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临床试验/NCT06788860
NCT06788860招募中不适用

Efficacy of Ultrasound-Guided Tri-Directional Needle Knife Release for Trigger Finger

Mohamed Maher Ismail Ahmed Elashmawy1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2025年1月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
46
试验地点
1
主要终点
Improvement in hand and finger function

研究概览

简要总结

Efficacy of ultrasound-guided tri-directional needle knife release in treating patients with trigger finger. The study evaluates safety, effectiveness, and recovery outcomes of a minimally invasive procedure compared to conventional approaches.

详细描述

This is a clinical trial designed to investigate the efficacy and safety of ultrasound-guided tri-directional needle knife release in patients with trigger finger, especially those patients for whom conservative treatments have failed. Trigger finger is caused by of thickening of the A1 pulley, leading to pain and stiffness, which results in limitation of the hand. The procedure will be carried out under local anesthesia and guided by ultrasound to be very accurate and safe, avoiding all possible risks. Patients will be assessed for better improvement in hand functioning, pain scale basing on visual analog scale, and above all patient overall satisfaction.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Idiopathic TF at the level of A1 pulley
  • •Trigger finger of Green's grades II or III or IV (moderate to severe)
  • •Symptoms persist for at least three months despite conservative treatments.
  • •Ability to provide informed consent and comply with follow-up requirements.

排除标准

  • •Patients with secondary causes of TF like diabetes mellitus, rheumatoid arthritis, gout, hypothyroidism, amyloidosis, and sarcoidosis.
  • •Patients with TF of Green's grade I.
  • •Previous surgical intervention on the affected digit.
  • •Allergy or contraindication to local anesthetics.
  • •Pregnancy or lactation.
  • •Inability to comply with follow-up assessments.

研究组 & 干预措施

Ultrasound-Guided Tri-directional Needle Knife Release Group

Experimental

Participants will undergo ultrasound- guided tri-directional needle knife release for treatment of trigger finger. Local anesthesia using 3-5 ml of 1% lidocaine and 0.25% bupivacaine will be administered for patient comfort. This procedure involves precise ultrasound guidance to ensure accurate and safe dissection of the thickened A1-Pulley.

干预措施: Tri-directional Ultrasound-guided Needle Knife Release (Procedure)

结局指标

主要结局

Improvement in hand and finger function

时间窗: 6 months

Functional improvement evaluation using the QuickDASH score (0-100 scale)

Reduction in Pain scores post-procedure

时间窗: 6 months

Evaluating of the effectiveness of ultrasound-guided tri-directional needle knife release in reducing pain scores among patients with trigger finger using the Visual Analog Scale (VAS) (scale 0-10)

Improvement of finger mobility

时间窗: 6 months

Measurment of joint mobility in degrees at MCP and PIP joints using goniometer.

次要结局

  • Rate of procedure-related complications(6 months)
  • Patient Satisfaction with the procedure(6 months)

研究者

发起方
Mohamed Maher Ismail Ahmed Elashmawy
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mohamed Maher Ismail Ahmed Elashmawy

Lecturer of Rheumatology, Physical Medicine and Rehabilitation

Mansoura University Hospital

研究点 (1)

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