- ICH GCP
- US Clinical Trials Registry
- 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 (PREDIBACK 2)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Manul ROULAUD, MSc
- Phone Number: +33 5 49 44 32 23
- Email: manuel.roulaud@chu-poitiers.fr
Study Locations
-
-
-
Caen, France, 14052
- Recruiting
- Parc Polyclinic
-
Contact:
- Violaine D'ANS, MD
- Email: violaine.dans@orange.fr
-
Principal Investigator:
- Violaine D'ANS, MD
-
Caen, France, 14000
- Recruiting
- Caen Univerisity Hospital
-
Contact:
- Camille DI PALMA, MD
- Phone Number: 02 31 06 46 04
- Email: dipalma-c@chu-caen.fr
-
Principal Investigator:
- Camille DI PALMA, MD
-
Colmar, France, 68000
- Recruiting
- Louis Pasteur Hospital
-
Contact:
- Jimmy VOIRIN, MD
- Phone Number: 03.89.12.42.07
- Email: jimmy.voirin@ch-colmar.fr
-
Principal Investigator:
- Jimmy VOIRIN, MD
-
Lyon, France, 69500
- Recruiting
- Lyon University Hospitals
-
Contact:
- Manon DURAFFOURG, MD
- Email: manon.duraffourg@yahoo.fr
-
Principal Investigator:
- Manon DURAFFOURG, MD
-
Nice, France, 06000
- Recruiting
- Nice University Hospital, Cimiez Hospital
-
Contact:
- Denys FONTAINE, MD, PhD
- Phone Number: 04 92 03 85 03
- Email: fontaine.d@chu-nice.fr
-
Principal Investigator:
- Denys FONTAINE, MD, PhD
-
Sub-Investigator:
- Aurélie LEPLUS WUERTZER, MD
-
Sub-Investigator:
- Michel LANTERI-MINET, MD
-
Sub-Investigator:
- Emilie PIQUET-RAYNAUD, MD
-
Poitiers, France, 86021
- Recruiting
- Poitiers Hospital University
-
Contact:
- Véronique FERRAND-RIGALLAUD
- Phone Number: +33 5 49 44 46 65
- Email: Veronique.FERRAND-RIGALLAUD@chu-poitiers.fr
-
Principal Investigator:
- Philippe RIGOARD, MD, PhD
-
Suresnes, France, 92151
- Completed
- Foch Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Spinal Cord Stimulation
|
Lead(s) and Implant Pulse Generator
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Composite SCS efficacy score
Time Frame: 6 months
|
Rate of SCS responders is defined as having at least three of these criteria:
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain intensity
Time Frame: 6 months
|
Pain intensity will be assessed using the Visual Analogic Scale (VAS score : 0 "no pain" to 10 "worst pain")
|
6 months
|
Pain surface
Time Frame: 6 months
|
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.
|
6 months
|
Functional capacity
Time Frame: 6 months
|
Functional capacity will be assessed using the Oswestry Disability Index (ODI, 0 "no disability" to 100% "complete disability")
|
6 months
|
Impact of Quality of life
Time Frame: 6 months
|
Quality of life will be assessed using the EuroQol Five Dimensions index (EQ5D, 0 "dead" to 1 "perfect health")
|
6 months
|
Psychological distress
Time Frame: 6 months
|
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)
|
6 months
|
Social insecurity
Time Frame: 6 months
|
Social insecurity will be assessed using the EPICES questionnaire [0 = low risk of insecurity to 100 = high risk of insecurity]
|
6 months
|
Psychological resilience
Time Frame: 6 months
|
Psychological resilience will be assessed using the CD-RISC-10 (10-item Connor-Davidson Resilience Scale) questionnaire.
[0 = low resilience to 40 = high resilience]
|
6 months
|
Effects of the technical parameters and Spinal Cord Stimulation devices on paresthesia
Time Frame: 6 months
|
% of Type of lead (Spinal Cord Stimulation Monocolumn vs Multicolumn Lead)
|
6 months
|
Effects of the technical parameters and Spinal Cord Stimulation devices on paresthesia
Time Frame: 6 months
|
Stimulation intensity (mA, milliAmper)
|
6 months
|
Effects of the technical parameters and Spinal Cord Stimulation devices on paresthesia
Time Frame: 6 months
|
Stimulation pulse width (µs, microsecond)
|
6 months
|
Effects of the technical parameters and Spinal Cord Stimulation devices on paresthesia
Time Frame: 6 months
|
Stimulation frequency (Hz, Hertz)
|
6 months
|
Effects of the technical parameters and Spinal Cord Stimulation devices on paresthesia
Time Frame: 6 months
|
% of Stimulation Waveform (Low Dose, High Dose, Both), Electrical parameters
|
6 months
|
Spinal Cord Stimulation efficacy using objective measurement tools
Time Frame: 6 months
|
Intellis/SnapshotTM platform to the ActiGraph GT9X. -Duration of standing position given by both Intellis and GT9X, |
6 months
|
Spinal Cord Stimulation efficacy using objective measurement tools
Time Frame: 6 months
|
Intellis/SnapshotTM platform to the ActiGraph GT9X. -Duration of sitting position given by both Intellis and GT9X, |
6 months
|
Spinal Cord Stimulation efficacy using objective measurement tools
Time Frame: 6 months
|
Intellis/SnapshotTM platform to the ActiGraph GT9X. -Duration of lying position given by both Intellis and GT9X, |
6 months
|
Spinal Cord Stimulation efficacy using objective measurement tools
Time Frame: 6 months
|
Intellis/SnapshotTM platform to the ActiGraph GT9X. -Duration of mobile position (activity) given by both Intellis and GT9X, |
6 months
|
Spinal Cord Stimulation efficacy using objective measurement tools
Time Frame: 6 months
|
Intellis/SnapshotTM platform to the ActiGraph GT9X. -Number of steps given by GT9X, |
6 months
|
Spinal Cord Stimulation efficacy using objective measurement tools
Time Frame: 6 months
|
Intellis/SnapshotTM platform to the ActiGraph GT9X. -Sleep duration given by GT9X, |
6 months
|
Spinal Cord Stimulation efficacy using objective measurement tools
Time Frame: 6 months
|
Intellis/SnapshotTM platform to the ActiGraph GT9X. -Sleep efficacy given by GT9X, |
6 months
|
Spinal Cord Stimulation efficacy using objective measurement tools
Time Frame: 6 months
|
Intellis/SnapshotTM platform to the ActiGraph GT9X. -Sleep onset latency given by GT9X, |
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Philippe RIGOARD, MD, PhD, Poitiers Hospital University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-A01734-35
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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