NCT05045157

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
13mo left

Started May 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
May 2022May 2027

First Submitted

Initial submission to the registry

September 7, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 16, 2021

Completed
9 months until next milestone

Study Start

First participant enrolled

May 31, 2022

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2027

Last Updated

September 23, 2025

Status Verified

September 1, 2025

Enrollment Period

4 years

First QC Date

September 7, 2021

Last Update Submit

September 18, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

percutaneous A1 pulley release with corticosteroid injection

EXPERIMENTAL
Procedure: Percutaneous A1 Pulley Release Under Ultrasound GuidanceDrug: Corticosteroid injection

corticosteroid injection alone

ACTIVE COMPARATOR
Drug: Corticosteroid injection

Interventions

the A1 pulley is cut off with Ultrasound guidance by a percutaneous insertion of the small needle under local anaesthesia.

percutaneous A1 pulley release with corticosteroid injection

corticosteroid injection is performed

corticosteroid injection alonepercutaneous A1 pulley release with corticosteroid injection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • Presence of several symptomatic fingers requiring treatment by ultrasound-guided section of the pulley
  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hopital Henri Mondor

Créteil, 94000, France

RECRUITING

CHD Vendée

La Roche-sur-Yon, 85925, France

RECRUITING

CHU Nantes

Nantes, 44000, France

RECRUITING

Hopital Lariboisière

Paris, 75010, France

RECRUITING

MeSH Terms

Conditions

Trigger Finger Disorder

Interventions

Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Tendon EntrapmentTendinopathyMuscular DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

HormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Grégoire Cormier, Dr

    CHD Vendée

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2021

First Posted

September 16, 2021

Study Start

May 31, 2022

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

May 31, 2027

Last Updated

September 23, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations