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Completed

NCT Number: NCT01129921

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

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.

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Key information

Conditions

Lumbar Spine Stenosis Central Canal

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Napa Pain Institute

Napa, California, 94558, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Percutaneous Lumbar Decompression

Device

Fluoroscopic percutaneous lumbar decompression of the central spinal canal

Other names: mild® Device Kit percutaneous decompression

Sham lumbar decompression

Device

Sham fluoroscopic percutaneous lumbar decompression with no bone or tissue removal.

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Napa Pain Institute

Other

Collaborators

  • Vertos Medical, Inc.

Registry information

Official study title

Comparative Study of Sham Versus Mild® (Minimally Invasive Lumbar Decompression) Procedure in Patients Diagnosed With Symptomatic Moderate to Severe Lumbar Central Canal Stenosis

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
May 25, 2010
Registry last updated
Jul 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.