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

Primary Purpose

Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Spinal Cord Stimulation (SCS) System
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring Spinal Cord Stimulation, Chronic Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Schreiber Klinik
  • Azienda Ospedale Monaldi
  • Ziekenhuis Rijnstate
  • Southmead Hospital Bristol
  • St. Bartholomews Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Spinal Cord Stimulation (SCS) System

Arm Description

Boston Scientific (BSC) PRECISION SCS System with MultiWave Technology

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 14, 2016
Last Updated
December 10, 2020
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02741297
Brief Title
VELOCITY: A Study to Characterize Real-World Outcomes of Spinal Cord Stimulation
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
April 19, 2016 (Actual)
Primary Completion Date
September 21, 2018 (Actual)
Study Completion Date
June 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Spinal Cord Stimulation, Chronic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Spinal Cord Stimulation (SCS) System
Arm Type
Experimental
Arm Description
Boston Scientific (BSC) PRECISION SCS System with MultiWave Technology
Intervention Type
Device
Intervention Name(s)
Spinal Cord Stimulation (SCS) System
Intervention Description
Boston Scientific (BSC) PRECISION SCS System with MultiWave Technology
Primary Outcome Measure Information:
Title
Percentage of Low Back Pain Responders
Description
Percentage of low back pain responders at 3 months post-activation with no increase in opioids from Baseline to 3 months post-activation
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vivek Mehta
Organizational Affiliation
St Bartholomew's Hospital, London, UK
Official's Role
Principal Investigator
Facility Information:
Facility Name
Schreiber Klinik
City
Muenchen
Country
Germany
Facility Name
Azienda Ospedale Monaldi
City
Naples
Country
Italy
Facility Name
Ziekenhuis Rijnstate
City
Velp
Country
Netherlands
Facility Name
Southmead Hospital Bristol
City
Bristol
Country
United Kingdom
Facility Name
St. Bartholomews Hospital
City
London
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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