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

NCT06785935 | Active Not Recruiting

• 1 other identifier: MS.24.10.2929
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Trigger Finger

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Patients undergoing ultrasonography-guided percutaneous A1 pulley release using a needle knife

ACTIVE COMPARATOR

Device: Needle knife

Patients undergoing ultrasonography-guided corticosteroid injection under the A1 pulley

ACTIVE COMPARATOR

Drug: Corticosteroid: Betamethasone

Interventions

Needle knife DEVICE

ultrasonography-guided percutaneous A1 pulley release using a needle knife

Patients undergoing ultrasonography-guided percutaneous A1 pulley release using a needle knife

Corticosteroid: Betamethasone DRUG

ultrasonography-guided corticosteroid injection under the A1 pulley

Patients undergoing ultrasonography-guided corticosteroid injection under the A1 pulley

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University Hospital: lead

Study Sites (1)

Mansoura University Hospitals

Al Mansurah, Egypt

Location

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: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Rheumatology, rehabilitation, and physical medicine department at Mansoura University Hospitals

Study Record Dates

• First Submitted: January 15, 2025
• First Posted: January 21, 2025
• Study Start: November 11, 2024
• Primary Completion: May 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 21, 2025

Record last verified: 2024-12

Locations

EG (1)