pRedicting the Long-term rEsponse of High Frequency sPinal cOrd sTimulation in Patients With Failed Back Surgery Syndrome.
REPORT
1 other identifier
observational
122
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2020
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 15, 2020
CompletedFirst Submitted
Initial submission to the registry
July 9, 2020
CompletedFirst Posted
Study publicly available on registry
August 5, 2020
CompletedAugust 5, 2020
August 1, 2020
Same day
July 9, 2020
August 4, 2020
Conditions
Keywords
Outcome Measures
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.
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.
Study Arms (1)
FBSS patients
FBSS patients who are treated with high frequency Spinal Cord Stimulation
Interventions
Eligibility Criteria
Patients with FBSS treated with high frequency spinal cord stimulation implantation.
You may qualify if:
- FBSS patients treated with high frequency spinal cord stimulation implantation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Moens Maartenlead
- AZ Nikolaascollaborator
Study Sites (2)
UZ Brussel
Jette, Belgium
AZ Nikolaas
Sint-Niklaas, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 9, 2020
First Posted
August 5, 2020
Study Start
June 15, 2020
Primary Completion
June 15, 2020
Study Completion
June 15, 2020
Last Updated
August 5, 2020
Record last verified: 2020-08