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

NCT04587674 | Completed

• 1 other identifier: 2020-A01734-35
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 7

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

Outcome Measures

Primary Outcomes (1)

• Composite SCS efficacy score

  Rate of SCS responders is defined as having at least three of these criteria: * Having at least a 30% decrease in Oswestry Disability Index (ODI) percentage. 10 items ranging from 0 to 5 where 0 indicates high ability and 5 indicate the inability. * Having at least a 50% decrease in the Visual Analogic Scale (VAS) (0 = no back pain, 10=worst imaginable pain) * Having at least a 0.2 points increase in the EuroQol-5 Dimensions (EQ-5D) questionnaire score. The maximum score of 1 indicates the best possible quality of life. * Having a decrease of 1.4 points in the Hospital Anxiety-Depression Scale (HADS) score. The total score ranges from 0 to 24 for each category. * 30% decrease pain surface (cm²): pain will assess painful area in terms of intensity, surface and pain typology. * Having a Patient Global Impression of Change (PGIC) score of at least 6. PGIC is a 7-point scale. * Drug intake will be measured using the Medication Quantification Scale (MQS) with a reduction of 3.4 points.

  6 months

Secondary Outcomes (20)

• Pain intensity

  6 months

• Pain surface

  6 months

• Functional capacity

  6 months

• Impact of Quality of life

  6 months

• Psychological distress

  6 months

Study Arms (1)

Spinal Cord Stimulation

OTHER

Device: Spinal Cord Stimulation

Interventions

Spinal Cord Stimulation DEVICE

Lead(s) and Implant Pulse Generator

Spinal Cord Stimulation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (7)

Caen Univerisity Hospital

Caen, 14000, France

Location

Parc Polyclinic

Caen, 14052, France

Location

Louis Pasteur Hospital

Colmar, 68000, France

Location

Lyon University Hospitals

Lyon, 69500, France

Location

Nice University Hospital, Cimiez Hospital

Nice, 06000, France

Location

Poitiers Hospital University

Poitiers, 86021, France

Location

Foch Hospital

Suresnes, 92151, France

Location

MeSH Terms

Conditions

Pain, Intractable

Interventions

Spinal Cord Stimulation

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Philippe RIGOARD, MD, PhD

  Poitiers Hospital University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2020
• First Posted: October 14, 2020
• Study Start: April 19, 2021
• Primary Completion: June 19, 2024
• Study Completion: May 16, 2025
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (7)