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Completed

NCT Number: NCT02741297

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

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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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Schreiber Klinik, München, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spinal Cord Stimulation (SCS) System

Device

Boston Scientific (BSC) PRECISION SCS System with MultiWave Technology

Primary outcomes

  1. Percentage of Low Back Pain Responders

    Time frame: 3 months

    Percentage of low back pain responders at 3 months post-activation with no increase in opioids from Baseline to 3 months post-activation

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Apr 18, 2016
Registry last updated
Jan 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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