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Trigger FingerUG-NKNCT06788860

Efficacy of Ultrasound-Guided Needle Knife Release for Trigger Finger

A study testing Tri-directional Ultrasound-guided Needle Knife Release in people with Trigger Finger, run by Mohamed Maher Ismail Ahmed Elashmawy at 1 site in Egypt.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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 more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Trigger Finger
What is being tested?
Tri-directional Ultrasound-guided Needle Knife Release
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteEgypt
Study dates
20 Jan 2025to 29 Oct 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Egypt1 site, 1 recruiting

  • Mansoura University Hospital

    Al Mansurah, Dakahlia Governorate, 35516

    Mohamed Maher Elashmawy, M.D, PHD., +201004303100, mohamedmaherismail@mans.edu.eg

    Ahmed Seifeldein Farag, M.D. PHD., +201006556110, ahmed_seif24@hotmail.com

    Recruiting

Other trials in Egypt

About this study

Official title: Efficacy of Ultrasound-Guided Tri-Directional 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.

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.

Conditions
Trigger Finger
Being tested
Tri-directional Ultrasound-guided Needle Knife Release
Keywords
Trigger Finger, A1 Pulley Release, Ultrasound-Guided Technique
Medical subject headings
Trigger Finger Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tri-directional Ultrasound-guided Needle Knife ReleaseProcedure or surgery

    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.

Study groups in NCT06788860
Study groupRoleWhat they receive
Ultrasound-Guided Tri-directional Needle Knife Release GroupExperimentalParticipants 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.
Receives: Procedure: Tri-directional Ultrasound-guided Needle Knife Release

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Improvement in hand and finger function

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

    Measured: 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)

    Measured: 6 months

  3. Improvement of finger mobility

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

    Measured: 6 months

Secondary outcomes (2)

  1. Patient Satisfaction with the procedure

    Evaluating of patient satisfaction levels using a structured questionnaire

    Measured: 6 months

  2. Rate of procedure-related complications

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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2025
  2. Study start20 Jan 2025
  3. Primary completion20 Apr 2025 (estimated)
  4. Study completion29 Oct 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Model description
All participants will undergo ultrasound-guided tri-directional needle knife release for trigger finger treatment
Masking
None (open label)
Enrolment
46 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06788860
Sponsor's protocol ID
Mansoura_UG-KN_TF
Acronym
UG-NK
Status last verified
Jan 2025
First submitted
17 Jan 2025
Last updated
27 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No plan to share individual participant date (IPD) with other researchers.

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.

Questions about this trial

What is this clinical trial studying?

A study testing Tri-directional Ultrasound-guided Needle Knife Release in people with Trigger Finger, run by Mohamed Maher Ismail Ahmed Elashmawy at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Improvement in hand and finger function (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06788860, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2025.

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