NCT02741297

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for not_applicable chronic-pain

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable chronic-pain

Geographic Reach
4 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 18, 2016

Completed
1 day until next milestone

Study Start

First participant enrolled

April 19, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 21, 2018

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2019

Completed
7 months until next milestone

Results Posted

Study results publicly available

January 10, 2020

Completed
Last Updated

January 5, 2021

Status Verified

December 1, 2020

Enrollment Period

2.4 years

First QC Date

April 14, 2016

Results QC Date

September 20, 2019

Last Update Submit

December 10, 2020

Conditions

Chronic Pain

Keywords

Spinal Cord StimulationChronic Pain

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Spinal Cord Stimulation (SCS) System

EXPERIMENTAL

Boston Scientific (BSC) PRECISION SCS System with MultiWave Technology

Device: Spinal Cord Stimulation (SCS) System

Interventions

Spinal Cord Stimulation (SCS) SystemDEVICE

Boston Scientific (BSC) PRECISION SCS System with MultiWave Technology

Spinal Cord Stimulation (SCS) System

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Schreiber Klinik

München, Germany

Location

Azienda Ospedale Monaldi

Naples, Italy

Location

Ziekenhuis Rijnstate

Velp, Netherlands

Location

Southmead Hospital Bristol

Bristol, United Kingdom

Location

St. Bartholomews Hospital

London, United Kingdom

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Spinal Cord StimulationDrug Delivery Systems

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationDrug Therapy

Results Point of Contact

Title
Roshini Jain, Director of Clinical Sciences
Organization
Boston Scientific
roshini.jain@bsci.com
6619494350

Study Officials

  • Vivek Mehta

    St Bartholomew's Hospital, London, UK

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2016

First Posted

April 18, 2016

Study Start

April 19, 2016

Primary Completion

September 21, 2018

Study Completion

June 25, 2019

Last Updated

January 5, 2021

Results First Posted

January 10, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)NL(1)DE(1)GB(2)