Comparison Between 2 Treatment Modalities of Trigger Finger: Ultrasound-guided Percutaneous Release of A1 Pulley by a Needle Knife Versus Ultrasound-guided Corticosteroid Injection in the Treatment of Trigger Finger

Ultrasound-guided Percutaneous Release of A1 Pulley by a Needle Knife Versus Ultrasound-guided Corticosteroid Injection in the Treatment of Trigger Finger: a Randomized Clinical Trial

Trigger finger is a common cause of hand disability and pain in the general population. It is a pathologic condition of the digital pulleys and flexor tendons. Although the pathogenesis is incompletely clear and multifactorial, the most common cause of the trigger finger is the thickened flexor tendon and/or thickened first annular (A1) pulley located at the metacarpophalangeal joint. Currently, ultrasound is considered an effective and valuable tool for assessing the trigger finger, providing static and dynamic evaluations of this condition and a comparison with the adjacent normal digits. Recently, it has been reported that ultrasound-guided percutaneous A1 pulley precise release using a needle knife has received increasing attention in the clinical treatment of trigger fingers and achieved good results. To our knowledge, this is the first clinical study comparing the efficacy and safety of ultrasonic-guided percutaneous A1 pulley release with a needle knife and the ultrasonic-guided steroid injection in treating trigger fingers.

Study Overview

• Status: Active, not recruiting
• Conditions: Trigger Finger
• Intervention / Treatment: Device: Needle knife; Drug: Corticosteroid: Betamethasone

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Mansoura, Egypt
    • Mansoura university hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Idiopathic trigger finger
• Trigger finger at the level of A1 pulley
• Trigger finger of Green's grades II or III

Exclusion Criteria:

• Patients with secondary causes of trigger fingers like diabetes mellitus, rheumatoid arthritis, gout, hypothyroidism, amyloidosis, and sarcoidosis.
• Patients with a previous history of first annular pulley release or injection.
• Patients with trigger fingers of Green's grade I and IV.
• Patients with trigger fingers at any level other than the A1 pulley.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Patients undergoing ultrasonography-guided percutaneous A1 pulley release using a needle knife	Device: Needle knife; ultrasonography-guided percutaneous A1 pulley release using a needle knife
Active Comparator: Patients undergoing ultrasonography-guided corticosteroid injection under the A1 pulley	Drug: Corticosteroid: Betamethasone; ultrasonography-guided corticosteroid injection under the A1 pulley

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pain intensity using the visual analog scale (VAS) scoring system	Before the procedure as well as after one week, one month, and three months
Functional ability according to the standard quick disabilities of the arm, shoulder, and hand score (Q DASH) questionnaire	Before the procedure as well as after one week, one month, and three months
Recurrence: The grade of trigger finger according to Green's classification	Before the procedure as well as after one week, one month, and three months
Complications such as inflammation, infection, scarring, wound healing problems, and sensory changes	After one week of the procedure

Collaborators and Investigators

• Sponsor: Mansoura University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2024
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: January 15, 2025
• First Submitted That Met QC Criteria: January 15, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 15, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Muscular Diseases; Tendinopathy; Tendon Entrapment; Trigger Finger Disorder; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Respiratory System Agents; Anti-Asthmatic Agents; Betamethasone
• Other Study ID Numbers: MS.24.10.2929

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No