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SMART Clinical Study: Surgical Multi-center Assessment of RF Ablation for the Treatment of Vertebrogenic Back Pain

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Relievant Medsystems, Inc.
ClinicalTrials.gov Identifier:
NCT01446419
First received: October 3, 2011
Last updated: April 17, 2014
Last verified: April 2014
  Purpose

To evaluate the safety and efficacy of RF ablation using the Intracept Intraosseous Nerve Ablation System to ablate intraosseous nerves for the relief of chronic axial low back pain. This is a prospective, double-blind, randomized, sham-controlled clinical trial with an optional crossover component.


Condition Intervention
Low Back Pain
Device: Intracept Treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Randomized, Double-blind, Controlled Investigation Evaluating the Intracept Intraosseous Nerve Ablation System for the Reduction of Pain in Patients With Chronic Axial Low Back Pain

Resource links provided by NLM:


Further study details as provided by Relievant Medsystems, Inc.:

Primary Outcome Measures:
  • Oswestry Disability Index [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    The primary variable is the Oswestry Disability Index (ODI) and the primary efficacy endpoint is the mean improvement from baseline to 3 months in the ODI. The primary endpoint will be evaluated in both the treatment and sham groups with between-group comparisons used to assess the success of the Intracept System in reducing chronic axial low back pain.


Secondary Outcome Measures:
  • Patient Success at 3 months and Oswestry Disability Index at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: October 2011
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intracept Treatment Device: Intracept Treatment
Percutaneous transpedicular RF ablation of an intraosseous nerve within the lumbar vertebral body to treat chronic axial low back.
Sham Comparator: Sham Treatment Device: Intracept Treatment
Percutaneous transpedicular access to the lumbar vertebra, no RF ablation delivered.

  Eligibility

Ages Eligible for Study:   25 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Skeletally mature patients age 25 - 70 years, inclusive
  • Chronic lower back pain for at least six (6) months
  • Failure to respond to at least six (6) months of non-operative conservative management. The minimum requirement is as follows:

    • Analgesic therapy (minimum of 2 weeks) and a minimum of 4 weeks of NSAID therapy
    • Supervised exercise program(minimum of 12 sessions)
  • Oswestry Disability Index (ODI) at time of evaluation of at least 30 points
  • Baseline Visual Analog Scale (VAS) of at least 4cm on a 10cm scale
  • The following test indicating that the vertebral body is the source of pain:

    1.MRI showing Type 1 or Type II Modic changes at least one vertebral endplate, at one or more levels from L3 to S1

  • Understands the local language and is willing and able to follow the requirements of the protocol
  • Understands the informed consent and signs the institutional review board/ independent ethics committee (IRB/IEC) approved informed consent form

Exclusion Criteria:

  • Radicular pain by history or evidence of pain or neurological deficit in a dermatomal zone at or below the medial thigh.
  • Previous surgery performed on the lumbar spine
  • History of symptomatic spinal stenosis
  • History of osteoporotic or tumor-related vertebral body compression fracture
  • History of vertebral cancer or spinal metastasis
  • History of spinal infection
  • Metabolic bone disease (e.g. osteogenesis imperfecta)
  • BMI ≥40
  • Osteoporosis, defined as T score <-2.5
  • Any radiographic evidence of other important back pathology, such as:

    1. Nerve root compression or severe effacement of the thecal sac that correlates with radicular pain or muscle weakness
    2. Disc extrusion or disc protrusion >5mm
    3. Facet arthrosis or facet effusion at any lumbar level that correlates with clinical evidence of facet mediated low back pain
    4. Spondylolisthesis 2mm or greater at any level
    5. Spondylolysis at any level
  • MRI evidence of Modic changes, Type I or Type II at greater than 3 vertebral bodies.
  • Any back pathology related to trauma, evidence of vertebral compression fracture or other spinal pathology that could affect assessment of response to back pain
  • Demonstrates 3 or more Waddell's signs of Inorganic Behavior
  • Any evidence of current systemic infection
  • Uncorrected bleeding diathesis
  • Any neurologic problem that prevents early mobilization after surgery or interferes with assessment of ODI
  • Contraindication to MRI or patients who have allergies to the components of the Intracept device
  • Pregnant, lactating or plan to become pregnant in next year
  • Diabetes requiring daily insulin
  • Current use of steroid therapy, with the exception of inhalation steroids for asthma
  • Evidence of mental instability or uncontrolled depression; patients requiring anti-depressants or anti-psychotics within 3 months of enrollment are not eligible; patients with a Beck Depression Score of greater than 24 are not eligible
  • Receiving Workmen's Compensation
  • Currently involved in litigation regarding back pain/injury or financial incentive to remain impaired
  • Any medical condition that impairs follow-up
  • Contraindications to the proposed anesthetic protocol.
  • Evidence of substance abuse; patients using prescribed extended release narcotics are not eligible (e.g. fentanyl patch,MS contin, oxycontin)
  • Known to require at the time of screening and/or randomization, additional surgery to the lumbar spinal region within six months
  • Being treated with radiation, chemotherapy, immunosuppression, or chronic steroid therapy (prednisone use up to 5 mg/qd or its equivalent is allowed)
  • Has a life expectancy of less than 1 year
  • Has active implantable devices, such as cardiac pacemakers, spinal cord stimulators, etc.
  • Is a prisoner
  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: NCT01446419

Locations
United States, Arizona
Desert Institute for Spine Care
Phoenix, Arizona, United States, 85020
United States, California
SpineCare Medical Group
Daly City, California, United States, 94015
Memorial Orthopedic Surgical Group
Long Beach, California, United States, 90806
The Spine Institute
Santa Monica, California, United States, 90403
United States, Georgia
Pain Center Solutions
Marietta, Georgia, United States, 30060
United States, Indiana
Indiana Spine Group
Carmel, Indiana, United States, 46032
United States, Maine
Maine Medical Partners
Scarborough, Maine, United States, 04074
United States, Michigan
Partners in Research and Educational Studies of Spinal Disorders (PressD)
Southfield, Michigan, United States, 48033
United States, North Carolina
OrthoCarolina
Charlotte, North Carolina, United States, 28207
United States, Oregon
NeuroSpine Institute
Eugene, Oregon, United States, 97401
United States, Pennsylvania
Rothman Institute
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
Seton Spine & Scoliosis Center
Austin, Texas, United States, 78731
United States, Virginia
Virginia iSpine Physicians
Richmond, Virginia, United States, 23235
Sponsors and Collaborators
Relievant Medsystems, Inc.
Investigators
Principal Investigator: Jeffrey Fischgrund, MD Michigan Orthopaedic Institute
  More Information

No publications provided

Responsible Party: Relievant Medsystems, Inc.
ClinicalTrials.gov Identifier: NCT01446419     History of Changes
Other Study ID Numbers: CIP 0003
Study First Received: October 3, 2011
Last Updated: April 17, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Relievant Medsystems, Inc.:
chronic axial low back pain
vertebrogenic pain
Radio frequency ablation

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on November 25, 2014