ESWT vs Orthosis in Trigger Finger

NCT ID: NCT06737601

Last Updated: 2025-07-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-15
• Study Completion Date: 2028-01-01

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.

Conditions

Trigger Finger

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

ESWT group

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

Group Type: EXPERIMENTAL

shock waves

Intervention Type: DEVICE

three sessions, weekly frequency

orthesis group

use of metacarpophalangeal orthosis for 4-6 weeks

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

shock waves

three sessions, weekly frequency

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Giuseppe Solarino, M.D.

Role: STUDY_DIRECTOR

University of Bari

Central Contacts

Angela Notarnicola, M.D.Ph.D.

Role: CONTACT

angelanotarnicola@yahoo.it

+390805592938

Ilaria Covelli, M.D.Ph.D.

Role: CONTACT

ilariacovelli@yahoo.it

0805592938

References

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

Reference Type: BACKGROUND

PMID: 7367373 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22189188 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34029555 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26763271 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24810861 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31106876 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19468879 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15994689 (View on PubMed)

Related Links

https://sitod.it/

Related Info

Other Identifiers

SWinTF

Identifier Type: -

Identifier Source: org_study_id