VELOCITY: A Study to Characterize Real-World Outcomes of Spinal Cord Stimulation

Study Overview
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Brief Summary
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The primary objective of this study is to characterize the real-world outcomes of spinal cord stimulation (SCS) therapy as an aid in the management of chronic intractable pain of the trunk, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back pain using the Boston Scientific (BSC) PRECISION Spinal Cord Stimulator System with MultiWave Technology.

Detailed Description
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The purpose of this study is to characterize the real-world outcomes of spinal cord stimulation (SCS) therapy as an aid in the management of chronic intractable pain of the trunk, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back pain using the Boston Scientific (BSC) PRECISION Spinal Cord Stimulator System with MultiWave Technology.

Official Title
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A Multi-Center Controlled Study to Characterize the Real-world Outcomes of High Rate Spinal Cord Stimulation Therapy Using Boston Scientific (BSC) PRECISION Spinal Cord Stimulator System

Conditions
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Chronic Pain

Intervention / Treatment
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* Device: Spinal Cord Stimulation (SCS) System


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Complaint of persistent or recurrent low back pain for at least 180 days prior to Screening Willing and able to comply with all protocol-required procedures and assessments/evaluations Subject signed a valid, ethics committee (EC)-approved informed consent form (ICF) provided in local language Key Exclusion Criteria: High surgical risk Previous spinal cord stimulation trial or is already implanted with an active implantable device(s) (e.g. pacemaker, drug pump, implantable pulse generator) A female who is pregnant, is breastfeeding, or is of childbearing potential and planning to get pregnant during the course of the study or not using adequate contraception. Participating (or intends to participate) in another drug or device clinical trial that may influence the data that will be collected for this study Any diagnosis or condition that, in the clinician's best judgment, might confound reporting of study outcomes

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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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spinal Cord Stimulation (SCS) System<br>Boston Scientific (BSC) PRECISION SCS System with MultiWave Technology | Device: Spinal Cord Stimulation (SCS) System<br>* Boston Scientific (BSC) PRECISION SCS System with MultiWave Technology<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Low Back Pain Responders | Percentage of low back pain responders at 3 months post-activation with no increase in opioids from Baseline to 3 months post-activation | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spinal Cord Stimulation, Chronic Pain