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

Chronic Pain Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02741297
• Other study ID #: 91113648
• Status: Completed
• Phase: N/A
• Start date: April 19, 2016
• Est. completion date: June 25, 2019

Study information

• Verified date: December 2020
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: June 25, 2019
• Est. primary completion date: September 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Device:
• Spinal Cord Stimulation (SCS) System
Boston Scientific (BSC) PRECISION SCS System with MultiWave Technology

Locations

Country	Name	City	State
Germany	Schreiber Klinik	Muenchen
Italy	Azienda Ospedale Monaldi	Naples
Netherlands	Ziekenhuis Rijnstate	Velp
United Kingdom	Southmead Hospital Bristol	Bristol
United Kingdom	St. Bartholomews Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

Germany,  Italy,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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