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Enrolling by Invitation

NCT Number: NCT06737601

ESWT vs Orthosis in Trigger Finger

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.

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Key information

Conditions

Trigger Finger Muscular Diseases Musculoskeletal Diseases Tendinopathy Tendon Entrapment Trigger Finger Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Angela Notarnicola

Bari, 70124, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Shock waves

Device

three sessions, weekly frequency

Primary outcomes

  1. recovery of pain

    Time frame: From enrollment to 1, 3 and 6 months

    The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."

Secondary outcomes

  1. Trigger frequency

    Time frame: From enrollment to 1, 3 and 6 months

    A 0 to 10-point trigger finger rating scale to evaluate this parameter according to a previous study (Tarbhai et al., 2012). This scale is also used to evaluate the severity of the trigger (ST) and the functional impact of the trigger (FIT).

  2. Quick-Disabilities of the Arm, Shoulder, and Hand (QuickDASH)

    Time frame: From enrollment to 1, 3 and 6 months

    The QuickDASH measures the effect of finger problems on function in terms of pain and disability. The scores range from 0 to 100; the higher the score, the more limitation/pain/disability is present. The scores range from 0 to 100; the higher the score, the more limitation/pain/disability is present

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Other

Registry information

Official study title

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

Acronym: SWinTF

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Dec 17, 2024
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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