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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Trigger Finger; Stenosing Tenosynovitis
• Intervention / Treatment: Device: Focused Extracorporeal Shock Wave Therapy (ESWT); Device: physiotherapy

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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); 2000 impulses of 5 Hz and 0.32 mJ/mm2 , twice per week for 3 weeks
Active Comparator: Physiotherapy; therapeutic ultrasound, 12 times in 3 weeks	Device: physiotherapy; therapeutic ultrasound, 12 times in 3 weeks

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cheng-Hsin General Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2021
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): August 31, 2022

Study Registration Dates

• First Submitted: March 10, 2021
• First Submitted That Met QC Criteria: April 20, 2021
• First Posted (Actual): April 22, 2021

Study Record Updates

• Last Update Posted (Actual): July 25, 2022
• Last Update Submitted That Met QC Criteria: July 21, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: trigger finger; extracorporeal shock wave; stenosing tenosynovitis
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Muscular Diseases; Tendinopathy; Tenosynovitis; Trigger Finger Disorder; Tendon Entrapment
• Other Study ID Numbers: (811)109A-50

Drug and device information, study documents

• 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