Comparing two treatments for trigger finger
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
NA · Centre Hospitalier Departemental Vendee · NCT05045157
This study tests if a combination of a specific finger surgery and a steroid shot works better for adults with trigger finger than just the steroid shot alone.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Departemental Vendee (other) |
| Locations | 4 sites (Créteil and 3 other locations) |
| Trial ID | NCT05045157 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of percutaneous A1 pulley release under ultrasound guidance combined with corticosteroid injection compared to corticosteroid injection alone for treating trigger finger. Trigger finger is a condition characterized by pain and catching of the finger in a bent position, often requiring intervention after conservative treatments fail. The study aims to determine if the surgical approach provides better symptom resolution than repeated injections. Participants will be adults who have experienced trigger finger symptoms and have not responded to initial corticosteroid treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a diagnosed trigger finger that has not improved after an initial corticosteroid injection.
Not a fit: Patients with multiple symptomatic fingers or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could offer a more effective treatment option for patients suffering from trigger finger.
How similar studies have performed: Other studies have shown promising results with similar surgical techniques for trigger finger, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Créteil and 3 other locations
- Hopital Henri Mondor — Créteil, France (RECRUITING)
- CHD Vendée — La Roche-sur-Yon, France (RECRUITING)
- CHU Nantes — Nantes, France (RECRUITING)
- Hopital Lariboisière — Paris, France (RECRUITING)
Study contacts
- Principal investigator: Grégoire Cormier, Dr — CHD Vendée
- Study coordinator: Clémentin GABORIAU
- Email: clementin.gaboriau@ght85.fr
- Phone: 02 51 44 65 72
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Trigger Finger