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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 (PREDIBACK 2)

Primary Purpose

Pain, Intractable

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Spinal Cord Stimulation
Sponsored by
Poitiers University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Pain, Intractable

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Caen Univerisity HospitalRecruiting
  • Parc PolyclinicRecruiting
  • Louis Pasteur HospitalRecruiting
  • Lyon University HospitalsRecruiting
  • Nice University Hospital, Cimiez HospitalRecruiting
  • Poitiers Hospital UniversityRecruiting
  • Foch Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Spinal Cord Stimulation

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Pain intensity
Pain intensity will be assessed using the Visual Analogic Scale (VAS score : 0 "no pain" to 10 "worst pain")
Pain surface
Pain mapping criteria will be compared. Pain mapping criteria include: Global Pain Surface (cm²), Pain intensities associated with the surface measurements, Mechanical/neuropathic components of pain surfaces.
Functional capacity
Functional capacity will be assessed using the Oswestry Disability Index (ODI, 0 "no disability" to 100% "complete disability")
Impact of Quality of life
Quality of life will be assessed using the EuroQol Five Dimensions index (EQ5D, 0 "dead" to 1 "perfect health")
Psychological distress
Psychological distress will be assessed using the Hospital Anxiety and Depression Scale (HADS, For each subscale the total score is at most 21. A score of ≥11 is considered a clinically significant disorder)
Social insecurity
Social insecurity will be assessed using the EPICES questionnaire [0 = low risk of insecurity to 100 = high risk of insecurity]
Psychological resilience
Psychological resilience will be assessed using the CD-RISC-10 (10-item Connor-Davidson Resilience Scale) questionnaire. [0 = low resilience to 40 = high resilience]
Effects of the technical parameters and Spinal Cord Stimulation devices on paresthesia
% of Type of lead (Spinal Cord Stimulation Monocolumn vs Multicolumn Lead)
Effects of the technical parameters and Spinal Cord Stimulation devices on paresthesia
Stimulation intensity (mA, milliAmper)
Effects of the technical parameters and Spinal Cord Stimulation devices on paresthesia
Stimulation pulse width (µs, microsecond)
Effects of the technical parameters and Spinal Cord Stimulation devices on paresthesia
Stimulation frequency (Hz, Hertz)
Effects of the technical parameters and Spinal Cord Stimulation devices on paresthesia
% of Stimulation Waveform (Low Dose, High Dose, Both), Electrical parameters
Spinal Cord Stimulation efficacy using objective measurement tools
Intellis/SnapshotTM platform to the ActiGraph GT9X. -Duration of standing position given by both Intellis and GT9X,
Spinal Cord Stimulation efficacy using objective measurement tools
Intellis/SnapshotTM platform to the ActiGraph GT9X. -Duration of sitting position given by both Intellis and GT9X,
Spinal Cord Stimulation efficacy using objective measurement tools
Intellis/SnapshotTM platform to the ActiGraph GT9X. -Duration of lying position given by both Intellis and GT9X,
Spinal Cord Stimulation efficacy using objective measurement tools
Intellis/SnapshotTM platform to the ActiGraph GT9X. -Duration of mobile position (activity) given by both Intellis and GT9X,
Spinal Cord Stimulation efficacy using objective measurement tools
Intellis/SnapshotTM platform to the ActiGraph GT9X. -Number of steps given by GT9X,
Spinal Cord Stimulation efficacy using objective measurement tools
Intellis/SnapshotTM platform to the ActiGraph GT9X. -Sleep duration given by GT9X,
Spinal Cord Stimulation efficacy using objective measurement tools
Intellis/SnapshotTM platform to the ActiGraph GT9X. -Sleep efficacy given by GT9X,
Spinal Cord Stimulation efficacy using objective measurement tools
Intellis/SnapshotTM platform to the ActiGraph GT9X. -Sleep onset latency given by GT9X,

Full Information

First Posted
September 4, 2020
Last Updated
July 27, 2023
Sponsor
Poitiers University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04587674
Brief 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
Acronym
PREDIBACK 2
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 19, 2021 (Actual)
Primary Completion Date
December 19, 2023 (Anticipated)
Study Completion Date
August 19, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Intractable

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Spinal Cord Stimulation
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Spinal Cord Stimulation
Intervention Description
Lead(s) and Implant Pulse Generator
Primary Outcome Measure Information:
Title
Composite SCS efficacy score
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Pain intensity
Description
Pain intensity will be assessed using the Visual Analogic Scale (VAS score : 0 "no pain" to 10 "worst pain")
Time Frame
6 months
Title
Pain surface
Description
Pain mapping criteria will be compared. Pain mapping criteria include: Global Pain Surface (cm²), Pain intensities associated with the surface measurements, Mechanical/neuropathic components of pain surfaces.
Time Frame
6 months
Title
Functional capacity
Description
Functional capacity will be assessed using the Oswestry Disability Index (ODI, 0 "no disability" to 100% "complete disability")
Time Frame
6 months
Title
Impact of Quality of life
Description
Quality of life will be assessed using the EuroQol Five Dimensions index (EQ5D, 0 "dead" to 1 "perfect health")
Time Frame
6 months
Title
Psychological distress
Description
Psychological distress will be assessed using the Hospital Anxiety and Depression Scale (HADS, For each subscale the total score is at most 21. A score of ≥11 is considered a clinically significant disorder)
Time Frame
6 months
Title
Social insecurity
Description
Social insecurity will be assessed using the EPICES questionnaire [0 = low risk of insecurity to 100 = high risk of insecurity]
Time Frame
6 months
Title
Psychological resilience
Description
Psychological resilience will be assessed using the CD-RISC-10 (10-item Connor-Davidson Resilience Scale) questionnaire. [0 = low resilience to 40 = high resilience]
Time Frame
6 months
Title
Effects of the technical parameters and Spinal Cord Stimulation devices on paresthesia
Description
% of Type of lead (Spinal Cord Stimulation Monocolumn vs Multicolumn Lead)
Time Frame
6 months
Title
Effects of the technical parameters and Spinal Cord Stimulation devices on paresthesia
Description
Stimulation intensity (mA, milliAmper)
Time Frame
6 months
Title
Effects of the technical parameters and Spinal Cord Stimulation devices on paresthesia
Description
Stimulation pulse width (µs, microsecond)
Time Frame
6 months
Title
Effects of the technical parameters and Spinal Cord Stimulation devices on paresthesia
Description
Stimulation frequency (Hz, Hertz)
Time Frame
6 months
Title
Effects of the technical parameters and Spinal Cord Stimulation devices on paresthesia
Description
% of Stimulation Waveform (Low Dose, High Dose, Both), Electrical parameters
Time Frame
6 months
Title
Spinal Cord Stimulation efficacy using objective measurement tools
Description
Intellis/SnapshotTM platform to the ActiGraph GT9X. -Duration of standing position given by both Intellis and GT9X,
Time Frame
6 months
Title
Spinal Cord Stimulation efficacy using objective measurement tools
Description
Intellis/SnapshotTM platform to the ActiGraph GT9X. -Duration of sitting position given by both Intellis and GT9X,
Time Frame
6 months
Title
Spinal Cord Stimulation efficacy using objective measurement tools
Description
Intellis/SnapshotTM platform to the ActiGraph GT9X. -Duration of lying position given by both Intellis and GT9X,
Time Frame
6 months
Title
Spinal Cord Stimulation efficacy using objective measurement tools
Description
Intellis/SnapshotTM platform to the ActiGraph GT9X. -Duration of mobile position (activity) given by both Intellis and GT9X,
Time Frame
6 months
Title
Spinal Cord Stimulation efficacy using objective measurement tools
Description
Intellis/SnapshotTM platform to the ActiGraph GT9X. -Number of steps given by GT9X,
Time Frame
6 months
Title
Spinal Cord Stimulation efficacy using objective measurement tools
Description
Intellis/SnapshotTM platform to the ActiGraph GT9X. -Sleep duration given by GT9X,
Time Frame
6 months
Title
Spinal Cord Stimulation efficacy using objective measurement tools
Description
Intellis/SnapshotTM platform to the ActiGraph GT9X. -Sleep efficacy given by GT9X,
Time Frame
6 months
Title
Spinal Cord Stimulation efficacy using objective measurement tools
Description
Intellis/SnapshotTM platform to the ActiGraph GT9X. -Sleep onset latency given by GT9X,
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Manul ROULAUD, MSc
Phone
+33 5 49 44 32 23
Email
manuel.roulaud@chu-poitiers.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe RIGOARD, MD, PhD
Organizational Affiliation
Poitiers Hospital University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Caen Univerisity Hospital
City
Caen
ZIP/Postal Code
14000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Camille DI PALMA, MD
Phone
02 31 06 46 04
Email
dipalma-c@chu-caen.fr
First Name & Middle Initial & Last Name & Degree
Camille DI PALMA, MD
Facility Name
Parc Polyclinic
City
Caen
ZIP/Postal Code
14052
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Violaine D'ANS, MD
Email
violaine.dans@orange.fr
First Name & Middle Initial & Last Name & Degree
Violaine D'ANS, MD
Facility Name
Louis Pasteur Hospital
City
Colmar
ZIP/Postal Code
68000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jimmy VOIRIN, MD
Phone
03.89.12.42.07
Email
jimmy.voirin@ch-colmar.fr
First Name & Middle Initial & Last Name & Degree
Jimmy VOIRIN, MD
Facility Name
Lyon University Hospitals
City
Lyon
ZIP/Postal Code
69500
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manon DURAFFOURG, MD
Email
manon.duraffourg@yahoo.fr
First Name & Middle Initial & Last Name & Degree
Manon DURAFFOURG, MD
Facility Name
Nice University Hospital, Cimiez Hospital
City
Nice
ZIP/Postal Code
06000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Denys FONTAINE, MD, PhD
Phone
04 92 03 85 03
Email
fontaine.d@chu-nice.fr
First Name & Middle Initial & Last Name & Degree
Denys FONTAINE, MD, PhD
First Name & Middle Initial & Last Name & Degree
Aurélie LEPLUS WUERTZER, MD
First Name & Middle Initial & Last Name & Degree
Michel LANTERI-MINET, MD
First Name & Middle Initial & Last Name & Degree
Emilie PIQUET-RAYNAUD, MD
Facility Name
Poitiers Hospital University
City
Poitiers
ZIP/Postal Code
86021
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Véronique FERRAND-RIGALLAUD
Phone
+33 5 49 44 46 65
Email
Veronique.FERRAND-RIGALLAUD@chu-poitiers.fr
First Name & Middle Initial & Last Name & Degree
Philippe RIGOARD, MD, PhD
Facility Name
Foch Hospital
City
Suresnes
ZIP/Postal Code
92151
Country
France
Individual Site Status
Completed

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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