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NCT04500691 Clinical Trial

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

Failed Back Surgery Syndrome Clinical Trial

— REPORT  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04500691
Other study ID # REPORT
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 15, 2020
Est. completion date June 15, 2020

Study information
Verified date August 2020
Source Universitair Ziekenhuis Brussel
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 122
Est. completion date June 15, 2020
Est. primary completion date June 15, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- FBSS patients treated with high frequency spinal cord stimulation implantation.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• pain intensity reporting
pain intensity reporting

Locations
Country Name City State
Belgium UZ Brussel Jette
Belgium AZ Nikolaas Sint-Niklaas

Sponsors (2)
Lead Sponsor Collaborator
Moens Maarten AZ Nikolaas

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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.
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