Failed Back Surgery SyndromePREDIBACKNCT02964130
Study on Failed Back Surgery Syndrome Pathway Optimization: A Focus on Patient Identification, Chronicization Factors and Outcome Predictors
A study testing No name in people with Failed Back Surgery Syndrome and Chronic Pain, run by Poitiers University Hospital at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Failed Back Surgery Syndrome, Chronic Pain
- What is being tested?
- No name
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2017to 31 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Failed Back Surgery Syndrome, Chronic Pain
- Being tested
- No name
- Medical subject headings
- Failed Back Surgery Syndrome, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No nameOther
| Study group | Role | What they receive |
|---|---|---|
| Follow-up patient | Other | Medical follow-up visit Receives: Other: No name |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 month-follow up visit
Secondary outcomes (7)
Pain intensity (NRPS)
- 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.
Measured: Initial visit and 3 month, 6 month, 9 month and 12 month-follow up Visits
Pain surface and intensity (Mapping Tool)
- 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.
Measured: Initial visit and 3 month, 6 month, 9 month and 12 month-follow up Visits
Functional capacity (ODI)
Measured: Initial visit and 3 month, 6 month, 9 month and 12 month-follow up Visits
Quality of life (EQ5D)
Measured: Initial visit and 3 month, 6 month, 9 month and 12 month-follow up Visits
Psychological State (HADS)
Measured: Initial visit and 3 month, 6 month, 9 month and 12 month-follow up Visits
Pain Catastrophizing Scale (PCS CF)
Measured: Initial visit and 3 month, 6 month, 9 month and 12 month-follow up Visits
Adverse Events/ Serious Adverse Events
Measured: Initial visit and 3 month, 6 month, 9 month and 12 month-follow up Visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2016 (estimated)
- Study startJan 2017
- Primary completion16 May 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Failed Back Surgery SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe RIGOARD, PU-PH, Principal investigator, Poitiers Hospital University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02964130
- Sponsor's protocol ID
- 2016-A01144-47
- Acronym
- PREDIBACK
- Status last verified
- Jul 2019
- First submitted
- 7 Nov 2016
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 39758999Billot 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.
PubMed 40239206Naiditch 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.
PubMed 34202362Ounajim 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.
PubMed 34682799Rigoard 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.
PubMed 34768428Ounajim 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.
PubMed 39639445
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Prospective Study on Failed Back Surgery Syndrome Pathway Optimization: A Focus on Patient Identification, Chronicization Factors and Outcome Predictors
- ClinicalTrials.gov ID
- NCT02964130
- Acronym / sponsor ID
- PREDIBACK / 2016-A01144-47
- Conditions
- Failed Back Surgery Syndrome, Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- 16 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 15 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Follow-up patient | Other | Other: No nameMedical follow-up visit |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No name | Other | Follow-up patient |
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.
7 secondary outcomes
Pain intensity (NRPS)
Time frame: Initial visit and 3 month, 6 month, 9 month and 12 month-follow up Visits
Pain surface and intensity (Mapping Tool)
Time frame: Initial visit and 3 month, 6 month, 9 month and 12 month-follow up Visits
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Results publication: PubMed 39758999Rigoard 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.
- Results publication: PubMed 40239206Billot 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.
- Results publication: PubMed 34202362Naiditch 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.
- Results publication: PubMed 34682799Ounajim 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.
- Results publication: PubMed 34768428Rigoard 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.
- Results publication: PubMed 39639445Ounajim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe RIGOARD, PU-PH principal investigator
Poitiers Hospital University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No name in people with Failed Back Surgery Syndrome and Chronic Pain, run by Poitiers University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of clinical diagnosis of FBSS (time frame: 12 month-follow up visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02964130, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026; AzTrials last refreshed its copy on 27 Oct 2026.