Patient Profiling and Outcome Assessment in Spinal Cord Stimulation for Chronic Back and/or Leg Pain

UnknownOBSERVATIONAL
Enrollment

200

Participants

Timeline

Start Date

May 1, 2022

Primary Completion Date

May 31, 2023

Study Completion Date

May 31, 2024

Conditions
Failed Back Surgery SyndromeChronic Pain
Interventions
DEVICE

Spinal cord stimulation

Eligible patients will undergo a SCS trial period for three weeks (as legally defined by the reimbursement authorities). The leads can be placed both surgically of percutaneously with an external trial stimulator. Surgical implantation of an implanted pulse generator (IPG) is performed if the patient achieves at least 50% pain reduction and a reduced pain medication use (reimbursement requirements) during the trial period. Subsequently, the implanted devices are programmed to the optimal parameters in collaboration with a nurse specialized in SCS treatment. The patients are educated on the use of the patient programmer.

Trial Locations (3)

Unknown

RECRUITING

Jessa Hospital, Hasselt

RECRUITING

Sint-Franciscus Ziekenhuis, Heusden-Zolder

RECRUITING

St. Trudo Ziekenhuis, Sint-Truiden

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Medtronic

INDUSTRY

lead

Studie- & Opleidingscentrum Neurochirurgie Virga Jesse

OTHER