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

ConditionsTrigger FingerShockwave Therapy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMahidol University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Trigger thumb

The patients who had received previous treatment (steroid injection, ESWT or surgical release)

Patients with local infections, malignancies, severe coagulopathy and pregnancy

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: ShockwaveExperimental treatment 1 intervention
Group B: SplintActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

100-mm. horizontal VAS score

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.

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

Secondary outcomes

1

QuickDASH score

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.

Time frame
at enrollment, fourth week, and sixth week after first intervention
2

Number of triggering

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

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mahidol University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: