Efficacy of Ultrasound-Guided Needle Knife Release for Trigger Finger

NCT ID: NCT06788860

Last Updated: 2025-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-20

Study Completion Date

2025-10-29

Brief Summary

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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.

Detailed Description

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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

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Trigger Finger

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

All participants will undergo ultrasound-guided tri-directional needle knife release for trigger finger treatment
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Tri-directional Ultrasound-guided Needle Knife Release

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mohamed Maher Ismail Ahmed Elashmawy

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Maher Ismail Ahmed Elashmawy

Lecturer of Rheumatology, Physical Medicine and Rehabilitation

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Mansoura University Hospital

Al Mansurah, Dakahlia Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Facility Contacts

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Mohamed Maher Elashmawy, M.D, PHD.

Role: primary

+201004303100

Ahmed Seifeldein Farag, M.D. PHD.

Role: backup

+201006556110

References

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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.

Reference Type BACKGROUND

Other Identifiers

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Mansoura_UG-KN_TF

Identifier Type: -

Identifier Source: org_study_id

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