Neurostimulation options for failed back surgery syndrome: The need for rational and objective measurements. Proposal of an international clinical network using an integrated database and health economic analysis: the PROBACK network

Abstract

Introduction: In the context of failed back surgery syndrome (FBSS) treatment, the current practice in neurostimulation varies from center-to-center and most clinical decisions are based on an individual diagnosis. Neurostimulation evaluation tools and pain relief assessment are of major concern, as they now constitute one of the main biases of clinical trials. Moreover, the proliferation of technological devices, in a fertile and unsatisfied market, fosters and only furthers the confusion. There are three options available to apply scientific debates to our daily neurostimulation practice: intentional ignorance, standardized evidence-based practice or alternative data mining approach.

Objective: In view of the impossibility of conducting multiple randomized clinical trials comparing various devices, one by one, the proposed concept would be to redefine the indications and the respective roles of the various spinal cord and peripheral nerve stimulation devices with large-scale computational modeling/data mining approach, by conducting a multicenter prospective database registry, supported by a clinician's global network called "PROBACK".

Methods: We chose to specifically analyze 6 parameters: device coverage performance/coverage selectivity/persistence of the long-term electrical response (technical criteria) and comparative mapping of patient pain relief/persistence of the long-term clinical response/safety and complications occurrence (clinical criteria). Two types of analysis will be performed: immediate analysis (including cost analysis) and computational analysis, i.e. demonstration of the robustness of certain correlations of variables, in order to extract response predictors.

Discussion/conclusion: By creating an international prospective database, the purpose of the PROBACK project was to set up a process of extraction and comparative analysis of data derived from the selection, implantation and follow-up of FBSS patients candidates for implanted neurostimulation. This evaluation strategy should help to change the opinions of each implanter and each health system towards a more rational decision-making approach subtended by mathematical reality.

Keywords: Base de données; Data mining; Database; Failed back surgery syndrome; Lombo-radiculalgies postopératoires; Network; Neurostimulation; Outcome predictors; Prédicteurs de réponse; Réseau de cliniciens.