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

NCT ID: NCT04587674

Last Updated: 2025-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-19
• Study Completion Date: 2025-05-16

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.

Conditions

Pain, Intractable

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Spinal Cord Stimulation

Group Type: OTHER

Spinal Cord Stimulation

Intervention Type: DEVICE

Lead(s) and Implant Pulse Generator

Interventions

Spinal Cord Stimulation

Lead(s) and Implant Pulse Generator

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Poitiers University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philippe RIGOARD, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Poitiers Hospital University

Locations

Caen Univerisity Hospital

Caen, , France

Parc Polyclinic

Caen, , France

Louis Pasteur Hospital

Colmar, , France

Lyon University Hospitals

Lyon, , France

Nice University Hospital, Cimiez Hospital

Nice, , France

Poitiers Hospital University

Poitiers, , France

Foch Hospital

Suresnes, , France

Countries

France

Other Identifiers

2020-A01734-35

Identifier Type: -

Identifier Source: org_study_id