TY - JOUR
T1 - Dutch injection versus surgery trial in patients with carpal tunnel syndrome (DISTRICTS)
T2 - protocol of a randomised controlled trial comparing two treatment strategies
AU - Palmbergen, Wijnand A C
AU - de Bie, Rob M A
AU - Alleman, Tim W H
AU - Verstraete, Esther
AU - Jellema, Korne
AU - Verhagen, Wim I M
AU - Brekelmans, Geert J F
AU - de Ruiter, Godard C W
AU - van de Beek, Diederik
AU - de Borgie, Corianne A J M
AU - de Haan, Rob
AU - Beekman, Roy
AU - Verhamme, Camiel
N1 - Funding Information: Funding This is an investigator-initiated study. This work is supported by ZonMw, 837004025 and 10330112010005. The funder has no role in study design; collection, management, analysis and interpretation of data; writing of the report; and the decision to submit the report for publication, and will have no ultimate authority over any of these activities. Publisher Copyright: ©
PY - 2022/4/6
Y1 - 2022/4/6
N2 - 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.
AB - 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.
KW - Adult neurology
KW - NEUROLOGY
KW - Neuromuscular disease
UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85127726058&origin=inward
UR - https://www.ncbi.nlm.nih.gov/pubmed/35387826
U2 - https://doi.org/10.1136/bmjopen-2021-057641
DO - https://doi.org/10.1136/bmjopen-2021-057641
M3 - Article
C2 - 35387826
SN - 2044-6055
VL - 12
SP - e057641
JO - BMJ Open
JF - BMJ Open
IS - 4
M1 - e057641
ER -