Subcutaneous Stimulation as Add on Therapy to SCS toTreat Low Back Pain in FBSS

NACompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

November 9, 2011

Primary Completion Date

December 20, 2014

Study Completion Date

July 11, 2015

Conditions
Low Back PainFailed Back Surgery SyndromeNeuropathic Pain
Interventions
DEVICE

SubQ

Spinal Cord Stimulation (SCS) and subcutaneous (SubQ) stimulation SCS trial stimulation: Implantation of the Octad lead in the epidural space. The lead implantation in the epidural space is performed under local anesthesia using a standard percutaneous technique. A key element to the technical success of an SCS procedure is the accurate placement of the lead, which results in paresthesia covering the patients' painful areas. This depends on the patients' feedback during intra-operative testing. Therefore, it is important that the patient is awake and fully cooperative during the trial stimulation.

Trial Locations (1)

3300 AK

Albert Schweitzer hospital, Dordrecht

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Radboud University Medical Center

OTHER

collaborator

Albert Schweitzer Hospital

OTHER

collaborator

Maastricht University Medical Center

OTHER

collaborator

Rijnstate Hospital

OTHER

collaborator

Rijnland Hospital

OTHER

collaborator

Medtronic

INDUSTRY

collaborator

Sint Maartenskliniek

OTHER

collaborator

Diakonessenhuis locatie Zeist

UNKNOWN

lead

SubQ

OTHER

NCT01776749 - Subcutaneous Stimulation as Add on Therapy to SCS toTreat Low Back Pain in FBSS | Biotech Hunter | Biotech Hunter