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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04500691

Acronym

REPORT

Enrollment

122

Registered

2020-08-05

Start date

2020-06-15

Completion date

2020-06-15

Last updated

2020-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Failed Back Surgery Syndrome

Keywords

High frequency Spinal Cord Stimulation, prediction

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.

Interventions

OTHERpain intensity reporting

pain intensity reporting

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026