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

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ClinicalTrials.gov Identifier: NCT01446419
Recruitment Status : Completed
First Posted : October 5, 2011
Results First Posted : October 31, 2016
Last Update Posted : October 31, 2016
Sponsor:
Information provided by (Responsible Party):
Relievant Medsystems, Inc.

Tracking Information
First Submitted Date  ICMJE October 3, 2011
First Posted Date  ICMJE October 5, 2011
Results First Submitted Date  ICMJE July 12, 2016
Results First Posted Date  ICMJE October 31, 2016
Last Update Posted Date October 31, 2016
Study Start Date  ICMJE October 2011
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 24, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 4, 2011)
Oswestry Disability Index [ 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 24, 2016)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 4, 2011)
Patient Success at 3 months and Oswestry Disability Index at 6 months [ Time Frame: 6 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SMART Clinical Study: Surgical Multi-center Assessment of RF Ablation for the Treatment of Vertebrogenic Back Pain
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Low Back Pain
Intervention  ICMJE
  • Device: Intracept Treatment
    Percutaneous transpedicular RF ablation of an intraosseous nerve within the lumbar vertebral body to treat chronic axial low back.
  • Device: Sham Treatment
    Percutaneous transpedicular access to the lumbar vertebra, no RF ablation delivered.
Study Arms  ICMJE
  • Experimental: Intracept Treatment
    Intervention: Device: Intracept Treatment
  • Sham Comparator: Sham Treatment
    Intervention: Device: Sham Treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 24, 2016)
225
Original Estimated Enrollment  ICMJE
 (submitted: October 4, 2011)
200
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01446419
Other Study ID Numbers  ICMJE CIP 0003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Relievant Medsystems, Inc.
Study Sponsor  ICMJE Relievant Medsystems, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jeffrey Fischgrund, MD Michigan Orthopaedic Institute
PRS Account Relievant Medsystems, Inc.
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP