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

NCT02964130 | Completed

• 1 other identifier: 2016-A01144-47
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Incidence of clinical diagnosis of FBSS

  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.

  12 month-follow up visit

Secondary Outcomes (7)

• Pain intensity (NRPS)

  Initial visit and 3 month, 6 month, 9 month and 12 month-follow up Visits

• Pain surface and intensity (Mapping Tool)

  Initial visit and 3 month, 6 month, 9 month and 12 month-follow up Visits

• Functional capacity (ODI)

  Initial visit and 3 month, 6 month, 9 month and 12 month-follow up Visits

• Quality of life (EQ5D)

  Initial visit and 3 month, 6 month, 9 month and 12 month-follow up Visits

• Psychological State (HADS)

  Initial visit and 3 month, 6 month, 9 month and 12 month-follow up Visits

Study Arms (1)

Follow-up patient

OTHER

Medical follow-up visit

Other: No name

Interventions

No name OTHER

Follow-up patient

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (1)

Poitiers Hospital University

Poitiers, France

Location

Related Publications (6)

• Rigoard P, Ounajim A, Moens M, Goudman L, Roulaud M, Naiditch N, Boukenna R, Page P, Bouche B, Lorgeoux B, Baron S, Nivole K, Many M, Lampert L, Brumauld de Montgazon G, Roy-Moreau B, David R, Billot M. A digital tool for multidimensional assessment and prediction of treatment effectiveness in chronic pain management. iScience. 2024 Oct 18;27(12):111200. doi: 10.1016/j.isci.2024.111200. eCollection 2024 Dec 20.

  PMID: 39758999 RESULT

• 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.

  PMID: 40239206 RESULT

• Naiditch N, Billot M, Moens M, Goudman L, Cornet P, Le Breton D, Roulaud M, Ounajim A, Page P, Lorgeoux B, Nivole K, Pries P, Swennen C, Teyssedou S, Charrier E, de Montgazon GB, Descoins PF, Roy-Moreau B, Grimaud N, David R, Vendeuvre T, Rigoard P. Persistent Spinal Pain Syndrome Type 2 (PSPS-T2), a Social Pain? Advocacy for a Social Gradient of Health Approach to Chronic Pain. J Clin Med. 2021 Jun 25;10(13):2817. doi: 10.3390/jcm10132817.

  PMID: 34202362 RESULT

• Ounajim A, Billot M, Louis PY, Slaoui Y, Frasca D, Goudman L, Roulaud M, Naiditch N, Lorgeoux B, Baron S, Nivole K, Many M, Adjali N, Page P, Bouche B, Charrier E, Poupin L, Rannou D, de Montgazon GB, Roy-Moreau B, Wood C, Rigoard R, David R, Moens M, Rigoard P. Finite Mixture Models Based on Pain Intensity, Functional Disability and Psychological Distress Composite Assessment Allow Identification of Two Distinct Classes of Persistent Spinal Pain Syndrome after Surgery Patients Related to Their Quality of Life. J Clin Med. 2021 Oct 13;10(20):4676. doi: 10.3390/jcm10204676.

  PMID: 34682799 RESULT

• Rigoard P, Ounajim A, Goudman L, Louis PY, Slaoui Y, Roulaud M, Naiditch N, Bouche B, Page P, Lorgeoux B, Baron S, Charrier E, Poupin L, Rannou D, de Montgazon GB, Roy-Moreau B, Grimaud N, Adjali N, Nivole K, Many M, David R, Wood C, Rigoard R, Moens M, Billot M. A Novel Multi-Dimensional Clinical Response Index Dedicated to Improving Global Assessment of Pain in Patients with Persistent Spinal Pain Syndrome after Spinal Surgery, Based on a Real-Life Prospective Multicentric Study (PREDIBACK) and Machine Learning Techniques. J Clin Med. 2021 Oct 24;10(21):4910. doi: 10.3390/jcm10214910.

  PMID: 34768428 RESULT

• Ounajim A, Billot M, Babin E, Goudman L, Moens M, Roulaud M, Lorgeoux B, Baron S, Nivole K, Many M, Lampert L, Borel S, David R, Rigoard P. Identification of health trajectories of patients with persistent spinal pain syndrome type 2 using latent class trajectory methods. Eur J Pain. 2025 Jan;29(1). doi: 10.1002/ejp.4762.

  PMID: 39639445 RESULT

MeSH Terms

Conditions

Failed Back Surgery Syndrome; Chronic Pain

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Philippe RIGOARD, PU-PH

  Poitiers Hospital University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2016
• First Posted: November 15, 2016
• Study Start: January 1, 2017
• Primary Completion: May 16, 2019
• Study Completion: May 31, 2019
• Last Updated: February 27, 2026

Record last verified: 2019-07

Locations

FR (1)