CLBP Single-Arm Long-Term Follow-up Study

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective, Open-Label, Single-Arm Study of Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain Long-term Follow Up

Conditions
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Chronic Low Back Pain

Intervention / Treatment
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* Device: Intracept Procedure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 70 Years

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Basivertebral nerve ablation treatment<br>Patient-reported outcomes at three (3) follow-up visits for previously treated participants from the CLBP Single-Arm study. | Device: Intracept Procedure<br>* Intraosseous Basivertebral Nerve (BVN) Ablation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean improvement in Oswestry Disability Index (ODI) from baseline to 3 years post Intracept procedure | Oswestry Disability Index (100-point scale, 0 being the least disability and 100 being the worst degree of disability/function) | Difference between baseline and 3-year post treatment measurements. | 
| Mean improvement in ODI from baseline to 4 years post Intracept procedure |  | Difference between baseline and 4-year post treatment measurements. | 
| Mean improvement in ODI from baseline to 5 years post Intracept procedure |  | Difference between baseline and 5-year post treatment measurements. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean reduction in patient-reported numeric pain score from baseline for each timepoint. | 10-point Numeric pain score (based on VAS): 0 representing no pain and 10 representing the worst pain imaginable. | 3+ years, 4-years and 5-years post procedure | 
| Responder rates for ODI: proportion of subjects who achieve ≥ 10-Point, ≥ 15-point and ≥ 20-point reduction in ODI from baseline for each timepoint |  | 3+ years, 4-years and 5-years post procedure | 
| Responder rates for Numeric Pain Score: proportion of subjects who achieve a ≥ 2.0-point reduction in NPS from baseline for each timepoint |  | 3+ years, 4-years and 5-years post procedure | 
| Number and proportion of subjects in each quartile (≤ 24%, 25-49%, 50-74%, 75-100%) for percent Numeric Pain Score reduction (in LBP) from baseline for each timepoint |  | 3+ years, 4-years and 5-years post procedure | 
| Composite responder rate at each timepoint defined as: 1) ODI decrease of ≥ 15 2) NPS decrease of ≥ 2 |  | 3+ years, 4-years and 5-years post procedure | 
| Composite responder rate at each timepoint defined as: 1) ODI decrease of ≥ 15 2) NPS decrease of greater than or equal to 50% |  | 3+ years, 4-years and 5-years post procedure | 
| Composite endpoint of long-term treatment success at each timepoint defined as: | ODI decrease of ≥15 NPS decrease of ≥2 No injections for the same low back pain etiology and location as treatment location No pain intervention or surgery for the same low back pain etiology and location as treatment location | 3+ years, 4-years and 5-years post procedure | 
| The number and proportion of subjects with surgical interventions for low back pain of the same treatment region post the Intracept procedure at each timepoint |  | 3+ years, 4-years and 5-years post procedure | 
| The number and proportion of subjects actively utilizing (defined as >25% of total dosage in 30 days prior to study visit) opioids for low back pain of the same treatment region at each timepoint |  | 3+ years, 4-years and 5-years post procedure | 
| The number and proportion of subjects utilizing therapeutic injections since the last study visit for low back pain of the same treatment region at each timepoint |  | 3+ years, 4-years and 5-years post procedure | 
| Work impact: number of missed workdays in past 30 days at each timepoint |  | 3+ years, 4-years and 5-years post procedure | 
| Patient satisfaction with the Intracept Procedure at each timepoint | Non-validated questionnaire about degree of improvement (improved, no change, worsened), satisfaction with treatment (yes/no) and willingness to repeat the treatment (yes/no). | 3+ years, 4-years and 5-years post procedure | 
| Work impact: number of days in bed in past 30 days |  | 3+ years, 4-years and 5-years post procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vertebrogenic chronic low back pain, Intraosseous basivertebral nerve ablation, Low back pain, Axial low back pain