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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.
Enrollment
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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:
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:
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
Primary purpose
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Interventional model
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225 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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