ReActiv8 Implantable Neurostimulation System for Chronic Low Back Pain

NACompletedINTERVENTIONAL
Enrollment

204

Participants

Timeline

Start Date

August 31, 2016

Primary Completion Date

November 30, 2018

Study Completion Date

January 31, 2024

Conditions
Chronic Low Back Pain
Interventions
DEVICE

ReActiv8 Implantable Stimulation System (Patient Appropriate Stimulation)

ReActiv8 implanted and configured to deliver stimulation at a patient-appropriate level, and participants instructed to deliver stimulation in two 30-minute sessions per day.

DEVICE

ReActiv8 Implantable Stimulation System (Low Stimulation)

ReActiv8 implanted and configured to deliver low stimulation, and participants instructed to deliver stimulation in two 30-minute sessions per day.

Trial Locations (26)

Unknown

University of California, San Diego, La Jolla

The Spine Institute, Santa Monica

University of Colorado Hospital, Aurora

Indiana Spine Group, Carmel

OrthoIndy, Indianapolis

University of Kansas Medical Center, Kansas City

The Brigham and Women's Hospital, Boston

Beaumont Health, Royal Oak

Duke University Medical Center, Durham

Center for Clinical Research, Winston-Salem

Louis Stokes VA Medical Center, Cleveland

University Hospitals Cleveland Medical Center, Cleveland

Rhode Island Hospital, Providence

Upstate Clinical Trials, Spartanburg

Northwest Orthopaedic Specialists, Spokane

Center for Pain Relief, Charleston

Genesis Research Services, Broadmeadow

Sunshine Coast Clinical Research, Noosa

Pain Medicine of South Australia, Welland

Monash Clinical Research, Clayton

AZ Nikolaas, Sint-Niklaas

Sint Augustinus, Wilrijk

Erasmus MC University Medical Center, Rotterdam

Seacroft Hospital, Leeds

St. Bartholomew's Hospital, London

The James Cook University Hospital, Middlesbrough

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Mainstay Medical

INDUSTRY

NCT02577354 - ReActiv8 Implantable Neurostimulation System for Chronic Low Back Pain | Biotech Hunter | Biotech Hunter