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

Moens Maarten122 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

122

Conditions

Failed Back Surgery Syndrome

Interventions

pain intensity reportingOTHER

pain intensity reporting

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * FBSS patients treated with high frequency spinal cord stimulation implantation.

Locations (2)

UZ Brussel

Jette, Belgium

AZ Nikolaas

Sint-Niklaas, Belgium

Outcomes

Primary Outcomes

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.

Data from ClinicalTrials.gov

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