 16, 2013
|Condition or disease||Intervention/treatment||Phase|
|Lumbar Spine Stenosis Central Canal||Device: Percutaneous Lumbar Decompression Device: Sham lumbar decompression||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Comparative Study of Sham Versus Mild® (Minimally Invasive Lumbar Decompression) Procedure in Patients Diagnosed With Symptomatic Moderate to Severe Lumbar Central Canal Stenosis|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||October 2011|
|Actual Study Completion Date :||October 2011|
Active Comparator: Decompression with mild® Device Kit
Fluoroscopically guided percutaneous lumbar decompression using the Vertos mild® Device Kit for bone and tissue removal to decompress the targeted stenosed level(s).
Device: Percutaneous Lumbar Decompression
Fluoroscopic percutaneous lumbar decompression of the central spinal canal
Other Name: mild® Device Kit percutaneous decompression
Sham Comparator: Sham lumbar decompression
Sham procedure of fluoroscopically guided percutaneous placement of mild® Device Kit instrumentation with no removal of bone or tissue.
Device: Sham lumbar decompression
Sham fluoroscopic percutaneous lumbar decompression with no bone or tissue removal.
- Visual Analog Scale (VAS) <=4 [ Time Frame: Week 6 to 12 prior to cross-over ]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 below.
- Visual Analog Scale (VAS) <=4 [ Time Frame: Week 6 to 12 & Year One After Sham to mild x-over ]VAS as measured on a 10-point scale. A score of 4 or less after treatment is considered favorable, as it indicates pain is less than the "moderate to severe" categories represented by scores of 5 to 10. All patients in each arm who reported a pain score of 4 or less at Week 6-12 and Year 1 are reported below.
- Visual Analog Scale (VAS) Mean Improvement [ Time Frame: Baseline and Year 1 ]VAS ten point scale where 0 = no pain and 10 represents worst pain imaginable. Mean improvement of two or more points is considered clinically relevant. The mean improvement from Baseline to Year-1 is presented below for the two treatment groups.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01129921
|United States, California|
|Napa Pain Institute|
|Napa, California, United States, 94558|
|Principal Investigator:||Eric Grigsby, MD||Napa Pain Institute|