Study Comparing Conventional, Burst and High Frequency (HF) Spinal Cord Stimulation (SCS) in Refractory Failed Back Surgery Syndrome (FBSS) Patients After a 32-contact Surgical Lead Implantation

Inclusion criteria

• Age ≥ 18 years or ≤ 80 years.
• Subject has FBSS and does not require further surgery. For the purposes of this study, FBSS is defined as persistent or recurrent low back and leg pain of at least 6 months duration following at least one decompression and/or fusion procedure.
• Subject has persistent low back and leg pain despite other treatment modalities (pharmacological, surgical, physical, or psychological therapies) that have been tried and did not prove satisfactory or are unsuitable or contraindicated for the subject.
• Average global pain is ≥ 50 mm as assessed by the baseline VAS.
• With significant back, with mean intensity on a back pain VAS ≥ 50 mm (mean daily VAS score calculated on 5 consecutive days).
• Meeting the criteria for spinal cord stimulation test according to HAS guidelines (multidisciplinary consultation, psychological assessment, etc.).
• Subject is a candidate for SCS.
• Absence of active psychosis or history of serious psychotic illness requiring hospitalisation.
• Understands and accepts the constraints of the study.
• Free subject, not under temporary or permanent guardianship and not subject to subordination.
• Patients covered by French national health insurance.
• Patients who have given their written consent to the study after having received clear information.

Exclusion criteria

• Age < 18 years or > 80 years
• Subject is or has been treated with SCS, subcutaneous or peripheral nerve stimulation, an intrathecal drug delivery system, requires back surgery at the location related to his/her original back pain complaint or experimental therapies.
• Cause of low back pain accessible to etiological "mechanical" surgical treatment (discogenic low back pain, vertebral instability, spinal deformity, etc.).
• Subject had most recent back surgery less than 6 months ago.
• Presenting a surgical, anaesthetic or psychiatric contraindication to implantation of a spinal cord stimulation system.
• Based on the opinion of the principal or sub-investigator, the subject is unable to operate the SCS equipment.
• Subject has a life expectancy of less than 24 months beyond study enrolment.
• Absence of signature of the informed consent form.
• Patients not covered by French national health insurance.
• Subjects requiring closer protection, i.e. minors, pregnant women, nursing mothers, subjects deprived of their freedom by a court or administrative decision, subjects admitted to a health or social welfare establishment, major subjects under legal protection, and finally patients in an emergency setting.
• Pregnant women, nursing mothers, women of childbearing potential not using effective contraception (hormonal/barrier: oral, parenteral, percutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total ovariectomy).