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

Author:

Raymaekers Vincent123ORCID,Meeuws Sacha4,Goudman Lisa56789,der Steen Gregory Van10,Moens Maarten567811,Vanloon Maarten12,Ridder Dirk De13,Menovsky Tomas13,Vesper Jan14,Plazier Mark24

Affiliation:

1. Faculty of Medicine & Health Sciences, University of Antwerp, Antwerp, 2650, Belgium

2. Faculty of Medicine & Life Science, Hasselt University, Hasselt, 3500, Belgium

3. Department of Neurosurgery, Antwerp University Hospital, Antwerp, 2650, Belgium

4. Department of Neurosurgery Jessa Hospital, Hasselt, 3500, Belgium

5. Department of Neurosurgery, Universitair Ziekenhuis Brussel, Laarbeeklaan 101, Brussels, 1090, Belgium

6. STIMULUS consortium (reSearch & TeachIng neuroModULation Uz bruSsel), Vrije Universiteit Brussel, Laarbeeklaan 103, Brussels, 1090, Belgium

7. Center for Neurosciences (C4N), Vrije Universiteit Brussel, Laarbeeklaan 103, Brussels, 1090, Belgium

8. Pain in Motion (PAIN) Research Group, Department of Physiotherapy, Human Physiology & Anatomy, Faculty of Physical Education & Physiotherapy, Vrije Universiteit Brussel, Laarbeeklaan 103, Brussels, 1090, Belgium

9. Research Foundation-Flanders (FWO), Brussels, 1090, Belgium

10. BACK-APP, Hasselt, 3500, Belgium

11. Department of Radiology, Universitair Ziekenhuis Brussel, Laarbeeklaan 101, Brussels, 1090, Belgium

12. Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, 6211, The Netherlands

13. Department of Surgical Sciences, Section of Neurosurgery, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand

14. Department of Stereotactic & Functional Neurosurgery, University Hospital Düsseldorf, Düsseldorf, 40204, Germany

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.

Funder

Medtronic Europe

Publisher

Future Medicine Ltd

Subject

General Medicine

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