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Completed

NCT Number: NCT04500691

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

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.

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Key information

Conditions

Failed Back Surgery Syndrome Back Pain Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UZ Brussel, Jette, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

pain intensity reporting

Other

pain intensity reporting

Primary outcomes

  1. Responder status

    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.

    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.

Sponsors and collaborators

Lead sponsor

Moens Maarten

Other

Collaborators

  • AZ Nikolaas

Registry information

Acronym: REPORT

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Aug 5, 2020
Registry last updated
Aug 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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