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

Not Applicable

Completed

Conditions: Low Back Pain

Interventions: Device: Sham Treatment
Device: Intracept Treatment

Registration Number: NCT01446419

Lead Sponsor: Relievant Medsystems, Inc.

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 225

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sham Treatment	Sham Treatment	-
Intracept Treatment	Intracept Treatment	-

Primary Outcome Measures

Name	Time	Method
Change in ODI From Baseline to 3 Months Post-treatment	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

Name	Time	Method
Patient Success at 3 Months	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.
Change in ODI From Baseline to 6 Months Post-treatment	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.

Trial Locations

Locations (13): Pain Center Solutions
🇺🇸
Marietta, Georgia, United States
Maine Medical Partners
🇺🇸
Scarborough, Maine, United States
Rothman Institute
🇺🇸
Philadelphia, Pennsylvania, United States
Desert Institute for Spine Care
🇺🇸
Phoenix, Arizona, United States
OrthoCarolina
🇺🇸
Charlotte, North Carolina, United States
Memorial Orthopedic Surgical Group
🇺🇸
Long Beach, California, United States
The Spine Institute
🇺🇸
Santa Monica, California, United States
SpineCare Medical Group
🇺🇸
Daly City, California, United States
NeuroSpine Institute
🇺🇸
Eugene, Oregon, United States
Indiana Spine Group
🇺🇸
Carmel, Indiana, United States
Seton Spine & Scoliosis Center
🇺🇸
Austin, Texas, United States
Partners in Research and Educational Studies of Spinal Disorders (PressD)
🇺🇸
Southfield, Michigan, United States
Virginia iSpine Physicians
🇺🇸
Richmond, Virginia, United States