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

NCT ID: NCT02964130

Last Updated: 2019-07-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2019-05-31

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 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.

Conditions

Failed Back Surgery Syndrome; Chronic Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Follow-up patient

Medical follow-up visit

Group Type: OTHER

No name

Intervention Type: OTHER

Interventions

No name

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patient has signed and dated the Informed Consent Form.
• Patient is ≥ 18 years of age at time of "Informed Consent Form" signature.
• Patient had most recent back surgery more than 6 months ago.
• Patient has developed post-operative Chronic Back with or without Leg Pain (potential FBSS).
• Patient has persistent back pain for more than 6 months.
• Average low back or leg pain is ≥ 4 as assessed by the baseline NPRS.

Exclusion Criteria

• Patient has already a confirmed FBSS diagnosis.
• Patient is or has been treated with SCS, subcutaneous or peripheral nerve stimulation, an intrathecal drug delivery system.
• Investigator suspects substance abuse that might confound the study results.
• Patient has a life expectancy of less than 12 months beyond study enrollment.
• Patient is less than 18 years of age.
• Patient is pregnant or planning to become pregnant during the course of the study.
• Patient is unable to undergo study assessments or complete questionnaires independently (e.g., is illiterate).
• Patient is a member of a vulnerable population.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Poitiers University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philippe RIGOARD, PU-PH

Role: PRINCIPAL_INVESTIGATOR

Poitiers Hospital University

Locations

Poitiers Hospital University

Poitiers, , France

Countries

France

References

Billot M, Ounajim A, Moens M, Goudman L, Deneuville JP, Roulaud M, Nivole K, Many M, Baron S, Lorgeoux B, Bouche B, Lampert L, David R, Rigoard P. The Added Value of Digital Body Chart Pain Surface Assessment as an Objective Biomarker: Multicohort Study. J Med Internet Res. 2025 Apr 16;27:e62786. doi: 10.2196/62786.

Reference Type: DERIVED

PMID: 40239206 (View on PubMed)

Other Identifiers

2016-A01144-47

Identifier Type: -

Identifier Source: org_study_id