Intracept Intraosseous Basivertebral Nerve Ablation

Study Overview
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Brief Summary
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This is an independent prospective, noninterventional, observational post market data collection of the patient-reported effectiveness, ongoing safety, and satisfaction outcomes for patients treated with the Intracept Procedure at a single study site. This study will be conducted according to Good Clinical Practice (GCP) guidelines, including participant verbal informed consent and Independent Review Board (IRB) / Ethics Committee (EC) approval and oversight. Study design, conduct, analysis, and reporting are overseen by the Principal Investigator (PI) and the cross-specialty Independent Physician Steering Committee.

Detailed Description
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Participants in the study will have four study visits over a period of two years (one prior to procedure and 3 post their procedure). Study visits will be conducted via telephone by a third-party CRO and independent clinical research coordinators. Participants will be verbally consented and then evaluated via telephonic study visits at baseline (prior to procedure) and at 3, 12, and 24 months post their intraosseous basivertebral nerve ablation procedure. Primary and secondary objectives are based on patient reported outcomes for functional improvement, pain reduction, and physical and mental health pre and post procedure. The study will also look at utilization of injections and pain interventions/surgery for treatment of low back pain post Intracept.

Official Title
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A Prospective Single Arm Cohort Study of Intraosseous Basivertebral Nerve Ablation

Conditions
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Low Back Pain

Intervention / Treatment
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* Procedure: Intracept Procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients scheduled for intraosseous basivertebral nerve ablation with the Intracept Procedure Exclusion Criteria: Not scheduled for an intraosseous basivertebral nerve ablation with the Intracept Procedure Intracept procedure for different location other than low back pain

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Intracept Procedure|Radiofrequency ablation of the basivertebral nerve for the relief of chronic vertebrogenic low back pain|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oswestry Disability Index (ODI) Change | 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). Comparison of mean ODI baseline to 3 months. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oswestry Disability Index (ODI) Change | Mean change in ODI scores from baseline (scale 0 to 100) | 3 months | 
| Oswestry Disability Index (ODI) Change | Mean change in ODI scores from baseline (scale 0 to 100) | 12 months | 
| Oswestry Disability Index (ODI) Change | Mean change in ODI scores from baseline (scale 0 to 100) | 24 months | 
| Numeric Pain Score | Mean change in patient reported low back pain from baseline (scale 0 no pain to 10 worst pain imaginable) | 3 months | 
| Numeric Pain Score | Mean change in patient reported low back pain from baseline (scale 0 no pain to 10 worst pain imaginable) | 12 months | 
| Numeric Pain Score | Mean change in patient reported low back pain from baseline (scale 0 no pain to 10 worst pain imaginable) | 24 months | 
| Combined Responder Rates (improvement thresholds of ODI ≥ 15 and NPS ≥ 2) | Percent of responders meeting both thresholds | 3 months | 
| Combined Responder Rates (improvement thresholds of ODI ≥ 15 and NPS ≥ 2) | Percent of responders meeting both thresholds | 12 months | 
| Combined Responder Rates (improvement thresholds of ODI ≥ 15 and NPS ≥ 2) | Percent of responders meeting both thresholds | 24 months | 
| PROMIS 29 Change | Mean change in PROMIS-29 from baseline. (PROMIS-29 includes Numeric Rating Score (NRS) and Seven Health Domains. [NRS 0-10 zero being none and 10 the worst. Seven health domains scaled 1-5: physical function (1 unable to do to 5 without any difficulty), fatigue (1 not at all and 5 very much), pain interference (1 not at all and 5 very much), depressive symptoms (1 never and 5 always), anxiety (1 never and 5 always), ability to participate in social roles and activities (1 never and 5 always), and sleep disturbance(1 not at all and 5 very much)]) | 3 months | 
| PROMIS 29 Change | Mean change in PROMIS-29 from baseline. (PROMIS-29 includes Numeric Rating Score (NRS) and Seven Health Domains. [NRS 0-10 zero being none and 10 the worst. Seven health domains scaled 1-5: physical function (1 unable to do to 5 without any difficulty), fatigue (1 not at all and 5 very much), pain interference (1 not at all and 5 very much), depressive symptoms (1 never and 5 always), anxiety (1 never and 5 always), ability to participate in social roles and activities (1 never and 5 always), and sleep disturbance(1 not at all and 5 very much)]) | 12 months | 
| PROMIS 29 Change | Mean change in PROMIS-29 from baseline. (PROMIS-29 includes Numeric Rating Score (NRS) and Seven Health Domains. [NRS 0-10 zero being none and 10 the worst. Seven health domains scaled 1-5: physical function (1 unable to do to 5 without any difficulty), fatigue (1 not at all and 5 very much), pain interference (1 not at all and 5 very much), depressive symptoms (1 never and 5 always), anxiety (1 never and 5 always), ability to participate in social roles and activities (1 never and 5 always), and sleep disturbance(1 not at all and 5 very much)]) | 24 months | 
| Injections utilization compared to baseline | Numbers of injections post procedure compared to baseline | 3 months | 
| Injections utilization compared to baseline | Numbers of injections post procedure compared to baseline | 12 months | 
| Injections utilization compared to baseline | Numbers of injections post procedure compared to baseline | 24 months | 
| Post ablation pain interventions/surgeries | Numbers of pain interventions/surgeries post procedure compared to baseline | 3 months | 
| Post ablation pain interventions/surgeries | Numbers of pain interventions/surgeries post procedure compared to baseline | 12 months | 
| Post ablation pain interventions/surgeries | Numbers of pain interventions/surgeries post procedure compared to baseline | 24 months |