ClinicalTrials.gg
Not yet recruitingNCT06746974Updated Dec 24, 2024

Comparing the Effects of Extracorporeal Shockwave Therapy and Splinting in the Treatment of Trigger Finger

An interventional study of Shockwave and Splint in Trigger Finger and Shockwave Therapy, sponsored by Mahidol University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-24.

Sponsored by Mahidol University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2026, 4 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The goal of this study is to compare the effects of extracorporeal shockwave therapy and splinting in the treatment of trigger finger.

Participants will:

Be randomized into two groups (shockwave group and splint group). Visit the clinic once a week for four weeks for therapy. Keep a diary of their symptoms, which will be reviewed at six weeks.

02

Conditions studied

  • Trigger Finger
  • Shockwave Therapy

Keywords

  • trigger finger
  • shockwave
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 24 is below the median of 66 across 75 interventional studies indexed under Trigger Finger Disorder.

Browse Trigger Finger Disorder studies →

Lead sponsor

Mahidol University is the lead sponsor of 747 studies on the registry; 119 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

  • Patients age ≥ 18 years
  • Grade I-III trigger finger patients (patients who has the presence of tenderness over the A1 pulley or painful locking or triggering as they fixed and extended the finger)
  • Patients who consented to participation in the study

Exclusion criteria

Exclusion Criteria:

  • Trigger thumb
  • The patients who had received previous treatment ( injection, ESWT or surgical release)
  • Patients with local infections, , severe coagulopathy 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.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    Shockwave

    Device: Shockwave

  • Active comparator
    Splint

    Device: Splint

Interventions

  • DeviceShockwave

    In the Shockwave group, will be applied focused shockwaves therapy of 1500 impulses at 0.01 mJ/mm2 over the painful area or the pathologic flexor tendon to each participant under the supervision of a physiatrist. The ESWT will be conducted once weekly for 4 weeks with a sham splint (DIP joint blocking splints) for at least 8 hours per day for 6 weeks.

  • DeviceSplint

    In the splinting group, will be provided a PIP blocking splint at least 8 hours per day for 6 weeks with the sham shockwave (the patients close their eyes, extend their hand through a partition, apply shockwave device head with gel on the patient's finger, and play a mobile phone sound that mimics the sound of a real shockwave machine) once a week for 4 weeks.

06

What researchers measure

Primary outcomes

  1. 100-mm. horizontal VAS score

    The VAS or Visual Analog Scale is a scale that is used to evaluate the level of pain. It is represented by a horizontal line that is 100-mm. long. The score is determined by measuring the distance in mm. A higher score on this scale indicates greater pain intensity.

    Time frame: at enrollment, fourth week, and sixth week after first intervention

Secondary outcomes

  1. QuickDASH score

    The QuickDASH or Quick Disabilities of the Arm, Shoulder and Hand is a questionnaire that is used to evaluate the ability to perform activities of the arm, shoulder, and hand. It consists of 11 questions that patients are required to answer all of them. The answers are summarized in a range of 0-100, where a higher score indicates greater disability.

    Time frame: at enrollment, fourth week, and sixth week after first intervention

  2. Number of triggering

    The number of triggering events in ten active full fists will be scored out of ten. If a participant's finger remain locked at any time in making ten active full fists, they will be asked to stop and given a score of 10/10

    Time frame: at enrollment, fourth week, and sixth week after first intervention

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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 ↗
  • Nadar MS. Orthosis vs. exercise for the treatment of adult idiopathic trigger fingers: A randomized clinical trial. Prosthet Orthot Int. 2024 Dec 1;48(6):713-719. doi: 10.1097/PXR.0000000000000294. Epub 2023 Oct 20. PubMed 37870373 ↗
  • Teo SH, Ng DCL, Wong YKY. Effectiveness of proximal interphalangeal joint-blocking orthosis vs metacarpophalangeal joint-blocking orthosis in trigger digit management: A randomized clinical trial. J Hand Ther. 2019 Oct-Dec;32(4):444-451. doi: 10.1016/j.jht.2018.02.007. Epub 2018 Jul 18. PubMed 30030005 ↗
  • 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 ↗
  • Vahdatpour B, Momeni F, Tahmasebi A, Taheri P. The Effect of Extracorporeal Shock Wave Therapy in the Treatment of Patients with Trigger Finger. Open Access J Sports Med. 2020 Mar 9;11:85-91. doi: 10.2147/OAJSM.S232727. eCollection 2020. PubMed 32210646 ↗
  • Gil JA, Hresko AM, Weiss AC. Current Concepts in the Management of Trigger Finger in Adults. J Am Acad Orthop Surg. 2020 Aug 1;28(15):e642-e650. doi: 10.5435/JAAOS-D-19-00614. PubMed 32732655 ↗
  • 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 ↗

Individual participant data

Plan to share: No — Due to concerns about patient privacy, confidentiality, and ethical obligations

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06746974
Lead sponsor
Mahidol University
Responsible party
Sponsor
First posted
Dec 24, 2024
Start date
Jan 15, 2025 (estimated)
Primary completion
Jun 30, 2026 (estimated)
Completion
Nov 30, 2026 (estimated)
Last update
Dec 24, 2024

Study contacts

Apisara Keesukphan, M.D., MS.c.,
Contact
apisara.kee@mahidol.edu
6622011154

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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