Dutch injection versus surgery trial in patients with carpal tunnel syndrome (DISTRICTS): protocol of a randomised controlled trial comparing two treatment strategies
Corianne A J M de Borgie,
WIM I M VERHAGEN,
Diederik van de Beek,
Esther Verstraete,
Korné Jellema,
Rob M A de Bie,
Camiel Verhamme,
Wijnand A C Palmbergen,
Tim W H Alleman,
Geert J F Brekelmans,
Godard C W de Ruiter,
Rob de Haan,
Roy Beekman
Affiliations
Corianne A J M de Borgie
Department of Epidemiology and Data Science, Amsterdam UMC location University of Amsterdam, Amsterdam, The Netherlands
WIM I M VERHAGEN
Department of Neurology, CWZ, Nijmegen, The Netherlands
Diederik van de Beek
1 Department of Neurology, Amsterdam UMC Location AMC, Amsterdam, The Netherlands
Esther Verstraete
Department of Neurology, Rijnstate Hospital, Arnhem, The Netherlands
Korné Jellema
Department of Neurology, Haaglanden Medical Center, Den Haag, The Netherlands
Rob M A de Bie
Neurology, Amsterdam UMC Location AMC, Amsterdam, The Netherlands
Camiel Verhamme
Department of Neurology and Clinical Neurophysiology, Amsterdam UMC Locatie AMC, University of Amsterdam, Amsterdam, The Netherlands
Wijnand A C Palmbergen
Department of Neurology, Amsterdam UMC location University of Amsterdam, Amsterdam Neuroscience, Amsterdam, The Netherlands
Tim W H Alleman
Department of Neurology, Saint Jans Hospital Weert, Weert, The Netherlands
Geert J F Brekelmans
Department of Neurology, ETZ, Tilburg, The Netherlands
Godard C W de Ruiter
Department of Neurology, Haaglanden Medical Center, Den Haag, The Netherlands
Rob de Haan
Department of Epidemiology and Data Science, Amsterdam UMC location University of Amsterdam, Amsterdam, The Netherlands
Roy Beekman
Department of Neurology, Zuyderland Medical Center, Heerlen, The Netherlands
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.
