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手术与超声引导下类固醇注射治疗扳机指疾病:一项随机对照试验的方案

Surgery versus ultrasound-guided steroid injections for trigger finger disease: protocol of a randomized controlled trial.

作者信息

Hansen Rehne L, Lange Jeppe

机构信息

Centre for Planned Surgery, Regional Hospital Silkeborg, 8600 Silkeborg, Denmark.

出版信息

Dan Med J. 2013 May;60(5):A4633.

Abstract

INTRODUCTION

Trigger fingers have been reported in the literature for over a century; yet, the lack of trials comparing open surgery to corticosteroid injection is pronounced. At the initiation of the present study in 2010, no randomized controlled trials could be found comparing open surgery to corticosteroid injection. In the present randomized controlled trial, we plan to compare the efficacy of a single ultrasound-guided corticosteroid injection with conventional open surgery in terms of ability to correct the trigger finger.

MATERIAL AND METHODS

The study is performed as an open-label single-centre, randomised controlled trial with a one-year follow-up. Patients are randomly assigned to either ultrasound-guided corticosteroid injection (n = 83) or to open surgical release of A1-pulley (n = 83). Follow-up is conducted at 12 weeks and one year after treatment. The affected finger will be assessed using a trigger finger score. Furthermore, any treatment complications, absence from work or sport and use of related medical services or additional treatment are also recorded.

DISCUSSION

The present study will be the first to compare treatment of trigger finger by conventional open surgery with ultrasound-guided corticosteroid injection in a randomized controlled trial. The results will contribute to evidence-based recommendations for the treatment of trigger finger patients.

FUNDING

not relevant.

TRIAL REGISTRATION

Danish Data Protection Agency (1-16-02-119-11). The Central Denmark Region Committees on Biomedical Research Ethics (M-20110157). Clinicaltrials.gov: NCT 01486420.

摘要

引言

文献中报道扳机指已有一个多世纪;然而,缺乏比较开放手术与皮质类固醇注射的试验是很明显的。在2010年本研究开始时,未发现比较开放手术与皮质类固醇注射的随机对照试验。在本随机对照试验中,我们计划比较单次超声引导下皮质类固醇注射与传统开放手术在矫正扳机指方面的疗效。

材料与方法

本研究作为一项开放标签的单中心随机对照试验进行,随访一年。患者被随机分配至超声引导下皮质类固醇注射组(n = 83)或A1滑车开放手术松解组(n = 83)。在治疗后12周和一年进行随访。使用扳机指评分评估患指。此外,还记录任何治疗并发症、缺勤或停止运动情况以及使用相关医疗服务或接受额外治疗的情况。

讨论

本研究将是首个在随机对照试验中比较传统开放手术与超声引导下皮质类固醇注射治疗扳机指的研究。结果将有助于为扳机指患者的治疗提供循证建议。

资金

无关。

试验注册

丹麦数据保护局(1-16-02-119-11)。丹麦中部地区生物医学研究伦理委员会(M-20110157)。Clinicaltrials.gov:NCT 01486420。

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