Pain, Intractable
Conditions
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.
Interventions
DEVICESpinal Cord Stimulation
Lead(s) and Implant Pulse Generator
Sponsors
Poitiers University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Functional capacity | 6 months | Functional capacity will be assessed using the Oswestry Disability Index (ODI, 0 no disability to 100% complete disability) |
| 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) |
| Pain intensity | 6 months | Pain intensity will be assessed using the Visual Analogic Scale (VAS score : 0 no pain to 10 worst pain) |
| 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 Type of lead (Spinal Cord Stimulation Monocolumn vs Multicolumn Lead) |
| Spinal Cord Stimulation efficacy using objective measurement tools | 6 months | Intellis/SnapshotTM platform to the ActiGraph GT9X. -Duration of standing position given by both Intellis and GT9X, |
| Social insecurity | 6 months | Social insecurity will be assessed using the EPICES questionnaire \[0 = low risk of insecurity to 100 = high risk of insecurity\] |
Countries
France
Outcome results
None listed