- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01446419
SMART Clinical Study: Surgical Multi-center Assessment of RF Ablation for the Treatment of Vertebrogenic Back Pain (SMART)
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Arizona
-
Phoenix, Arizona, United States, 85020
- Desert Institute for Spine Care
-
-
California
-
Daly City, California, United States, 94015
- SpineCare Medical Group
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Long Beach, California, United States, 90806
- Memorial Orthopedic Surgical Group
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Santa Monica, California, United States, 90403
- The Spine Institute
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Georgia
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Marietta, Georgia, United States, 30060
- Pain Center Solutions
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Indiana
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Carmel, Indiana, United States, 46032
- Indiana Spine Group
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Maine
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Scarborough, Maine, United States, 04074
- Maine Medical Partners
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Michigan
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Southfield, Michigan, United States, 48033
- Partners in Research and Educational Studies of Spinal Disorders (PressD)
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North Carolina
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Charlotte, North Carolina, United States, 28207
- OrthoCarolina
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Oregon
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Eugene, Oregon, United States, 97401
- Neurospine Institute
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Rothman Institute
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Texas
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Austin, Texas, United States, 78731
- Seton Spine & Scoliosis Center
-
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Virginia
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Richmond, Virginia, United States, 23235
- Virginia iSpine Physicians
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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:
- Nerve root compression or severe effacement of the thecal sac that correlates with radicular pain or muscle weakness
- Disc extrusion or disc protrusion >5mm
- Facet arthrosis or facet effusion at any lumbar level that correlates with clinical evidence of facet mediated low back pain
- Spondylolisthesis 2mm or greater at any level
- 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
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
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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 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
Sponsor
Investigators
- Principal Investigator: Jeffrey Fischgrund, MD, Michigan Orthopaedic Institute
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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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