Percutaneous Trigger Finger Release Concomitant Steroid Injection Versus Percutaneous Trigger Finger Release Alone

NCT06288685 | Completed Phase 3 DMC

• 1 other identifier: 73/256
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Percutaneous A1 pulley release is a cost-effective and straightforward procedure with outcomes comparable to open A1 pulley release. Postoperative pain is a prevalent concern. Corticosteroid injection is a common nonoperative treatment for trigger finger, providing favorable outcomes but associated with a notable risk of recurrence. Numerous studies have explored the combined approach of percutaneous trigger finger release with corticosteroid injection. However, to date, there is no report on early postoperative results. Objective: To conduct a comparative analysis of early postoperative outcomes between percutaneous A1 pulley release with steroid injection and percutaneous A1 pulley release alone. Study Design \& Methods: This study constitutes a randomized controlled trial involving patients with trigger finger who underwent percutaneous release surgery from October 2023 to January 2024. A total of 38 patients were enrolled, with 18 assigned to the percutaneous A1 pulley release with steroid injection group and 20 to the percutaneous A1 pulley release alone group. Postoperative assessments included pain scores using the Visual Analog Scale (VAS), evaluation of quality of life through the QuickDASH score (qDASH), patient satisfaction, and complications.

Conditions

Trigger Finger; Percutaneous A1 Pulley Release; Steroid Injection; Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• postoperative pain score

  VAS(visual analog scale) from 0 to 10, 0 mean there is no pain, 10 there is the most pain in participants life

  post operative Day0 until 2 months

Secondary Outcomes (2)

• hand function by quickDASH

  post operative Day0 until 2 months

• patients satisfaction

  post operative Day0 until 2 months

Study Arms (2)

group1

EXPERIMENTAL

percutaneous A1 pulley release with Triamcinolone injection

Procedure: percutaneous A1 pulley release; Drug: Triamcinolone

group0

ACTIVE COMPARATOR

percutaneous A1 pulley release alone

Procedure: percutaneous A1 pulley release

Interventions

percutaneous A1 pulley release PROCEDURE

Treatment trigger finger by release A1 pulley by percutaneous procedure

group0; group1

Triamcinolone DRUG

Triamcinolone 40mg/ml 1 ml injection concomitant percutaneous A1 pulley release

group1

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• clinical diagnosis of trigger finger
• aged 18 years or older
• trigger finger are classified under Quinell's grade 2, 3, or 4

You may not qualify if:

• a history of prior hand surgery
• Dupuytren's disease
• type 1 diabetes
• previous phalangeal fractures
• recent steroid injection within the last month
• autoimmune diseases

Sponsors & Collaborators

• Police General Hospital, Thailand: lead

Study Sites (1)

Police General Hospital

Bangkok, Pathumwan, 10330, Thailand

Location

MeSH Terms

Conditions

Trigger Finger Disorder; Pain, Postoperative

Interventions

Triamcinolone

Condition Hierarchy (Ancestors)

Tendon Entrapment; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Group allocation and Randomization: Patients were enrolled and randomized into two groups, percutaneous A1 pulley release with steroid injection (Group A) and percutaneous A1 pulley release alone (Group B), by utilizing computer generate randomization and the results were put in opaque sealed envelopes. Informed consent was obtained from all participants, and surgeries were performed by the same surgeon (WJ).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopedic Resident

Model Details: Patients diagnosed with trigger finger, aged 18 years or older, and classified under Quinell's grade 2, 3, or 4, were included in the study \[ \]. Recruitment took place at the Outpatient Orthopedic Department of the Police General Hospital between October 2023 and January 2024. Exclusion criteria encompassed individuals with a history of prior hand surgery, Dupuytren's disease, type 1 diabetes, previous phalangeal fractures, recent steroid injection within the last month, and autoimmune diseases.

Study Record Dates

• First Submitted: February 17, 2024
• First Posted: March 1, 2024
• Study Start: October 11, 2023
• Primary Completion: January 23, 2024
• Study Completion: January 30, 2024
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: This may be from April 2024 until April 2029

Locations

TH (1)