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Войти в исследования Danish medical journal · 2024
Adjuvant steroid to percutaneous needle fasciotomy for Dupuytren's contracture. An RCT study protocol.
Протокол клинического исследованияСтатьяНазвание и аннотация: Перевод в очереди
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Matthiesen Laura Houstrup, Skov Simon Toftegaard, Lange Jeppe
Аннотация
INTRODUCTION: Percutaneous needle fasciotomy (PNF) is a non-invasive treatment option for finger flexion contractures caused by Dupuytren's disease. Variations in PNF techniques include the use of corticosteroid injection. In the presented randomised controlled trial, we compare the efficacy of PNF +/- corticosteroid injection in terms of reducing the recurrence rate.
METHODS: This study is performed as a two-armed, randomised controlled trial with a two-year follow-up. Patients will be allocated 1:1 to either PNF with corticosteroid injection (n = 200) or PNF with saline injection (n = 200). Follow-up is conducted at 90 days, one year, and two years after treatment. A finger goniometer will be used to assess finger extension deficit. Treatment complications and adverse events will be recorded, and patient-reported outcomes will be registered utilizing hand-specific and quality-of-life questionnaires.
CONCLUSIONS: This study is expected to be the first randomised controlled trial to compare PNF +/- single corticosteroid injection in a large cohort of patients with Dupuytren's contracture. The results will contribute to evidence-based recommendations for the treatment of Dupuytren's contracture.
FUNDING: The trial is funded by grants from the Graduate School of Health at Aarhus University, the Danish Rheumatism Association, the Danish Medical Association Foundation and the AP. Møller Foundation.
TRIAL REGISTRATION: The trial is registered with the CTIS (EU CT: 2022-501549-57-00) and Clinicaltrials.gov (NCT05440240).
METHODS: This study is performed as a two-armed, randomised controlled trial with a two-year follow-up. Patients will be allocated 1:1 to either PNF with corticosteroid injection (n = 200) or PNF with saline injection (n = 200). Follow-up is conducted at 90 days, one year, and two years after treatment. A finger goniometer will be used to assess finger extension deficit. Treatment complications and adverse events will be recorded, and patient-reported outcomes will be registered utilizing hand-specific and quality-of-life questionnaires.
CONCLUSIONS: This study is expected to be the first randomised controlled trial to compare PNF +/- single corticosteroid injection in a large cohort of patients with Dupuytren's contracture. The results will contribute to evidence-based recommendations for the treatment of Dupuytren's contracture.
FUNDING: The trial is funded by grants from the Graduate School of Health at Aarhus University, the Danish Rheumatism Association, the Danish Medical Association Foundation and the AP. Møller Foundation.
TRIAL REGISTRATION: The trial is registered with the CTIS (EU CT: 2022-501549-57-00) and Clinicaltrials.gov (NCT05440240).