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

October 24, 2016 updated by: Relievant Medsystems, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

225

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Arizona
      • Phoenix, Arizona, United States, 85020
        • Desert Institute for Spine Care
    • California
      • Daly City, California, United States, 94015
        • SpineCare Medical Group
      • Long Beach, California, United States, 90806
        • Memorial Orthopedic Surgical Group
      • Santa Monica, California, United States, 90403
        • The Spine Institute
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Pain Center Solutions
    • Indiana
      • Carmel, Indiana, United States, 46032
        • Indiana Spine Group
    • Maine
      • Scarborough, Maine, United States, 04074
        • Maine Medical Partners
    • Michigan
      • Southfield, Michigan, United States, 48033
        • Partners in Research and Educational Studies of Spinal Disorders (PressD)
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • OrthoCarolina
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Neurospine Institute
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Rothman Institute
    • Texas
      • Austin, Texas, United States, 78731
        • Seton Spine & Scoliosis Center
    • Virginia
      • Richmond, Virginia, United States, 23235
        • Virginia iSpine Physicians

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Percutaneous transpedicular access to the lumbar vertebra, no RF ablation delivered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months
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.

6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jeffrey Fischgrund, MD, Michigan Orthopaedic Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

October 3, 2011

First Submitted That Met QC Criteria

October 4, 2011

First Posted (Estimate)

October 5, 2011

Study Record Updates

Last Update Posted (Estimate)

October 31, 2016

Last Update Submitted That Met QC Criteria

October 24, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIP 0003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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