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© 2022 Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://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/ . Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.

Abstract

Introduction

Carpal tunnel syndrome (CTS) is the most common peripheral neuropathy. The optimal treatment strategy is still unknown. The objective of the Dutch Injection versus Surgery TRIal in patients with CTS (DISTRICTS) is to investigate if initial surgery of CTS results in a better clinical outcome and is more cost-effective when compared with initial treatment with corticosteroid injection.

Methods and analysis

The DISTRICTS is an ongoing multicenter, open-label randomised controlled trial. Participants with CTS are randomised to treatment with surgery or with a corticosteroid injection. If needed, any additional treatments after this first treatment are allowed and these are not dictated by the study protocol. The primary outcome is the difference between the groups in the proportion of participants recovered at 18 months. Recovery is defined as having no or mild symptoms as measured with the 6-item carpal tunnel symptoms scale. Secondary outcome measurements are among others: time to recovery, hand function, patient satisfaction, quality of life, additional treatments, adverse events, and use of care and health-related costs.

Ethics and dissemination

The study was approved by the Medical Ethical Committee of the Amsterdam University Medical Centers (study number 2017-171). Study results will be disseminated in peer-reviewed journals and conferences.

Trial registration number

ISRCTN Registry: 13164336.

Details

Title
Dutch injection versus surgery trial in patients with carpal tunnel syndrome (DISTRICTS): protocol of a randomised controlled trial comparing two treatment strategies
Author
Palmbergen, Wijnand A C 1   VIAFID ORCID Logo  ; Rob M A de Bie 2 ; Alleman, Tim W H 3 ; Verstraete, Esther 4 ; Jellema, Korne 5 ; Verhagen, Wim I M 6 ; Brekelmans, Geert J F 7 ; Godard C W de Ruiter 5 ; van de Beek, Diederik 2 ; Corianne A J M de Borgie 8 ; de Haan, Rob 8 ; Beekman, Roy 9 ; Verhamme, Camiel 2 

 Department of Neurology, Amsterdam UMC location University of Amsterdam, Amsterdam Neuroscience, Amsterdam, The Netherlands; Department of Neurology, BovenIJ hospital, Amsterdam, The Netherlands 
 Department of Neurology, Amsterdam UMC location University of Amsterdam, Amsterdam Neuroscience, Amsterdam, The Netherlands 
 Department of Neurology, Saint Jans Hospital Weert, Weert, The Netherlands 
 Department of Neurology, Rijnstate Hospital, Arnhem, The Netherlands 
 Department of Neurology, Haaglanden Medical Center, Den Haag, The Netherlands 
 Department of Neurology, CWZ, Nijmegen, The Netherlands 
 Department of Neurology, ETZ, Tilburg, The Netherlands 
 Department of Epidemiology and Data Science, Amsterdam UMC location University of Amsterdam, Amsterdam, The Netherlands 
 Department of Neurology, Zuyderland Medical Center, Heerlen, The Netherlands 
First page
e057641
Section
Neurology
Publication year
2022
Publication date
2022
Publisher
BMJ Publishing Group LTD
e-ISSN
20446055
Source type
Scholarly Journal
Language of publication
English
ProQuest document ID
2647784295
Copyright
© 2022 Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://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/ . Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.