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RecruitingNCT06788860UG-NKUpdated Jan 27, 2025

Efficacy of Ultrasound-Guided Needle Knife Release for Trigger Finger

An interventional study of Tri-directional Ultrasound-guided Needle Knife Release in Trigger Finger, sponsored by Mohamed Maher Ismail Ahmed Elashmawy. Recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-27.

Sponsored by Mohamed Maher Ismail Ahmed Elashmawy · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Apr 2025, 1 year 6 months ago, but the record still lists the study as recruiting.
  • Started Jan 2025; still recruiting 1 year 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
46
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Trigger Finger

Keywords

  • Trigger Finger
  • A1 Pulley Release
  • Ultrasound-Guided Technique
03

In context

Trigger Finger Disorder

93 studies on the registry are indexed under Trigger Finger Disorder; 22 are open to participants now.

This study's planned enrollment of 46 is below the median of 66 across 75 interventional studies indexed under Trigger Finger Disorder.

Browse Trigger Finger Disorder studies →

Lead sponsor

Mohamed Maher Ismail Ahmed Elashmawy is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 and comply with follow-up requirements.

Exclusion criteria

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 to local anesthetics.
  • Pregnancy or lactation.
  • Inability to comply with follow-up assessments.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
46 participants (estimated)

Study arms

  • Experimental
    Ultrasound-Guided Tri-directional Needle Knife Release Group

    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.

    Procedure: Tri-directional Ultrasound-guided Needle Knife Release

Interventions

  • ProcedureTri-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.

06

What researchers measure

Primary outcomes

  1. Improvement in hand and finger function

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

    Time frame: 6 months

  2. Reduction in Pain scores post-procedure

    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)

    Time frame: 6 months

  3. Improvement of finger mobility

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

    Time frame: 6 months

Secondary outcomes

  1. Patient Satisfaction with the procedure

    Evaluating of patient satisfaction levels using a structured questionnaire

    Time frame: 6 months

  2. Rate of procedure-related complications

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

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • 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(Suppl 1). 3. Lee SH, Choi YC, Kang HJ. Comparative study of ultrasonography-guided percutaneous A1 pulley release versus blinded percutaneous A1 pulley release. Journal of Orthopaedic Surgery. 2018;26(2):2309499018772368. 4. Sutter D, Treier A, Vögelin E. Sonographically controlled minimally-invasive A1 pulley release using a new guide instrument-a case series of 106 procedures in 64 patients. BMC musculoskeletal disorders. 2023;24(1):875. 5. Caballero EQ, Horcajadas ÁLB, Chaparro EC, Gana MDI, Franco IL-V, Villagrán JM. Ultrasound (US) of the fingers: anatomy and pathology. Quantitative Imaging in Medicine and Surgery. 2024;14(11):8012. 6. Pan M, Sheng S, Fan Z, Lu H, Yang H, Yan F, et al. Ultrasound-guided percutaneous release of A1 pulley by using a needle knife: a prospective study of 41 cases. Frontiers in Pharmacology. 2019;10:267. 7. Nikolaou VS, Malahias M-A, Kaseta M-K, Sourlas I, Babis GC. Comparative clinical study of ultrasound-guided A1 pulley release vs open surgical intervention in the treatment of trigger finger. World journal of orthopedics. 2017;8(2):163. 8. Langley G, Sheppeard H. The visual analogue scale: its use in pain measurement. Rheumatology international. 1985;5(4):145-8. 9. Kennedy CA, Beaton DE, Smith P, Van Eerd D, Tang K, Inrig T, et al. Measurement properties of the Quick DASH (disabilities of the arm, shoulder and hand) outcome measure and cross-cultural adaptations of the Quick DASH: A systematic review. Quality of life research. 2013;22:2509-47. 10. Wolfe SW. Tendinopathy. Green's operative hand surgery. 2011:2067-88.

Individual participant data

Plan to share: No — No plan to share individual participant date (IPD) with other researchers.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06788860
Lead sponsor
Mohamed Maher Ismail Ahmed Elashmawy
Responsible party
Mohamed Maher Ismail Ahmed Elashmawy (Lecturer of Rheumatology, Physical Medicine and Rehabilitation, Mansoura University Hospital) — Sponsor-investigator
First posted
Jan 23, 2025
Start date
Jan 20, 2025
Primary completion
Apr 20, 2025 (estimated)
Completion
Oct 29, 2025 (estimated)
Last update
Jan 27, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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