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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Low Back Pain

Intervention / Treatment
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* Device: Intracept Treatment
* Device: Sham Treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intracept Treatment<br> | Device: Intracept Treatment<br>* Percutaneous transpedicular RF ablation of an intraosseous nerve within the lumbar vertebral body to treat chronic axial low back.<br>|
| Sham Comparator: Sham Treatment<br> | Device: Sham Treatment<br>* Percutaneous transpedicular access to the lumbar vertebra, no RF ablation delivered.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in ODI From Baseline to 3 Months Post-treatment | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic axial low back pain, vertebrogenic pain, Radio frequency ablation