Efficacy of Ultrasound-Guided Needle Knife Release for Trigger Finger

NCT06788860 | Recruiting

• 1 other identifier: Mansoura_UG-KN_TF
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Trigger Finger

Keywords

Trigger Finger; A1 Pulley Release; Ultrasound-Guided Technique

Outcome Measures

Primary Outcomes (3)

• Improvement in hand and finger function

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

  6 months

• 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)

  6 months

• Improvement of finger mobility

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

  6 months

Secondary Outcomes (2)

• Patient Satisfaction with the procedure

  6 months

• Rate of procedure-related complications

  6 months

Study Arms (1)

Ultrasound-Guided Tri-directional Needle Knife Release Group

EXPERIMENTAL

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

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.

Ultrasound-Guided Tri-directional Needle Knife Release Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mohamed Maher Ismail Ahmed Elashmawy: lead

Study Sites (1)

Mansoura University Hospital

Al Mansurah, Dakahlia Governorate, 35516, Egypt

RECRUITING

Related Publications (1)

• 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.

  BACKGROUND

MeSH Terms

Conditions

Trigger Finger Disorder

Condition Hierarchy (Ancestors)

Tendon Entrapment; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer of Rheumatology, Physical Medicine and Rehabilitation

Model Details: All participants will undergo ultrasound-guided tri-directional needle knife release for trigger finger treatment

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: January 23, 2025
• Study Start: January 20, 2025
• Primary Completion: April 20, 2025
• Study Completion: October 29, 2025
• Last Updated: January 27, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)