Chronic Low Back Pain
Conditions
Brief summary
Prospective, open-label, 1:1 randomized controlled trial of Basivertebral nerve (BVN) Ablation arm vs Standard Care Control for the treatment of vertebrogenic chronic low back pain (CLBP). Participants in the the BVN Ablation arm will receive radiofrequency ablation of the BVN using the Intracept procedure for treatment of up to 4 vertebral bodies (L3 to S1). Participants in the Standard Care Control arm will continue on non-surgical standard care and will be offered optional crossover after 12 months of follow-up with follow-up of 6 months post crossover treatment. The study had a pre-specified Interim Analysis with stopping rules for superiority when approximately 60% of the randomized participants have completed their 3-month primary endpoint study visit. An independent Data Safety Management Board (DSMB) reviewed the interim analysis results and recommended stopping enrollments for superiority and offering early crossover to the control arm participants.
Detailed description
Participants in the BVN Ablation arm will be followed for 24 months following treatment. BVN Ablation arm participants will be approached to participate in a sub study of 3 additional years of follow-up at their 24 month visit (total of 5 years of follow-up). Control arm subjects who were originally to be offered optional crossover treatment after the 12 month follow-up visit were offered crossover per the DSMB recommendation at a mean of 176.5 days.
Interventions
DEVICEIntracept System
BVN ablation using radiofrequency energy
OTHERStandard Care
Non-surgical standard care
Sponsors
Relievant Medsystems, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
BVN Ablation vs Standard Care Control
Eligibility
Sex/Gender
ALL
Age
25 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Skeletally mature subjects at least 25 years of age * Chronic lower back pain for at least 6 months * Failure to respond to at least 6 months of non-operative conservative management
Exclusion criteria
* Radicular pain * Current or history of spinal infection * Modic changes at vertebral bodies other than L3 to S1 * Contraindication to MRI * Pregnant, lactating or plan to become pregnant in next year * Has life expectancy of less than 2 years * Compensated injuries or ongoing litigation regarding back pain/injury, or financial incentive to remain impaired
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference Between Arms in Least Squared (LS) Mean Change in Oswestry Disability Index (ODI) | 3 months | Difference between arms in LS Mean change in ODI (baseline to 3 months post-treatment). ODI is measured on a scale of 0 (no disability) to 100 (complete disability), with categories of 0-20 (minimal disability), 21-40 (moderate disability), 41-60 (severe disability), 61-80 (crippling back pain), and 81-100 (bed-bound or exaggerating). The minimally clinically important difference for this tool is considered to be a 10 point reduction in ODI from a baseline in a patient. These data are for interim analysis of the primary endpoint. Data for later time points will be included in the current Outcome Measures as additional Rows, once available. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference Between Arms in LS Mean Change in Visual Analog Scale (VAS) | 3 months post treatment / randomization | Difference between arms in LS Mean reduction in Visual Analog Scale (VAS) for low back pain from baseline to 3 months post treatment. VAS is a 10 point scale with 0 being no pain and 10 being worst imaginable pain. Participants are asked to indicate an x on the scale that corresponds to their perceived level of pain in their low back. The published minimal clinically important change in VAS is 2 points from baseline. These data are for interim analysis of the primary endpoint. Data for later time points will be included in the current Outcome Measures as additional Rows, once available. |
Countries
United States
Participant flow
Pre-assignment details
420 patients screened for MRI Modic changes at levels L3 to S1 to achieve 140 enrollments. Patients with Modic changes at other levels or who had other primary etiologies for their low back pain (i.e. disc herniation, stenosis, facet joint) were excluded. An independent orthopedic surgeon medical reviewer confirmed eligibility prior to randomization. A pre-specified interim analysis was conducted when 60% of randomized patients completed their 3-month primary endpoint visit.
Participants by arm
| Arm | Count |
|---|---|
| Basivertebral Nerve (BVN) Ablation BVN ablation with standard care
Intracept System: BVN ablation | 51 |
| Standard Care Control Continue standard care | 53 |
| Total | 104 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Still in follow-up | 15 | 21 |
Baseline characteristics
| Characteristic | Standard Care Control | Total | Basivertebral Nerve (BVN) Ablation |
|---|---|---|---|
| Age, Continuous | 50.0 years STANDARD_DEVIATION 11.1 | 50.0 years STANDARD_DEVIATION 10.1 | 50.0 years STANDARD_DEVIATION 9 |
| Baseline Oswestry Disability Index (ODI) | 48.1 units on a scale STANDARD_DEVIATION 11.2 | 46.1 units on a scale STANDARD_DEVIATION 11.3 | 44.0 units on a scale STANDARD_DEVIATION 11.8 |
| Baseline Visual Analogue Scale (VAS) | 6.82 units on a scale of 0 to 10 STANDARD_DEVIATION 1.34 | 6.67 units on a scale of 0 to 10 STANDARD_DEVIATION 1.33 | 6.51 units on a scale of 0 to 10 STANDARD_DEVIATION 1.31 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 48 Participants | 97 Participants | 49 Participants |
| Region of Enrollment United States | 53 Participants | 104 Participants | 51 Participants |
| Sex: Female, Male Female | 28 Participants | 53 Participants | 25 Participants |
| Sex: Female, Male Male | 25 Participants | 51 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 66 | 0 / 74 |
| other Total, other adverse events | 16 / 66 | 6 / 74 |
| serious Total, serious adverse events | 0 / 66 | 0 / 74 |
Outcome results
Primary
Difference Between Arms in Least Squared (LS) Mean Change in Oswestry Disability Index (ODI)
Difference between arms in LS Mean change in ODI (baseline to 3 months post-treatment). ODI is measured on a scale of 0 (no disability) to 100 (complete disability), with categories of 0-20 (minimal disability), 21-40 (moderate disability), 41-60 (severe disability), 61-80 (crippling back pain), and 81-100 (bed-bound or exaggerating). The minimally clinically important difference for this tool is considered to be a 10 point reduction in ODI from a baseline in a patient. These data are for interim analysis of the primary endpoint. Data for later time points will be included in the current Outcome Measures as additional Rows, once available.
Time frame: 3 months
Population: Interim Analysis N=104 (pre-specified interim analysis when approximately 60% of randomized participants complete their 3-month primary endpoint
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Basivertebral Never (BVN) Ablation | Difference Between Arms in Least Squared (LS) Mean Change in Oswestry Disability Index (ODI) | -25.3 units on a scale |
| Standard Care Control | Difference Between Arms in Least Squared (LS) Mean Change in Oswestry Disability Index (ODI) | -4.4 units on a scale |
Comparison: Estimates and p-value from an ANCOVA with a factor of treatment group and a covariate of baseline ODI score. Values have been adjusted for multiple imputation. Note: 3 month visit is computed as post-treatment for the RF Ablation Arm, and post-randomization for the Control Arm.p-value: <0.001ANCOVA
Secondary
Difference Between Arms in LS Mean Change in Visual Analog Scale (VAS)
Difference between arms in LS Mean reduction in Visual Analog Scale (VAS) for low back pain from baseline to 3 months post treatment. VAS is a 10 point scale with 0 being no pain and 10 being worst imaginable pain. Participants are asked to indicate an x on the scale that corresponds to their perceived level of pain in their low back. The published minimal clinically important change in VAS is 2 points from baseline. These data are for interim analysis of the primary endpoint. Data for later time points will be included in the current Outcome Measures as additional Rows, once available.
Time frame: 3 months post treatment / randomization
Population: Interim Analysis population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Basivertebral Never (BVN) Ablation | Difference Between Arms in LS Mean Change in Visual Analog Scale (VAS) | -3.46 units on a scale |
| Standard Care Control | Difference Between Arms in LS Mean Change in Visual Analog Scale (VAS) | -1.02 units on a scale |
p-value: <0.001ANCOVA