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

Study Overview
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Brief Summary
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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.

Official Title
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Focused Extracorporeal Shock Wave Therapy (ESWT) Versus Traditional Physiotherapy in the Treatment of Trigger Finger: a Randomized Controlled Study

Conditions
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Trigger Finger, Stenosing Tenosynovitis

Intervention / Treatment
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* Device: Focused Extracorporeal Shock Wave Therapy (ESWT)
* Device: physiotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Focused Extracorporeal Shock Wave Therapy (ESWT)<br>2000 impulses of 5 Hz and 0.32 mJ/mm2 , twice per week for 3 weeks | Device: Focused Extracorporeal Shock Wave Therapy (ESWT)<br>* 2000 impulses of 5 Hz and 0.32 mJ/mm2 , twice per week for 3 weeks<br>|
| Active Comparator: Physiotherapy<br>therapeutic ultrasound, 12 times in 3 weeks | Device: physiotherapy<br>* therapeutic ultrasound, 12 times in 3 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 15 weeks | 
| 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. | 15 weeks | 
| 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. | 15 weeks | 
| 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. | 15 weeks | 
| 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. | 15 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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extracorporeal shock wave, trigger finger, stenosing tenosynovitis