Comparative Study of Sham Versus Mild® Procedure in Patients Diagnosed With Symptomatic Lumbar Central Canal Stenosis
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|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|
|Lumbar Spine Stenosis Central Canal||Device: Percutaneous Lumbar Decompression Device: Sham lumbar decompression|
|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|
|Primary Completion Date :||October 2011|
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|