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

Completed

• Conditions: Failed Back Surgery Syndrome
• Interventions: Other: pain intensity reporting

• Registration Number: NCT04500691
• Lead Sponsor: Moens Maarten

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-15
• Primary Completion: 2020-06-15
• Study Completion: 2020-06-15
• Study First Submitted: 2020-07-09
• Status Verified: 2020-08
• Study First Submitted QC: 2020-08-04
• Last Update Submitted: 2020-08-04
• Study First Posted: 2020-08-05
• Last Update Posted: 2020-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
FBSS patients	pain intensity reporting	FBSS patients who are treated with high frequency Spinal Cord Stimulation

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

UZ Brussel; 🇧🇪 Jette, Belgium

AZ Nikolaas; 🇧🇪 Sint-Niklaas, Belgium