CClinicalTrials.gg
RecruitingNCT06296017Updated Aug 5, 2026

Effectiveness of Conservative Interventions in the Treatment of Trigger Finger

An interventional study of Experimental: Extracorporeal Shock Wave Therapy and Trigger Finger Splint in Trigger Finger and Stenosing Tenosynovitis, sponsored by Hacettepe University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-05.

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

Phase
Not applicable
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Trigger Finger
  • Stenosing Tenosynovitis
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
54 participants (estimated)

Study arms

  • 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.

    Other: Experimental: Extracorporeal Shock Wave Therapy

  • Experimental
    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.

    Other: Trigger Finger Splint

  • Experimental
    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.

    Other: Extracorporeal Shock Wave Therapy+ Trigger Finger Splint

Interventions

  • OtherExperimental: 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.

  • OtherTrigger 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.

  • OtherExtracorporeal 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.

05

What researchers measure

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').

    Time frame: pre-treatment and post-treatment at 8 week

Secondary outcomes

  1. Grip and pinch strength

    Grip Strength Measurement: Standard, tip, lateral and tripod grip strengths will be performed in the test position standardized by the American Association of Hand Therapists. Jamar hand dynamometer and pinchmeter (Pro Med Products, Atlanta, GA, USA) will be used for evaluation. Grip strength will be measured at the 2nd position of the dynamometer. The evaluation will be made three times for each measurement and the average will be recorded in kg.

    Time frame: pre-treatment and post-treatment at 8 weeks

  2. Number of trigger

    Patients will be asked to open and close their hand ten times and the number of triggers will be recorded out of 10. If the patient's finger becomes locked at any time while making a full fist, they will be asked to stop and a score of 10/10 will be given.

    Time frame: pre-treatment and post-treatment at 8 weeks

  3. Functional assessment

    The Disabilities of the Arm, Shoulder and Hand Questionnaire: DASH contains thirty items regarding symptoms and activities of daily living. The total score is 100, with higher scores indicating more apology.

    Time frame: pre-treatment and post-treatment at 8 weeks

  4. Treatment satisfaction

    Roles and Maudsley Score is used to score treatment satisfaction level. The patient is asked to compare his/her pain level before and after treatment and to indicate whether he or she has benefited. 1. Excellent: I have no pain, I can do my movements and activities fully, I benefited from the treatment. 2. Good: I have some discomfort, but I can do my movements and activities fully, my complaints have decreased after the treatment. 3. Acceptable: My pain level has decreased compared to before the treatment, but I feel discomfort after long-term activities. I received little benefit from the treatment. 4. Bad: I cannot do activities due to my pain, I did not benefit from the treatment.

    Time frame: pre-treatment and post-treatment at 8 weeks

  5. Functional assessment

    Michigan Hand Outcomes Questionnaire: It consists of six subheadings: general hand function, ADL (unilateral and bilateral), work, pain, aesthetics and satisfaction. Subheadings are filled separately for right and left hands. The score for each title is calculated separately. It is normalized by calculating the percentage of raw scores obtained by summing the scores (0 to 100) given to each question. Higher scores indicate better functional level.

    Time frame: pre-treatment and post-treatment at 8 weeks

06

Study locations

1 of 1 sites recruiting
  • Feray Karademir
    Ankara, 06100, Turkey (Türkiye)
    Recruiting
07

References and documents

Publications

  • 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. PubMed 3385301 ↗
  • 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. PubMed 1880372 ↗
  • 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 ↗
  • 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. PubMed 17431449 ↗
  • Froimson A. Tenosynovitis and tennis elbow. Operative hand surgery. 1993:1989-2006.
  • 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.
  • 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 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT06296017
Lead sponsor
Hacettepe University
Responsible party
Feray Karademir (Principal Investigator, Hacettepe University) — Principal investigator
First posted
Mar 6, 2024
Start date
Oct 2, 2025
Primary completion
May 15, 2026
Completion
Aug 2027 (estimated)
Last update
Aug 5, 2026

Study contacts

Feray Karademir
Contact
karademirferay@gmail.com
+90 505 313 75 82
Tüzün Fırat
Contact
tuzun75@gmail.com
+90 312 305 25 25
Kadir ÇEVİK
study director · Etlik Şehir Hastanesi

Oversight

Data monitoring committee
No
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.

Contact study team

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