Five-Plus Year Follow-Up of SMART Randomized Controlled Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Five-Plus Year Follow-Up of SMART (Surgical Multicenter Assessment of RF Ablation for the Treatment of Vertebrogenic Back Pain) Trial

Conditions
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Chronic Low Back Pain

Intervention / Treatment
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* Device: Basivertebral Nerve (BVN) Ablation


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Basivertebral Nerve (BVN) Ablation|Single follow-up visit of previously treated participants from the SMART trial.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Difference between baseline and 5 year post treatment measurements | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Difference between baseline and 5 year post treatment measurements | 
| 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. | At 5 year post treatment | 
| 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. | Difference between baseline and 5 years post treatment. | 
| 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. | Difference from baseline percentage measurement to 5 years post treatment measurement | 
| 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. | Measured form treatment data to 5 years post treatment visit date |