Matthiesen Laura Houstrup, Skov Simon Toftegaard, Lange Jeppe
University Clinic for Interdisciplinary Orthopaedic Pathways, Elective Surgery Centre, Silkeborg Regional Hospital.
Department of Clinical Medicine, Aarhus University.
Dan Med J. 2024 Nov 12;71(12):A05240324. doi: 10.61409/A05240324.
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.
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.
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.
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.
The trial is registered with the CTIS (EU CT: 2022-501549-57-00) and Clinicaltrials.gov (NCT05440240).
经皮针状筋膜切开术（PNF）是治疗杜普伊特伦挛缩症所致手指屈曲挛缩的一种非侵入性治疗选择。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联合/不联合皮质类固醇注射在降低复发率方面的疗效。
本研究为双臂随机对照试验，随访两年。患者将按1:1随机分配至接受皮质类固醇注射的PNF组（n = 200）或接受生理盐水注射的PNF组（n = 200）。在治疗后90天、1年和2年进行随访。将使用手指测角仪评估手指伸展受限情况。记录治疗并发症和不良事件，并使用针对手部的特定问卷和生活质量问卷记录患者报告的结果。
本研究有望成为第一项在大量杜普伊特伦挛缩症患者中比较PNF联合/不联合单次皮质类固醇注射的随机对照试验。研究结果将为杜普伊特伦挛缩症的治疗提供循证建议。
该试验由奥胡斯大学健康研究生院、丹麦风湿病协会、丹麦医学协会基金会和AP. 穆勒基金会提供的资助。
该试验已在CTIS（欧盟临床试验注册号：2022 - 501549 - 57 - 00）和Clinicaltrials.gov（NCT05440240）注册。
