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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Withdrawn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
Cheng-Hsin General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trigger Finger focused on measuring extracorporeal shock wave, trigger finger, stenosing tenosynovitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    March 10, 2021
    Last Updated
    July 21, 2022
    Sponsor
    Cheng-Hsin General Hospital
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    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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