ClinicalTrials.gg
Enrolling by invitationNCT06737601SWinTFUpdated Jul 28, 2026

ESWT vs Orthosis in Trigger Finger

An interventional study of shock waves in Trigger Finger, sponsored by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari. Enrolling by invitation at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-28.

Sponsored by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Trigger Finger

Keywords

  • extracorporeal shock waves therapy
  • trigger finger
  • orthesis
  • conservative treatment
03

In context

Trigger Finger Disorder

93 studies on the registry are indexed under Trigger Finger Disorder; 22 are open to participants now.

This study's planned enrollment of 40 is below the median of 66 across 75 interventional studies indexed under Trigger Finger Disorder.

Browse Trigger Finger Disorder studies →

Lead sponsor

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari is the lead sponsor of 47 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Previous treatment via physiotherapy, local 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.
    • to treatment with ESWT: local infection; epilepsy; malignant tumor; inflammatory arthritis; cardiac arrhythmia or cardiac pacemaker; and pregnancy.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    ESWT group

    3 shock waves sessions, weekly, EDF 1500 pulses, 0.01-0,08 mJ/mm2 (Minilith SL1 Storz, Swiss)

    Device: shock waves

  • No intervention
    orthesis group

    use of metacarpophalangeal orthosis for 4-6 weeks

Interventions

  • Deviceshock waves

    three sessions, weekly frequency

06

What researchers measure

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."

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

Secondary outcomes

  1. Trigger frequency

    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).

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

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

    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

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

07

Study locations

1 site
08

References and documents

Publications

  • Quinnell RC. Conservative management of trigger finger. Practitioner. 1980 Feb;224(1340):187-90. No abstract available. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 15994689 ↗

Related links

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2025 (actual). Primary completion is estimated for Jan 2027, 13 months after the start.

Of 34 interventional studies with no phase under Trigger Finger Disorder, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 41. This study's planned 13 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 12, 2024
First posted
Dec 17, 2024
StartActual
Nov 15, 2025
Primary completionEst.
Jan 1, 2027
CompletionEst.
Jan 1, 2028
Last update
Jul 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06737601
Lead sponsor
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Responsible party
Sponsor
First posted
Dec 17, 2024
Start date
Nov 15, 2025
Primary completion
Jan 1, 2027 (estimated)
Completion
Jan 1, 2028 (estimated)
Last update
Jul 28, 2026

Study contacts

Giuseppe Solarino, M.D.
study director · University of Bari

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion