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

Primary Purpose

Lumbar Spine Stenosis Central Canal

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Percutaneous Lumbar Decompression
Sham lumbar decompression
Sponsored by
Napa Pain Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Spine Stenosis Central Canal focused on measuring Lumbar Spine Stenosis, Decompression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Napa Pain Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Decompression with mild® Device Kit

Sham lumbar decompression

Arm Description

Fluoroscopically guided percutaneous lumbar decompression using the Vertos mild® Device Kit for bone and tissue removal to decompress the targeted stenosed level(s).

Sham procedure of fluoroscopically guided percutaneous placement of mild® Device Kit instrumentation with no removal of bone or tissue.

Outcomes

Primary Outcome Measures

Visual Analog Scale (VAS) <=4
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
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
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.

Secondary Outcome Measures

Full Information

First Posted
April 30, 2010
Last Updated
June 11, 2013
Sponsor
Napa Pain Institute
Collaborators
Vertos Medical, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01129921
Brief Title
Comparative Study of Sham Versus Mild® Procedure in Patients Diagnosed With Symptomatic Lumbar Central Canal Stenosis
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 Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Napa Pain Institute
Collaborators
Vertos Medical, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Spine Stenosis Central Canal
Keywords
Lumbar Spine Stenosis, Decompression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Decompression with mild® Device Kit
Arm Type
Active Comparator
Arm Description
Fluoroscopically guided percutaneous lumbar decompression using the Vertos mild® Device Kit for bone and tissue removal to decompress the targeted stenosed level(s).
Arm Title
Sham lumbar decompression
Arm Type
Sham Comparator
Arm Description
Sham procedure of fluoroscopically guided percutaneous placement of mild® Device Kit instrumentation with no removal of bone or tissue.
Intervention Type
Device
Intervention Name(s)
Percutaneous Lumbar Decompression
Other Intervention Name(s)
mild® Device Kit percutaneous decompression
Intervention Description
Fluoroscopic percutaneous lumbar decompression of the central spinal canal
Intervention Type
Device
Intervention Name(s)
Sham lumbar decompression
Intervention Description
Sham fluoroscopic percutaneous lumbar decompression with no bone or tissue removal.
Primary Outcome Measure Information:
Title
Visual Analog Scale (VAS) <=4
Description
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.
Time Frame
Week 6 to 12 prior to cross-over
Title
Visual Analog Scale (VAS) <=4
Description
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.
Time Frame
Week 6 to 12 & Year One After Sham to mild x-over
Title
Visual Analog Scale (VAS) Mean Improvement
Description
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.
Time Frame
Baseline and Year 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Grigsby, MD
Organizational Affiliation
Napa Pain Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Napa Pain Institute
City
Napa
State/Province
California
ZIP/Postal Code
94558
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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