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NCT Number: NCT06746974

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

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

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

Treatment and study plan

Shockwave

Device

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.

Splint

Device

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.

Primary outcomes

  1. 100-mm. horizontal VAS score

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

    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.

Secondary outcomes

  1. QuickDASH score

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

    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.

  2. Number of triggering

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

    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

Study contacts

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

Apisara Keesukphan, M.D., MS.c.,

CONTACT

[email protected]

6622011154

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 24, 2024
Registry last updated
Dec 24, 2024

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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