Chronic Low Back Pain
Conditions
Keywords
Vertebrogenic chronic low back pain, Intraosseous basivertebral nerve ablation, Low back pain, Axial low back pain
Brief summary
This is a prospective, noninterventional, observational post market data collection of long-term effectiveness and satisfaction outcomes for A Prospective, Open-Label, Single-Arm Study of Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain (CLBP Single-Arm Study) population at three (3), four (4), and five (5) years post Intracept Procedure. The working hypothesis is that data collected in this study will demonstrate safety, efficacy, durability and reproducibility of BVN ablation treatment outcomes out to 3, 4, and 5-years post-procedure.
Detailed description
Patients were originally enrolled under NCT03266107 and followed through 12-months post Intracept Procedure. This study approached patients from NCT03266107 to collect additional long-term effectiveness and satisfaction outcomes at three (3), four (4), and five (5) years post Intracept Procedure.
Interventions
DEVICEIntracept Procedure
Intraosseous Basivertebral Nerve (BVN) Ablation
Sponsors
Boston Scientific Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
25 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
\- Patient received the Intracept procedure while participating in A Prospective, Open-Label, Single-Arm Study of Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain (CLBP Single-Arm Long-Term Study)
Exclusion criteria
\- None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in ODI From Baseline to 5 Years Post Intracept Procedure | Difference between baseline and 5-year post treatment measurements. Patients originally enrolled under NCT03266107. Baseline information for this analysis is from NCT03266107. 5-years post Intracept Procedure data collected through this NCT record/study. | The Oswestry Disability Index (ODI) is a validated questionnaire of pain-related disability with total score on a scale of 0 (no disability) to 100 (complete disability). Categories for ODI total score are 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 published minimally clinically important difference for change in ODI is 10 points. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Oswestry Disability Index (ODI) From Baseline to 3 Years Post Intracept Procedure | Difference between baseline and 3-year post treatment measurements. Patients originally enrolled under NCT03266107. Baseline information for this analysis is from NCT03266107. 3-years post Intracept Procedure data collected through this NCT record/study. | The Oswestry Disability Index (ODI) is a validated questionnaire of pain-related disability with total score on a scale of 0 (no disability) to 100 (complete disability). Categories for ODI total score are 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 published minimally clinically important difference for change in ODI is 10 points. |
| Mean Change in ODI From Baseline to 4 Years Post Intracept Procedure | Difference between baseline and 4-year post treatment measurements. Patients originally enrolled under NCT03266107. Baseline information for this analysis is from NCT03266107. 4-years post Intracept Procedure data collected through this NCT record/study. | The Oswestry Disability Index (ODI) is a validated questionnaire of pain-related disability with total score on a scale of 0 (no disability) to 100 (complete disability). Categories for ODI total score are 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 published minimally clinically important difference for change in ODI is 10 points. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Basivertebral Nerve Ablation Treatment Patient-reported outcomes at three (3) follow-up visits for previously treated participants from the CLBP Single-Arm study.
Intracept Procedure: Intraosseous Basivertebral Nerve (BVN) Ablation | 40 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
Baseline characteristics
| Characteristic | Basivertebral Nerve Ablation Treatment | — |
|---|---|---|
| Age, Continuous | 45.75 years STANDARD_DEVIATION 8.53 | — |
| Oswestry Disability Index (ODI) | 47.05 score on a scale STANDARD_DEVIATION 10.17 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 40 participants | — |
| Sex: Female, Male Female | 23 Participants | — |
| Sex: Female, Male Male | 17 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 40 |
| other Total, other adverse events | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 |
Outcome results
Primary
Mean Change in ODI From Baseline to 5 Years Post Intracept Procedure
The Oswestry Disability Index (ODI) is a validated questionnaire of pain-related disability with total score on a scale of 0 (no disability) to 100 (complete disability). Categories for ODI total score are 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 published minimally clinically important difference for change in ODI is 10 points.
Time frame: Difference between baseline and 5-year post treatment measurements. Patients originally enrolled under NCT03266107. Baseline information for this analysis is from NCT03266107. 5-years post Intracept Procedure data collected through this NCT record/study.
Population: Patients who completed all long-term follow-up visits (3-, 4-, 5-year follow-up visit).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Basivertebral Nerve Ablation Treatment | Mean Change in ODI From Baseline to 5 Years Post Intracept Procedure | 34.63 units on a scale | Standard Deviation 10.12 |
Secondary
Mean Change in ODI From Baseline to 4 Years Post Intracept Procedure
The Oswestry Disability Index (ODI) is a validated questionnaire of pain-related disability with total score on a scale of 0 (no disability) to 100 (complete disability). Categories for ODI total score are 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 published minimally clinically important difference for change in ODI is 10 points.
Time frame: Difference between baseline and 4-year post treatment measurements. Patients originally enrolled under NCT03266107. Baseline information for this analysis is from NCT03266107. 4-years post Intracept Procedure data collected through this NCT record/study.
Population: Patients who completed all long-term follow-up visits (3-, 4-, 5-year follow-up visit).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Basivertebral Nerve Ablation Treatment | Mean Change in ODI From Baseline to 4 Years Post Intracept Procedure | 34.50 units on a scale | Standard Deviation 12.26 |
Secondary
Mean Change in Oswestry Disability Index (ODI) From Baseline to 3 Years Post Intracept Procedure
The Oswestry Disability Index (ODI) is a validated questionnaire of pain-related disability with total score on a scale of 0 (no disability) to 100 (complete disability). Categories for ODI total score are 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 published minimally clinically important difference for change in ODI is 10 points.
Time frame: Difference between baseline and 3-year post treatment measurements. Patients originally enrolled under NCT03266107. Baseline information for this analysis is from NCT03266107. 3-years post Intracept Procedure data collected through this NCT record/study.
Population: Patients who completed all long-term follow-up visits (3-, 4-, 5-year follow-up visit).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Basivertebral Nerve Ablation Treatment | Mean Change in Oswestry Disability Index (ODI) From Baseline to 3 Years Post Intracept Procedure | 33.25 units on a scale | Standard Deviation 10.75 |