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

Boston Scientific

Status: Completed

Conditions: Chronic Pain

Treatments: Device: Spinal Cord Stimulation (SCS) System

Study type: Interventional

Funder types: Industry

Identifiers

NCT02741297

91113648

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 73 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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73 participants in 1 patient group

Spinal Cord Stimulation (SCS) System

Experimental group

Description:

Boston Scientific (BSC) PRECISION SCS System with MultiWave Technology

Treatment:

Device: Spinal Cord Stimulation (SCS) System