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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Follow-up patient | Other | Medical follow-up visit |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No name | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity (NRPS) |
| Initial visit and 3 month, 6 month, 9 month and 12 month-follow up Visits |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philippe RIGOARD, PU-PH | Poitiers Hospital University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Poitiers Hospital University | Poitiers | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39758999 | Result | 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. | |
| 40239206 |
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| 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 |
| Pain Catastrophizing Scale (PCS CF) | Initial visit and 3 month, 6 month, 9 month and 12 month-follow up Visits |
| Adverse Events/ Serious Adverse Events | Initial visit and 3 month, 6 month, 9 month and 12 month-follow up Visits |
| 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. |
| 34202362 | 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. |
| 34682799 | 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. |
| 34768428 | 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. |
| 39639445 | 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. |
| ID | Term |
|---|---|
| D055111 | Failed Back Surgery Syndrome |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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