Comparison of DTM™ SCS Therapy Combined With Conventional Medical Management (CMM) to CMM Alone in the Treatment of Intractable Back Pain Subjects Without Previous History of Lumbar Spine Surgery

NACompletedINTERVENTIONAL
Enrollment

115

Participants

Timeline

Start Date

July 24, 2020

Primary Completion Date

May 9, 2022

Study Completion Date

October 17, 2023

Conditions
Pain, IntractablePain, Chronic
Interventions
DEVICE

DTM™ spinal cord stimulation therapy delivered via Intellis™ neurostimulator system

Along with the appropriate Conventional Medical Management treatment made by the Investigator, the subject will be trialed and implanted with an Intellis™ neurostimulator system using DTM™ SCS programming parameters.

OTHER

Conventional Medical Management (CMM)

The CMM treatment can be modified at any moment by the investigators based on their clinical evaluation and local standard of care. They may also consists of one or more of the following treatments: medications, combined physical and psychological management, physical therapy, back rehabilitation program, spinal manipulation and spinal mobilization, traction, acupuncture, cognitive behavioral therapy, biofeedback, nerve blocks, radio frequency ablation, epidural steroid injections, transcutaneous electrical nerve stimulation, intradiscal electrothermal therapy, nucleoplasty, also called plasma disc decompression (PDD) or similar

Trial Locations (12)

Unknown

AZ Delta, Roeselare

AZ Nikolaas, Sint-Niklaas

GZA - Sint Augustinus Ziekenhuis, Wilrijk

Universitätsklinikum Düsseldorf, Düsseldorf

München Klinik Bogenhausen, München

Rijnstate - Locatie Elst, Elst

Maastricht University Medical Center, Maastricht

Diakonessenhuis Locatie Zeist, Zeist

Hospital Clínico Universitario de Santiago, A Coruña

Hospital Universitario Puerta de Hierro Majadahonda, Majadahonda

Hospital Universitario Virgen del Rocío, Seville

Hospital Clínico Universitario de Valencia, Valencia

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

SGX Group

INDUSTRY

lead

MedtronicNeuro

INDUSTRY