Effectiveness of Conservative Interventions in the Treatment of Trigger Finger

NCT ID: NCT06296017

Last Updated: 2025-09-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-02
• Study Completion Date: 2026-02-28

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.

Detailed Description

Volunteer patients who were clinically diagnosed with trigger finger by consulting a doctor at Etlik City Hospital, Hand Surgery Clinic will be included in the randomized controlled prospective study. Patients will be randomly divided into three groups using the 'Random Sequence Generator tab' on Random.org, a randomization website, and different treatment programs will be applied. ESWT application to a group; splint treatment with ESWT to the second group; The third group will receive only splint treatment. ESWT application will be performed on A1 puley at 15 Hz, 1000 shock wave impuls and 2.0 bar level, for a total of 5 sessions, one week apart. In addition to ESWT with the same parameters, a trigger finger splint that immobilizes the MCP joint will be recommended to the ESWT and splint treatment group. The patient will be asked to use this splint throughout the day for 8 weeks. The Splint Group will be offered the same trigger finger splint and will be asked to use it throughout the day for 8 weeks. Evaluation and measurements will be repeated for all three groups before treatment, immediately after treatment (8th week) and 4 weeks after the end of treatment (12th week). The number of individuals to participate in the study was calculated as 54 in total, with 18 people in each group (ESWT Group, ESWT+ Splint Group and Splint Group), according to the power and sample size analysis based on 80% power and 5% Type 1 error rate. Power analysis was performed based on pain intensity as the clinical endpoint.

Conditions

Trigger Finger; Stenosing Tenosynovitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Extracorporeal Shock Wave Therapy

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.

Group Type: EXPERIMENTAL

Experimental: Extracorporeal Shock Wave Therapy

Intervention Type: OTHER

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.

Trigger Finger Splint

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.

Group Type: EXPERIMENTAL

Trigger Finger Splint

Intervention Type: OTHER

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.

Extracorporeal Shock Wave Therapy+Trigger Finger Splint

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.

Group Type: EXPERIMENTAL

Extracorporeal Shock Wave Therapy+ Trigger Finger Splint

Intervention Type: OTHER

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.

Interventions

Experimental: Extracorporeal Shock Wave Therapy

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.

Intervention Type: OTHER

Trigger Finger Splint

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.

Intervention Type: OTHER

Extracorporeal Shock Wave Therapy+ Trigger Finger Splint

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hacettepe University

OTHER

Sponsor Role: lead

Responsible Party

Feray Karademir

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kadir ÇEVİK

Role: STUDY_DIRECTOR

Etlik Şehir Hastanesi

Locations

Feray Karademir

Ankara, Ankara, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Feray Karademir

Role: CONTACT

karademirferay@gmail.com

+90 505 313 75 82

Tüzün Fırat

Role: CONTACT

tuzun75@gmail.com

+90 312 305 25 25

Facility Contacts

Feray Karademir

Role: primary

karademirferay@gmail.com

90 505 313 75 82

Feray Karademir

Role: backup

References

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.

Reference Type: BACKGROUND

PMID: 3385301 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 1880372 (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)

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.

Reference Type: BACKGROUND

PMID: 17431449 (View on PubMed)

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

Reference Type: 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.

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 26763271 (View on PubMed)

Other Identifiers

AEŞH- EK1- 2023-115

Identifier Type: -

Identifier Source: org_study_id