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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-19

Study Completion Date

2019-06-25

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.

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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.

Conditions

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Chronic Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Spinal Cord Stimulation (SCS) System

Boston Scientific (BSC) PRECISION SCS System with MultiWave Technology

Group Type EXPERIMENTAL

Spinal Cord Stimulation (SCS) System

Intervention Type DEVICE

Boston Scientific (BSC) PRECISION SCS System with MultiWave Technology

Interventions

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Spinal Cord Stimulation (SCS) System

Boston Scientific (BSC) PRECISION SCS System with MultiWave Technology

Intervention Type DEVICE

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No