NCT06296017

Brief Summary

There is no study in the literature comparing the effectiveness of ESWT and splint therapy, which are the most commonly used approaches in the treatment of Trigger Finger (TF). The aim in this study is to investigate the effectiveness of ESWT and splint therapy used in the treatment of TF.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 2, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 14, 2024

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 6, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

September 9, 2025

Status Verified

September 1, 2025

Enrollment Period

2.3 years

First QC Date

February 14, 2024

Last Update Submit

September 2, 2025

Conditions

Trigger FingerStenosing Tenosynovitis

Outcome Measures

Primary Outcomes (1)

  • Visual analog scale

    The severity of pain felt by individuals at rest and during challenging activities will be evaluated using the Visual Analog Scale (VAS). The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').

    pre-treatment and post-treatment at 8 week

Secondary Outcomes (5)

  • Grip and pinch strength

    pre-treatment and post-treatment at 8 weeks

  • Number of trigger

    pre-treatment and post-treatment at 8 weeks

  • Functional assessment

    pre-treatment and post-treatment at 8 weeks

  • Treatment satisfaction

    pre-treatment and post-treatment at 8 weeks

  • Functional assessment

    pre-treatment and post-treatment at 8 weeks

Study Arms (3)

Extracorporeal Shock Wave Therapy

EXPERIMENTAL

Extracorporeal Shock Wave Therapy (ESWT for short) application will be performed on A1 pulley at 15 Hz, 1000 shock wave impulses, and 2.0 bar level, for a total of 5 sessions, one week apart.

Other: Experimental: Extracorporeal Shock Wave Therapy

Trigger Finger Splint

EXPERIMENTAL

A trigger finger splint that immobilizes the MCF joint will be recommended for the splint treatment group. The patient will be asked to use this splint throughout the day for 8 weeks.

Other: Trigger Finger Splint

Extracorporeal Shock Wave Therapy+Trigger Finger Splint

EXPERIMENTAL

Splint treatment will be applied together with ESWT. ESWT application will be performed on A1 pulley at 15 Hz, 1000 shock wave impulses, and 2.0 bar level, in a total of 5 sessions, one week apart. A trigger finger splint that immobilizes the MCF joint will be recommended for the splint treatment group. The patient will be asked to use this splint throughout the day for 8 weeks.

Other: Extracorporeal Shock Wave Therapy+ Trigger Finger Splint

Interventions

Experimental: Extracorporeal Shock Wave TherapyOTHER

Extracorporeal Shock Wave Therapy (ESWT for short) application will be performed on A1 pulley at 15 Hz, 1000 shock wave impulses, and 2.0 bar level, for a total of 5 sessions, one week apart.

Extracorporeal Shock Wave Therapy
Trigger Finger SplintOTHER

A trigger finger splint that immobilizes the MCF joint will be recommended for the splint treatment group. The patient will be asked to use this splint throughout the day for 8 weeks.

Trigger Finger Splint
Extracorporeal Shock Wave Therapy+ Trigger Finger SplintOTHER

Extracorporeal Shock Wave Therapy (ESWT for short) application will be performed on A1 pulley at 15 Hz, 1000 shock wave impulses, and 2.0 bar level, for a total of 5 sessions, one week apart. Also, A trigger finger splint that immobilizes the MCF joint will be recommended.

Extracorporeal Shock Wave Therapy+Trigger Finger Splint

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Volunteering
  • Being between the ages of 18-65
  • Being diagnosed with stage 1 or stage 2 (according to the Froimson classification) trigger finger
  • Having the language and cognitive skills to answer the questionnaires used in the evaluation

You may not qualify if:

  • Being pregnant
  • Having an inflammatory disorder
  • Having had surgery on the hand/wrist
  • Having a neurological disease
  • NSAIDs, painkillers, etc. being on medication
  • De Quervain's tenosynovitis, carpal tunnel syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Feray Karademir

Ankara, Ankara, 06100, Turkey (Türkiye)

RECRUITING

Related Publications (7)

  • Bonnici AV, Spencer JD. A survey of 'trigger finger' in adults. J Hand Surg Br. 1988 May;13(2):202-3. doi: 10.1016/0266-7681_88_90139-8.

    PMID: 3385301BACKGROUND

  • Sampson SP, Badalamente MA, Hurst LC, Seidman J. Pathobiology of the human A1 pulley in trigger finger. J Hand Surg Am. 1991 Jul;16(4):714-21. doi: 10.1016/0363-5023(91)90200-u.

    PMID: 1880372BACKGROUND

  • 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: 19468879BACKGROUND

  • Flatt AE. Notta's nodules and trigger digits. Proc (Bayl Univ Med Cent). 2007 Apr;20(2):143-5. doi: 10.1080/08998280.2007.11928272. No abstract available.

    PMID: 17431449BACKGROUND

  • Froimson A. Tenosynovitis and tennis elbow. Operative hand surgery. 1993:1989-2006.

    BACKGROUND

  • Alsancak S, Güner S, Bilgin S. Efficacy of splinting variations in two different treatment protocols in trigger thumb. JPO: Journal of Prosthetics and Orthotics. 2015;27(1):17-22.

    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: 26763271BACKGROUND

MeSH Terms

Conditions

Trigger Finger DisorderTendon Entrapment

Condition Hierarchy (Ancestors)

TendinopathyMuscular DiseasesMusculoskeletal Diseases

Study Officials

  • Kadir ÇEVİK

    Etlik Şehir Hastanesi

    STUDY DIRECTOR

Central Study Contacts

Feray Karademir

CONTACT

+90 505 313 75 82karademirferay@gmail.com

Tüzün Fırat

CONTACT

+90 312 305 25 25tuzun75@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 14, 2024

First Posted

March 6, 2024

Study Start

October 2, 2023

Primary Completion

January 1, 2026

Study Completion

February 1, 2026

Last Updated

September 9, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)