Low Back Pain
Conditions
Keywords
chronic axial low back pain, vertebrogenic pain, Radio frequency ablation
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.
Interventions
DEVICEIntracept Treatment
Percutaneous transpedicular RF ablation of an intraosseous nerve within the lumbar vertebral body to treat chronic axial low back.
DEVICESham Treatment
Percutaneous transpedicular access to the lumbar vertebra, no RF ablation delivered.
Sponsors
Relievant Medsystems, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
Subjects were screened and enrolled at 15 sites in the US and 3 sites in Germany
Pre-assignment details
2:1 Randomization (treatment: sham)
Participants by arm
| Arm | Count |
|---|---|
| Intracept Treatment Intracept Treatment: Percutaneous access and RF ablation of the basivertebral nerve within the lumbar vertebral body to treat chronic axial low back. | 147 |
| Sham Treatment Sham Treatment: Percutaneous access to the lumbar vertebra, no RF ablation delivered. | 78 |
| Total | 225 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Terminated per protocol | 3 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Sham Treatment | Intracept Treatment | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 9 Participants | 13 Participants |
| Age, Categorical Between 18 and 65 years | 74 Participants | 138 Participants | 212 Participants |
| Age, Continuous | 47.1 years STANDARD_DEVIATION 8.97 | 46.9 years STANDARD_DEVIATION 10.46 | 47.0 years STANDARD_DEVIATION 9.95 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 9 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 73 Participants | 138 Participants | 211 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Gender Female | 37 Participants | 65 Participants | 102 Participants |
| Gender Male | 41 Participants | 82 Participants | 123 Participants |
| Oswestry Disability Index (ODI) | 41.1 units on a scale STANDARD_DEVIATION 10.39 | 42.9 units on a scale STANDARD_DEVIATION 10.73 | 42.2 units on a scale STANDARD_DEVIATION 10.63 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 6 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 4 Participants | 8 Participants |
| Race (NIH/OMB) White | 71 Participants | 134 Participants | 205 Participants |
| Region of Enrollment Germany | 9 participants | 14 participants | 23 participants |
| Region of Enrollment United States | 69 participants | 133 participants | 202 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 78 / 147 | 24 / 78 |
| serious Total, serious adverse events | 9 / 147 | 5 / 78 |
Outcome results
Primary
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.
Time frame: 3 months
Population: Per Protocol Population: subjects that received the intended therapy per randomization assignment (appropriate ablation of the basivertebral nerve in the Intracept System arm) and completed follow-up per the study protocol.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Intracept Treatment | Change in ODI From Baseline to 3 Months Post-treatment | -20.5 units on a scale |
| Sham Treatment | Change in ODI From Baseline to 3 Months Post-treatment | -15.2 units on a scale |
p-value: 0.019ANCOVA
Secondary
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.
Time frame: 6 months
Population: Per Protocol Population: subjects that received the intended therapy per randomization assignment (appropriate ablation of the basivertebral nerve in the Intracept System arm) and completed follow-up per the study protocol.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Intracept Treatment | Change in ODI From Baseline to 6 Months Post-treatment | -20.8 units on a scale |
| Sham Treatment | Change in ODI From Baseline to 6 Months Post-treatment | -17.0 units on a scale |
Secondary
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.
Time frame: 3 months
Population: Per Protocol Population: subjects that received the intended therapy per randomization assignment (appropriate ablation of the basivertebral nerve in the Intracept System arm) and completed follow-up per the study protocol.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intracept Treatment | Patient Success at 3 Months | 55.5 percentage of patients |
| Sham Treatment | Patient Success at 3 Months | 45.5 percentage of patients |