A novel, objective, quantitative method of evaluation of the back pain component using comparative computerized multi-parametric tactile mapping before/after spinal cord stimulation and database analysis: The “Neuro-Pain’t” software

Comparison of conventional, burst and high-frequency spinal cord stimulation on pain relief in refractory failed back surgery syndrome patients: study protocol for a prospective randomized double-blinded cross-over trial (MULTIWAVE study)

“…2 An artistic view illustrating SCS implantation with a 32-contact surgical lead. TCS, BURST and HF waveforms are described by frequency, pulse width and amplitude Software) [24,25]. The goal of the lead implantation is to address the sweet spot location (an anatomical area located within the dorsal columns (DC) of the spinal cord), able when electrically stimulated to generate significant paraesthesia in the appropriate back dermatoma.…”

“…Some TCS patterns will be tested using various predetermined combinations, in order to achieve good pain coverage, by targeting the sweet spot location with objective quantitative measurements by tactile interface mapping data (NeuroMapping Tools Software) [24,25]. This is facilitated by our integrated operating theatre, dedicated to SCS implantation, including several of the new computer-assisted and imaging-assisted technologies (multiple screens with live wall projection, full HD camera filming patient feedback and C-arm screen implementation, HF microphones and earphones enhancing surgeon/patient per-operative interactions).…”

“…After completion of lead programming testing, the lead will be permanently implanted and secured with appropriate anchoring, at its final vertebral level. A final X-ray check will be performed to ensure that the lead has been adequately secured and will not be subject to displacement, once the lead programming and the patient coverage are optimal [24,25].…”

“…Secondary outcomes are variation of leg and back pain relief, as measured by VAS [32]; proportion of responders in each group, as responder defined by ≥ 50% reduction of pain; variation of functional disability, as measured by the Oswestry Disability Index Questionnaire (ODI) [33]; variation of quality of life, as measured by EuroQol-5 Dimension (EQ5D) [34]; variation of anxiety and depression, as measured by Hospital Anxiety and Depression Scale (HADS) [35]; variation of paraesthesia, as measured by VAS; the patient satisfaction, as measured by Patient Global Impression of Change (PGIC) [36]; and adverse events, device deficiencies and concomitant treatments. Further, pain surface, pain intensities and paraesthesia surface are quantified with objective quantitative measurements (Neuro-Pain Software) to compare Global Pain Surface reduction, pain intensity reduction and paraesthesia coverage surface between arms groups [24,25].…”

“…Subjects who proceed to device implantation have the following information collected: pain/paraesthesia by tactile interface mapping data (NeuroMapping Tools software), lead programming parameter settings, electrode location and device implant information. The NeuroMapping tool is a validated quantitative tactile interface allowing the patient to delineate painful zones in the back and legs and to precisely map objective changes in pain coverage and SCS performance [24,25]. Unscheduled patient visits could occur between scheduled study follow-up visits due to patient discontinuation from the study or device reprogramming and management of any complication.…”