Clinical trial NCT06788860: Efficacy of Ultrasound-Guided Needle Knife Release for Trigger Finger
Official title: Efficacy of Ultrasound-Guided Tri-Directional Needle Knife Release for Trigger Finger
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Trigger Finger
Keywords: Trigger Finger
A1 Pulley Release
Ultrasound-Guided Technique
Lead sponsor: Mansoura University Hospital
Sponsor class: OTHER
First posted: 2025-01-23
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: All participants will undergo ultrasound-guided tri-directional needle knife release for trigger finger treatment
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Improvement in hand and finger function
timeFrame: 6 months
measure: Reduction in Pain scores post-procedure
timeFrame: 6 months
measure: Improvement of finger mobility
timeFrame: 6 months
Secondary outcomes:
measure: Patient Satisfaction with the procedure
timeFrame: 6 months
measure: Rate of procedure-related complications
timeFrame: 6 months
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University Hospital
state: Dakahlia
Study officials:
References:
citation: 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.