Clinical trial NCT04587674: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Intractable
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2020-10-14
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Composite SCS efficacy score
timeFrame: 6 months
Secondary outcomes:
measure: Pain intensity
timeFrame: 6 months
measure: Pain surface
timeFrame: 6 months
measure: Functional capacity
timeFrame: 6 months
measure: Impact of Quality of life
timeFrame: 6 months
measure: Psychological distress
timeFrame: 6 months
measure: Social insecurity
timeFrame: 6 months
measure: Psychological resilience
timeFrame: 6 months
measure: Effects of the technical parameters and Spinal Cord Stimulation devices on paresthesia
timeFrame: 6 months
measure: Effects of the technical parameters and Spinal Cord Stimulation devices on paresthesia
timeFrame: 6 months
measure: Effects of the technical parameters and Spinal Cord Stimulation devices on paresthesia
timeFrame: 6 months
measure: Effects of the technical parameters and Spinal Cord Stimulation devices on paresthesia
timeFrame: 6 months
measure: Effects of the technical parameters and Spinal Cord Stimulation devices on paresthesia
timeFrame: 6 months
measure: Spinal Cord Stimulation efficacy using objective measurement tools
timeFrame: 6 months
measure: Spinal Cord Stimulation efficacy using objective measurement tools
timeFrame: 6 months
measure: Spinal Cord Stimulation efficacy using objective measurement tools
timeFrame: 6 months
measure: Spinal Cord Stimulation efficacy using objective measurement tools
timeFrame: 6 months
measure: Spinal Cord Stimulation efficacy using objective measurement tools
timeFrame: 6 months
measure: Spinal Cord Stimulation efficacy using objective measurement tools
timeFrame: 6 months
measure: Spinal Cord Stimulation efficacy using objective measurement tools
timeFrame: 6 months
measure: Spinal Cord Stimulation efficacy using objective measurement tools
timeFrame: 6 months
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen Univerisity Hospital
city: Caen
country: France
facility: Parc Polyclinic
city: Colmar
country: France
facility: Louis Pasteur Hospital
city: Lyon
country: France
facility: Lyon University Hospitals
city: Nice
country: France
facility: Nice University Hospital, Cimiez Hospital
city: Poitiers
country: France
facility: Poitiers Hospital University
city: Suresnes
country: France
facility: Foch Hospital
Study officials:
affiliation: Poitiers Hospital University
name: Philippe RIGOARD, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: