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WithdrawnNCT04855942Updated Jul 25, 2022

Focused Extracorporeal Shock Wave Therapy (ESWT) Versus Traditional Physiotherapy in the Treatment of Trigger Finger

An interventional study of Focused Extracorporeal Shock Wave Therapy (ESWT) and physiotherapy in Trigger Finger and Stenosing Tenosynovitis, sponsored by Cheng-Hsin General Hospital. Withdrawn. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-25.

Sponsored by Cheng-Hsin General Hospital · Not applicable, Interventional, and Treatment

Why this study was withdrawn
Due to the outbreak COVID-19 in our country, the patients coming to our hospital drastically decreased. We could hardly enroll participants due to the paucity of our patients for more than six months, so we decided to withdrawn this study.
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Trigger finger is the common name of stenosing tenosynovitis of fingers, caused by repetitive trauma. Conservative treatment includes NSAIDs or other analgesic agents, activity modification, splint, and physiotherapy. Operation could be considered if conservative treatments fails. With literature reviewed, there is no treatment which is both non-invasive and effective, and also could avoid recurrence well.

Extracorporeal shock wave therapy could induce angiogenesis, anti-inflammatory reaction, and recruitment of fibroblast. Although extracorporeal shock wave has been utilized in musculoskeletal diseases for more than twenty years, there is no well-designed clinical trial to prove the effectiveness of extracorporeal shock wave in treating trigger finger. The purpose of this study is to compare the effectiveness of extracorporeal shock wave therapy with traditional physical therapy for the management of trigger finger.

02

Conditions studied

  • Trigger Finger
  • Stenosing Tenosynovitis

Keywords

  • extracorporeal shock wave
  • trigger finger
  • stenosing tenosynovitis
03

In context

Trigger Finger Disorder

93 studies on the registry are indexed under Trigger Finger Disorder; 22 are open to participants now.

Browse Trigger Finger Disorder studies →

Lead sponsor

Cheng-Hsin General Hospital is the lead sponsor of 23 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Quinnel classification grade 2 or 3
  • who has only one trigger

Exclusion criteria

Exclusion Criteria:

  • who had ever treated the trigger finger
  • who has other musculoskeletal disease of the upper limb
  • who has severe coagulopathy disease
  • who is pregnant
  • who has arrhythmia or has a pacemaker
  • there is sensory impairment, scar, edema at the trigger finger
  • who has cognitive dysfunction
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Focused Extracorporeal Shock Wave Therapy (ESWT)

    2000 impulses of 5 Hz and 0.32 mJ/mm2 , twice per week for 3 weeks

    Device: Focused Extracorporeal Shock Wave Therapy (ESWT)

  • Active comparator
    Physiotherapy

    therapeutic ultrasound, 12 times in 3 weeks

    Device: physiotherapy

Interventions

  • DeviceFocused Extracorporeal Shock Wave Therapy (ESWT)

    2000 impulses of 5 Hz and 0.32 mJ/mm2 , twice per week for 3 weeks

  • Devicephysiotherapy

    therapeutic ultrasound, 12 times in 3 weeks

06

What researchers measure

Primary outcomes

  1. Quinnell stages of triggering

    Quinnell stages of triggering classifies the trigger finger using five types during flexion and extension: normal movement (Type 0), uneven movement (Type I), actively correctable (Type II), passively correctable (Type III) and fixed deformity (Type IV).

    Time frame: 15 weeks

  2. 11-point numeric scale of pain

    The 11-point numeric scale of pain requires the patient to rate their pain on a defined scale. 0 is no pain and 10 is the worst pain imaginable.

    Time frame: 15 weeks

  3. Chinese quick DASH (disabilities of the Arm, Shoulder, and Hand questionnaire)

    This questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The investigators chose the first two components: the disability and symptom section (11 items, scored 1-5). The lower score means better condition of upper limbs, and vice versa.

    Time frame: 15 weeks

  4. strength of hand grip

    The strength of hand grip is to measure the maximum isometric strength of the hand and forearm muscles by a electicial grip strength device.

    Time frame: 15 weeks

  5. sonographic image

    The investigators would record the characteristics of acquired sonographic images, such like the thickness of finger flexor tendon and A1 pulley, the presence of tendon sheath effusion, and the presence of increased vascularity by Doppler images.

    Time frame: 15 weeks

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for May 2021; primary completion for Dec 2021, 7 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 10, 2021
First posted
Apr 22, 2021
StartEst.
May 1, 2021
Primary completionEst.
Dec 31, 2021
CompletionEst.
Aug 31, 2022
Last update
Jul 25, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 25, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04855942
Lead sponsor
Cheng-Hsin General Hospital
Responsible party
Sponsor
First posted
Apr 22, 2021
Start date
May 1, 2021 (estimated)
Primary completion
Dec 31, 2021 (estimated)
Completion
Aug 31, 2022 (estimated)
Last update
Jul 25, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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