ESWT vs Orthosis in Trigger Finger

NCT06737601 | Enrolling By Invitation DMC

• 1 other identifier: SWinTF
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Trigger Finger

Keywords

extracorporeal shock waves therapy; trigger finger; orthesis; conservative treatment

Outcome Measures

Primary Outcomes (1)

• recovery of pain

  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."

  From enrollment to 1, 3 and 6 months

Secondary Outcomes (2)

• Trigger frequency

  From enrollment to 1, 3 and 6 months

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

  From enrollment to 1, 3 and 6 months

Study Arms (2)

ESWT group

EXPERIMENTAL

3 shock waves sessions, weekly, EDF 1500 pulses, 0.01-0,05 mJ/mm2 (minilith Storz, Swiss)

Device: shock waves

orthesis group

NO INTERVENTION

use of metacarpophalangeal orthosis for 4-6 weeks

Interventions

shock waves DEVICE

three sessions, weekly frequency

ESWT group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari: lead

Study Sites (1)

Angela Notarnicola

Bari, 70124, Italy

Location

Related Publications (8)

• Quinnell RC. Conservative management of trigger finger. Practitioner. 1980 Feb;224(1340):187-90. No abstract available.

  PMID: 7367373 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Trigger Finger Disorder

Condition Hierarchy (Ancestors)

Tendon Entrapment; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases

Study Officials

• Giuseppe Solarino, M.D.

  University of Bari

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Given the nature of the therapy, it is not possible to blind the operators or patients. The medical staff responsible for collecting the disease scores, however, will be blind regarding the assignment of patients to one or the other group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: PROSPECTIVE RANDOMIZED CLINICAL TRIAL

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: December 17, 2024
• Study Start: November 15, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)