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NCT Number: NCT06788860

Efficacy of Ultrasound-Guided Needle Knife Release for Trigger Finger

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Tri-directional Ultrasound-guided Needle Knife Release

Procedure

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.

Primary outcomes

  1. Improvement in hand and finger function

    Time frame: 6 months

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

  2. Reduction in Pain scores post-procedure

    Time frame: 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)

  3. Improvement of finger mobility

    Time frame: 6 months

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

Secondary outcomes

  1. Patient Satisfaction with the procedure

    Time frame: 6 months

    Evaluating of patient satisfaction levels using a structured questionnaire

  2. Rate of procedure-related complications

    Time frame: 6 months

    Monitoring and documentation of procedure-related complications, including infection, nerve injury, and other adverse events.

Sponsors and collaborators

Lead sponsor

Mohamed Maher Ismail Ahmed Elashmawy

Other

Registry information

Official study title

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

Acronym: UG-NK

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 23, 2025
Registry last updated
Jan 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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