Patient Profiling and Outcome Assessment in Spinal Cord Stimulation for Chronic Back and/or Leg Pain (the PROSTIM study): A Study Protocol

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.

Plain language summary

What is the study about? Spinal cord stimulation (SCS) is a treatment for chronic back and leg pain, in which an electrical stimulation is delivered to the spinal cord in order to reduce pain experience. It is important to choose the right patients to make sure the treatment works well.

The PROSTIM study is a research project in which we study patients selected to be treated with SCS. We want to understand how different groups of patients selected for this treatment do after getting SCS. The study includes patients in different European centers, following them for 6 weeks, 3 months and 1 year after getting SCS.

This study is the first one to use a cluster analysis to group patients based on different aspects of their psychological and physical health and see how they respond differently to SCS treatment.

Clinical Trial Registration: NCT05349695 (ClinicalTrials.gov)

Keywords::

• descending pain modulation
• lateral pathway
• medial pathway
• outcome assessment
• patient profiling
• spinal cord stimulation
• treatment pathways

Author contributions

The authors confirm contribution to the paper as follows. Study conception and design: V Raymaekers, S Meeuws, G van der Steen, J Vesper, M Plazier, T Menovsky; study interpretations/discussion: V Raymaekers, M Plazier, L Goudman, M Moens, J Vesper, D de Ridder, M Plazier; draft manuscript preparation: V Raymaekers, M Plazier, D de Ridder. All authors reviewed and approved the final version of the manuscript.

Financial disclosure

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

The authors have no competing interests or relevant affiliations with any organization or entity with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Writing disclosure

No writing assistance was utilized in the production of this manuscript.

Ethical conduct of research

Ethical approval was achieved in each participating center’s Ethical Review Boards (ERB). The study is conducted in accordance with good clinical practice and the ethical principles in the Declaration of Helsinki. All patients provide written informed consent before participation.

Previous presentation

Pilot data were presented at the International Neuromodulation Society in Paris on 4 September 2021 [40].

Additional information

Funding

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.