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NCT Number: NCT06296017

Effectiveness of Conservative Interventions in the Treatment of Trigger Finger

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.

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Key information

Conditions

Trigger Finger Muscular Diseases Musculoskeletal Diseases Stenosing Tenosynovitis Tendinopathy Tendon Entrapment Trigger Finger Disorder

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Feray Karademir

Ankara, 06100, Turkey (Türkiye)

Location status: Recruiting

Location contact

Feray Karademir

CONTACT

[email protected]

90 505 313 75 82

Feray Karademir

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Experimental: Extracorporeal Shock Wave Therapy

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

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

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.

Primary outcomes

  1. Visual analog scale

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

    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').

Secondary outcomes

  1. Grip and pinch strength

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

    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.

  2. Number of trigger

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

    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.

  3. Functional assessment

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

    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.

  4. Treatment satisfaction

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

    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.

    • Excellent: I have no pain, I can do my movements and activities fully, I benefited from the treatment.
    • Good: I have some discomfort, but I can do my movements and activities fully, my complaints have decreased after the treatment.
    • 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.
    • Bad: I cannot do activities due to my pain, I did not benefit from the treatment.

  5. Functional assessment

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Feray Karademir

CONTACT

[email protected]

+90 505 313 75 82

Tüzün Fırat

CONTACT

[email protected]

+90 312 305 25 25

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 6, 2024
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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