The Intracept Global Registry ( TIGR ) - Pilot Study

Study Overview
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Brief Summary
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The Intracept Global Registry is a prospective, noninterventional, observational global post market independent data collection of the ongoing effectiveness, safety, and satisfaction outcomes for patients treated with the Intracept Procedure. This registry 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. Registry design, conduct, analysis, and reporting are overseen by the Principal Investigator (PI) and the cross-specialty TIGR Physician Steering Committee.

Detailed Description
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Participants in the registry will have seven study visits over a period of five years (one prior to procedure and 6 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, 24, 36, 48, and 60 months post their Intracept 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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The Intracept Global Registry

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 the Intracept procedure and whose treating physician is referring to the registry Exclusion Criteria: No exclusion criteria

Ages Eligible for Study
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Minimum Age: 18 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

| Intervention/Treatment |
| --- |
|Procedure: Intracept Procedure|radio frequency 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) Reduction | 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 post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oswestry Disability Index (ODI) improvement | Mean improvement in ODI scores from baseline (scale 0 to 100) | 3, 12, 24, 36, 48 and 60 months post procedure | 
| Numeric Pain Score | Mean reduction in patient reported low back pain from baseline (scale 0 no pain to 10 worst pain imaginable) | 3, 12, 24, 36, 48 and 60 months post procedure | 
| Combined Responder Rates (improvement thresholds of ODI ≥ 15 and NPS ≥ 2) | Percent of responders meeting both thresholds | 3, 12, 24, 36, 48 and 60 months post procedure | 
| PROMIS 29 Change | Mean change in PROMIS-29 from baseline | 3, 12, 24, 36, 48 and 60 months post procedure | 
| Injections utilization compared to baseline | Numbers of injections post procedure compared to baseline | 3, 12, 24, 36, 48 and 60 months post procedure | 
| Post ablation pain interventions/surgeries | Numbers of pain interventions/surgeries post procedure compared to baseline | 3, 12, 24, 36, 48 and 60 months post procedure |