Study of Basivertebral Nerve Ablation Treatment of Chronic Low Back Pain

Study Overview
=================
Brief Summary
-----------------
Prospective, single arm, open label, multi-center study to evaluated the effectiveness of intraosseous basivertebral nerve radiofrequency ablation using the Intracept System.

Detailed Description
-----------------
This is a prospective, open-label, single-arm study of patients diagnosed with vertebrogenic low back pain for a minimum of 6 months with conservative care. Participants will receive the Intracept System procedure to ablate the basivertebral nerve within the vertebral body. Treatment is performed on all vertebral bodies with Modic type 1 or type 2 changes on MRI from L3-S1.

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

Conditions
-----------------
Chronic Low Back Pain

Intervention / Treatment
-----------------
* Device: Intracept


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Skeletally mature subjects at least 25 years of age Chronic low back pain for at least 6 months Failure to respond to at least 6 months of non-operative conservative management Oswestry Disability Index (ODI) at least 30 points Modic changes Type 1 or 2 Exclusion Criteria: Current or history of vertebral cancer or spinal metastasis History of a fragility fracture Any back pathology related to trauma, evidence of vertebral compression fracture or other spinal pathology that could affect assessment of response to back pain Disc extrusion or protrusion

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>BVN Ablation | Device: Intracept<br>* Radiofrequency ablation of the basivertebral nerve using the Intracept System<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oswestry Disability Index (ODI) - 3 Months | Change in mean Oswestry Disability Index (ODI) total score from baseline to 3 months post-treatment. ODI total score 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). The minimally clinically important difference in ODI from baseline is considered to be a 10 points reduction from baseline. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale (VAS) - 3 Months | Change in the mean visual analog scale (VAS) low back pain from baseline to 3 months post treatment. VAS is a 10 point numeric scale with 0 being no pain and 10 being worst imaginable pain. The minimal clinically important difference is a 2 point reduction from baseline. | 3 Months | 
| ODI Responder Rate - 3-Month | Number & percent of patients with greater than or equal to 15 point reduction in Oswestry Disability Index (ODI) from baseline to 3 months post treatment. 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). The minimally clinically important difference for this tool is considered to be 10 points. | 3 Months | 
| VAS Responder Rate - 3 Month | Number and percentage of participants with a greater than or equal to 2 point reduction from baseline in visual analog scale (VAS) for low back pain at 3 months post treatment. VAS is a patient-reported 10 point numeric pain scale with 0 being no pain and 10 being worst imaginable pain. The minimal clinically important difference in VAS from baseline is a 2 point reduction. | 3 Months | 
| ODI -12 Months | Change in mean Oswestry Disability Index (ODI) total score from baseline to 12 months post treatment. ODI total score is 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). The minimally clinically important difference for this tool is considered to be 10 point reduction in ODI. | 12 Months | 
| VAS - 12 Month | Change in mean visual analog scale (VAS) for low back pain score from baseline at 12 months. VAS is a patient-reported 10 point numeric pain scale with 0 being no pain and 10 being worst imaginable pain. The minimal clinically important difference in VAS from baseline is a 2 point reduction. | 12 Months | 
| ODI Responder Rate - 12-Month | Number and percent of patients with greater than or equal to 15 point reduction in Oswestry Disability Index (ODI) total score from baseline to 12 months post treatment. ODI total score 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). The minimally clinically important difference for this tool is considered to be 10 points. | 12 Months | 
| VAS Responder Rate - 12 Months | Number and percent of participants with a reduction of greater than or equal to 2 points of the visual analog scale (VAS) at 12 months post treatment. VAS is a patient-reported 10 point numeric pain scale with 0 being no pain and 10 being worst imaginable pain. The minimal clinically important difference in VAS from baseline is a 2 point reduction in score. | 12 Months | 
| VAS Reduction 50% or More - 12 Month | Number and percent of participants that reported a 50% or greater reduction in Visual Analog Scale (VAS) from baseline to 12 months. | 12 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vertebrogenic Low Back Pain