Efficacy of Ultrasound-Guided Needle Knife Release for Trigger Finger

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Tri-directional Ultrasound-guided Needle Knife Release
  This procedure involves ultrasound-guided tri-directional needle knife release for the treatment of trigger finger. Local anesthesia using 3-5 ml of 1% lidocaine and 0.25% bupivacaine will be administered for patient comfort. It aims to ensure precise tissue dissection while minimizing risks and improving outcomes. Device: Sonosite M-Turbo Ultrasound Machine with Linear Probe HFL38x (6-13 MHz) is used for real-time imaging during the procedure.

Первичные конечные точки

• Improvement in hand and finger function [Срок оценки: 6 months]
• Reduction in Pain scores post-procedure [Срок оценки: 6 months]
• Improvement of finger mobility [Срок оценки: 6 months]

Вторичные конечные точки (2)

• Patient Satisfaction with the procedure [Срок оценки: 6 months]
• Rate of procedure-related complications [Срок оценки: 6 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Mansoura University Hospital — Al Mansurah

Публикации

• 1. Huisstede BM, Hoogvliet P, Coert JH, Fridén J, Group EH. Multidisciplinary consensus guideline for managing trigger finger: results from the European HANDGUIDE Study. Physical therapy. 2014;94(10):1421-33. 2. Ferrara PE, Codazza S, Maccauro G, Zirio G, Ferriero G, Ronconi G. Physical therapies for the conservative treatment of the trigger finger: a narrative review. Orthopedic Reviews. 2020;12(

Идентификаторы

NCT: NCT06788860 · Mansoura_UG-KN_TF

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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