ESWT vs Orthosis in Trigger Finger

Not Applicable

Not yet recruiting

• Conditions: Trigger Finger

• Registration Number: NCT06737601
• Lead Sponsor: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Brief Summary

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.

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-12
• Study First Submitted QC: 2024-12-12
• Study First Posted: 2024-12-17
• Last Update Submitted: 2024-12-18
• Last Update Posted: 2024-12-20
• Study Start: 2025-01-15
• Primary Completion: 2027-01-01
• Study Completion: 2028-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
recovery of pain	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 Outcome Measures

Name	Time	Method
Trigger frequency	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).
Quick-Disabilities of the Arm, Shoulder, and Hand (QuickDASH)	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