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Enrolling by invitation NCT06737601

ESWT vs Orthosis in Trigger Finger

No phase Interventional Trigger Finger

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: shock waves.
Who it may be relevant to
Registry conditions: Trigger Finger. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

ESWT vs Orthosis in Trigger Finger Treatment: Prospective Randomized Clinical Study

Overview

Recently, two works have proposed the application of Extracorporeal Shock Waves Therapy (ESWT) in the treatment of trigger finger. Yildirim and colleagues (2016) compared shock waves with corticosteroid infiltration. both methods proved effective at 6 months. The authors suggested that shock wave treatment could be a valid non-invasive therapy option for this pathology. Chen and colleagues (2021) analyzed two different shock wave protocols \[high and low Energy Density Flux (EDF)\] vs placebo. All treatment groups showed improvements within 6 months. The high-energy treatment (EDF 0.01 mj/mm2) demonstrated greater effects on clinical remission and functional recovery compared to the other two groups in the study. The aim of our study is to compare the effects of shock waves vs the use of the orthosis.

Detailed description

Trigger finger, also called flexor digitorum stenosing tenosynovitis, is a pathological condition characterized by a size discrepancy between the flexor tendon/tendon sheath and the A1 pulley, located in the metacarpal head. This pathology causes pain and blockage of the flexion tendon of the finger, with a frequency of 2.6% in the general population, with a higher incidence in the female population, especially in the fifth and sixth decade. The 4th, 3rd and 1st fingers are most involved. trigger finger limits daily activities, such as grasping and holding objects with handles, manipulating coins and buttoning.

The diagnosis is based on the clinical history of transient locking of the finger when flexed with subsequent painful snapping when extended. The trigger phenomenon can be preceded by pain and joint stiffness. The instrumental study, with ultrasound and/or MRI, allows you to monitor the severity of the disease, identify the underlying cause and decide on the appropriate treatment. Surgical treatment should be reserved for those who do not respond to conservative treatment and desire definitive resolution.

A consensus was conducted to identify the consensus treatment guideline for trigger finger, including nonsteroidal anti-inflammatories, orthoses, corticosteroid infiltration and percutaneous release, and surgery. No evidence was found to support the use of nonsteroidal anti-inflammatory drugs. There has been evidence regarding the use of an orthosis, because by immobilizing the finger joint, it would prevent the occurrence of a trigger. Corticosteroid infiltration was effective, albeit with shorter-term effects than the orthosis, with high rates of relapses and exacerbations after 6 months. Surgical treatment is reserved for those who do not benefit from conservative therapy and need a definitive result.

Interventions

  • Device shock waves
    three sessions, weekly frequency

Primary outcome measures

  • recovery of pain [Time frame: From enrollment to 1, 3 and 6 months]
Secondary outcome measures (2)
  • Trigger frequency [Time frame: From enrollment to 1, 3 and 6 months]
  • Quick-Disabilities of the Arm, Shoulder, and Hand (QuickDASH) [Time frame: From enrollment to 1, 3 and 6 months]

Eligibility criteria

Inclusion criteria

  • Grade 2\~3 trigger finger according to Quinnell classification
  • problem that has been occurring for at least 3 months

Exclusion criteria

  • Previous treatment via physiotherapy, local corticosteroid injection or surgical release for trigger finger within 3 months prior to recruitment.
  • Presence of musculoskeletal disease or previous nerve injury to the upper extremities.
  • Multiple trigger finger.
  • contraindications to treatment with ESWT: local infection; epilepsy; malignant tumor; inflammatory arthritis; cardiac arrhythmia or cardiac pacemaker; and pregnancy.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Italy · 1 center
  • Angela Notarnicola — Bari

Publications

  • Quinnell RC. Conservative management of trigger finger. Practitioner. 1980 Feb;224(1340):187-90. No abstract available. PMID 7367373
  • Tarbhai K, Hannah S, von Schroeder HP. Trigger finger treatment: a comparison of 2 splint designs. J Hand Surg Am. 2012 Feb;37(2):243-9, 249.e1. doi: 10.1016/j.jhsa.2011.10.038. Epub 2011 Dec 20. PMID 22189188
  • Chen YP, Lin CY, Kuo YJ, Lee OK. Extracorporeal Shockwave Therapy in the Treatment of Trigger Finger: A Randomized Controlled Study. Arch Phys Med Rehabil. 2021 Nov;102(11):2083-2090.e1. doi: 10.1016/j.apmr.2021.04.015. Epub 2021 May 21. PMID 34029555
  • Yildirim P, Gultekin A, Yildirim A, Karahan AY, Tok F. Extracorporeal shock wave therapy versus corticosteroid injection in the treatment of trigger finger: a randomized controlled study. J Hand Surg Eur Vol. 2016 Nov;41(9):977-983. doi: 10.1177/1753193415622733. Epub 2016 Sep 28. PMID 26763271
  • Huisstede BM, Hoogvliet P, Coert JH, Friden J; European HANDGUIDE Group. Multidisciplinary consensus guideline for managing trigger finger: results from the European HANDGUIDE Study. Phys Ther. 2014 Oct;94(10):1421-33. doi: 10.2522/ptj.20130135. Epub 2014 May 8. PMID 24810861
  • Bianchi S, Gitto S, Draghi F. Ultrasound Features of Trigger Finger: Review of the Literature. J Ultrasound Med. 2019 Dec;38(12):3141-3154. doi: 10.1002/jum.15025. Epub 2019 May 20. PMID 31106876
  • Makkouk AH, Oetgen ME, Swigart CR, Dodds SD. Trigger finger: etiology, evaluation, and treatment. Curr Rev Musculoskelet Med. 2008 Jun;1(2):92-6. doi: 10.1007/s12178-007-9012-1. PMID 19468879
  • Akhtar S, Bradley MJ, Quinton DN, Burke FD. Management and referral for trigger finger/thumb. BMJ. 2005 Jul 2;331(7507):30-3. doi: 10.1136/bmj.331.7507.30. No abstract available. PMID 15994689

Identifiers

NCT: NCT06737601 · SWinTF

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗