Adjuvant steroid to percutaneous needle fasciotomy for Dupuytren's contracture. An RCT study protocol.

IF 1 4区医学 Q3 MEDICINE, GENERAL & INTERNAL

Danish medical journal Pub Date : 2024-11-12 DOI:10.61409/A05240324

Laura Houstrup Matthiesen, Simon Toftegaard Skov, Jeppe Lange

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引用次数: 0

Abstract

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).

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经皮筋膜穿刺术辅助类固醇治疗Dupuytren挛缩。随机对照试验研究方案。

简介：经皮针筋膜切开术（PNF）是一种治疗由Dupuytren病引起的手指屈曲挛缩的无创治疗方法。PNF技术的变化包括使用皮质类固醇注射。在本随机对照试验中，我们比较了PNF +/-皮质类固醇注射在降低复发率方面的疗效。方法：本研究采用双臂随机对照试验，随访2年。患者将按1:1分配到PNF联合皮质类固醇注射组（n = 200）或PNF联合生理盐水注射组（n = 200）。随访时间分别为治疗后90天、1年和2年。手指测角仪将用于评估手指伸展缺陷。将记录治疗并发症和不良事件，并使用手部特异性和生活质量问卷记录患者报告的结果。结论：该研究有望成为首个在Dupuytren挛缩患者中比较PNF +/-单次皮质类固醇注射的随机对照试验。该结果将有助于为治疗Dupuytren挛缩提供循证建议。资助：该试验由奥胡斯大学卫生研究生院、丹麦风湿病协会、丹麦医学协会基金会和AP Møller基金会资助。试验注册：该试验已在CTIS （EU CT: 2022-501549-57-00）和Clinicaltrials.gov （NCT05440240）注册。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Danish medical journal MEDICINE, GENERAL & INTERNAL-

CiteScore

2.30

自引率

6.20%

发文量

审稿时长

3-8 weeks

期刊介绍： The Danish Medical Journal (DMJ) is a general medical journal. The journal publish original research in English – conducted in or in relation to the Danish health-care system. When writing for the Danish Medical Journal please remember target audience which is the general reader. This means that the research area should be relevant to many readers and the paper should be presented in a way that most readers will understand the content. DMJ will publish the following articles: • Original articles • Protocol articles from large randomized clinical trials • Systematic reviews and meta-analyses • PhD theses from Danish faculties of health sciences • DMSc theses from Danish faculties of health sciences.