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Lead
Relievant Medsystems, Inc.
Age
25–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
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.
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
Clareo Health | SMART Clinical Study: Surgical Multi-center Assessment of RF Ablation for the Treatment of Vertebrogenic Back Pain
