Clinical Trial: Study on Failed Back Surgery Syndrome Pathway Optimization: A Focus on Patient Identification, Chronicization Factors and Outcome Predictors

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: A Multicenter Prospective Study on Failed Back Surgery Syndrome Pathway Optimization: A Focus on Patient Identification, Chronicization Factors and Outcome Predictors

Brief Summary:

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

Detailed Summary:
Sponsor: Poitiers University Hospital

Current Primary Outcome: Incidence of clinical diagnosis of FBSS [ Time Frame: 12 month-follow up visit ]

Incidence of clinical diagnosis of FBSS in the broad population of post-surgical pain syndrome, identified by multidisciplinary team of independent experts (1 pain physician, 1 neurosurgeon and 1 psychiatric), with morphological and clinical characterization of the syndrome.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Pain intensity (NRPS) [ Time Frame: Initial visit and 3 month, 6 month, 9 month and 12 month-follow up Visits ]
    • Reduction of the NRPS score measuring pain intensity: Global pain, Back pain and Leg pain.
    • Proportion of patients with NRPS score < 4.
    • Proportion of patients obtaining a reduction ≥ 25%, 50% and 75%: Global pain, Back pain and Leg pain NRPS.
  • Pain surface and intensity (Mapping Tool) [ Time Frame: Initial visit and 3 month, 6 month, 9 month and 12 month-follow up Visits ]
    • Reduction of the Global Pain Surface measured on the NeuroPain't module of the software, during treatment, before/after a therapeutic strategy is used.
    • Reduction of pain intensities associated with the quantitative surface measurements.
    • Reduction of the mechanical/neuropathic component of objective pain.
  • Functional capacity (ODI) [ Time Frame: Initial visit and 3 month, 6 month, 9 month and 12 month-follow up Visits ]
  • Quality of life (EQ5D) [ Time Frame: Initial visit and 3 month, 6 month, 9 month and 12 month-follow up Visits ]
  • Psychological State (HADS) [ Time Frame: Initial visit and 3 month, 6 month, 9 month and 12 month-follow up Visits ]
  • Pain Catastrophizing Scale (PCS CF) [ Time Frame: Initial visit and 3 month, 6 month, 9 month and 12 month-follow up Visits ]
  • Adverse Events/ Serious Adverse Events [ Time Frame: Initial visit and 3 month, 6 month, 9 month and 12 month-follow up Visits ]


Original Secondary Outcome: Same as current

Information By: Poitiers University Hospital

Dates:
Date Received: November 7, 2016
Date Started: November 2016
Date Completion: November 2017
Last Updated: November 14, 2016
Last Verified: November 2016