Comparison of Senza to Commercial Spinal Cord Stimulation for the Treatment of Chronic Pain

Study Overview
=================
Brief Summary
-----------------
The purpose of this investigational study is to establish the safety and effectiveness of electrical stimulation delivered to the spinal cord in subjects with chronic, intractable pain of the trunk and/or limbs and will be a comparison of the Senza System with commercially available SCS systems.

Official Title
-----------------
Multi-Center, Prospective, Randomized, Controlled Clinical Trial to Demonstrate Non-Inferiority of the Senza™ Spinal Cord Stimulation (SCS) System in the Treatment of Chronic Pain as Compared to Commercially Available SCS Devices

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

Intervention / Treatment
-----------------
* Device: Spinal Cord Stimulator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have been diagnosed with chronic, intractable pain of the trunk and/or limbs (VAS ≥ 5) which has been refractory to conservative therapy for a minimum of 3 months. Be an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician Be 18 years of age or older at the time of enrollment Be willing and capable of giving informed consent Be willing and able to comply with study-related requirements, procedures, and visits Exclusion Criteria: Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention and/or ability to evaluate treatment outcome, as determined by a psychologist Have a current diagnosis of a coagulation disorder, bleeding diathesis, progressive peripheral vascular disease or uncontrolled diabetes mellitus Have a diagnosis of scoliosis that precludes lead placement Have an existing drug pump and/or SCS system or another active implantable device such as a pacemaker Have prior experience with SCS Have a condition currently requiring or likely to require the use of MRI or diathermy Have metastatic malignant disease or active local malignant disease Have a life expectancy of less than 1 year Have an active systemic or local infection Be pregnant (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile or be at least 2 years post-menopausal) Have within 6 months of enrollment a significant untreated addiction to dependency producing medications or have been a substance abuser (including alcohol and illicit drugs) Be concomitantly participating in another clinical study Be involved in an injury claim under current litigation Have a pending or approved worker's compensation claim

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test<br>Subjects randomized to this arm will be trialed and implanted with the Nevro Senza System | Device: Spinal Cord Stimulator<br>* Non-inferior comparison of implantable spinal cord stimulators<br>|
| Active Comparator: Control<br>Subjects randomized to this arm will be trialed and implanted with a commercially available SCS system. | Device: Spinal Cord Stimulator<br>* Non-inferior comparison of implantable spinal cord stimulators<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in back pain VAS and neurological status from Baseline | The primary endpoint is a composite of effectiveness and safety. Specifically, the primary endpoint is the percentage of randomized subjects (the ITT analysis population) and subjects completing the Primary Efficacy Assessment (the PP analysis population) who respond to SCS therapy (as assessed by VAS) for back pain and do not have a stimulation-related neurological deficit at the Primary Efficacy Assessment (non-inferiority analysis). Subjects who do not have a successful Trial Phase are considered failures (non-responders) toward the primary endpoint. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in disability as measured by Oswestry Disability Index |  | 3, 6, 12 months | 
| Number of subjects with adverse events |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Back pain, Spinal Cord Stimulation