AzTrials
AzTrials

Pain, IntractablePREDIBACK 2NCT04587674

Identification of Outcome Predictors and Stratification of Responder Profiles Implanted With Spinal Cord Stimulation. An AI-based-pathway & Algorithmic Approach to Treat Failed Back Surgery Syndrome Patients

A study testing Spinal Cord Stimulation in people with Pain, Intractable, run by Poitiers University Hospital at 7 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Failed Back Surgery Syndrome is commonly defined as new, recurrent, or persistent pain in the back and/or leg(s) of at least 6-month duration following spinal surgery. The literature estimates that 10-50% of patients undergoing spinal surgery are likely to develop such pain, representing a substantial financial… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Pain, Intractable
What is being tested?
Spinal Cord Stimulation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
7 sitesFrance
Study dates
19 Apr 2021to 16 May 2025
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

Selection Criteria:

  • Subject is ≥ 18 years and ≤ 80 years.
  • Subject has FBSS and does not require further surgery. For the purpose of this study, FBSS is defined as persistent or recurrent low back and leg pain of at least 6-month duration following at least one decompression and/or fusion procedure.
  • Subject has persistent low back and leg pain despite other treatment modalities (pharmacological, surgical, physical, or psychological therapies) that have been tried and did not prove satisfactory or are unsuitable or contraindicated for the subject.
  • VAS global pain is ≥ 50 mm.
  • Subject meets the criteria for spinal cord stimulation test according to HAS guidelines (multidisciplinary consultation, psychological assessment...).
  • Absence of active psychosis or history of serious psychotic illness requiring hospitalization.
  • Subject understands and accepts the constraints of the study.
  • Patient covered by French national health insurance.
  • Patient who has given written consent to the study after having received clear information.

Non-inclusion Criteria:

  • Subject is or has been treated with SCS, subcutaneous or peripheral nerve stimulation, an intrathecal drug delivery system, requires back surgery at the localization related to his/her original back pain complaint or experimental therapies.
  • Subject low back pain is coming from a non-FBSS etiology (i.e. cancerous pain, infectious disease, etc.).
  • Cause of low back pain accessible to etiological "mechanical" surgical treatment (discogenic low back pain, vertebral instability, spinal deformity, etc.).
  • Subject had most recent back surgery less than 6 months ago.
  • Simultaneous participation to any interventional study during the study
  • Subject requiring closer protection, i.e. minors, pregnant women, nursing mothers, subjects deprived of their freedom by a court or administrative decision, subjects admitted to a health or social welfare establishment, major subjects under legal protection, and finally patient in an emergency setting.
  • MRI contraindications if MRI is not available within a time frame of 2 years from the last spinal surgery. Absolute contraindications are: Cardiac implantable electronic device, metallic intraocular foreign bodies, cochlear implants, drug infusion pumps, catheters with metallic components, cerebral artery aneurysm clips, magnetic dental implants, tissue expander, artificial limb, hearing aid, piercing

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

France7 sites

  • Caen Univerisity Hospital

    Caen, 14000

  • Parc Polyclinic

    Caen, 14052

  • Louis Pasteur Hospital

    Colmar, 68000

  • Lyon University Hospitals

    Lyon, 69500

  • Nice University Hospital, Cimiez Hospital

    Nice, 06000

  • Poitiers Hospital University

    Poitiers, 86021

  • Foch Hospital

    Suresnes, 92151

Other trials in France

About this study

Failed Back Surgery Syndrome is commonly defined as new, recurrent, or persistent pain in the back and/or leg(s) of at least 6-month duration following spinal surgery. The literature estimates that 10-50% of patients undergoing spinal surgery are likely to develop such pain, representing a substantial financial burden. Among them, 5-10% would suffer from severe pain, which are intense, neuropathic and generally refractory to conventional therapeutic strategies considerably affect patients' functional capacity as well as their psychological and social well-being.

Spinal Cord Stimulation (SCS) is a well-established therapy to alleviate severe intractable neuropathic pain such as FBSS. SCS is a safe and reversible treatment option, which leads to improvement in pain relief and quality of life for patients with FBSS. Despite encouraging results in a chronic painful patient population that is refractory to conventional therapies, the literature estimates that only 58% [53% - 64%] of patients implanted with SCS devices achieved adequate pain relief.

Read more

FBSS population characterization and stratification and predictive modeling of SCS outcome are thus crucial to delineate future treatment options and to deliver neuromodulation therapy to the right patient.

The investigators designed a clinical prospective project based on SCS outcome optimization and SCS candidates' stratification: PREDIBACK 2.

This study would be a following part of a continuous project (PREDIBACK) that aims to better understand and stratify the therapies (drugs, surgery, psychological therapy or SCS) proposed to FBSS patients. The goal of PREDIBACK 1 was to develop a decision tool that simplifies the therapeutic decision process.

PREDIBACK 2 will focus on the neuromodulation pathway. Easing and helping patient orientation should improve referral yielding to specialists and accelerate patient flow through care pathway. Hence, facilitating access to adequate therapies for FBSS patients who usually have a longstanding history of pain.

Being tested
Spinal Cord Stimulation
Medical subject headings
Pain, Intractable

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Spinal Cord StimulationDevice

    Lead(s) and Implant Pulse Generator

Study groups in NCT04587674
Study groupRoleWhat they receive
Spinal Cord StimulationOtherNot described
Receives: Device: Spinal Cord Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite SCS efficacy score

    Rate of SCS responders is defined as having at least three of these criteria:

    • Having at least a 30% decrease in Oswestry Disability Index (ODI) percentage. 10 items ranging from 0 to 5 where 0 indicates high ability and 5 indicate the inability.
    • Having at least a 50% decrease in the Visual Analogic Scale (VAS) (0 = no back pain, 10=worst imaginable pain)
    • Having at least a 0.2 points increase in the EuroQol-5 Dimensions (EQ-5D) questionnaire score. The maximum score of 1 indicates the best possible quality of life.
    • Having a decrease of 1.4 points in the Hospital Anxiety-Depression Scale (HADS) score. The total score ranges from 0 to 24 for each category.
    • 30% decrease pain surface (cm²): pain will assess painful area in terms of intensity, surface and pain typology.
    • Having a Patient Global Impression of Change (PGIC) score of at least 6. PGIC is a 7-point scale.
    • Drug intake will be measured using the Medication Quantification Scale (MQS) with a reduction of 3.4 points.

    Measured: 6 months

Secondary outcomes (20)

  1. Pain intensity

    Pain intensity will be assessed using the Visual Analogic Scale (VAS score : 0 "no pain" to 10 "worst pain")

    Measured: 6 months

  2. Pain surface

    Pain mapping criteria will be compared. Pain mapping criteria include: Global Pain Surface (cm²), Pain intensities associated with the surface measurements, Mechanical/neuropathic components of pain surfaces.

    Measured: 6 months

  3. Functional capacity

    Functional capacity will be assessed using the Oswestry Disability Index (ODI, 0 "no disability" to 100% "complete disability")

    Measured: 6 months

  4. Impact of Quality of life

    Quality of life will be assessed using the EuroQol Five Dimensions index (EQ5D, 0 "dead" to 1 "perfect health")

    Measured: 6 months

  5. Psychological distress

    Psychological distress will be assessed using the Hospital Anxiety and Depression Scale (HADS, For each subscale the total score is at most 21. A score of ≥11 is considered a clinically significant disorder)

    Measured: 6 months

  6. Social insecurity

    Social insecurity will be assessed using the EPICES questionnaire [0 = low risk of insecurity to 100 = high risk of insecurity]

    Measured: 6 months

  7. Psychological resilience

    Psychological resilience will be assessed using the CD-RISC-10 (10-item Connor-Davidson Resilience Scale) questionnaire. [0 = low resilience to 40 = high resilience]

    Measured: 6 months

  8. Effects of the technical parameters and Spinal Cord Stimulation devices on paresthesia

    % of Type of lead (Spinal Cord Stimulation Monocolumn vs Multicolumn Lead)

    Measured: 6 months

  9. Effects of the technical parameters and Spinal Cord Stimulation devices on paresthesia

    Stimulation intensity (mA, milliAmper)

    Measured: 6 months

  10. Effects of the technical parameters and Spinal Cord Stimulation devices on paresthesia

    Stimulation pulse width (µs, microsecond)

    Measured: 6 months

  11. Effects of the technical parameters and Spinal Cord Stimulation devices on paresthesia

    Stimulation frequency (Hz, Hertz)

    Measured: 6 months

  12. Effects of the technical parameters and Spinal Cord Stimulation devices on paresthesia

    % of Stimulation Waveform (Low Dose, High Dose, Both), Electrical parameters

    Measured: 6 months

  13. Spinal Cord Stimulation efficacy using objective measurement tools

    Intellis/SnapshotTM platform to the ActiGraph GT9X.

    -Duration of standing position given by both Intellis and GT9X,

    Measured: 6 months

  14. Spinal Cord Stimulation efficacy using objective measurement tools

    Intellis/SnapshotTM platform to the ActiGraph GT9X.

    -Duration of sitting position given by both Intellis and GT9X,

    Measured: 6 months

  15. Spinal Cord Stimulation efficacy using objective measurement tools

    Intellis/SnapshotTM platform to the ActiGraph GT9X.

    -Duration of lying position given by both Intellis and GT9X,

    Measured: 6 months

  16. Spinal Cord Stimulation efficacy using objective measurement tools

    Intellis/SnapshotTM platform to the ActiGraph GT9X.

    -Duration of mobile position (activity) given by both Intellis and GT9X,

    Measured: 6 months

  17. Spinal Cord Stimulation efficacy using objective measurement tools

    Intellis/SnapshotTM platform to the ActiGraph GT9X.

    -Number of steps given by GT9X,

    Measured: 6 months

  18. Spinal Cord Stimulation efficacy using objective measurement tools

    Intellis/SnapshotTM platform to the ActiGraph GT9X.

    -Sleep duration given by GT9X,

    Measured: 6 months

  19. Spinal Cord Stimulation efficacy using objective measurement tools

    Intellis/SnapshotTM platform to the ActiGraph GT9X.

    -Sleep efficacy given by GT9X,

    Measured: 6 months

  20. Spinal Cord Stimulation efficacy using objective measurement tools

    Intellis/SnapshotTM platform to the ActiGraph GT9X.

    -Sleep onset latency given by GT9X,

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2020
  2. Study start19 Apr 2021
  3. Primary completion19 Jun 2024
  4. Study completion16 May 2025

Resources

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
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04587674
Sponsor's protocol ID
2020-A01734-35
Acronym
PREDIBACK 2
Status last verified
May 2025
First submitted
4 Sep 2020
Last updated
30 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Spinal Cord Stimulation in people with Pain, Intractable, run by Poitiers University Hospital at 7 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites 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?

Composite SCS efficacy score (time frame: 6 months). 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 NCT04587674.

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 30 May 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in