Chronic Pain Clinical Trial
Official title:
A Multicenter Prospective Study on Failed Back Surgery Syndrome Pathway Optimization: A Focus on Patient Identification, Chronicization Factors and Outcome Predictors
This pilot study is part of a global project that aims to better define and understand
features of FBSS/POPS "post-operative persistent syndrome patients (shortened as "FBSS" in
the following project). FBSS is the acronym for Failed Back Surgery Syndrome, which has been
defined as a chronic condition resulting from spinal interventions. Despite anatomically
successful spine surgery, a significant proportion of patients is experiencing chronic
refractory back and leg pain. In a recent multicentre study conducted on more than 100
refractory FBSS patients, (ESTIMET Study), the mean delay between pain occurrence and FBSS
diagnosis was 5 years. Therefore, FBSS pattern and potential responder stratification might
guide us to eventually develop a decision tool for identifying FBSS patients. Easing and
helping diagnosis of FBSS should improve referral yield to specialists and accelerate patient
flow through the care pathway. Hence, FBSS patients, who usually present a long standing
history of pain, would have access to "appropriate" therapies earlier. This could lead to
better outcomes. The aim of this multicentre, prospective study is to collect specific data
that are not collected in routine in order to better define and understand the potential FBSS
population and to accelerate the diagnostic and optimize the choice of appropriate treatment.
A multidisciplinary approach through a pain management clinical network, as it has been
structured in Poitiers, will ensure that an exhaustive characterization of FBSS patients and
their care pathway will be collected. In addition, since the cooperation between orthopaedic
and neuro spine surgeons is not a common relationship found all over Europe (as it is
observed in Poitiers), this study also aims to better understand the development of
interactions between physicians/professionals and the substantial advantage which would
result from bridging this gap. The N3MT (NeuroMapping Tools) software developed in Poitiers
to collect data and assess objectively pain surface and intensity changes, before/after any
treatment, with quantitative measurements, will be used as the central key of this project.
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