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Betamethasone vs Dextrose Injections in Trigger Finger

2026年7月26日 更新者:Merve Yıldız、Istanbul University - Cerrahpasa

Comparison of Ultrasound-Guided Betamethasone and Dextrose Injections in the Treatment of Trigger Finger: A Randomized Controlled Trial

This study aims to compare the effectiveness of ultrasound-guided betamethasone and dextrose injections in patients with trigger finger.

Trigger finger is a common hand condition characterized by pain, clicking, and locking of the finger due to tendon entrapment at the A1 pulley. Corticosteroid injections are widely used as a first-line treatment; however, they may be associated with potential side effects.

Dextrose injection is an alternative treatment that may promote tissue healing through regenerative mechanisms. However, there is limited high-quality evidence regarding its effectiveness in trigger finger.

In this randomized controlled trial, patients will be assigned to receive either betamethasone or dextrose injection under ultrasound guidance. The primary outcome will be pain intensity measured by the Numeric Rating Scale (NRS). Secondary outcomes will include triggering severity, hand function, grip and pinch strength, and fine motor skills evaluated over a 12-week follow-up period.

The results of this study may help determine whether dextrose injection is a safe and effective alternative to corticosteroid treatment in trigger finger.

研究概览

详细说明

Trigger finger, also known as stenosing tenosynovitis, is a common hand disorder characterized by pain, catching, and locking of the affected digit due to impaired gliding of the flexor tendon at the A1 pulley. It can significantly impair hand function and quality of life.

Corticosteroid injections are widely accepted as an effective first-line treatment for trigger finger. However, potential adverse effects such as skin atrophy, tendon rupture, and systemic effects, particularly in patients with metabolic disorders, have led to increasing interest in alternative treatment options.

Dextrose injection has emerged as a potential alternative treatment modality in musculoskeletal disorders. However, there is limited high-quality evidence evaluating its effectiveness in trigger finger.

The aim of this prospective, randomized controlled trial is to compare the clinical effectiveness of ultrasound-guided betamethasone injection and dextrose injection in patients with trigger finger.

Eligible participants aged 18 to 75 years with clinically diagnosed trigger finger of at least 4 weeks' duration will be enrolled. Patients will be randomly assigned to one of two groups. One group will receive an ultrasound-guided injection of 1 ml lidocaine and 1 ml betamethasone, while the other group will receive an ultrasound-guided injection of 1 ml lidocaine and 1 ml 30% dextrose solution (resulting in a final concentration of 15% dextrose). All injections will be performed under sterile conditions at the A1 pulley level.

The study is designed as a randomized, participant-, injector-, and assessor-blinded trial. The injector will be blinded to the injectate using opaque-covered syringes. Randomization will be performed by an independent researcher who will not be involved in outcome assessment.

The primary outcome of the study is the change in pain intensity, assessed using the Numeric Rating Scale (NRS).

Secondary outcomes include triggering severity assessed using the Modified Quinnell classification, functional status assessed using the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire, grip and pinch strength, and fine motor skills evaluated with the Purdue Pegboard test.

Outcome assessments will be conducted at baseline, 1 hour, 2 weeks, 4 weeks, and 12 weeks after injection, according to the predefined schedule of each outcome measure.

This study is expected to provide high-quality evidence regarding the effectiveness of dextrose injection as a potential alternative to corticosteroid treatment in trigger finger.

研究类型

介入性

注册 (估计的)

42

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

      • Istanbul、土耳其(türkiye)、34098
        • 招聘中
        • Istanbul University - Cerrahpasa, Cerrahpasa Faculty of Medicine
        • 接触:
        • 首席研究员:
          • Merve Yıldız, MD

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Age between 18 and 75 years
  • Clinical diagnosis of trigger finger
  • Presence of symptoms for at least 4 weeks

Exclusion Criteria:

  • Previous surgery on the affected finger
  • Injection treatment to the affected finger within the previous 3 months
  • Active local or systemic infection
  • Active malignancy
  • Active inflammatory rheumatic disease (e.g., rheumatoid arthritis, ankylosing spondylitis, polymyalgia rheumatica, vasculitis)
  • Uncontrolled diabetes mellitus and/or uncontrolled hypertension
  • Autoimmune connective tissue diseases (e.g., systemic lupus erythematosus, antiphospholipid syndrome, systemic sclerosis, Sjögren syndrome, polymyositis, dermatomyositis, adult-onset Still's disease)
  • Coagulopathy that increases the risk of injection procedures
  • Pregnancy
  • Known allergy or hypersensitivity to lidocaine, betamethasone, or dextrose
  • Mental impairment or severe psychiatric disorder that may interfere with study participation or informed consent

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:三倍

武器和干预

参与者组/臂
干预/治疗
有源比较器:Betamethasone Injection
Participants in this arm will receive an ultrasound-guided injection of 1 ml lidocaine combined with 1 ml betamethasone at the A1 pulley level for the treatment of trigger finger.
Ultrasound-guided injection of 1 ml lidocaine combined with 1 ml betamethasone administered at the A1 pulley level for the treatment of trigger finger.
其他名称:
  • 皮质类固醇注射液
有源比较器:Dextrose Injection
Participants in this arm will receive an ultrasound-guided injection of 1 ml lidocaine combined with 1 ml 30% dextrose solution (final concentration 15%) at the A1 pulley level for the treatment of trigger finger.
Ultrasound-guided injection of 1 ml lidocaine combined with 1 ml 30% dextrose solution resulting in a final concentration of 15% dextrose, administered at the A1 pulley level for the treatment of trigger finger.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in pain intensity assessed by Numeric Rating Scale (NRS)
大体时间:Baseline, 1 hour, 2 weeks, 4 weeks, and 12 weeks
Pain intensity will be evaluated using the 11-point Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates worst imaginable pain.
Baseline, 1 hour, 2 weeks, 4 weeks, and 12 weeks

次要结果测量

结果测量
措施说明
大体时间
Change in triggering severity assessed by Modified Quinnell classification
大体时间:Baseline, 2 weeks, 4 weeks, and 12 weeks
Triggering severity will be evaluated using the Modified Quinnell classification system.
Baseline, 2 weeks, 4 weeks, and 12 weeks
Change in hand function assessed by QuickDASH
大体时间:Baseline, 2 weeks, 4 weeks, and 12 weeks
Functional status will be assessed using the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire.
Baseline, 2 weeks, 4 weeks, and 12 weeks
Change in grip strength
大体时间:Baseline, 2 weeks, 4 weeks, and 12 weeks
Grip strength will be measured using a hand dynamometer.
Baseline, 2 weeks, 4 weeks, and 12 weeks
Change in pinch strength
大体时间:Baseline, 2 weeks, 4 weeks, and 12 weeks
Pinch strength will be measured using a pinch meter.
Baseline, 2 weeks, 4 weeks, and 12 weeks
Change in fine motor skills assessed by Purdue Pegboard test
大体时间:Baseline, 4 weeks, and 12 weeks
Fine motor skills and manual dexterity will be evaluated using the Purdue Pegboard test.
Baseline, 4 weeks, and 12 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年6月30日

初级完成 (估计的)

2027年4月1日

研究完成 (估计的)

2027年5月1日

研究注册日期

首次提交

2026年6月27日

首先提交符合 QC 标准的

2026年6月27日

首次发布 (实际的)

2026年7月2日

研究记录更新

最后更新发布 (实际的)

2026年7月28日

上次提交的符合 QC 标准的更新

2026年7月26日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

IPD 计划说明

The investigators have not yet determined whether de-identified individual participant data (IPD) will be shared. If data sharing is approved after completion of the study and publication of the primary results, the de-identified dataset underlying the reported outcomes may be made available. Any decision regarding data sharing will be based on institutional policies, ethical approval, participant confidentiality, and applicable regulations.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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