Intraosseous Basivertebral Nerve Ablation for Treatment of Chronic Low Back Pain

Study Overview
=================
Brief Summary
-----------------
Objective of study is to evaluate the procedural success rate, clinical effectiveness, and heath-economic profile using the Intercept Intraosseous Nerve Ablation System in adult subjects with chronic low back pain in the post-market setting

Detailed Description
-----------------
This is a prospective, open-label, single-arm, single-center study. There is no randomization or blinding. Subjects will receive the Intercept System procedure to treat one or two motion segments at L3/L4, L4/L5, or L5/S1 as identified by Modic Type 1 or 2 changes.

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

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Skeletally mature subjects age 25-70 years, inclusive Chronic lower back pain for at least six months Failure to respond to at least six months of non-operative conservative management Oswestry Disability Index (ODI) at time of evaluation of at least 30 points Modic changes (Type 1 or 2) in at least one vertebral endplate, at one or more levels from L3 to S1 Exclusion Criteria: Radicular pain by history or evidence of pain neurological deficit within the past one year. Previous surgery performed on the lumbar spine Current or history of symptomatic spinal stenosis Current or history of osteoporotic or tumor-related vertebral body compression fracture Current or history of vertebral cancer or spinal metastasis Current or history of spinal infection Metabolic bone disease BMI greater or equal to 40 Any radiographic evidence of other important back pathology MRI evidence of Modic changes, Type 1 or 2 at greater than 3 vertebral bodies or at non-consecutive levels, or at vertebral bodies other than L3 to S1 Any back pathology related to trauma, evidence of vertebral compression fracture or other spinal pathology that could affect assessment of response to back pain Subjects who are bed bound Demonstrates 3 or more Waddell's signs of Inorganic Behavior Any evidence of current systemic infection

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

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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: Intracept System Ablation<br> | Device: Intracept System Ablation<br>* Radiofrequency ablation using Intracept System<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oswestry Disability Index (ODI) | Mean change in Oswestry Disability Index Score from baseline to 3 months post-treatment. Scale is measured from 0 to 100, better to worse respectively. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale (VAS) | Mean change in Visual Analog Scale (VAS) pain score from baseline to 3, 6, 9 and 12 months post-treatment. Scale is measured from 0 to 10, better to worse respectively. | 3, 6, 9, and 12 months | 
| Oswestry Disability Index (ODI) | Mean change in Oswestry Disability Index (ODI) score from baseline to 6, 9 and 12 months post-treatment. Scale is measured from 0 to 100, better to worse respectively. | 6, 9, and 12 months |