REPORT: pRedicting the Long-term rEsponse of High Frequency sPinal cOrd sTimulation in Patients With Failed Back Surgery Syndrome.
Sponsor
Moens Maarten (Other)
Overall Status
Completed
CT.gov ID
NCT04500691
Collaborator
AZ Nikolaas (Other)
122
2
61
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
122 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
pRedicting the Long-term rEsponse of High Frequency sPinal cOrd sTimulation in Patients With Failed Back Surgery Syndrome.
Actual Study Start Date
:
Jun 15, 2020
Actual Primary Completion Date
:
Jun 15, 2020
Actual Study Completion Date
:
Jun 15, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| FBSS patients FBSS patients who are treated with high frequency Spinal Cord Stimulation |
Other: pain intensity reporting
pain intensity reporting
|
Outcome Measures
Primary Outcome Measures
- Responder status [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.]
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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- FBSS patients treated with high frequency spinal cord stimulation implantation.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UZ Brussel | Jette | Belgium | ||
| 2 | AZ Nikolaas | Sint-Niklaas | Belgium |
Sponsors and Collaborators
- Moens Maarten
- AZ Nikolaas
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Moens Maarten,
Principal Investigator,
Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier:
NCT04500691
Other Study ID Numbers:
- REPORT
First Posted:
Aug 5, 2020
Last Update Posted:
Aug 5, 2020
Last Verified:
Aug 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Moens Maarten,
Principal Investigator,
Universitair Ziekenhuis Brussel
Additional relevant MeSH terms: