An interventional study of Spinal Cord Stimulation in Pain, Intractable, sponsored by Poitiers University Hospital. Completed at 7 sites in France. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-05-30.
Sponsored by Poitiers University Hospital · Not applicable, Interventional, and Screening
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.
90 studies on the registry are indexed under Pain, Intractable; 16 are open to participants now.
This study's enrollment of 110 is above the median of 60 across 64 interventional studies indexed under Pain, Intractable.
Browse Pain, Intractable studies →Poitiers University Hospital is the lead sponsor of 314 studies on the registry; 62 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Selection Criteria:
Non-inclusion Criteria:
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Spinal Cord Stimulation
Lead(s) and Implant Pulse Generator
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.
Time frame: 6 months
Pain intensity
Pain intensity will be assessed using the Visual Analogic Scale (VAS score : 0 "no pain" to 10 "worst pain")
Time frame: 6 months
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.
Time frame: 6 months
Functional capacity
Functional capacity will be assessed using the Oswestry Disability Index (ODI, 0 "no disability" to 100% "complete disability")
Time frame: 6 months
Impact of Quality of life
Quality of life will be assessed using the EuroQol Five Dimensions index (EQ5D, 0 "dead" to 1 "perfect health")
Time frame: 6 months
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)
Time frame: 6 months
Social insecurity
Social insecurity will be assessed using the EPICES questionnaire \[0 = low risk of insecurity to 100 = high risk of insecurity\]
Time frame: 6 months
Psychological resilience
Psychological resilience will be assessed using the CD-RISC-10 (10-item Connor-Davidson Resilience Scale) questionnaire. \[0 = low resilience to 40 = high resilience\]
Time frame: 6 months
Effects of the technical parameters and Spinal Cord Stimulation devices on paresthesia
% of Type of lead (Spinal Cord Stimulation Monocolumn vs Multicolumn Lead)
Time frame: 6 months
Effects of the technical parameters and Spinal Cord Stimulation devices on paresthesia
Stimulation intensity (mA, milliAmper)
Time frame: 6 months
Effects of the technical parameters and Spinal Cord Stimulation devices on paresthesia
Stimulation pulse width (µs, microsecond)
Time frame: 6 months
Effects of the technical parameters and Spinal Cord Stimulation devices on paresthesia
Stimulation frequency (Hz, Hertz)
Time frame: 6 months
Effects of the technical parameters and Spinal Cord Stimulation devices on paresthesia
% of Stimulation Waveform (Low Dose, High Dose, Both), Electrical parameters
Time frame: 6 months
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,
Time frame: 6 months
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,
Time frame: 6 months
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,
Time frame: 6 months
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,
Time frame: 6 months
Spinal Cord Stimulation efficacy using objective measurement tools
Intellis/SnapshotTM platform to the ActiGraph GT9X. -Number of steps given by GT9X,
Time frame: 6 months
Spinal Cord Stimulation efficacy using objective measurement tools
Intellis/SnapshotTM platform to the ActiGraph GT9X. -Sleep duration given by GT9X,
Time frame: 6 months
Spinal Cord Stimulation efficacy using objective measurement tools
Intellis/SnapshotTM platform to the ActiGraph GT9X. -Sleep efficacy given by GT9X,
Time frame: 6 months
Spinal Cord Stimulation efficacy using objective measurement tools
Intellis/SnapshotTM platform to the ActiGraph GT9X. -Sleep onset latency given by GT9X,
Time frame: 6 months
Plan to share: No
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This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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