Effectiveness of Percutaneous Pulley Release With Infiltration, Versus Infiltration Alone in Trigger Finders (SECOIA)

Effectiveness of Percutaneous A1 Pulley Release Under Ultrasound Guidance Associated With Infiltration, Versus Infiltration Alone, in Patients With Trigger Finders Who Have Failed a First Infiltration: a Randomized Controlled Trial

Trigger finger is a mechanical problem characterized by pain and catching of digit in flexion.

Histological changes of A1 pulley and synovial proliferation have been identified as factors that prompt trigger finger The first-line treatment of trigger finger is conservative with splinting and corticosteroid injection.

If the first infiltration fails, either a second infiltration or surgical sectioning of the pulley is proposed.

Surgery can be performed by several techniques (open section, percutaneous section with palpatory guidance, or under ultrasound guidance).

Percutaneous A1 pulley release under ultrasound guidance consists of cutting the A1 pulley by a percutaneous insertion with small needle under local anaesthesia.

The hypothesis of the study is that percutaneous A1 pulley release under ultrasound guidance followed by a corticosteroid injection would be more effective than a second corticosteroid injection alone on complete resolution of the trigger finger symptoms

Study Overview

• Status: Active, not recruiting
• Conditions: Trigger Finger
• Intervention / Treatment: Procedure: Percutaneous A1 Pulley Release Under Ultrasound Guidance; Drug: Corticosteroid injection

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Créteil, France, 94000
    • Hopital Henri Mondor
  • La Roche-sur-Yon, France, 85925
    • CHD Vendée
  • Nantes, France, 44000
    • CHU Nantes
  • Paris, France, 75010
    • Hopital Lariboisière

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient ≥ 18 years old,
• Presence of a trigger finger (thumb or long fingers) to be treated
• Quinnell score >1
• Episode of trigger characterized on questioning or clinical examination
• Failure of a first corticosteroid infiltration > 3 months before inclusion
• First infiltration within 15 months of inclusion
• Thickening A1 pulley on ultrasound ≥ 0.5 mm
• Patient who has the capacity to understand the protocol and has given consent to participate in the research,
• Patient with social security coverage

Exclusion Criteria:

• Presence of several symptomatic fingers requiring treatment by ultrasound-guided section of the pulley
• Patient who are pregnant, breastfeeding, or who have the potential to become pregnant without effective contraception at the time of inclusion
• Known allergy to corticoid (Hydrocortancyl®) including its excipients ((benzyl alcohol, sodium carmellose, sodium chloride, polysorbate 80)
• Known allergies to lidocaine
• Ongoing anticoagulant treatments (AVK, New Oral Anti-Coagulants)
• Local or general infection, or suspicion of infection
• Live vaccines
• Evolving viruses (hepatitis, herpes, varicella, shingles)
• Severe or uncontrolled hypertension
• Unbalanced diabetes
• Underlying progressive cardiovascular disease
• Hemodialysis patients
• Prosthesis on the finger to be treated
• Echographic tendon fissure
• Inflammatory disease (rheumatoid arthritis, spondyloarthritis, connective tissue diseases, etc.) with tenosynovitis.
• History of surgery on the fingers
• Dupuytren's disease
• Patient participating in another interventional clinical research protocol involving a drug or medical device
• Patient under guardianship, curators or legal protection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: percutaneous A1 pulley release with corticosteroid injection	Procedure: Percutaneous A1 Pulley Release Under Ultrasound Guidance; the A1 pulley is cut off with Ultrasound guidance by a percutaneous insertion of the small needle under local anaesthesia.; Drug: Corticosteroid injection; corticosteroid injection is performed
Active Comparator: corticosteroid injection alone	Drug: Corticosteroid injection; corticosteroid injection is performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness of pulley section with ultrasound guidance combined with corticosteroid infiltration versus corticosteroid alone on complete resolution of trigger finger's symptoms	Trigger finger's symptoms defined by a clinical Quinnell score ≤1 without the use of an alternative therapy	1 year postoperatively

Collaborators and Investigators

• Sponsor: Centre Hospitalier Departemental Vendee
• Investigators: Principal Investigator: Grégoire Cormier, Dr, CHD Vendée

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2022
• Primary Completion (Actual): May 31, 2026
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: September 7, 2021
• First Submitted That Met QC Criteria: September 7, 2021
• First Posted (Actual): September 16, 2021

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Muscular Diseases; Tendinopathy; Tendon Entrapment; Trigger Finger Disorder; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Adrenal Cortex Hormones
• Other Study ID Numbers: CHD21_0024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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