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

Not Applicable

Withdrawn

• Conditions: Trigger Finger; Stenosing Tenosynovitis
• Interventions: Device: Focused Extracorporeal Shock Wave Therapy (ESWT); Device: physiotherapy

• Registration Number: NCT04855942
• Lead Sponsor: Cheng-Hsin General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-10
• Study First Submitted QC: 2021-04-20
• Study First Posted: 2021-04-22
• Study Start: 2021-05-01
• Primary Completion: 2021-12-31
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-21
• Last Update Posted: 2022-07-25
• Study Completion: 2022-08-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Focused Extracorporeal Shock Wave Therapy (ESWT)	Focused Extracorporeal Shock Wave Therapy (ESWT)	2000 impulses of 5 Hz and 0.32 mJ/mm2 , twice per week for 3 weeks
Physiotherapy	physiotherapy	therapeutic ultrasound, 12 times in 3 weeks

Primary Outcome Measures

Name	Time	Method
Quinnell stages of triggering	15 weeks	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).
sonographic image	15 weeks	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.
11-point numeric scale of pain	15 weeks	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)	15 weeks	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	15 weeks	The strength of hand grip is to measure the maximum isometric strength of the hand and forearm muscles by a electicial grip strength device.