Identification of Outcome Predictors and Stratification of Responder Profiles Implanted With Spinal Cord Stimulation. An AI-based-pathway & Algorithmic Approach to Treat Failed Back Surgery Syndrome Patients
Identification of Outcome Predictors and Stratification of Responder Profiles Implanted With Spinal Cord Stimulation. An AI-based-pathway & Algorithmic Approach to Treat Failed Back Surgery Syndrome Patients
Failed Back Surgery Syndrome is commonly defined as new, recurrent, or persistent pain in the
 back and/or leg(s) of at least 6-month duration following spinal surgery. The literature
 estimates that 10-50% of patients undergoing spinal surgery are likely to develop such pain,
 representing a substantial financial burden. Among them, 5-10% would suffer from severe pain,
 which are intense, neuropathic and generally refractory to conventional therapeutic
 strategies considerably affect patients' functional capacity as well as their psychological
 and social well-being.

 Spinal Cord Stimulation (SCS) is a well-established therapy to alleviate severe intractable
 neuropathic pain such as FBSS. SCS is a safe and reversible treatment option, which leads to
 improvement in pain relief and quality of life for patients with FBSS. Despite encouraging
 results in a chronic painful patient population that is refractory to conventional therapies,
 the literature estimates that only 58% [53% - 64%] of patients implanted with SCS devices
 achieved adequate pain relief.

 FBSS population characterization and stratification and predictive modeling of SCS outcome
 are thus crucial to delineate future treatment options and to deliver neuromodulation therapy
 to the right patient.

 The investigators designed a clinical prospective project based on SCS outcome optimization
 and SCS candidates' stratification: PREDIBACK 2.

 This study would be a following part of a continuous project (PREDIBACK) that aims to better
 understand and stratify the therapies (drugs, surgery, psychological therapy or SCS) proposed
 to FBSS patients. The goal of PREDIBACK 1 was to develop a decision tool that simplifies the
 therapeutic decision process.

 PREDIBACK 2 will focus on the neuromodulation pathway. Easing and helping patient orientation
 should improve referral yielding to specialists and accelerate patient flow through care
 pathway. Hence, facilitating access to adequate therapies for FBSS patients who usually have
 a longstanding history of pain.
Selection Criteria:

 -  Subject is ≥ 18 years and ≤ 80 years.

 -  Subject has FBSS and does not require further surgery. For the purpose of this study,
 FBSS is defined as persistent or recurrent low back and leg pain of at least 6-month
 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.

 -  VAS global pain is ≥ 50 mm.

 -  Subject meets the criteria for spinal cord stimulation test according to HAS
 guidelines (multidisciplinary consultation, psychological assessment...).

 -  Absence of active psychosis or history of serious psychotic illness requiring
 hospitalization.

 -  Subject understands and accepts the constraints of the study.

 -  Patient covered by French national health insurance.

 -  Patient who has given written consent to the study after having received clear
 information.

 Non-inclusion Criteria:

 -  Subject is or has been treated with SCS, subcutaneous or peripheral nerve stimulation,
 an intrathecal drug delivery system, requires back surgery at the localization related
 to his/her original back pain complaint or experimental therapies.

 -  Subject low back pain is coming from a non-FBSS etiology (i.e. cancerous pain,
 infectious disease, etc.).

 -  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.

 -  Simultaneous participation to any interventional study during the study

 -  Subject 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 patient in an emergency setting.

 -  MRI contraindications if MRI is not available within a time frame of 2 years from
 the last spinal surgery. Absolute contraindications are: Cardiac implantable
 electronic device, metallic intraocular foreign bodies, cochlear implants, drug
 infusion pumps, catheters with metallic components, cerebral artery aneurysm
 clips, magnetic dental implants, tissue expander, artificial limb, hearing aid,
 piercing