CClinicalTrials.gg
CompletedNCT04500691REPORTUpdated Aug 5, 2020

pRedicting the Long-term rEsponse of High Frequency sPinal cOrd sTimulation in Patients With Failed Back Surgery Syndrome.

An observational study in Failed Back Surgery Syndrome, sponsored by Moens Maarten. Completed at 2 sites in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-08-05.

Sponsored by Moens Maarten · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
122
Ages
18 Years and older
Sex
All
01

Study summary

The aim of the current retrospective study is to predict responders for HF10-SCS therapy by only using baseline data. Data collected through clinical practice until June 2020 will be used in this retrospective analysis.

02

Conditions studied

  • Failed Back Surgery Syndrome

Keywords

  • High frequency Spinal Cord Stimulation
  • prediction
03

In context

Syndrome

9,217 studies on the registry are indexed under Syndrome; 1,031 are open to participants now.

This study's enrollment of 122 is above the median of 102 across 2,209 observational studies indexed under Syndrome.

Browse Syndrome studies →

Lead sponsor

Moens Maarten is the lead sponsor of 22 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with FBSS treated with high frequency spinal cord stimulation implantation.

Eligibility criteria

Inclusion Criteria:

  • FBSS patients treated with high frequency spinal cord stimulation implantation.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
122 participants (actual)
Patient registry
No

Groups and cohorts

  • FBSS patients

    FBSS patients who are treated with high frequency Spinal Cord Stimulation

    Other: pain intensity reporting

Interventions

  • Otherpain intensity reporting

    pain intensity reporting

06

What researchers measure

Primary outcomes

  1. Responder status

    A responder is defined as a patient who has 50% pain relief for the predominant pain location at the last follow-up visit compared to baseline.

    Time frame: The difference in pain intensity from the date that a patient was eligible for Spinal Cord Stimulation (i.e. baseline) up to the date of the last routine care visit with Spinal Cord Stimulation with database lock at 15th of June 2020.

07

Study locations

2 sites
  • UZ Brussel
    Jette, Belgium
  • AZ Nikolaas
    Sint-Niklaas, Belgium
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 5, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04500691
Lead sponsor
Moens Maarten
Collaborators
AZ Nikolaas
Responsible party
Moens Maarten (Principal Investigator, Universitair Ziekenhuis Brussel) — Sponsor-investigator
First posted
Aug 5, 2020
Start date
Jun 15, 2020
Primary completion
Jun 15, 2020
Completion
Jun 15, 2020
Last update
Aug 5, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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