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

Not Applicable

Completed

• Conditions: Chronic Pain
• Interventions: Device: Spinal Cord Stimulation (SCS) System

• Registration Number: NCT02741297
• Lead Sponsor: Boston Scientific Corporation

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.

Study Timeline

• Study First Submitted: 2016-04-14
• Study First Submitted QC: 2016-04-14
• Study First Posted: 2016-04-18
• Study Start: 2016-04-19
• Primary Completion: 2018-09-21
• Study Completion: 2019-06-25
• Results First Submitted: 2019-09-20
• Results First Submitted QC: 2019-12-23
• Results First Posted: 2020-01-10
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-10
• Last Update Posted: 2021-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Spinal Cord Stimulation (SCS) System	Spinal Cord Stimulation (SCS) System	Boston Scientific (BSC) PRECISION SCS System with MultiWave Technology

Primary Outcome Measures

Name	Time	Method
Percentage of Low Back Pain Responders	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

Trial Locations

Locations (5)

Schreiber Klinik; 🇩🇪 Muenchen, Germany

Azienda Ospedale Monaldi; 🇮🇹 Naples, Italy

St. Bartholomews Hospital; 🇬🇧 London, United Kingdom

Southmead Hospital Bristol; 🇬🇧 Bristol, United Kingdom

Ziekenhuis Rijnstate; 🇳🇱 Velp, Netherlands