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

• 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: Relievant Medsystems, Inc.
• Information provided by (Responsible Party): Relievant Medsystems, Inc.

Study Description

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

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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.

Eligibility Criteria

• Ages Eligible for Study: 25 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: Relievant Medsystems, Inc.
• ClinicalTrials.gov Identifier: NCT01446419
• Other Study ID Numbers: CIP 0003
• First Posted: October 5, 2011
• 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:

Back Pain; Low Back Pain; Pain; Neurologic Manifestations