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sPinal coRd stimulatiOn coMpared with lumbar InStrumEntation for low back pain after previous lumbar decompression (PROMISE): a prospective multicentre RCT
INTRODUCTION: Persistent spine pain syndrome type 2 (PSPS2) represents a significant burden to the individual and society. Treatment options include revision surgery, stabilisation surgery of the spine, neuromodulation, analgesics and cognitive behavioural therapy. Nevertheless, structured treatment...
Autores principales: | , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BMJ Publishing Group
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10083801/ https://www.ncbi.nlm.nih.gov/pubmed/37012023 http://dx.doi.org/10.1136/bmjopen-2022-067784 |
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author | Krauss, Philipp Motov, Stefan Bonk, Maximilian Niklas Prescher, Andrea Scorzin, Jasmin Hajiabadi, Mohammad Mehdi Schulte, Dirk Michael Sommer, Bjoern Seiz-Rosenhagen, Marcel Ahmadi, Rezvan Maciaczyk, Jaroslaw Lehmberg, Jens Shiban, Ehab |
author_facet | Krauss, Philipp Motov, Stefan Bonk, Maximilian Niklas Prescher, Andrea Scorzin, Jasmin Hajiabadi, Mohammad Mehdi Schulte, Dirk Michael Sommer, Bjoern Seiz-Rosenhagen, Marcel Ahmadi, Rezvan Maciaczyk, Jaroslaw Lehmberg, Jens Shiban, Ehab |
author_sort | Krauss, Philipp |
collection | PubMed |
description | INTRODUCTION: Persistent spine pain syndrome type 2 (PSPS2) represents a significant burden to the individual and society. Treatment options include revision surgery, stabilisation surgery of the spine, neuromodulation, analgesics and cognitive behavioural therapy. Nevertheless, structured treatment algorithms are missing as high-level evidence on the various treatments is sparse. The aim of this study is to compare higher frequency neuromodulation with instrumentation surgery in patients suffering from PSPS2. METHODS AND ANALYSIS: The sPinal coRd stimulatiOn coMpared with lumbar InStrumEntation for low back pain after previous lumbar decompression (PROMISE) trial is a prospective randomised rater blinded multicentre study. Patients suffering from PSPS2 with a functional burden of Oswestry Disability Index (ODI) >20 points are randomised to treatment via spinal cord stimulation or spinal instrumentation. Primary outcome is back-related functional outcome according to the ODI 12 months after treatment. Secondary outcomes include pain perception (visual analogue scale), Short Form-36, EuroQOL5D, the amount of analgesics, the length of periprocedural hospitalisation and adverse events. Follow-up visits are planned at 3 and 12 months after treatment. Patients with previous lumbar instrumentation, symptomatic spinal stenosis, radiographical apparent spinal instability or severe psychiatric or systemic comorbidities are excluded from the study. In order to detect a significant difference of ≥10 points (ODI) with a power of 80%, n=72 patients need to be included. The recruitment period will be 24 months with a subsequent 12 months follow-up. The beginning of enrolment is planned for October 2022. ETHICS AND DISSEMINATION: The PROMISE trial is the first randomised rater blinded multicentre study comparing the functional effectiveness of spinal instrumentation versus neuromodulation in patients with PSPS2 in order to achieve high-level evidence for these commonly used treatment options in this severely disabling condition. Patient recruitment will be performed at regular outpatient clinic visits. No further (print, social media) publicity is planned. The study is approved by the local ethics committee (LMU Munich, Germany) and will be conducted according to the Declaration of Helsinki. TRIAL REGISTRATION NUMBER: NCT05466110. |
format | Online Article Text |
id | pubmed-10083801 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-100838012023-04-11 sPinal coRd stimulatiOn coMpared with lumbar InStrumEntation for low back pain after previous lumbar decompression (PROMISE): a prospective multicentre RCT Krauss, Philipp Motov, Stefan Bonk, Maximilian Niklas Prescher, Andrea Scorzin, Jasmin Hajiabadi, Mohammad Mehdi Schulte, Dirk Michael Sommer, Bjoern Seiz-Rosenhagen, Marcel Ahmadi, Rezvan Maciaczyk, Jaroslaw Lehmberg, Jens Shiban, Ehab BMJ Open Neurology INTRODUCTION: Persistent spine pain syndrome type 2 (PSPS2) represents a significant burden to the individual and society. Treatment options include revision surgery, stabilisation surgery of the spine, neuromodulation, analgesics and cognitive behavioural therapy. Nevertheless, structured treatment algorithms are missing as high-level evidence on the various treatments is sparse. The aim of this study is to compare higher frequency neuromodulation with instrumentation surgery in patients suffering from PSPS2. METHODS AND ANALYSIS: The sPinal coRd stimulatiOn coMpared with lumbar InStrumEntation for low back pain after previous lumbar decompression (PROMISE) trial is a prospective randomised rater blinded multicentre study. Patients suffering from PSPS2 with a functional burden of Oswestry Disability Index (ODI) >20 points are randomised to treatment via spinal cord stimulation or spinal instrumentation. Primary outcome is back-related functional outcome according to the ODI 12 months after treatment. Secondary outcomes include pain perception (visual analogue scale), Short Form-36, EuroQOL5D, the amount of analgesics, the length of periprocedural hospitalisation and adverse events. Follow-up visits are planned at 3 and 12 months after treatment. Patients with previous lumbar instrumentation, symptomatic spinal stenosis, radiographical apparent spinal instability or severe psychiatric or systemic comorbidities are excluded from the study. In order to detect a significant difference of ≥10 points (ODI) with a power of 80%, n=72 patients need to be included. The recruitment period will be 24 months with a subsequent 12 months follow-up. The beginning of enrolment is planned for October 2022. ETHICS AND DISSEMINATION: The PROMISE trial is the first randomised rater blinded multicentre study comparing the functional effectiveness of spinal instrumentation versus neuromodulation in patients with PSPS2 in order to achieve high-level evidence for these commonly used treatment options in this severely disabling condition. Patient recruitment will be performed at regular outpatient clinic visits. No further (print, social media) publicity is planned. The study is approved by the local ethics committee (LMU Munich, Germany) and will be conducted according to the Declaration of Helsinki. TRIAL REGISTRATION NUMBER: NCT05466110. BMJ Publishing Group 2023-04-03 /pmc/articles/PMC10083801/ /pubmed/37012023 http://dx.doi.org/10.1136/bmjopen-2022-067784 Text en © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) . |
spellingShingle | Neurology Krauss, Philipp Motov, Stefan Bonk, Maximilian Niklas Prescher, Andrea Scorzin, Jasmin Hajiabadi, Mohammad Mehdi Schulte, Dirk Michael Sommer, Bjoern Seiz-Rosenhagen, Marcel Ahmadi, Rezvan Maciaczyk, Jaroslaw Lehmberg, Jens Shiban, Ehab sPinal coRd stimulatiOn coMpared with lumbar InStrumEntation for low back pain after previous lumbar decompression (PROMISE): a prospective multicentre RCT |
title | sPinal coRd stimulatiOn coMpared with lumbar InStrumEntation for low back pain after previous lumbar decompression (PROMISE): a prospective multicentre RCT |
title_full | sPinal coRd stimulatiOn coMpared with lumbar InStrumEntation for low back pain after previous lumbar decompression (PROMISE): a prospective multicentre RCT |
title_fullStr | sPinal coRd stimulatiOn coMpared with lumbar InStrumEntation for low back pain after previous lumbar decompression (PROMISE): a prospective multicentre RCT |
title_full_unstemmed | sPinal coRd stimulatiOn coMpared with lumbar InStrumEntation for low back pain after previous lumbar decompression (PROMISE): a prospective multicentre RCT |
title_short | sPinal coRd stimulatiOn coMpared with lumbar InStrumEntation for low back pain after previous lumbar decompression (PROMISE): a prospective multicentre RCT |
title_sort | spinal cord stimulation compared with lumbar instrumentation for low back pain after previous lumbar decompression (promise): a prospective multicentre rct |
topic | Neurology |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10083801/ https://www.ncbi.nlm.nih.gov/pubmed/37012023 http://dx.doi.org/10.1136/bmjopen-2022-067784 |
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