Overview

Evaluation of the effectiveness of differential target multiplexed spinal cord stimulation for treatment of chronic back and leg pain. Additionally, a subgroup analysis will be performed to evaluate potential differences between paddle/surgical leads versus percutaneous leads.

Eligibility

Inclusion Criteria:

• Patients with severe chronic pain (> 5 on numeric rating scale, NRS) for at least 6 months due to FBSS (PSPS T2) and suitable for treatment with DTM SCS according to the treating physician
• Age > 18 years
• Patient has been informed of the study procedures and has given written informed consent
• Patient willing to comply with study protocol including attending the study visits

Exclusion Criteria:

• Expected inability of the patient to receive or properly operate the spinal cord stimulation system
• History of coagulation disorder, lupus erythematosus, diabetic neuropathy, rheumatoid arthritis, or morbus Bechterew
• Active malignancy
• Addiction to drugs, alcohol (>5 units per day) and/or medication
• Evidence of an active disruptive psychiatric disorder or other known condition that may impact perception of pain, compliance to the intervention, and/or ability to evaluate treatment outcome as determined by investigator
• Immune deficiency (e.g. HIV positive, immunosuppressive treatment)
• Life expectancy < 1 year
• Local infection or any other skin disorder at site of incision
• Pregnancy
• Other implanted active medical device