Chronic Low Back Pain
Conditions
Brief summary
The objective of this study is to evaluate long-term ongoing effectiveness of the Intracept Intraosseous Nerve Ablation System for the treatment of chronic low back pain.
Detailed description
This is a prospective multi-center, nonintervention, observational, single arm post market data collection of the 5+ year effectiveness and satisfaction outcome for the SMART trial population.
Interventions
DEVICEBasivertebral Nerve (BVN) Ablation
Single follow-up visit of previously treated participants from the SMART trial.
Sponsors
Relievant Medsystems, Inc.
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* LBP at least 6 months from original SMART Trial * RF Ablation Arm from SMART Trial
Exclusion criteria
-Control Arm Subjects from SMART Trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LS Mean Reduction in Oswestry Disability Index (ODI) From Baseline | Difference between baseline and 5 year post treatment measurements | Validated questionnaire of low back pain related disability. Comprised of 10 questions evaluating the impact of low back pain on activities of daily living. The ODI is scored 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). Difference in mean ODI at baseline and 5 years post treatment measurements. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| LS Mean Reduction in VAS From Baseline | Difference between baseline and 5 year post treatment measurements | Numeric pain scale with minimum of 0 to maximum of 10; with 0 being no pain and 10 being worst imaginable pain. Difference in mean VAS at baseline and at 5 years post treatment. |
| Responder Rates | At 5 year post treatment | Proportion of participants that achieve a threshold of \> 15 point reduction in ODI and \> 2 point reduction in VAS calculated as the difference between the baseline measurements and the 5 year post treatment measurements. |
| Narcotics Use | Difference between baseline and 5 years post treatment. | Proportion of participants using a narcotic more than once per week in the 30 days prior to the study visit. Difference in baseline to 5 year post treatment percentage measurements. |
| Injections | Difference from baseline percentage measurement to 5 years post treatment measurement | Proportion of participants receiving an injection for low back pain (adjudicated as same location and etiology as BVN ablation treatment) compared to baseline. Difference in percentage of participants at baseline and 5 years post treatment measurements. |
| Interventions | Measured form treatment data to 5 years post treatment visit date | Proportion of participants receiving a pain intervention or surgery for low back pain (adjudicated as the same location and etiology as BVN ablation treatment) from procedure date to 5 year visit date. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BVN Ablation Arm Randomized and successfully treated with basivertebral nerve ablation | 100 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 3 |
| Overall Study | Lost to Follow-up | 10 |
| Overall Study | Refused participation | 1 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | BVN Ablation Arm |
|---|---|
| Age, Continuous | 47.2 years STANDARD_DEVIATION 10.9 |
| Baseline Oswestry Disability Index (ODI) | 42.8 units on a scale STANDARD_DEVIATION 11.6 |
| Baseline Visual Analog Scale (VAS) | 6.73 units on a scale STANDARD_DEVIATION 1.43 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 94 Participants |
| Region of Enrollment United States | 100 participants |
| Sex: Female, Male Female | 42 Participants |
| Sex: Female, Male Male | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 100 |
| other Total, other adverse events | 0 / 100 |
| serious Total, serious adverse events | 0 / 100 |
Outcome results
Primary
LS Mean Reduction in Oswestry Disability Index (ODI) From Baseline
Validated questionnaire of low back pain related disability. Comprised of 10 questions evaluating the impact of low back pain on activities of daily living. The ODI is scored 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). Difference in mean ODI at baseline and 5 years post treatment measurements.
Time frame: Difference between baseline and 5 year post treatment measurements
Population: US per protocol BVN ablation treated participants who consented to participate
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| BVN Ablation Arm | LS Mean Reduction in Oswestry Disability Index (ODI) From Baseline | 25.95 units on a scale of 0 to 100 points | Standard Deviation 18.54 |
p-value: 0.001ANCOVA
Secondary
Injections
Proportion of participants receiving an injection for low back pain (adjudicated as same location and etiology as BVN ablation treatment) compared to baseline. Difference in percentage of participants at baseline and 5 years post treatment measurements.
Time frame: Difference from baseline percentage measurement to 5 years post treatment measurement
Population: US per protocol BVN ablation treated participants that consented to participate
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BVN Ablation Arm | Injections | 1 Participants |
Secondary
Interventions
Proportion of participants receiving a pain intervention or surgery for low back pain (adjudicated as the same location and etiology as BVN ablation treatment) from procedure date to 5 year visit date.
Time frame: Measured form treatment data to 5 years post treatment visit date
Population: US per protocol BVN ablation treated participants that consented to participate
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BVN Ablation Arm | Interventions | 11 Participants |
Secondary
LS Mean Reduction in VAS From Baseline
Numeric pain scale with minimum of 0 to maximum of 10; with 0 being no pain and 10 being worst imaginable pain. Difference in mean VAS at baseline and at 5 years post treatment.
Time frame: Difference between baseline and 5 year post treatment measurements
Population: US per protocol BVN ablation treated participants who consented to participate
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| BVN Ablation Arm | LS Mean Reduction in VAS From Baseline | 4.38 score on a scale of 0 to 10 | Standard Deviation 2.35 |
p-value: 0.001ANCOVA
Secondary
Narcotics Use
Proportion of participants using a narcotic more than once per week in the 30 days prior to the study visit. Difference in baseline to 5 year post treatment percentage measurements.
Time frame: Difference between baseline and 5 years post treatment.
Population: US per protocol BVN ablation treated participants that consented to participate
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BVN Ablation Arm | Narcotics Use | 8 Participants |
Secondary
Responder Rates
Proportion of participants that achieve a threshold of \> 15 point reduction in ODI and \> 2 point reduction in VAS calculated as the difference between the baseline measurements and the 5 year post treatment measurements.
Time frame: At 5 year post treatment
Population: US per protocol BVN ablation treated participants who consented to participate
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BVN Ablation Arm | Responder Rates | 75 Participants |