Patient profiling and outcome assessment in spinal cord stimulation for chronic back and/or leg pain (the PROSTIM study): a study protocol

Vincent Raymaekers; Sacha Meeuws; Lisa Goudman; Gregory Van der Steen; Maarten Moens; Maarten Vanloon; Dirk De Ridder; Tomas Menovsky; Jan Vesper; Mark Plazier

doi:10.2217/pmt-2023-0103

Patient profiling and outcome assessment in spinal cord stimulation for chronic back and/or leg pain (the PROSTIM study): a study protocol

Vincent Raymaekers, Sacha Meeuws, Lisa Goudman, Gregory Van der Steen, Maarten Moens, Maarten Vanloon, Dirk De Ridder, Tomas Menovsky, Jan Vesper, Mark Plazier

Research output: Contribution to journal › Article › peer-review

1 Citation (Scopus)

Abstract

Spinal cord stimulation (SCS) is a well-established treatment option in the multidisciplinary approach to chronic back and leg pain. Nevertheless, careful patient selection remains crucial to provide the most optimal treatment and prevent treatment failure. We report the protocol for the PROSTIM study, an ongoing prospective, multicentric and observational clinical study (NCT05349695) that aims to identify different patient clusters and their outcomes after SCS. Patients are recruited in different centers in Europe. Analysis focuses on identifying significant patient clusters based on different health domains and the changes in biopsychosocial variables 6 weeks, 3 and 12 months after implantation. This study is the first to include a biopsychosocial cluster analysis to identify significant patient groups and their response to treatment with SCS.

Original language	English
Pages (from-to)	677-687
Number of pages	11
Journal	Pain Management
Volume	13
Issue number	12
DOIs	https://doi.org/10.2217/pmt-2023-0103
Publication status	Published - Dec 2023

Bibliographical note

Funding Information:
This investigator-initiated study is part of a prospective big data collection in spine pathology, supported by Medtronic, Inc., Europe (grant no. NM-3422). Medtronic was not involved in the collection and analysis of the data or in writing the article. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties. Competing interests disclosure

Publisher Copyright:
© 2023 Future Medicine Ltd.. All rights reserved.

Keywords

Humans
Chronic Pain/therapy
Low Back Pain/therapy
Spinal Cord Stimulation/methods
Leg
Prospective Studies
Outcome Assessment, Health Care
Treatment Outcome
Spinal Cord

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abstract = "Spinal cord stimulation (SCS) is a well-established treatment option in the multidisciplinary approach to chronic back and leg pain. Nevertheless, careful patient selection remains crucial to provide the most optimal treatment and prevent treatment failure. We report the protocol for the PROSTIM study, an ongoing prospective, multicentric and observational clinical study (NCT05349695) that aims to identify different patient clusters and their outcomes after SCS. Patients are recruited in different centers in Europe. Analysis focuses on identifying significant patient clusters based on different health domains and the changes in biopsychosocial variables 6 weeks, 3 and 12 months after implantation. This study is the first to include a biopsychosocial cluster analysis to identify significant patient groups and their response to treatment with SCS.",

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author = "Vincent Raymaekers and Sacha Meeuws and Lisa Goudman and {der Steen}, {Gregory Van} and Maarten Moens and Maarten Vanloon and Ridder, {Dirk De} and Tomas Menovsky and Jan Vesper and Mark Plazier",

note = "Funding Information: This investigator-initiated study is part of a prospective big data collection in spine pathology, supported by Medtronic, Inc., Europe (grant no. NM-3422). Medtronic was not involved in the collection and analysis of the data or in writing the article. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties. Competing interests disclosure Publisher Copyright: {\textcopyright} 2023 Future Medicine Ltd.. All rights reserved.",

year = "2023",

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language = "English",

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Patient profiling and outcome assessment in spinal cord stimulation for chronic back and/or leg pain (the PROSTIM study): a study protocol

Abstract

Bibliographical note

Keywords

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