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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01446419
Recruitment Status : Completed
First Posted : October 5, 2011
Results First Posted : October 31, 2016
Last Update Posted : October 31, 2016
Information provided by (Responsible Party):
Relievant Medsystems, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Low Back Pain Device: Intracept Treatment Device: Sham Treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 225 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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
Study Start Date : October 2011
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
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: Sham Treatment
Percutaneous transpedicular access to the lumbar vertebra, no RF ablation delivered.

Primary Outcome Measures :
  1. Change in ODI From Baseline to 3 Months Post-treatment [ Time Frame: 3 months ]

    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.

    ODI is a patient questionnaire that assesses back dysfunction due to back pain. There are 10 questions that are scored from 0-5. The obtained score is multiplied by 2 to produce a percentage score that is reported on a scale of 0-100. Scores are interpreted as follows: 0-20% minimum disability; 21-40% moderate disability; 41-60% severe disability; 61-80% crippled; 81-100% bed bound or exaggerating their symptoms.

Secondary Outcome Measures :
  1. Patient Success at 3 Months [ Time Frame: 3 months ]

    Proportion of subjects with clinical success at 3 months, where clinical success was defined as:

    • 3 month ODI score represented at least a 15-point reduction from baseline
    • no device or procedure related SAE between baseline and 3 mos.
    • no increase in opioid use between procedure and 3 mos.
    • no deficit in a motor or dermatomal sensory group at the treated level at 3 mos.
    • no operative interventions or invasive procedures for lumbar back pain by a pain management or spinal specialist between procedure and 3 mos.

  2. Change in ODI From Baseline to 6 Months Post-treatment [ Time Frame: 6 months ]

    The improvement in ODI at 6 months compared to baseline.

    ODI is a patient questionnaire that assesses back dysfunction due to back pain. There are 10 questions that are scored from 0-5. The obtained score is multiplied by 2 to produce a percentage score that is reported on a scale of 0-100. Scores are interpreted as follows: 0-20% minimum disability; 21-40% moderate disability; 41-60% severe disability; 61-80% crippled; 81-100% bed bound or exaggerating their symptoms.

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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): NCT01446419

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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
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.
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Principal Investigator: Jeffrey Fischgrund, MD Michigan Orthopaedic Institute
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Responsible Party: Relievant Medsystems, Inc.
ClinicalTrials.gov Identifier: NCT01446419    
Other Study ID Numbers: CIP 0003
First Posted: October 5, 2011    Key Record Dates
Results First Posted: October 31, 2016
Last Update Posted: October 31, 2016
Last Verified: October 2016
Keywords provided by Relievant Medsystems, Inc.:
chronic axial low back pain
vertebrogenic pain
Radio frequency ablation
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Neurologic Manifestations