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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
Sponsor:
Collaborator:
Vertos Medical, Inc.
Information provided by (Responsible Party):
Eric J. Grigsby, MD, Napa Pain Institute

Brief 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.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Symptomatic and lumbar spine stenosis (LSS) primarily caused by dorsal element hypertrophy.
  • Prior failure of conservative therapy and Oswestry Disability Index (ODI) Score of >20%.
  • Radiologic evidence of LSS, ligamentum flavum hypertrophy (typically > 2.5mm)confirmed by pre op MRI and/or CT.
  • Central canal cross sectional area clearly reduced per MRI/CT report.
  • If present, anterior listhesis ≤ 5.0mm (preferred) and stable.
  • Able to walk at least 10 feet unaided before being limited by pain.
  • Available to complete 26 weeks of follow-up.
  • A signed Informed consent Form is obtained from the subject.
  • Adults at least 18 years of age.

Exclusion Criteria:

  • Prior surgery at intended treatment level.
  • History of recent spinal fractures with concurrent pain symptoms as determined by the Investigator.
  • Disabling back or leg pain from causes other than LSS (e.g. acute compression fracture, metabolic neuropathy, or vascular claudication symptoms, etc.).
  • Disk protrusion or osteophyte formation severe enough to confound study outcome.
  • Facet hypertrophy severe enough to confound study outcome.
  • Bleeding disorders and/or current use of anti-coagulants.
  • Use of acetylsalicylic acid (ASA) and/or non-steroidal anti-inflammatory (NSAID) within five days of treatment.
  • Epidural steroid administration within prior 3 weeks(of procedure or sham)
  • Inability of the subject to lie prone for any reason with anesthesia support (e.g. chronic obstructive pulmonary disease (COPD), obesity, etc.).
  • Metabolic wound healing pathologies deemed by Investigator to compromise study outcome.
  • Dementia and/or inability to give informed consent.
  • Pregnancy and/or breastfeeding.
  • On Workman's Compensation or considering litigation associated with back pain.

Information from the National Library of Medicine

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


Locations
United States, California
Napa Pain Institute
Napa, California, United States, 94558
Sponsors and Collaborators
Napa Pain Institute
Vertos Medical, Inc.
Investigators
Principal Investigator: Eric Grigsby, MD Napa Pain Institute

Responsible Party: Eric J. Grigsby, MD, Founder / Medical Director, Napa Pain Institute
ClinicalTrials.gov Identifier: NCT01129921     History of Changes
Other Study ID Numbers: Protocol #G01
First Posted: May 25, 2010    Key Record Dates
Results First Posted: July 16, 2013
Last Update Posted: July 16, 2013
Last Verified: June 2013

Keywords provided by Eric J. Grigsby, MD, Napa Pain Institute:
Lumbar Spine Stenosis
Decompression

Additional relevant MeSH terms:
Constriction, Pathologic
Pathological Conditions, Anatomical