NCT02916498

Brief Summary

The study aims to better understand how to program Spinal Cord Stimulation for the treatment of chronic low back and leg pain

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

2 active sites

Status
terminated

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

September 22, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 27, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

February 7, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 23, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 23, 2018

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

October 2, 2019

Completed
Last Updated

January 29, 2021

Status Verified

January 1, 2021

Enrollment Period

1.5 years

First QC Date

September 22, 2016

Results QC Date

July 23, 2019

Last Update Submit

January 27, 2021

Conditions

Chronic Neuropathic Pain in the Low Back and Legs

Keywords

chronic neuropathic pain in the low back and legssubperception spinal cord stimulation

Outcome Measures

Primary Outcomes (1)

  • Patient Preferred Field Shape

    Number of participants preferring bipolar field shape and alternative field shape

    42 days post randomization

Study Arms (2)

Bipolar then alternative field shape stimulation

ACTIVE COMPARATOR

Boston Scientific's Precision SPECTRA™ Spinal Cord Stimulation System: Spinal cord stimulation for the management of chronic neuropathic pain programmed with bipolar stimulation for 21 days, then alternative field shape stimulation for 21 days

Device: Boston Scientific's Precision SPECTRA™ Spinal Cord Stimulation System

Alternative then bipolar field shape stimulation

EXPERIMENTAL

Boston Scientific's Precision SPECTRA™ Spinal Cord Stimulation System: Spinal cord stimulation for the management of chronic neuropathic pain programmed with alternative field shape stimulation for 21 days, then bipolar stimulation for 21 days

Device: Boston Scientific's Precision SPECTRA™ Spinal Cord Stimulation System

Interventions

Boston Scientific's Precision SPECTRA™ Spinal Cord Stimulation SystemDEVICE

Spinal cord stimulation for the management of chronic neuropathic pain

Alternative then bipolar field shape stimulationBipolar then alternative field shape stimulation

Eligibility Criteria

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

You may qualify if:

  • Documented average low back pain intensity of at least 6 out of 10 and greater or equal than average leg pain intensity over 7 days during screening (Numerical Rating Scale)
  • Stable daily pain-related medication prescription and intake of ≤100mg morphine-equivalents
  • Capacity to describe and rate pain intensity, complete study measurements, and use the study device (e.g. patient remote control, charger, diary ratings) (physician discretion)

You may not qualify if:

  • Presence of pain or psychological condition that in the opinion of the investigator may interfere with the subject's ability to rate their pain and communicate such ratings
  • Previous Spinal Cord Stimulation trial or is already implanted with an active implantable device(s) (e.g. pacemaker, drug pump, implantable pulse generator)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

St. Bartholomew's Hospital

London, EC1A 7Be, United Kingdom

Location

James Cook University Hospital

Middlesbrough, TS4 3BW, United Kingdom

Location

Results Point of Contact

Title
Director, Clinical Sciences and Scientific Communication
Organization
Boston Scientific
BSNClinicalTrials@bsci.com
855-213-9890

Study Officials

  • Sam Eldabe, MD

    James Cook University Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2016

First Posted

September 27, 2016

Study Start

February 7, 2017

Primary Completion

July 23, 2018

Study Completion

July 23, 2018

Last Updated

January 29, 2021

Results First Posted

October 2, 2019

Record last verified: 2021-01

Locations

GB(2)