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
- Conditions
- Pain, Intractable
- Interventions
- Device: Spinal Cord Stimulation
- Registration Number
- NCT04587674
- Lead Sponsor
- Poitiers University Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 110
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Spinal Cord Stimulation Spinal Cord Stimulation -
- Primary Outcome Measures
Name Time Method Composite SCS efficacy score 6 months 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
Name Time Method Functional capacity 6 months Functional capacity will be assessed using the Oswestry Disability Index (ODI, 0 "no disability" to 100% "complete disability")
Spinal Cord Stimulation efficacy using objective measurement tools 6 months Intellis/SnapshotTM platform to the ActiGraph GT9X.
-Sleep onset latency given by GT9X,Impact of Quality of life 6 months Quality of life will be assessed using the EuroQol Five Dimensions index (EQ5D, 0 "dead" to 1 "perfect health")
Psychological distress 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)
Psychological resilience 6 months Psychological resilience will be assessed using the CD-RISC-10 (10-item Connor-Davidson Resilience Scale) questionnaire. \[0 = low resilience to 40 = high resilience\]
Effects of the technical parameters and Spinal Cord Stimulation devices on paresthesia 6 months % of Stimulation Waveform (Low Dose, High Dose, Both), Electrical parameters
Pain intensity 6 months Pain intensity will be assessed using the Visual Analogic Scale (VAS score : 0 "no pain" to 10 "worst pain")
Pain surface 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.
Social insecurity 6 months Social insecurity will be assessed using the EPICES questionnaire \[0 = low risk of insecurity to 100 = high risk of insecurity\]
Trial Locations
- Locations (7)
Caen Univerisity Hospital
🇫🇷Caen, France
Parc Polyclinic
🇫🇷Caen, France
Louis Pasteur Hospital
🇫🇷Colmar, France
Nice University Hospital, Cimiez Hospital
🇫🇷Nice, France
Lyon University Hospitals
🇫🇷Lyon, France
Poitiers Hospital University
🇫🇷Poitiers, France
Foch Hospital
🇫🇷Suresnes, France