Focused Extracorporeal Shock Wave Therapy (ESWT) Versus Traditional Physiotherapy in the Treatment of Trigger Finger
Primary Purpose
Trigger Finger, Stenosing Tenosynovitis
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Focused Extracorporeal Shock Wave Therapy (ESWT)
physiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Trigger Finger focused on measuring extracorporeal shock wave, trigger finger, stenosing tenosynovitis
Eligibility Criteria
Inclusion Criteria:
- Quinnel classification grade 2 or 3
- who has only one trigger
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Focused Extracorporeal Shock Wave Therapy (ESWT)
Physiotherapy
Arm Description
2000 impulses of 5 Hz and 0.32 mJ/mm2 , twice per week for 3 weeks
therapeutic ultrasound, 12 times in 3 weeks
Outcomes
Primary Outcome Measures
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).
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04855942
First Posted
March 10, 2021
Last Updated
July 21, 2022
Sponsor
Cheng-Hsin General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04855942
Brief Title
Focused Extracorporeal Shock Wave Therapy (ESWT) Versus Traditional Physiotherapy in the Treatment of Trigger Finger
Official Title
Focused Extracorporeal Shock Wave Therapy (ESWT) Versus Traditional Physiotherapy in the Treatment of Trigger Finger: a Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Withdrawn
Why Stopped
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.
Study Start Date
May 1, 2021 (Anticipated)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
August 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cheng-Hsin General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trigger Finger, Stenosing Tenosynovitis
Keywords
extracorporeal shock wave, trigger finger, stenosing tenosynovitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Our study design is mainly to compare the therapeutic effect to trigger finger between extracorporeal shock wave (PiezoWave2 ECO, produced by Richard Wolf) and traditional physiotherapy.
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Focused Extracorporeal Shock Wave Therapy (ESWT)
Arm Type
Experimental
Arm Description
2000 impulses of 5 Hz and 0.32 mJ/mm2 , twice per week for 3 weeks
Arm Title
Physiotherapy
Arm Type
Active Comparator
Arm Description
therapeutic ultrasound, 12 times in 3 weeks
Intervention Type
Device
Intervention Name(s)
Focused Extracorporeal Shock Wave Therapy (ESWT)
Intervention Description
2000 impulses of 5 Hz and 0.32 mJ/mm2 , twice per week for 3 weeks
Intervention Type
Device
Intervention Name(s)
physiotherapy
Intervention Description
therapeutic ultrasound, 12 times in 3 weeks
Primary Outcome Measure Information:
Title
Quinnell stages of triggering
Description
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
Title
11-point numeric scale of pain
Description
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
Title
Chinese quick DASH (disabilities of the Arm, Shoulder, and Hand questionnaire)
Description
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
Title
strength of hand grip
Description
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
Title
sonographic image
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Quinnel classification grade 2 or 3
who has only one trigger
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
12. IPD Sharing Statement
Learn more about this trial
Focused Extracorporeal Shock Wave Therapy (ESWT) Versus Traditional Physiotherapy in the Treatment of Trigger Finger
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