Comparative Study of Sham Versus Mild® Procedure in Patients Diagnosed With Symptomatic Lumbar Central Canal Stenosis

This study has been completed.
Sponsor:
Collaborator:
Vertos Medical, Inc.
Information provided by (Responsible Party):
Eric J. Grigsby, MD, Napa Pain Institute
ClinicalTrials.gov Identifier:
NCT01129921
First received: April 30, 2010
Last updated: June 11, 2013
Last verified: June 2013
  Purpose

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 Intervention
Lumbar Spine Stenosis Central Canal
Device: Percutaneous Lumbar Decompression
Device: Sham lumbar decompression

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Further study details as provided by Napa Pain Institute:

Primary Outcome Measures:
  • Visual Analog Scale (VAS) <=4 [ Time Frame: Week 6 to 12 prior to cross-over ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 40
Study Start Date: April 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: April 30, 2010
Results First Received: January 7, 2013
Last Updated: June 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Napa Pain Institute:
Lumbar Spine Stenosis
Decompression

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

ClinicalTrials.gov processed this record on August 27, 2014